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Alhuseinalkhudhur, Ali
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
Lubberink, Mark
Velikyan, Irina
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Preparative Medicinal Chemistry.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science.
Frejd, Fredrik
Feldwisch, Joachim
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology.
Sörensen, Jens
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
Kinetic Analysis of the HER2-binding ABY-025 Affibody Using Dynamic PET in Patients with Metastatic Breast Cancer2018In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 45, p. S457-S457Article in journal (Other academic)
Cazzaniga, Marina E.
ASST Monza, Phase 1 Trials Res Unit, Monza, MB, Italy; ASST Monza, Oncol Unit, Monza, MB, Italy; Milano Bicocca Sch Med, Monza, MB, Italy.
Ciruelos, E.
Ctr Integral Oncol Clara Campal HM CIOCC, Unidad Canc Mama, Madrid, Spain.
Fabi, A.
Regina Elena Inst Canc Res, Med Oncol, Rome, Italy.
Garcia-Saenz, J.
Hosp Clin San Carlos, ISCIII, IdISSC CIBERONC, Dept Med Oncol, Madrid, Spain.
Mavroudis, D.
Univ Hosp Heraklion, Dept Med Oncol, Iraklion, Crete, Greece.
Schem, C.
Mammazentrum, Hamburg, Germany.
Steger, G.
Med Univ Vienna, Dept Internal Med 1, Vienna, Austria.
Timotheadou, E.
Aristotle Univ Thessaloniki, Sch Med, Papageorgiou Gen Hosp, Thessaloniki, Greece.
Zaman, K.
Univ Hosp CHUV, Dept Oncol, Breast Ctr, Lausanne, Switzerland.
Torri, V.
Ist IRCCS Ist Mario Negri, Milan, Italy.
Metastatic or locally advanced breast cancer patients: towards an expert consensus on nab-paclitaxel treatment in HER2-negative tumoursthe MACBETH project2019In: Cancer Chemotherapy and Pharmacology, ISSN 0344-5704, E-ISSN 1432-0843, Vol. 83, no 2, p. 301-318Article in journal (Refereed)
Introduction: Despite the large use of nab-paclitaxel as a treatment option in metastatic breast cancer (MBC) across different countries, no definitive data are available in particular clinical situations.
Areas covered: Efficacy, safety and schedule issues concerning available literature on nab-paclitaxel in advanced breast cancer and in specific subgroups of patients have been discussed and voted during an International Expert Meeting. Ten expert specialists in oncology, with extensive clinical experience on Nab-P and publications in the field of MBC have been identified. Six scientific areas of interest have been covered, generating 13 specific Statements for Nab-P, after literature review. For efficacy issues, a summary of research quality was performed adopting the GRADE algorithm for evidence scoring. The panel members were invited to express their opinion on the statements, in case of disagreement all the controversial opinions and the relative motivations have been made public.
Expert opinion: Consensus was reached in 30.8% of the Nab-P statements, mainly those regarding safety issues, whereas ones regarding efficacy and schedule still remain controversial areas, requiring further data originated by the literature.
Ciray, Ipek
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Radiology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Oncology.
Åström, Gunnar
Bergh, J
Ahlström, Håkan
Early response of breast cancer bone metastases to chemotherapy evaluated with MR imaging2001In: Acta Radiologica, ISSN 0284-1851, E-ISSN 1600-0455, Vol. 42, no 2, p. 198-206Article in journal (Other academic)
To compare T1-weighted spin-echo and fat-suppressed long echo time inversion recovery turbo spin-echo (long TE IR-TSE) MR images in the evaluation of early response of breast cancer bone metastases to chemotherapy.
Eighteen breast cancer patients with known bone metastases were investigated prospectively by MR, using T1-weighted and long TE IR-TSE sequences on the sternum, spine, pelvis and proximal femora, before and after a median of 6 courses of chemotherapy. Therapeutic response evaluation with MR was based on change in tumor size assessed quantitatively by measuring all focal metastases, and change in pattern and signal intensity (SI) of the metastases, assessed visually. Combined response evaluation based on clinical findings, conventional radiography, and scintigraphy was used as reference.
Progressive disease (2 patients) and no change (4 patients) were assessed equally well on both MR sequences. Long TE IR-TSE demonstrated partial response with higher accuracy than T1-weighted images, 58% (7/12 patients) vs. 17% (2/12 patients). In patients without progression there was an SI increase in or around the metastases in 6 patients on T1-weighted images and in 7 patients on long TE IR-TSE images.
The long TE IR-TSE sequence demonstrated early partial response of breast cancer bone metastases to chemotherapy more accurately than the T1-weighted sequence.
4. Fredholm, H.
Magnusson, Kristina
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Molecular and Morphological Pathology. Uppsala University, Science for Life Laboratory, SciLifeLab.
Lindstrom, L. S.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences.
Eaker, Sonja
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery.
Bergh, J.
Pontén, Fredrik
Uppsala University, Science for Life Laboratory, SciLifeLab. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Molecular and Morphological Pathology.
Frisell, J.
Fredriksson, I.
Breast cancer in young women - age a risk factor only in those not given chemotherapy2014In: Breast, ISSN 0960-9776, E-ISSN 1532-3080, Vol. 23, no S1, p. S12-S12, article id HM31Article in journal (Other academic)
Fredholm, Hanna
Karolinska Inst, Dept Mol Med & Surg, Stockholm, Sweden.;Karolinska Univ Hosp, Dept Breast & Endocrine Surg, P9 03, SE-17176 Stockholm, Sweden..
Uppsala University, Science for Life Laboratory, SciLifeLab. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology.
Lindstrom, Linda S.
Karolinska Inst, Dept Biosci & Nutr, Stockholm, Sweden..
Tobin, Nicholas P.
Karolinska Inst, Dept Pathol & Oncol, Canc Ctr Karolinska, Stockholm, Sweden..
Bergh, Jonas
Karolinska Inst, Dept Pathol & Oncol, Canc Ctr Karolinska, Stockholm, Sweden.;Karolinska Oncol, Radiumhemmet, Karolinska Univ Hosp, Stockholm, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Endocrine Surgery. Regional Cancer Center, Uppsala University Hospital, Uppsala, Sweden.
Ponten, Fredrik
Uppsala University, Science for Life Laboratory, SciLifeLab. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Clinical and experimental pathology.
Frisell, Jan
Fredriksson, Irma
Breast cancer in young women and prognosis: How important are proliferation markers?2017In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 84, p. 278-289Article in journal (Refereed)
Compared to middle-aged women, young women with breast cancer have a higher risk of systemic disease. We studied expression of proliferation markers in relation to age and subtype and their association with long-term prognosis.
Distant disease-free survival (DDFS) was studied in 504 women aged <40 years and 383 women aged >= 40 years from a population-based cohort. Information on patient characteristics, treatment and follow-up was collected from medical records. Tissue microarrays were produced for analysis of oestrogen receptor, progesterone receptor (PR), Her2, Ki-67 and cyclins.
Young women with luminal tumours had significantly higher expression of Ki-67 and cyclins. Proliferation markers were prognostic only within this subtype. Ki-67 was a prognostic indicator only in young women with luminal PR+ tumours. The optimal cut-off for Ki-67 varied by age. High expression of cyclin E1 conferred a better DDFS in women aged <40 years with luminal PR- tumours (hazard ratio [HR] 0.47 [0.24-0.92]). Age < 40 years was an independent risk factor of DDFS exclusively in women with luminal B PR+ tumours (HR 2.35 [1.22-4.50]). Young women with luminal B PR- tumours expressing low cyclin E1 had a six-fold risk of distant disease compared with luminal A ( HR 6.21 [2.17-17.6]).
The higher expression of proliferation markers in young women does not have a strong impact on prognosis. Ki-67 is only prognostic in the subgroup of young women with luminal PR tumours. The only cyclin adding prognostic value beyond subtype is cyclin E1. Age is an independent prognostic factor only in women with luminal B PR+ tumours.
Frenzel, K.
BioNTech Grp Mainz, Mainz, Germany..
Heesen, L.
Bolte, S.
Bukur, V.
Diken, M.
TRON gGmbH, TRON, Mainz, Germany..
Derhovanessian, E.
Kreiter, S.
Kuhn, A.
Kuehlcke, K.
EUFETS GmbH, Idar Oberstein, Germany..
Löwer, M.
De Greve, J.
UZ Brussels, Dept Med & Mol Oncol, Brussels, Belgium..
Pascolo, S.
Univ Zurich, URPP Translat Canc Res, Zurich, Switzerland..
Schmidt, M.
Univ Med Mainz, Klin & Poliklin Geburtshilfe & Frauengesundheit, Mainz, Germany..
Schneeweiss, A.
NCT Heidelberg, Sekt Gynakol Onkol, Heidelberg, Germany..
Sjöblom, Tobias
Thielemans, K.
Univ Hosp Brussels, Dept Immunol Physiol, Brussels, Belgium..
Zitvogel, L.
Gustave Roussy Inst Cancerol, Tumour Immunol & Immunotherapy, Villejuif, France..
Tuereci, Ö.
CI3 Cluster Individualized Immunointervent, Mainz, Germany..
Sahin, U.
Mutanome engineered RNA immuno-therapy (MERIT) for patients with triple negative breast cancer2017In: Annals of Oncology, ISSN 0923-7534, E-ISSN 1569-8041, Vol. 28, no suppl 11Article in journal (Other academic)
Melin, Beatrice
Umeå Univ, Dept Radiat Sci, Umeå.
Enblad, Gunilla
Alafuzoff, Irina
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Clinical and experimental pathology.
Beskow, Anna H.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Urology.
Birgisson, Helgi
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Upper Abdominal Surgery.
Björ, Ove
Edqvist, Per-Henrik D
Hansson, Tony
Helleday, Thomas
Karolinska Inst, Div Translat Med & Chem Biol, Dept Med Biochem & Biophys, Sci Life Lab, Stockholm.
Hellman, Per
Henriksson, Kerstin
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology.
Hesselager, Göran
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Neurosurgery.
Hultdin, Magnus
Umeå Univ, Dept Med Biosci, Pathol, Umeå.
Häggman, Michael
Höglund, Martin
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Haematology.
Jonsson, Håkan
Larsson, Chatarina
Ljuslinder, Ingrid
Mindus, Stephanie
Akad Sjukhuset, Lung & Allergy Clin, Uppsala.
Nygren, Peter
Riklund, Katrine
Rosenquist, Richard
Sandin, Fredrik
Uppsala Univ Hosp, RCC Uppsala Örebro, Uppsala.
Schwenk, Jochen M.
KTH Royal Inst Technol, Sch Biotechnol, Affin Prote, SciLifeLab, Solna.
Stenling, Roger
Stålberg, Karin
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health.
Stålberg, Peter
Sundström, Christer
Thellenberg Karlsson, Camilla
Westermark, Bengt
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Neuro-Oncology.
Bergh, Anders
Claesson-Welsh, Lena
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Vascular Biology.
Palmqvist, Richard
U-CAN: a prospective longitudinal collection of biomaterials and clinical information from adult cancer patients in Sweden.2018In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 57, no 2, p. 187-194Article in journal (Refereed)
Background: Progress in cancer biomarker discovery is dependent on access to high-quality biological materials and high-resolution clinical data from the same cases. To overcome current limitations, a systematic prospective longitudinal sampling of multidisciplinary clinical data, blood and tissue from cancer patients was therefore initiated in 2010 by Uppsala and Umeå Universities and involving their corresponding University Hospitals, which are referral centers for one third of the Swedish population.
Material and Methods: Patients with cancer of selected types who are treated at one of the participating hospitals are eligible for inclusion. The healthcare-integrated sampling scheme encompasses clinical data, questionnaires, blood, fresh frozen and formalin-fixed paraffin-embedded tissue specimens, diagnostic slides and radiology bioimaging data.
Results: In this ongoing effort, 12,265 patients with brain tumors, breast cancers, colorectal cancers, gynecological cancers, hematological malignancies, lung cancers, neuroendocrine tumors or prostate cancers have been included until the end of 2016. From the 6914 patients included during the first five years, 98% were sampled for blood at diagnosis, 83% had paraffin-embedded and 58% had fresh frozen tissues collected. For Uppsala County, 55% of all cancer patients were included in the cohort.
Conclusions: Close collaboration between participating hospitals and universities enabled prospective, longitudinal biobanking of blood and tissues and collection of multidisciplinary clinical data from cancer patients in the U-CAN cohort. Here, we summarize the first five years of operations, present U-CAN as a highly valuable cohort that will contribute to enhanced cancer research and describe the procedures to access samples and data.
Hansson, Emma K.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Wallin, Johan
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology, Oncology.
Sandström, Marie
Karlsson, Mats O.
Friberg, Lena E.
Limited inter-occasion variability in relation to inter-individual variability in chemotherapy-induced myelosuppression2010In: Cancer Chemotherapy and Pharmacology, ISSN 0344-5704, E-ISSN 1432-0843, Vol. 65, no 5, p. 839-848Article in journal (Refereed)
Purpose: A previously developed semi-physiological model of chemotherapy-induced myelosuppression has shown consistent system-related parameter and inter-individual variability (IIV) estimates across drugs. A requirement for dose individualization to be useful is relatively low variability between treatment courses (IOV) in relation to IIV. The objective of this study was to evaluate and compare magnitudes of IOV and IIV in myelosuppression model parameters across six different anti-cancer drug treatments.Methods: Neutrophil counts from several treatment courses following therapy with docetaxel, paclitaxel, epirubicin-docetaxel, 5-fluorouracil-epirubicin-cyclophosphamide, topotecan and etoposide were included in the analysis. The myelosuppression model was fitted to the data using NONMEM VI. IOV in the model parameters baseline neutrophil counts (ANC0), mean transit time through the non-mitotic maturation chain (MTT) and the parameter describing the concentration-effect relationship (Slope) were evaluated for statistical significance (P < 0.001).Results: IOV in MTT was significant for all the investigated datasets, except for topotecan, and was of similar magnitude (8-16 CV %). IOV in Slope was significant for docetaxel, topotecan and etoposide (19-39 CV %). For all six investigated datasets the IOV in myelosuppression parameters was lower than the IIV. There was no indication of systematic shifts in the system- or drug sensitivity-related parameters over time across data sets.Conclusion: This study indicates that the semi-physiological model of chemotherapy-induced myelosuppression has potential to be used for prediction of the time-course of myelosuppression in future courses and is thereby a valuable step towards individually tailored anticancer drug therapy.
9. Hatschek, Thomas
Bjoehle, Judith
Lidbrink, Elisabet
Lekberg, Tobias
Loman, Niklas
Vaeppling, Anna von Wachenfeldt
Soederberg, Martin
Einbeigi, Zakaria
Carlsson, Lena
Loefgren, Lars
Ryden, Lisa
Hellstroem, Mats
Fernoe, Marten
Is pathologic complete response (pCR) a valid marker of outcome even in large breast cancer?: Clinical results from a neoadjuvant trial using a combination of epirubicin, docetaxel and bevacizumab (PROMIX)2015In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 75, no 9, article id P3-11-14Article in journal (Other academic)
Heesch, Sandra
BioNTech AG, Mainz, Germany..
Britten, Cedrik M.
BioNTech RNA Pharmaceut GmbH, Mainz, Germany..
Bukur, Valesca
Buck, Janina
Castle, John
TRON, Mainz, Germany..
Diekmann, Jan
Diken, Mustafa
Frenzel, Katrin
Kreiter, Sebastian
Kuhn, Andreas N.
Kuehlcke, Klaus
Loewer, Martin
Haas, Heinrich
Kemmer-Brueck, Alexandra
Kloke, Bjoern-Philipp
Otte, Burkhard
Paruzynski, Anna
Petri, Sebastian
Schwarck-Kokarakis, Doreen
Schmidt, Marcus
Univ Hosp, Mainz, Germany..
Andre, Fabrice
Gustave Roussy, Villejuif, France..
De Greve, Jacques
Vrije Univ Brussel, Brussels, Belgium..
Kuendig, Thomas
Univ Zurich Hosp, CH-8091 Zurich, Switzerland..
Pascolo, Steve
Thielemans, Kris
Zitvogel, Laurence
Gustave Roussy Comprehens Canc Ctr, Villejuif, France..
Tuereci, Oezlem
Johannes Gutenberg Univ Mainz, Univ Med Ctr, D-55122 Mainz, Germany..
Sahin, Ugur
The Mutanome Engineered RNA Immuno-Therapy (MERIT) project2015In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 75Article in journal (Other academic)
Fraser, Judith
Wildiers, Hans
Huovinen, Riikka
Utriainen, Meri
Villman, Kenneth K.
Halonen, Paivi
Granstam Björneklett, Helena
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, Centre for Clinical Research, County of Västmanland. Västerås Central Hospital, Västerås, Sweden.
Lundgren, Lotta
Yachnin, Jeffrey
Turpeenniemi-Hujanen, Taina
Ritchie, Diana
Huttunen, Teppo
Neven, Patric
Canney, Peter
Harvey, Vernon J.
Abstract GS3-04: A randomized phase III study of adjuvant trastuzumab for a duration of 9 weeks versus 1 year, combined with adjuvant taxane-anthracycline chemotherapy, for early HER2-positive breast cancer (the SOLD study)2018In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 78, no 4Article in journal (Other academic)
Joensuu, Heikki
Helsinki Univ Hosp, Dept Oncol, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland;Univ Helsinki, Haartmaninkatu 4,POB 180, FIN-00029 Helsinki, Finland.
Univ Hosp Leuven, Leuven, Belgium.
Turku Univ, Dept Oncol, Cent Hosp, Turku, Finland.
Kuopio Univ Hosp, Dept Oncol, Kuopio, Finland.
Paijat Hame Cent Hosp, Lahti, Finland.
Orebro Univ Hosp, Orebro, Sweden.
Granstam-Bjorneklett, Helena
Vasteras Hosp, Vasteras, Sweden.
Skane Univ Hosp, Lund, Sweden.
Sailas, Liisa
Vaasa Cent Hosp, Vaasa, Finland;North Carelia Cent Hosp, Joensuu, Finland.
Oulu Univ Hosp, Dept Radiotherapy & Oncol, Oulu, Finland.
Tampere Univ Hosp, Dept Oncol, Tampere, Finland.
Eskilstuna Hosp, Eskilstuna, Sweden.
Johansson, Oskar
Landspitali Univ Hosp, Reykjavik, Iceland.
4Pharma, Turku, Finland.
Neven, Patrick
Auckland City Hosp, Auckland, New Zealand.
Effect of Adjuvant Trastuzumab for a Duration of 9 Weeks vs 1 Year With Concomitant Chemotherapy for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer The SOLD Randomized Clinical Trial2018In: JAMA Oncology, ISSN 2374-2437, E-ISSN 2374-2445, Vol. 4, no 9, p. 1199-1206Article in journal (Refereed)
Importance: Trastuzumab plus chemotherapy is the standard adjuvant treatment for patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. While the standard duration of trastuzumab treatment is 12 months, the benefits and harms of trastuzumab continued beyond the chemotherapy are unclear.
Objective: To evaluate the efficacy and safety of adjuvant trastuzumab continued beyond chemotherapy in women treated with up-front chemotherapy containing a taxane and trastuzumab.
Design, Setting, and Participants: Open-label, randomized (1:1) clinical trial including women with HER2-positive breast cancer. Chemotherapy was identical in the 2 groups, consisting of 3 cycles of 3-weekly docetaxel (either 80 or 100 mg/m2) plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide. Thereafter, no trastuzumab was administered in the 9-week group, whereas controls received trastuzumab to complete 1 year of administration. Disease-free survival (DFS) was compared between the groups using a Cox model and the noninferiority approach. The estimated sample size was 2168 patients (1-sided testing, with a relative noninferiority margin of 1.3). From January 3, 2008, to December 16, 2014, 2176 patients were accrued from 7 countries.
Intervention: Docetaxel plus trastuzumab for 9 weeks, followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide in both groups. Controls continued trastuzumab to 1 year.
Main Outcomes and Measures: The primary objective was DFS; secondary objectives included distant disease–free survival, overall survival, cardiac DFS, and safety.
Results: In the 2174 women analyzed, median age was 56 (interquartile range [IQR], 48-64) years. The median follow-up was 5.2 (IQR, 3.8-6.7) years. Noninferiority of the 9-week treatment could not be demonstrated for DFS (hazard ratio, 1.39; 2-sided 90% CI, 1.12-1.72). Distant disease–free survival and overall survival did not differ substantially between the groups. Thirty-six (3%) and 21 (2%) patients in the 1-year and the 9-week groups, respectively, had cardiac failure; the left ventricle ejection fraction was better maintained in the 9-week group. An interaction was detected between the docetaxel dose and DFS; patients in the 9-week group treated with 80 mg/m2 had inferior and those treated with 100 mg/m2 had similar DFS as patients in the 1-year group.
Conclusions and Relevance: Nine weeks of trastuzumab was not noninferior to 1 year of trastuzumab when given with similar chemotherapy. Cardiac safety was better in the 9-week group. The docetaxel dosing with trastuzumab requires further study.
Trial Registration: ClinicalTrials.gov Identifier: NCT00593697
Univ Helsinki, Haartmaninkatu 4,PO 180, FIN-00029 Helsinki, Finland.;Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland..
Tampere Univ Hosp, Dept Oncol, Tampere, Finland.;Univ Tampere, Tampere, Finland..
Turku Univ, Dept Oncol, Cent Hosp, Turku, Finland..
Oulu Univ Hosp, Dept Oncol & Radiotherapy, Oulu, Finland..
Kanta Hame Cent Hosp, Hameenlinna, Finland..
Gavle Cent Hosp, Gavle, Sweden..
Kuopio Univ Hosp, Canc Ctr, Kuopio, Finland..
Lahdenpera, Outi
Kosonen, Sanna
Kotka Cent Hosp, Kotka, Finland..
Orebro Univ Hosp, Orebro, Sweden..
Paijat Hame Cent Hosp, Lahti, Finland..
Poikonen-Saksela, Paula
Kuopio Univ Hosp, Canc Ctr, Kuopio, Finland.;Vaasa Cent Hosp, Vaasa, Finland..
Junnila, Jouni
4Pharma, Turku, Finland..
Adjuvant Capecitabine in Combination With Docetaxel, Epirubicin, and Cyclophosphamide for Early Breast Cancer: The Randomized Clinical FinXX Trial2017In: JAMA Oncology, ISSN 2374-2437, E-ISSN 2374-2445, Vol. 3, no 6, p. 793-800Article in journal (Refereed)
IMPORTANCE Capecitabine is not considered a standard agent in the adjuvant treatment of early breast cancer. The results of this study suggest that addition of adjuvant capecitabine to a regimen that contains docetaxel, epirubicin, and cyclophosphamide improves survival outcomes of patients with triple-negative breast cancer (TNBC).
OBJECTIVE To investigate the effect of capecitabine on long-term survival outcomes of patients with early breast cancer, particularly in subgroups defined by cancer estrogen receptor (ER) and progesterone receptor (PR) content, and HER2 content (human epidermal growth factor receptor 2).
DESIGN, SETTING, AND PARTICIPANTS This is an exploratory analysis of the multicenter FinXX randomized clinical trial that accrued 1500 women in Finland and Sweden between January 27, 2004, and May 29, 2007. About half received 3 cycles of docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and fluorouracil (T+CEF), while the other half received 3 cycles of docetaxel plus capecitabine followed by 3 cycles of cyclophosphamide, epirubicin, and capecitabine (TX+CEX). Data analysis took place between January 27, 2004, and December 31, 2015.
MAIN OUTCOMES AND MEASURES Recurrence-free survival (RFS).
RESULTS Following random allocation, 747 women received T+CEF, and 753 women received TX+CEX. Five patients were excluded from the intention-to-treat population (3 had overt distant metastases at the time of randomization; 2 withdrew consent). The median age of the remaining 1495 patients was 53 years at the time of study entry; 157 (11%) had axillary node-negative disease; 1142 (76%) had ER-positive cancer; and 282 (19%) had HER2-positive cancer. The median follow-up time after random allocation was 10.3 years. There was no significant difference in RFS or overall survival between the groups (hazard ratio [HR], 0.88; 95% CI, 0.71-1.08; P = .23; and HR, 0.84, 95% CI, 0.66-1.07; P = .15; respectively). Breast cancer-specific survival tended to favor the capecitabine group (HR, 0.79; 95% CI, 0.60-1.04; P = .10). When RFS and survival of the patients were compared within the subgroups defined by cancer steroid hormone receptor status (ER and/or PR positive vs ER and PR negative) and HER2 status (positive vs negative), TX+CEX was more effective than T+CEF in the subset of patients with TNBC (HR, 0.53; 95% CI, 0.31-0.92; P = .02; and HR, 0.55, 95% CI, 0.31-0.96; P = .03; respectively).
CONCLUSIONS AND RELEVANCE Capecitabine administration with docetaxel, epirubicin, and cyclophosphamide did not prolong RFS or survival compared with a regimen that contained only standard agents. Patients with TNBC had favorable survival outcomes when treated with the capecitabine-containing regimen in an exploratory subgroup analysis.
Adjuvant Capecitabine, Docetaxel, Cyclophosphamide, and Epirubicin for Early Breast Cancer: Final Analysis of the Randomized FinXX Trial2012In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 30, no 1, p. 11-18Article in journal (Refereed)
Purpose: Capecitabine is an active agent in the treatment of breast cancer. It is not known whether integration of capecitabine into an adjuvant regimen that contains a taxane, an anthracycline, and cyclophosphamide improves outcome in early breast cancer.
Patients and Methods: Women with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive either three cycles of docetaxel and capecitabine (TX) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX; n = 753) or three cycles of docetaxel (T) followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF; n = 747). The primary end point was recurrence-free survival (RFS).
Results: During a median follow-up time of 59 months, 214 RFS events occurred (local or distant recurrences or deaths; TX/CEX, n = 96; T/CEF, n = 118). RFS was not significantly different between the groups (hazard ratio [HR], 0.79; 95% CI, 0.60 to 1.04; P = .087; 5-year RFS, 86.6% for TX/CEX v 84.1% for T/CEF). Fifty-six patients assigned to TX/CEX died during the follow-up compared with 75 of patients assigned to T/CEF (HR, 0.73; 95% CI, 0.52 to 1.04; P = .080). In exploratory analyses, TX/CEX improved breast cancer-specific survival (HR, 0.64; 95% CI, 0.44 to 0.95; P = .027) and RFS in women with triple-negative disease and in women who had more than three metastatic axillary lymph nodes at the time of diagnosis. We detected little severe late toxicity.
Conclusion: Integration of capecitabine into a regimen that contains docetaxel, epirubicin, and cyclophosphamide did not improve RFS significantly compared with a similar regimen without capecitabine.
Saarni, Outi
Outcome of patients with HER2-positive breast cancer treated with or without adjuvant trastuzumab in the Finland Capecitabine Trial (FinXX)2014In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 53, no 2, p. 186-194Article in journal (Refereed)
Little information is available about survival outcomes of patients with HER2-positive early breast cancer treated with adjuvant capecitabine-containing chemotherapy with or without trastuzumab.
One thousand and five hundred patients with early breast cancer were entered to the Finland Capecitabine trial (FinXX) between January 2004 and May 2007, and were randomly assigned to receive either three cycles of adjuvant TX (docetaxel, capecitabine) followed by three cycles of CEX (cyclophosphamide, epirubicin, capecitabine; TX-CEX) or three cycles of docetaxel followed by three cycles of CEF (cyclophosphamide, epirubicin, fluorouracil; T-CEF). The primary endpoint was recurrence-free survival (RFS). The study protocol was amended in May 2005 while study accrual was ongoing to allow adjuvant trastuzumab for patients with HER2-positive cancer. Of the 284 patients with HER2-positive cancer accrued to FinXX, 176 (62.0%) received trastuzumab after amending the study protocol, 131 for 12 months and 45 for nine weeks. The median follow-up time was 6.7 years.
Patients with HER2-positive cancer who received trastuzumab had better RFS than those who did not (five-year RFS 89.2% vs. 75.9%; HR 0.41, 95% CI 0.23 -0.72; p = 0.001). Patients treated with trastuzumab for 12 months or nine weeks had similar RFS. There was no significant interaction between trastuzumab administration and the type of chemotherapy. Four (2.3%) patients treated with trastuzumab had heart failure or left ventricular dysfunction, three of these received capecitabine.
Adjuvant trastuzumab improves RFS of patients treated with TX-CEX or T-CEF. Few patients had cardiac failure.
Helsinki Univ Hosp, Dept Oncol, Helsinki, Finland.;Univ Helsinki, Haartmaninkatu 4,PO 180, FIN-00029 Helsinki, Finland..
Taxane Followed by Anthracycline or Vice Versa: Impact of Sequential Order on Breast Cancer Recurrence? Reply2018In: JAMA Oncology, ISSN 2374-2437, E-ISSN 2374-2445, Vol. 4, no 3, p. 423-424Article in journal (Other academic)
Karlsson, Katarina
KI.
Wallenius, Imke
Nilsson-Wikmar, Lena
Johansson, Birgitta
Lymphoedema and health-related quality of life by early treatment in long-term survivors of breast cancer. A comparative retrospective study up to 15 years after diagnosis2015In: Supportive Care in Cancer, ISSN 0941-4355, E-ISSN 1433-7339, Vol. 23, no 10, p. 2965-2972Article in journal (Refereed)
Purpose The purpose was to compare progression/regression of arm lymphoedema, health-related quality of life and medical background data among women who discontinued their treatment (non-continued treatment group, NCTG) with these factors among women who continued treatment (continued treatment group, CTG).
Methods Seventy-two women were included in the NCTG and 58 women in the CTG. Women in the NCTG were invited to an examination and measurement of affected arm volume at the clinic in 2008. Medical background data and arm volume values, measured using the water displacement method, were collected from patient records and the Breast Cancer Quality Register of the Uppsala Örebro Region. The functional assessment of cancer therapy for breast cancer (FACT-B) was used to assess health-related quality of life in both groups.
Results There were no differences with regard to progression/regression of arm lymphoedema or health-related quality of life. The CTG had experienced more advanced disease and received more extensive surgical and oncological treatment. The CTG had significantly larger arm volume due to lymphoedema at diagnosis (mean 422 ml) compared to the NCTG (mean 283 ml; p < 0.001), and at the last visit at the clinic (CTG mean 414 ml versus NCTG mean 239 ml; p < 0.001).
Conclusions The results indicate that there might be a spontaneous regression of lymphoedemas in the NCTG but there is a need for more research to make it possible to draw firm conclusions regarding this.
Andersson, M.
Rigshosp, Dept Oncol, Copenhagen, Denmark.
Ahlgren, J.
Gavle Cent Hosp, Dept Oncol, Gavle, Sweden;Orebro Univ Hosp, Dept Oncol, Orebro, Sweden.
Balslev, E.
Herlev Hosp, Dept Oncol, Herlev, Denmark.
Sverrisdottir, A.
Soder Sjukhuset, Dept Oncol, Stockholm, Sweden;Landspitali, Dept Oncol, Reykjavik, Iceland.
Holmberg, S. B.
Dept Surg, Molndal, Sweden.
Bengtsson, N. O.
Umea Univ Hosp, Dept Oncol, Umea, Sweden.
Jacobsen, E. H.
Vejle Hosp, Dept Oncol, Vejle, Denmark.
Jensen, A. B.
Hansen, J.
Vasteras Hosp, Dept Oncol, Vasteras, Sweden;Aalborg Univ Hosp, Dept Oncol, Aalborg, Denmark.
Tuxen, M. K.
Malmberg, L.
Karlstad Hosp, Dept Oncol, Karlstad, Sweden;Boras Hosp, Dept Oncol, Boras, Sweden.
Villman, K.
Orebro Univ Hosp, Dept Oncol, Orebro, Sweden.
Anderson, H.
Lund Univ, Dept Clin Sci, Div Canc Epidemiol, Lund, Sweden.
Ejlertsen, B.
Karolinska Univ Hosp, Karolinska Inst, Radiumhemmet, Stockholm, Sweden.
Blomqvist, C.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology. Orebro Univ Hosp, Dept Oncol, Orebro, Sweden.
A randomised study of tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy for early breast cancer (SBG 2000-1)2018In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 94, p. 79-86Article in journal (Refereed)
Study aim: Retrospective studies have demonstrated a worse outcome in breast cancer patients not developing leukopenia during adjuvant chemotherapy. The SBG 2000-1 is the first randomised trial designed to compare individually dosed chemotherapy without G-CSF support based on grade of toxicity to standard-dosed chemotherapy based on body surface area (BSA). Methods: Patients with early breast cancer were included and received the first cycle of standard FEC (fluorouracil 600 mg/m(2), epirubicin 60 mg/m(2), cyclophosphamide 600 mg/m2). Patients with nadir leukopenia grade 0-2 after first cycle were randomised between either 6 additional courses of tailored FEC with increased doses (E 75-90 mg/m(2), C 900-1200 mg/m(2)) or fixed treatment with 6 standard FEC. Patients with grade 3-4 leukopenia were registered and treated with 6 standard FEC. Primary end-point was distant disease-free survival (DDFS). Results: The study enrolled 1535 patients, of which 1052 patients were randomised to tailored FEC (N = 524) or standard FEC (N = 528), whereas 401 patients with leukopenia grade 3-4 continued standard FEC and formed the registered cohort. Dose escalation did not statistically significantly improve 10-year DDFS (79% and 77%, HR 0.87, CI 0.67-1.14, P = 0.32) or OS (82% and 78%, respectively, HR 0.89, CI 0.57e1.16, P = 0.38). Corresponding estimates for the registered group of patients were DDFS 79% and OS 82%, respectively. Conclusions: The SBG 2000-1 study failed to show a statistically significant improvement of escalated and tailored-dosed chemotherapy compared with standard BSA-based chemotherapy in patients with low haematological toxicity, although all efficacy parameters showed a numerical advantage for tailored treatment.
Haji, A.
The development of the metastatic site pattern during time in different subtypes of breast cancer2016In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 76Article in journal (Other academic)
Apoteket Hjartat, Dept Oncol, Uppsala, Sweden..
Jernling, M.
Akad Sjuhuset, Dept Oncol, Uppsala, Sweden..
Schiza, Aglaia
Evidence on the occurrence of brain metastases amongst deceased metastatic breast cancer patients from an Uppsala county disease registry2018In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 92, p. S118-S118Article in journal (Other academic)
Nilsson, A.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences.
Gullbo, Joachim
Clinical characteristics of CNS metastases of different breast cancer subtypes - Results from a cohort study2017In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 77Article in journal (Refereed)
Wennborg, Anders
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Preclinical PET Platform. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
Sandberg, Dan
Olofsson, Helena
Sandström, Mattias
Carlsson, Jörgen
Non-invasive determination of HER2-expression in metastatic breast cancer by using Ga-68-ABY025 PET/CT.2015In: Journal of Clinical Oncology, ISSN 0732-183X, E-ISSN 1527-7755, Vol. 33, no 15Article in journal (Other academic)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm , Centre for Research and Development, Gävleborg.
Blomqvist, Carl
Individually tailored toxicity-based 5-fluorouracil, epirubicin and cyclophosphamide (FEC) therapy of metastatic breast cancer2007In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 46, no 2, p. 165-171Article in journal (Refereed)
Chemotherapy dosing only based on body surface area (BSA) results in marked pharmacokinetic and toxicity variations, which may result in an inferior outcome for some patients. A toxicity-based dosing schedule for individually tailored treatment with granulocyte colony-stimulating factor (G-CSF) supported 5-fluorouracil (F), epirubicin (E) and cyclophosphamide (C) (dFEC) was developed and studied in patients with metastatic breast cancer with the purpose to determine its efficiency and toxicity. Twenty-six women, median age 48 years, were included and the individual E and C doses were tailored stepwise based on the recorded hematological toxicity. Twenty-one patients (81%; 95% confidence interval (CI), 66% to 96%) had an objective response, including six complete responses (23%; CI, 7%-39%). At median follow-up of 113 months, the median time to progression and median overall survival were 14 and 36 months, respectively. The delivered dose intensity was high but varied substantially between patients (ranges F 126-202, E 14.4-36.0, C 160-510 mg/m2/w). The dominating grade III/IV toxicity was nausea (12% of patients) and febrile neutropenia (31% of patients). The tailored and dose-escalated FEC was highly active and feasible in metastatic breast cancer and may provide a pragmatic way of overcoming the shortcomings of standard BSA-based dosing.
24. Loman, N.
Linderholm, B.
Joensuu, H.
Johannsson, O. T.
Geisler, J.
Bendahl, P-O
Nordic trip, a randomized phase 3 study in early triple negative breast cancer2016In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 76Article in journal (Other academic)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Section of Nuclear Medicine and PET.
Lindskog, K.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Medical Radiation Sciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Biomedical Radiation Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
Wennborg, A.
Feldwisch, J.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Section of Nuclear Medicine and PET. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology.
Olofsson, H.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Biomedical Radiation Sciences.
Radiation dosimetry and tracer kinetic analysis of Ga-68-ABY025 Affibody in breast cancer patients2014In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 41, no S2, p. S292-S293, article id OP606Article in journal (Other academic)
Lundgren, Christine
Dept Oncol, Jonkoping, Region Jonkopin, Sweden;Linkoping Univ, Dept Clin & Expt Med, Linkoping, Sweden;Lund Univ, Div Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden.
Bendahl, Pär-Ola
Lund Univ, Div Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden.
Borg, Åke
Ehinger, Anna
Hegardt, Cecilia
Larsson, Christer
Lund Univ, Div Translat Canc Res, Dept Lab Med Lund, Lund, Sweden.
Lund Univ, Div Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden;Skane Univ Hosp, Dept Hematol Oncol & Radiat Phys, Lund, Sweden.
Malmberg, Martin
Saal, Lao H.
Klintman, Marie
Häkkinen, Jari
Vallon-Christersson, Johan
Fernö, Mårten
Rydén, Lisa
Lund Univ, Div Surg, Dept Clin Sci Lund, Lund, Sweden.
Ekholm, Maria
Agreement between molecular subtyping and surrogate subtype classification: a contemporary population-based study of ER-positive/HER2-negative primary breast cancer2019In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217, Vol. 178, no 2, p. 459-467Article in journal (Refereed)
Purpose: Oestrogen receptor-positive (ER+) and human epidermal receptor 2-negative (HER2-) breast cancers are classified as Luminal A or B based on gene expression, but immunohistochemical markers are used for surrogate subtyping. The aims of this study were to examine the agreement between molecular subtyping (MS) and surrogate subtyping and to identify subgroups consisting mainly of Luminal A or B tumours.
Methods: The cohort consisted of 2063 patients diagnosed between 2013-2017, with primary ER+/HER2- breast cancer, analysed by RNA sequencing. Surrogate subtyping was performed according to three algorithms (St. Gallen 2013, Maisonneuve and our proposed Grade-based classification). Agreement (%) and kappa statistics (kappa) were used as concordance measures and ROC analysis for luminal distinction. Ki67, progesterone receptor (PR) and histological grade (HG) were further investigated as surrogate markers.
Results: The agreement rates between the MS and St. Gallen 2013, Maisonneuve and Grade-based classifications were 62% (kappa = 0.30), 66% (kappa = 0.35) and 70% (kappa = 0.41), respectively. PR did not contribute to distinguishing Luminal A from B tumours (auROC = 0.56). By classifying HG1-2 tumours as Luminal A-like and HG3 as Luminal B-like, agreement with MS was 80% (kappa = 0.46). Moreover, by combining HG and Ki67 status, a large subgroup of patients (51% of the cohort) having > 90% Luminal A tumours could be identified.
Conclusions: Agreement between MS and surrogate classifications was generally poor. However, a post hoc analysis showed that a combination of HG and Ki67 could identify patients very likely to have Luminal A tumours according to MS.
Ryhov Cty Hosp, Dept Oncol, Jonkoping, Sweden;Lund Univ, Dept Clin Sci Lund, Div Oncol & Pathol, Bldg 406,Scheelevagen 8, SE-22363 Lund, Sweden.
Rolander, Bo
Acad Hlth & Care, Futurum, Reg Jonkoping Cty, Jonkoping, Sweden;Jonkoping Univ, Sch Hlth & Welf, Dept Social Work, Jonkoping, Sweden.
Ryhov Cty Hosp, Dept Oncol, Jonkoping, Sweden;Acad Hlth & Care, Futurum, Reg Jonkoping Cty, Jonkoping, Sweden.
Good adherence to adjuvant endocrine therapy in early breast cancer: a population-based study based on the Swedish prescribed Drug Register2018In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 57, no 7, p. 935-940Article in journal (Refereed)
Introduction: Adjuvant endocrine therapy improves recurrence-free and overall survival in primary breast cancer. However, not all patients complete their planned treatment, mostly because of side-effects. The aim of this study was to examine the adherence to adjuvant endocrine therapy in a cohort of primary breast cancer patients in Region Jonkoping County, Sweden, after 3 and 5 years.
Material and methods: The Swedish Breast Cancer Register was used to identify patients diagnosed with hormone receptor positive breast cancer in Region Jonkoping County between 2009 and 2012. Adherence was evaluated based on data from the Swedish Prescribed Drug Register, and Medication Possession Ratio (MPR), defined as the days' supply of medication during the period from the first dispensing till the last dispensing in the time period (3 and 5 years), divided by number of days. Adherence was defined as MPR >= 80%. Regression analyses were used to identify subgroups associated with adherence; age, type of endocrine treatment, additional adjuvant therapy, and hospital responsible for the follow-up (Eksjo, Jonkoping, and Varnamo).
Results: We identified 634 patients who were recommended adjuvant endocrine therapy and to be able to estimate adherence after 3 and 5 years, 488 patients were included in the analysis. After 3 years of treatment, 91.2% of the patients (95% confidence interval (0) 88.7-93.6; n = 445), were found to be adherent. The corresponding figure for the 271 patients who had completed 5 years of treatment was 91.5% (95% CI 88.2-94.8; n=248). No subgroups (age, endocrine therapy, radio/chemotherapy, or hospital) were significantly associated with adherence in the multiple logistic regression analysis.
Discussion: This study shows substantially higher adherence to adjuvant endocrine therapy than previously reported. Reasons for this could be differences in routines for therapy information and follow-up, but this needs to be further investigated.
Maenpaa, Johanna
Univ Tampere, Tampere Univ Hosp, FIN-33101 Tampere, Finland..
Varthalitis, Ioannis
Chania Gen Hosp, Khania, Greece..
Erdkamp, Frans
Orbis Med Ctr, Sittard, Netherlands..
Trojan, Andreas
Brust Zentrum Zurich, Zurich, Switzerland..
Krzemieniecki, Krzysztof
Jagiellonian Univ, Oncol Clin, PL-31007 Krakow, Poland..
Bendall, Kate
Amgen Ltd, Uxbridge, Middx, England..
Vogl, Florian D.
Amgen Inc, Thousand Oaks, CA 91320 USA..
Verma, Shailendra
Ottawa Reg Canc Ctr, Ottawa, ON K1Y 4K7, Canada..
The use of granulocyte colony stimulating factor (G-CSF) and management of chemotherapy delivery during adjuvant treatment for early-stage breast cancer-Further observations from the IMPACT solid study2016In: Breast, ISSN 0960-9776, E-ISSN 1532-3080, Vol. 25, p. 27-33Article in journal (Refereed)
Objective: To investigate the use and impact of granulocyte colony-stimulating factors (G-CSF) on chemotherapy delivery and neutropenia management in breast cancer in a clinical practice setting. Methods: IMPACT Solid was an international, prospective observational study in patients with a physician-assessed febrile neutropenia (FN) risk of >= 20%. This analysis focused on stages I-III breast cancer patients who received a standard chemotherapy regimen for which the FN risk was published. Chemotherapy delivery and neutropenia-related outcomes were reported according to the FN risk of the regimen and intent of G-CSF use. Results: 690 patients received a standard chemotherapy regimen; 483 received the textbook dose/schedule with a majority of these regimens (84%) having a FN risk >= 10%. Patients receiving a regimen with a FN risk >= 10% were younger with better performance status than those receiving a regimen with a FN risk < 10%. Patients who received higher-risk regimens were more likely to receive G-CSF primary prophylaxis (48% vs 22%), complete their planned chemotherapy (97% vs 88%) and achieve relative dose intensity >= 85% (93% vs 86%) than those receiving lower-risk regimens. Most first FN events (56%) occurred in cycles not supported with G-CSF primary prophylaxis. Conclusion: Physicians generally recommend standard adjuvant chemotherapy regimens and were more likely to follow G-CSF guidelines for younger, good performance status patients in the curative setting, and often modify standard regimens in more compromised patients. However, G-CSF support is not optimal, indicated by G-CSF primary prophylaxis use in < 50% of high-risk patients and observation of FN without G-CSF support.
Matikas, Alexios
Karolinska Univ Hosp, Radiumhemmet, Dept Oncol, Stockholm, Sweden..
Margolin, Sara
Stockholm South Gen Hosp, Dept Oncol, Stockholm, Sweden..
Hellström, Mats
Bengtsson, Nils-Olof
Norrland Univ Hosp, Umea, Sweden..
Karlsson, Lena
Cty Hosp, Sundsvall, Sweden..
Edlund, Per
Karlsson, Per
Univ Gothenburg, Sahlgrenska Univ Hosp, Sahlgrenska Acad, Dept Oncol,Inst Clin Sci, Gothenburg, Sweden..
Linderholm, Barbro
Malmstrom, Per
Skane Univ Hosp, Dept Oncol & Radiat Phys, Lund, Sweden..
Foukakis, Theodoros
Long-term safety and survival outcomes from the Scandinavian Breast Group 2004-1 randomized phase II trial of tailored dose-dense adjuvant chemotherapy for early breast cancer2018In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217, Vol. 168, no 2, p. 349-355Article in journal (Refereed)
Although adjuvant polychemotherapy improves outcomes for early breast cancer, the significant variability in terms of pharmacokinetics results in differences in efficacy and both short and long-term toxicities. Retrospective studies support the use of dose tailoring according to the hematologic nadirs. The SBG 2004-1 trial was a randomized feasibility phase II study which assessed tailored dose-dense epirubicin and cyclophosphamide (EC) followed by docetaxel (T) (group A), the same regimen with fixed doses (group B) and the TAC regimen (group C). Women aged 18-65 years, ECOG PS 0-1 with at least one positive axillary lymph node were randomized 1:1:1. The primary endpoint of the study was the safety and feasibility of the treatment. Toxicity was graded according to CTC-AE version 3.0. The design and short-term toxicity have been previously published. Here, we report safety and efficacy data after 10 years of follow-up. A total of 124 patients were included in the study. After a median follow-up of 10.3 years, the probability for 10-year survival was 78.5, 75.1, and 63.4% and for relapse free survival 64.1, 71.0, and 59.5% for groups A, B, and C, respectively. There were no cases of clinically diagnosed cardiotoxicity or hematologic malignancies. No patient was lost to follow-up. In this randomized phase II trial, tailored dose adjuvant chemotherapy was feasible, without an increased risk for long-term adverse events after a median follow-up of 10 years.
Netterberg, Ida
Karlsson, Mats O
Nielsen, Elisabet I.
Quartino, Angelica L
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. Genentech Inc, Dept Clin Pharmacol, Genentech, San Francisco, USA.
Friberg, Lena E
The risk of febrile neutropenia in breast cancer patients following adjuvant chemotherapy is predicted by the time course of interleukin-6 and C-reactive protein by modelling.2018In: British Journal of Clinical Pharmacology, ISSN 0306-5251, E-ISSN 1365-2125, Vol. 84, no 3, p. 490-500Article in journal (Refereed)
AIMS: Early identification of patients with febrile neutropenia (FN) is desirable for initiation of preventive treatment, such as with antibiotics. In this study, the time courses of two inflammation biomarkers, interleukin (IL)-6 and C-reactive protein (CRP), following adjuvant chemotherapy of breast cancer, were characterized. The potential to predict development of FN by IL-6 and CRP, and other model-derived and clinical variables, was explored.
METHODS: The IL-6 and CRP time courses in cycles 1 and 4 of breast cancer treatment were described by turnover models where the probability for an elevated production following initiation of chemotherapy was estimated. Parametric time-to-event models were developed to describe FN occurrence to assess: (i) predictors available before chemotherapy is initiated; (ii) predictors available before FN occurs; and (iii) predictors available when FN occurs.
RESULTS: The IL-6 and CRP time courses were successfully characterized with peak IL-6 typically occurring 2 days prior to CRP peak. Of all evaluated variables the CRP time course was most closely associated with the occurrence of FN. Since the CRP peak typically occurred at the time of FN diagnosis it will, however, have limited value for identifying the need for preventive treatment. The time course of IL-6 was the predictor that could best forecast FN events. Of the variables available at baseline, age was the best, although in comparison a relatively weak, predictor.
CONCLUSIONS: The developed models add quantitative knowledge about IL-6 and CRP and their relationship to the development of FN. The study suggests that IL-6 may have potential as a clinical predictor of FN if monitored during myelosuppressive chemotherapy.
31. Nilsson, A.
Lundkvist, J.
Time and value of chemotherapy administration burden in a Swedish hospital2016In: Cancer Research, ISSN 0008-5472, E-ISSN 1538-7445, Vol. 76Article in journal (Other academic)
Quartino, Angelica L.
Characterization of Endogenous G-CSF and the Inverse Correlation to Chemotherapy-Induced Neutropenia in Patients with Breast Cancer Using Population Modeling2014In: Pharmaceutical research, ISSN 0724-8741, E-ISSN 1573-904X, Vol. 31, no 12, p. 3390-3403Article in journal (Refereed)
Neutropenia is a severe adverse-event of chemotherapeutics. Neutrophils (ANC) are mainly regulated by granulocyte colony stimulating factor (G-CSF). The aim was to characterize the dynamics between endogenous G-CSF and ANC over time following chemotherapy. Endogenous G-CSF and ANC were monitored in forty-nine breast cancer patients treated with sequential adjuvant 5-fluorouracil-epirubicin-cyclophosphamide and docetaxel. During treatment courses ANC was transiently decreased and was reflected in an endogenous G-CSF increase, which was well described by a semi-mechanistic model including control mechanisms; when G-CSF concentrations increased the proliferation rate increased and the bone maturation time reduced for ANC. Subsequently, ANC in the circulation increased leading to increased elimination of G-CSF. Additionally, a non-specific elimination for G-CSF was quantified. The ANC-dependent elimination contributed to 97% at baseline and 49% at an ANC of 0.1 center dot 10(9)/L to the total G-CSF elimination. The integrated G-CSF-myelosuppression model captured the initial rise in endogenous G-CSF following chemotherapy-induced neutropenia and the return to baseline of G-CSF and ANC. The model supported the self-regulatory properties of the system and may be a useful tool for further characterization of the biological system and in optimization of chemotherapy treatment.
33. Rosell, Johan
Nordenskjold, Bo
Fornander, Tommy
Hatschek, Thomas
Malmstrom, Per-Olof
Wallgren, Arne
Stal, Olle
Carstensen, John
Effects of adjuvant tamoxifen therapy on cardiac disease: results from a randomized trial with long-term follow-up2013In: Breast Cancer Research and Treatment, ISSN 0167-6806, E-ISSN 1573-7217, Vol. 138, no 2, p. 467-473Article in journal (Refereed)
Tamoxifen is associated with a reduced risk of coronary heart disease (CHD). However, there are few reports on long-term effects. Using data from a large Swedish randomized trial of 5 and 2 years of adjuvant tamoxifen in women with early breast cancer, we here present results on morbidity and mortality from cardiac diseases during treatment and long-term after treatment. A total of 4,150 patients were breast cancer recurrence-free after 2 years. Data from the Swedish National Hospital Discharge Registry combined with information from the Swedish Cause of Death Registry were used to define events of disease. Hazard ratios were estimated using Cox regression. Patients assigned to 5 years in comparison with 2 years of postoperative tamoxifen experienced a reduced incidence of CHD [hazard ratio (HR), 0.83; 95 % CI 0.70-1.00], especially apparent during the active treatment period (HR 0.65; 95 % CI 0.43-1.00). The mortality from CHD was significantly reduced (HR 0.72; 95 % CI 0.53-0.97). During the active treatment, the morbidity of other heart diseases was also significantly reduced (HR 0.40; 95 % CI 0.25-0.64) but not after treatment stopped (HR 1.06; 95 % CI 0.87-1.30). Similar results were seen for both heart failure and atrial fibrillation/flutter. As compared to 2 years of therapy, 5 years of postoperative tamoxifen therapy prevents CHD as well as other heart diseases. The risk reduction is most apparent during the active treatment period, and later tends to diminish.
Rosell, Johan
Reg Canc Ctr South East Sweden, Linkoping, Sweden.;Linkoping Univ, Dept Clin & Expt Med, Oncol, Fac Hlth Sci, Linkoping, Sweden..
Nordenskjöld, Bo
Linkoping Univ, Dept Clin & Expt Med, Oncol, Fac Hlth Sci, Linkoping, Sweden..
Umea Univ Hosp, Dept Oncol, Umea, Sweden..
Karolinska Univ Hosp, Dept Oncol, Stockholm, Sweden..
Malmström, Per-Olof
Skane Univ Hosp, Skanes Dept Oncol, Lund, Sweden..
Sahlgrens Univ Hosp, Dept Oncol, Gothenburg, Sweden..
Stål, Olle
Linkoping Univ, Dept Med & Hlth Sci, Linkoping, Sweden..
Long-term effects on the incidence of second primary cancers in a randomized trial of two and five years of adjuvant tamoxifen2017In: Acta Oncologica, ISSN 0284-186X, E-ISSN 1651-226X, Vol. 56, no 4, p. 614-617Article in journal (Refereed)
Background: Tamoxifen is a well established treatment for breast cancer, but its long-term effects on the incidence of secondary cancers are not fully evaluated.Material and methods: We have studied 4128 postmenopausal patients with early stage breast cancer who were alive and free of breast cancer recurrence after two years of tamoxifen, and who were randomized to receive totally two or five years of therapy.Results: Compared to patients randomized to two years of tamoxifen the incidence of contralateral breast cancer [hazard ratio (HR) 0.73; 95% CI 0.56-0.96] and of lung cancer (HR 0.45; 95% CI 0.27-0.77), especially squamous cell and small cell lung cancer, were reduced in the five-year group, and similar results were seen when restricting the analysis to the 10-year period after treatment stopped. An increased incidence of endometrial cancer was observed in the five-year group, but the excess risk decreased over time.Conclusion: Further studies of the effects of tamoxifen on the risk of different histological types of lung cancer are needed.
Ryden, L.
Lund Univ, Surg, Dept Clin Sci Lund, Lund, Sweden.;Skane Univ Hosp, Dept Surg, Med Serv, Lund, Sweden..
Loman, N.
Lund Univ, Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden.;Skane Univ Hosp, Dept Haematol Oncol & Radiotherapy, Med Serv, Lund, Sweden..
Larsson, C.
Lund Univ, Dept Lab Med Lund, Translat Canc Res, Lund, Sweden..
Hegardt, C.
Lund Univ, Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden..
Vallon-Christersson, J.
Malmberg, M.
Ehinger, A.
Lund Univ, Oncol & Pathol, Dept Clin Sci Lund, Lund, Sweden.;Skane Univ Hosp, Dept Pathol & Cytol, Med Serv, Lund, Sweden..
Saal, L. H.
Borg, Å.
Minimizing inequality in access to precision medicine in breast cancer by real-time population-based molecular analysis in the SCAN-B initiative2018In: British Journal of Surgery, ISSN 0007-1323, E-ISSN 1365-2168, Vol. 105, no 2, p. E158-E168Article in journal (Refereed)
Background: Selection of systemic therapy for primary breast cancer is currently based on clinical biomarkers along with stage. Novel genomic tests are continuously being introduced as more precise tools for guidance of therapy, although they are often developed for specific patient subgroups. The Sweden Cancerome Analysis Network - Breast (SCAN-B) initiative aims to include all patients with breast cancer for tumour genomic analysis, and to deliver molecular subtype and mutational data back to the treating physician.
Methods: An infrastructure for collection of blood and fresh tumour tissue from all patients newly diagnosed with breast cancer was set up in 2010, initially including seven hospitals within the southern Sweden regional catchment area, which has 1.8 million inhabitants. Inclusion of patients was implemented into routine clinical care, with collection of tumour tissue at local pathology departments for transport to the central laboratory, where routines for rapid sample processing, RNA sequencing and biomarker reporting were developed.
Results: More than 10 000 patients from nine hospitals have currently consented to inclusion in SCAN-B with high (90 per cent) inclusion rates from both university and secondary hospitals. Tumour samples and successful RNA sequencing arc being obtained from more than 70 per cent of patients, showing excellent representation compared with the national quality registry as a truly population-based cohort. Molecular biomarker reports can be delivered to multidisciplinary conferences within 1 week.
Conclusion: Population-based collection of fresh tumour tissue is feasible given a decisive joint effort between academia and collaborative healthcare groups, and with governmental support. An infrastructure for genomic analysis and prompt data output paves the way for novel systemic therapy for patients from all hospitals, irrespective of size anti location.
BioNTech AG, Erlangen, Germany..
Gustave Roussy Comprehens Canc Ctr, Nice, France..
Kundig, Thomas
Univ Zurich Hosp, Zurich, Switzerland..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Experimental and Clinical Oncology. Univ Uppsala Hosp, Uppsala, Sweden..
Mutanome Engineered RNA Immunotherapy (MERIT)2015In: HUMAN GENE THERAPY CLINICAL DEVELOPMENT, ISSN 2324-8637, Vol. 26, no 2, p. 84-86Article in journal (Refereed)
Carlsson, J.
Sandström, M.
Molecular imaging using the Affibody molecule [111In]ABY-025 can identify the HER2 status in breast cancer patients2012In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 39, no S2, p. S296-S296Article in journal (Other academic)
Sandberg, Dan T
Affibody AB, Solna, Sweden.
Intra-image referencing for simplified assessment of HER2-expression in breast cancer metastases using the Affibody molecule ABY-025 with PET and SPECT.2017In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 44, no 8, p. 1337-1346Article in journal (Refereed)
PURPOSE: In phase I/II-studies radiolabelled ABY-025 Affibody molecules identified human epidermal growth factor receptor 2 (HER2) expression in breast cancer metastases using PET and SPECT imaging. Here, we wanted to investigate the utility of a simple intra-image normalization using tumour-to-reference tissue-ratio (T/R) as a HER2 status discrimination strategy to overcome potential issues related to cross-calibration of scanning devices.
METHODS: Twenty-three women with pre-diagnosed HER2-positive/negative metastasized breast cancer were scanned with [(111)In]-ABY-025 SPECT/CT (n = 7) or [(68)Ga]-ABY-025 PET/CT (n = 16). Uptake was measured in all metastases and in normal spleen, lung, liver, muscle, and blood pool. Normal tissue uptake variation and T/R-ratios were established for various time points and for two different doses of injected peptide from a total of 94 whole-body image acquisitions. Immunohistochemistry (IHC) was used to verify HER2 expression in 28 biopsied metastases. T/R-ratios were compared to IHC findings to establish the best reference tissue for each modality and each imaging time-point. The impact of shed HER2 in serum was investigated.
RESULTS: Spleen was the best reference tissue across modalities, followed by blood pool and lung. Spleen-T/R was highly correlated to PET SUV in metastases after 2 h (r = 0.96, P < 0.001) and reached an accuracy of 100% for discriminating IHC HER2-positive and negative metastases at 4 h (PET) and 24 h (SPECT) after injection. In a single case, shed HER2 resulted in intense tracer retention in blood. In the remaining patients shed HER2 was elevated, but without significant impact on ABY-025 biodistribution.
CONCLUSION: T/R-ratios using spleen as reference tissue accurately quantify HER2 expression with radiolabelled ABY-025 imaging in breast cancer metastases with SPECT and PET. Tracer binding to shed HER2 in serum might affect quantification in the extreme case.
Sandström, M
Uppsala University, Medicinska vetenskapsområdet, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Faculty of Medicine, Department of Oncology, Radiology and Clinical Immunology. Enheten för onkologi.
Lidbrink, E
Karlsson, M O
Model describing the relationship between pharmacokinetics and hematologic toxicity of the epirubicin-docetaxel regimen in breast cancer patients.2005In: J Clin Oncol, ISSN 0732-183X, Vol. 23, no 3, p. 413-21Article in journal (Refereed)
Lindskog, Karolina
Velikyan, Irma
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Division of Molecular Imaging.
Affibody AB, Solna, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science. Affibody AB, Solna, Sweden..
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Division of Molecular Imaging.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Radiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Clinical Physiology.
Biodistribution and Radiation Dosimetry of the Anti-HER2 Affibody Molecule Ga-68-ABY-025 in Breast Cancer Patients2016In: Journal of Nuclear Medicine, ISSN 0161-5505, E-ISSN 1535-5667, Vol. 57, no 6, p. 867-871Article in journal (Refereed)
Ga-68-ABY-025 is a radiolabeled Affibody molecule for in vivo diagnosis of human epidermal growth factor receptor 2 (HER2)-positive breast cancer tumors with PET. The aim of the present work was to measure the biodistribution and estimate the radiation dosimetry of Ga-68-ABY-025 for 2 different peptide mass doses in a single group of patients using dynamic and serial whole-body PET/CT. Methods: Eight patients with metastatic breast cancer were included. Each patient underwent an abdominal 45-min dynamic and 3 whole-body PET/CT scans at 1, 2, and 4 h after injection of a low peptide dose (LD) and a high peptide dose (HD), with approximately the same amount of radioactivity, in separate investigations 1 wk apart. As input to the absorbed dose calculations, volumes of interest were drawn on all clearly identifiable source organs: liver, kidneys, spleen, descending aorta, and upper large intestine. Absorbed doses were calculated using OLINDA/EXM, version 1.1. Results: Of the major organs, the highest radionuclide uptake at 1, 2, and 4 h after injection was observed in the kidneys and liver. The highest absorbed organ doses were seen in the kidneys, followed by the liver for both LD and HD Ga-68-ABY-025. Absorbed doses to liver and kidneys were slightly but significantly higher for LD. Total effective dose was 0.030 +/- 0.003 mSv/MBq for LD and 0.028 +/- 0.002 mSv/MBq for HD. Conclusion: The effective dose for a typical 200-MBq administration of Ga-68-ABY-025 is 6.0 mSv for LD and 5.6 mSv for HD. Therefore, from a radiation dosimetry point of view, HD is preferred for PET/CT evaluation of HER2-expressing breast cancer tumors. These effective doses are somewhat higher than earlier published values for other Ga-68-labeled tracers, such as 0.021 +/- 0.003 mSv/MBq for Ga-68-DOTATATE and Ga-68-DOTATOC, mainly because of higher uptake in liver and kidney.
41. Sharma, R.
Kallur, K. G.
Ryu, J. S.
Parameswaran, R. V.
Avril, N.
Gleeson, F. V.
Lee, J. D.
Lee, K. H.
O'Doherty, M. J.
Groves, A. M.
Miller, M. P.
Paterson, C. L.
Coombes, C.
Aboagye, E. O.
Test-retest reproducibility of [F-18]fluciclatide PET imaging in subjects with solid tumors2012In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 39, no S2, p. S226-S226Article in journal (Other academic)
Sharma, Rohini
Univ London Imperial Coll Sci Technol & Med, Hammersmith Hosp, Fac Med, Dept Expt Med, London W12 0NN, England..
Kallur, Kumar G.
HCG, PETCT, Bangalore, Karnataka, India.;HCG, Cyclotron Dept, Bangalore, Karnataka, India..
Ryu, Jin S.
Asan Med Ctr, Dept Nucl Med, Seoul, South Korea..
Parameswaran, Ramanathapuram V.
Manipal Hosp, Dept Nucl Med, Bangalore, Karnataka, India.;Manipal Hosp, PET CT Div, Bangalore, Karnataka, India..
Avril, Norbert
Queen Mary Univ London, Barts Hlth, Dept Nucl Med, London, England..
Gleeson, Fergus V.
Oxford Radcliffe Hosp Trust, Churchill Hosp, Dept Radiol, Oxford, England..
Lee, Jong D.
Yonsei Univ Hlth Syst, Dept Nucl Med, Seoul, South Korea..
Lee, Kyung-Han
Sungkyunkwan Univ, Sch Med, Samsung Med Ctr, Dept Nucl Med, Seoul, South Korea..
O'Doherty, Michael J.
Kings Coll London, Div Imaging Sci & Biomed Engn, PET Imaging Ctr, London WC2R 2LS, England..
Groves, Ashley M.
UCL, Inst Nucl Med, London, England..
Miller, Matthew P.
GE Healthcare Life Sci, Imaging R&D, Amersham, England..
Somer, Edward J.
Coombes, Charles R.
Univ London Imperial Coll Sci Technol & Med, Fac Med, Hammersmith Hosp, Dept Surg & Canc, London, England..
Aboagye, Eric O.
Multicenter Reproducibility of F-18-Fluciclatide PET Imaging in Subjects with Solid Tumors2015In: Journal of Nuclear Medicine, ISSN 0161-5505, E-ISSN 1535-5667, Vol. 56, no 12, p. 1855-1861Article in journal (Refereed)
Integrins are upregulated on both tumor cells and associated vasculature, where they play an important role in angiogenesis and metastasis. Fluciclatide is an arginine-glycine-aspartic acid peptide with high affinity for alpha(v)beta(3)/alpha(v)beta(5) integrin, which can be radio-labeled for PET imaging of angiogenesis. Thus, F-18-fluciclatide is a potential biomarker of therapeutic response to antiangiogenic inhibitors. The aim of this study was to evaluate the reproducibility of F-18-fluciclatide in multiple solid-tumor types. Methods: Thirty-nine patients underwent PET/CT scanning at 40, 65, and 90 min after injection of F-18-fluciclatide (maximum, 370 MBq) on 2 separate days (2-9 d apart). Patients did not receive any therapy between PET/CT scans. F-18-fluciclatide images were reported and quantitative measures of uptake were extracted using the PERCIST methodology. Intrasubject reproducibility of PET uptake in all measurable lesions was evaluated by calculating relative differences in SUV between PET scans for each lesion during the 2 imaging sessions. Results: Thirty-nine measurable lesions were detected in 26 patients. Lesion uptake correlated strongly across imaging sessions (r = 0.92, P < 0.05, at 40 min; r = 0.94, P < 0.05, at 65 min; r = 0.94, P, 0.05, at 90 min) with a mean relative difference and SD of the relative difference of 0.006 +/- 0.18 at 40 min, 0.003 +/- 0.19 at 65 min, and 0.025 +/- 0.20 at 90 min. This reflects 95% limits of repeatability of 35%-39% for the difference between the 2 SUV measurements or a variability of 18%-20% in agreement from that observed in well-calibrated multicenter F-18-FDG studies. Conclusion: The test-retest reproducibility of F-18-fluciclatide across multiple tumor types has been measured and shown to be acceptable. This is an important step in the development of this in vivo biomarker to identify and quantify response to antiangiogenic therapy in cancer patients.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Section of Nuclear Medicine and PET. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Radiology, Oncology and Radiation Science, Radiology.
Garske-Roman, Ulrike
First-in-Human Molecular Imaging of HER2 Expression in Breast Cancer Metastases Using the In-111-ABY-025 Affibody Molecule2014In: Journal of Nuclear Medicine, ISSN 0161-5505, E-ISSN 1535-5667, Vol. 55, no 5, p. 730-735Article in journal (Refereed)
The expression status of human epidermal growth factor receptor type 2 (HER2) predicts the response of HER2-targeted therapy in breast cancer. ABY-025 is a small reengineered Affibody molecule targeting a unique epitope of the HER2 receptor, not occupied by current therapeutic agents. This study evaluated the distribution, safety, dosimetry, and efficacy of In-111-ABY-025 for determining the HER2 status in metastatic breast cancer. Methods: Seven patients with metastatic breast cancer and HER2-positive (n = 5) or - negative (n 5 2) primary tumors received an intravenous injection of approximately 100 mu g (similar to 140 MBq) of In-111-ABY-025. Planar gamma-camera imaging was performed after 30 min, followed by SPECT/CT after 4, 24, and 48 h. Blood levels of radioactivity, antibodies, shed serum HER2, and toxicity markers were evaluated. Lesional HER2 status was verified by biopsies. The metastases were located by F-18-FDG PET/CT 5 d before In-111-ABY-025 imaging. Results: Injection of In-111-ABY-025 yielded a mean effective dose of 0.15 mSv/MBq and was safe, well tolerated, and without drug-related adverse events. Fast blood clearance allowed high-contrast HER2 images within 4-24 h. No anti-ABY025 antibodies were observed. When metastatic uptake at 24 h was normalized to uptake at 4 h, the ratio increased in HER2-positive metastases and decreased in negative ones (P, < 0.05), with no overlap and confirmation by biopsies. In 1 patient, with HER2- positive primary tumor, In-111-ABY-025 imaging correctly suggested a HER2negative status of the metastases. The highest normal-tissue uptake was in the kidneys, followed by the liver and spleen. Conclusion: In-111-ABY- 025 appears safe for use in humans and is a promising noninvasive tool for discriminating HER2 status in metastatic breast cancer, regardless of ongoing HER2-targeted antibody treatment.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Division of Molecular Imaging.
Measuring HER2-Receptor Expression In Metastatic Breast Cancer Using [(68)Ga]ABY-025 Affibody PET/CT2016In: Theranostics, ISSN 1838-7640, E-ISSN 1838-7640, Vol. 6, no 2, p. 262-271 Article in journal (Refereed)
PURPOSE: Positron Emission Tomography (PET) imaging of HER2 expression could potentially be used to select patients for HER2-targed therapy, predict response based on uptake and be used for monitoring. In this phase I/II study the HER2-binding Affibody molecule ABY-025 was labeled with (68)Ga-gallium ([(68)Ga]ABY-025) for PET to study effect of peptide mass, test-retest variability and correlation of quantified uptake in tumors to histopathology.
EXPERIMENTAL DESIGN: Sixteen women with known metastatic breast cancer and on-going treatment were included and underwent FDG PET/CT to identify viable metastases. After iv injection of 212±46 MBq [(68)Ga]ABY-025 whole-body PET was performed at 1, 2 and 4 h. In the first 10 patients (6 with HER2-positive and 4 with HER2-negative primary tumors), [(68)Ga]ABY-025 PET/CT with two different doses of injected peptide was performed one week apart. In the last six patients (5 HER2-positive and 1 HER2-negative primary tumors), repeated [(68)Ga]ABY-025 PET were performed one week apart as a test-retest of uptake in individual lesions. Biopsies from 16 metastases in 12 patients were collected for verification of HER2 expression by immunohistochemistry and in-situ hybridization.
RESULTS: Imaging 4h after injection with high peptide content discriminated HER2-positive metastases best (p<0.01). PET SUV correlated with biopsy HER2-scores (r=0.91, p<0.001). Uptake was five times higher in HER2-positive than in HER2-negative lesions with no overlap (p=0.005). The test-retest intra-class correlation was r=0.996. [(68)Ga]ABY-025 PET correctly identified conversion and mixed expression of HER2 and targeted treatment was changed in 3 of the 16 patients.
CONCLUSION: [(68)Ga]ABY-025 PET accurately quantifies whole-body HER2-receptor status in metastatic breast cancer.
Measuring HER2-expression in metastatic breast cancer using 68Ga-ABY025 PET/CT2014In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 41, no S2, p. S226-S226, article id OP298Article in journal (Other academic)
Lund Univ, Dept Clin Sci Lund, Div Oncol & Pathol, SE-22381 Lund, Sweden.
Lund Univ, Div Translat Canc Res, Dept Lab Med, SE-22381 Lund, Sweden.
Lund Univ, Dept Clin Sci Lund, Div Oncol & Pathol, SE-22381 Lund, Sweden;Dept Lab Med, Div Clin Genet & Pathol, SE-22185 Lund, Sweden.
Wärnberg, Fredrik
Lund Univ, Dept Clin Sci, Div Surg, SE-22185 Lund, Sweden.
Lund Univ, Dept Clin Sci Lund, Div Oncol & Pathol, SE-22381 Lund, Sweden;Skane Univ Hosp, Dept Hematol Oncol & Radiat Phys, SE-22185 Lund, Sweden.
Staaf, Johan
Cross comparison and prognostic assessment of breast cancer multigene signatures in a large population-based contemporary clinical series2019In: Scientific Reports, ISSN 2045-2322, E-ISSN 2045-2322, Vol. 9, article id 12184 Article in journal (Refereed)
Multigene expression signatures provide a molecular subdivision of early breast cancer associated with patient outcome. A gap remains in the validation of such signatures in clinical treatment groups of patients within population-based cohorts of unselected primary breast cancer representing contemporary disease stages and current treatments. A cohort of 3520 resectable breast cancers with RNA sequencing data included in the population-based SCAN-B initiative (ClinicalTrials.gov ID NCT02306096) were selected from a healthcare background population of 8587 patients diagnosed within the years 2010-2015. RNA profiles were classified according to 19 reported gene signatures including both gene expression subtypes (e.g. PAM50, IC10, CIT) and risk predictors (e.g. Oncotype DX, 70-gene, ROR). Classifications were analyzed in nine adjuvant clinical assessment groups: TNBC-ACT (adjuvant chemotherapy, n = 239), TNBC-untreated (n = 82), HER2+/ER- with anti-HER2+ACT treatment (n = 110), HER2+/ER+ with anti-HER2 + ACT + endocrine treatment (n = 239), ER+/HER2-/LN- with endocrine treatment (n = 1113), ER+/HER2-/LN- with endocrine +ACT treatment (n = 243), ER+/HER2-/LN+ with endocrine treatment (n = 423), ER+/HER2-/LN+ with endocrine +ACT treatment (n = 433), and ER+/HER2-/LN- untreated (n = 200). Gene signature classification (e.g., proportion low-, high-risk) was generally well aligned with stratification based on current immunohistochemistry-based clinical practice. Most signatures did not provide any further risk stratification in TNBC and HER2+/ER- disease. Risk classifier agreement (low-, medium/intermediate-, high-risk groups) in ER+ assessment groups was on average 50-60% with occasional pair-wise comparisons having <30% agreement. Disregarding the intermediate-risk groups, the exact agreement between low- and high-risk groups was on average similar to 80-95%, for risk prediction signatures across all assessment groups. Outcome analyses were restricted to assessment groups of TNBC-ACT and endocrine treated ER+/HER2-/LN- and ER+/HER2-/LN+ cases. For ER+/HER2- disease, gene signatures appear to contribute additional prognostic value even at a relatively short follow-up time. Less apparent prognostic value was observed in the other groups for the tested signatures. The current study supports the usage of gene expression signatures in specific clinical treatment group within population-based breast cancer. It also stresses the need of further development to reach higher consensus in individual patient classifications, especially for intermediate-risk patients, and the targeting of patients where current gene signatures and prognostic variables provide little support in clinical decision-making.
Schweighoefer, Philip
Eckert & Ziegler Eurotope GmbH, Berlin, Germany.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science. Affibody AB, Solna, Sweden.
Seemann, Johanna
Frejd, Fredrik Y.
Diagnostic HER2-binding radiopharmaceutical, [Ga-68]Ga-ABY-025, for routine clinical use in breast cancer patients2019In: American Journal of Nuclear Medicine and Molecular Imaging, ISSN 2160-8407, Vol. 9, no 1, p. 12-23 Article in journal (Refereed)
[Ga-68]Ga-ABY-025/PET-CT targeting human epidermal growth factor receptor type 2 (HER2) has demonstrated its potential clinical value for the detection and quantification of HER2 in a phase I clinical study with breast cancer patients. Previously, the radiopharmaceutical was prepared manually, however larger scale of multicenter clinical trials and routine healthcare requires automation of the production process to limit the operator radiation dose, improve tracer manufacturing robustness, and provide on-line documentation for good manufacturing practice (GMP) compliance. The production of [Ga-68]Ga-ABY-025 was implemented on the Modular-Lab PharmTrace synthesis platform (Eckert & Ziegler) and disposable cassettes were developed. Pharmaceutical grade Ge-68/Ga-68 generator (GalliaPharm (R)) was used in the study. The active pharmaceutical ingredient starting material ABY-025 (GMP grade) was provided by Affibody AB. The patient examinations were conducted using a Discovery MI PET/CT scanner (20 cm FOV, GE Healthcare). Reproducible and GMP compliant fully automated production of [Ga-68]Ga-ABY-025 was developed. The radiochemical purity of the product was 98.7 +/- 0.6% with total peptide content of 315 +/- 15 mu g (n = 3). Radionuclidic purity, sterility, endotoxin content, residual solvent content, and sterile filter integrity were controlled and met acceptance criteria. The product was stable at ambient temperature for at least 2 h. The primary tumor and metastasis were detected with SUVmax values of 8.3 and 16.0, respectively. Automated production of [Ga-68]Ga-ABY-025 was established and the process was validated enabling standardized multicenter phase II and III clinical trials and routine clinical use. Patient examinations conformed to the radiopharmaceutical biodistribution observed in the previous phase I study.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Preclinical PET Platform.
GMP compliant preparation of a (68)Gallium-labeled Affibody analogue for breast cancer patient examination: first-in-man2014In: European Journal of Nuclear Medicine and Molecular Imaging, ISSN 1619-7070, E-ISSN 1619-7089, Vol. 41, no S2, p. S228-S229, article id OP308Article in journal (Other academic)
Affibody AB, Solna.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science. Affibody AB, Solna.
Good manufacturing practice production of [68Ga]Ga-ABY-025 for HER2 specific breast cancer imaging.2016In: American Journal of Nuclear Medicine and Molecular Imaging, ISSN 2160-8407, Vol. 6, no 2, p. 135-153 Article in journal (Refereed)
Therapies targeting human epidermal growth factor receptor type 2 (HER2) have revolutionized breast cancer treatment, but require invasive biopsies and rigorous histopathology for optimal patient stratification. A non-invasive and quantitative diagnostic method such as positron emission tomography (PET) for the pre-therapeutic determination of the presence and density of the HER2 would significantly improve patient management efficacy and treatment cost. The essential part of the PET methodology is the production of the radiopharmaceutical in compliance with good manufacturing practice (GMP). The use of generator produced positron emitting (68)Ga radionuclide would provide worldwide accessibility of the agent. GMP compliant, reliable and highly reproducible production of [(68)Ga]Ga-ABY-025 with control over the product peptide concentration and amount of radioactivity was accomplished within one hour. Two radiopharmaceuticals were developed differing in the total peptide content and were validated independently. The specific radioactivity could be kept similar throughout the study, and it was 6-fold higher for the low peptide content radiopharmaceutical. Intrapatient comparison of the two peptide doses allowed imaging optimization. The high peptide content decreased the uptake in healthy tissue, in particular liver, improving image contrast. The later imaging time points enhanced the contrast. The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Medicinal Chemistry, Division of Molecular Imaging. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology, Medical Radiation Science.
Good manufacturing practice compliant production of a Ga-68-labelled Affibody agent for breast cancer imaging: first-in-human2015In: Journal of labelled compounds & radiopharmaceuticals, ISSN 0362-4803, E-ISSN 1099-1344, Vol. 58, p. S358-S358Article in journal (Other academic)
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The Australian dollar continued to slide on Friday, continuing the selloff that began on Thursday.
The AUD/USD has lost over 2% during the past two sessions, the largest percentage decline since Brexit.
It has now lost over 5% since late January.
The Australian dollar was smoked again on Friday, falling heavily against all of the major crosses, mirroring its performance from a day earlier.
Having broken its March uptrend a day earlier, the AUD/USD was hammered lower once again, undermined by a combination of technical selling, tweaks to positioning ahead of next weeks US Fed meeting, strong US economic data and ongoing political and trade policy uncertainty.
After sitting in the red for most of the Asian session, the selling really kicked off during European trade following a failure to break back above its 200-day moving average.
From there it was one-way traffic for the Aussie, losing over 1% against the US dollar for a second consecutive session.
Combined with Thursday's losses, the two-day percentage decline was the largest since the immediate aftermath of the UK Brexit vote, extending its slide from late January to over 5%.
As seen in the daily chart below, the AUD/USD found support at the lows it previous hit in early March. It's weekly close was the lowest since mid-December.


The Oregon Electronics Manufacturers Association has been serving the electronics community in Oregon for over 40 years.
In the early days, the EMA, formerly known as the Northwest Printed Circuit Association, had a focus on the manufacture of printed circuit boards and printed circuit board assemblies. The Association was heavily weighted with corporate members directly associated with the manufacture of printed circuit boards and printed circuit board assemblies. Over the years there has been an evolution within the Association that has led to serving corporate members from the many various types of businesses that serve the electronics industry.
The Electronics Manufacturers Association of Oregon empowers and encourages local manufacturers' growth and success. We are an organization that stands for keeping Oregon a place of economic opportunity for our member firms by informing and educating our members on leading technological, regulatory, and economic topics, promoting their interests to local and state governments, and facilitating productive relationships. Our aim is to serve our members so they continue to be Oregon's job creators and innovators, helping them stay competitive, sustainable, and profitable in Oregon, the U.S., and around the world.
We continue to evolve and serve the electronics manufacturing community by offering programs and tours that relate to a broad range of topics that apply to the overall industry. One of the objectives is to provide a forum where people can learn to operate more effectively and become more aware of suppliers and companies in the local area that support the range of products required.
Every October since 2000, the EMA and the Oregon Electronics Representatives Association (ERA) host the Northwest Electronics Design & Manufacturing Expo (NEDME), the region's largest show of its kind. We encourage you to attend or exhibit at the next show.
It is our intention to continue to keep pace with the electronics industry as it moves forward. If you have suggestions that will help the success of our efforts please don't hesitate to contact us.


text:
Neesha Meminger was born in Punjab, India, grew up in Toronto, Canada, and lived in New York City for 25 years. She currently divides her time between Toronto and NYC.
Neesha holds a Bachelor's degree in Film and Media Studies from Ryerson University in Toronto, and a Master's degree in Creative Writing from The New School For Social Resea
Neesha holds a Bachelor's degree in Film and Media Studies from Ryerson University in Toronto, and a Master's degree in Creative Writing from The New School For Social Research in New York City.
Her independent films have screened at international film festivals, she has taught literature and creative writing courses to undergraduate students in New York and Toronto, served as a board member for many arts and cultural organizations, and counseled women and youth in crisis.
SHINE, COCONUT MOON, her first novel, made the Smithsonian's Notable Books for Children list and was selected as one of the Top 100 Books of 2009 by the New York Public Library's Stuff for the Teen Age. The novel was also nominated as a Best Book for Young Adults by the American Library Association as well as the online CYBILS award.
Neesha's second novel, JAZZ IN LOVE, released to rave reviews from online bloggers and industry professionals. It was nominated for a CYBILS award and was picked as a top YA selection by the Pennsylvania School Librarians' Association, as well as Bookslut's Recommended Summer Reading List.
INTO THE WISE DARK, a time-travel fantasy, was released in 2012. The Canadian Children's Book News had this to say: "Meminger's third novel, Into the Wise Dark, is rich in languid tones and emotional fragility, particularly when she's describing Pammi's connection to Zanum and her boyfriend Dhan. Indeed, it is one of the best sex scenes I've read in a long time, describing the passion, fear and all-encompassing joy of first love, without the clichés... [T]he novel's lyrical rhythms give the reader a sense of history, ancient Goddess spirituality and the emotional turmoil of Pammi's experience. Inspired by South Asian mysticism and history, teens will appreciate this rich tapestry of experience that shows the multicultural reality of our modern world."
WHAT GIRLS KNOW, a memoir in free verse and poetry, is Neesha's fourth book.

redpajama_set_name: RedPajamaCommonCrawl


Another land, another time, another place.
A child runs towards his mother as she sings a beautiful duet in front of an audience. She takes him against her, lifts him up into her loving arms and smiles radiantly, all without missing a single note.
A man off a cycle feeding the birds with no trifles. A flock of grey flutters.
Clear blue sky and sunshine on a crisp autumn morning that makes the hint of frost that's settled overnight shimmer like little diamonds, and warms the face with its effortless radiance.


text:
Q: Need for XEventsQueued(display, QueuedAfterReading) in XCB I am migrating some code of CYBOI from Xlib to XCB.
CYBOI uses a couple of threads for different communication channels like:
serial_port, terminal, socket, x_window_system.
However, it uses these threads only for signal/event/data detection;
the actual receiving and sending is done in the main thread,
in order to avoid any multi-threading conflicts of address space.
For the x_window_system channel, I previously detected events in a thread:
int n = XEventsQueued(display, QueuedAfterReading);

Upon detection of an event, an "interrupt flag" was set.
Afterwards, the main thread was reading the actual event using:
XNextEvent(display, &event);

When no more events were available, the main thread stopped receiving events
and the x_window_system channel thread started listening with XEventsQueued again.
Now, I am migrating the code to X C Binding (XCB).
There is a blocking function "xcb_wait_for_event" which is fine for reading an event.
What I miss is some function "peeking ahead" if there are events pending,
WITHOUT actually returning/removing the event from the queue.
I was reading the web for a couple of hours now, but am not able to find such a function.
The "xcb_poll_for_event" does not help. Blocking is fine for me,
since my event detection runs in its own thread.
The "xcb_request_check" as third input function does not seem to be what I want.
Could somebody help me out?
Thanks,
Christian

A: Are you looking for xcb_poll_for_queued_event(xcb_connection_t *c) which returns the next event without reading from the connection?

A: First, thanks to Julien for his reply.
I have studied the XCB 1.9 sources and found out that the
"xcb_poll_for_queued_event" function is not what I need.
The functions "xcb_poll_for_event" and "xcb_poll_for_queued_event"
both call "poll_for_next_event".
The functions "poll_for_next_event" and "xcb_wait_for_event"
both call "get_event".
If "get_event" finds an event, it changes the internal
linked list to point to the next event. However, I would
prefer NOT to change the event queue AT ALL, independent
from whether or not events are available.
I therefore propose to add a function like the following to XCB:
void* NULL_POINTER = (void*) 0;

int xcb_test_for_event(xcb_connection_t* c) {

    int r = 0;

    if (c != NULL_POINTER) {

        struct _xcb_in in = c->in;
        struct event_list* l = in.events;

        if (l != NULL_POINTER) {

            xcb_generic_event_t* e = l->event;

            if (e != NULL_POINTER) {

                r = 1;
            }
        }
    }

    return r;
}

This would allow me to write an endless loop like:
while (!xcb_test_for_event(connection)) {

    sleep(t);
}

This is comparable to the old Xlib function:
int n = XEventsQueued(d, QueuedAfterReading);

which just checked the number of events in the event queue.
The "XEventsQueued" function always returns immediately WITHOUT
input/output, if there are events already in the queue.
Thanks
Christian

redpajama_set_name: RedPajamaStackExchange


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