6/29/23, 11:44 PM SOLSTICE Pathway Feedback Search Clinical Topics Home Studies SOLSTICE SOLSTICE Disease Disease Colon cancer Rectal cancer Trial question Is first-line trifluridine-tipiracil plus bevacizumab superior to capecitabine plus bevacizumab in patients with metastatic colorectal cancer ineligible for intensive therapy? Study design Multi-center Open label RCT Population Characteristics of study participants 46.0% female N = 856 54.0% male 856 patients (394 female, 462 male) Inclusion criteria: adult patients with histologically confirmed metastatic colorectal cancer, ineligible for full-dose doublet or triplet chemotherapy and curative resection Key exclusion criteria: pregnancy; symptomatic CNS metastases; major surgery within 4 weeks prior to randomization; allergy/contraindication to study drugs Interventions N=426 trifluridine-tipiracil plus bevacizumab (oral trifluridine-tipiracil 35 mg/m BID on days 1-5 and 8-12 plus 5 mg/kg bevacizumab IV on days 1 and 15 of each 28-day cycle) N=430 capecitabine plus bevacizumab (oral capecitabine 1,250 mg/m BID on days 1-15 of each cycle plus 7.5 mg/kg intravenous bevacizumab on day 1 of each 21-day cycle) https://web.pathway.md/studies/recYJJ7lhghVTCAKZ 1/2 6/29/23, 11:45 PM SOLSTICE Pathway Primary outcome Progression-free survival 9.4 months 9.4 9.3 7.1 months 4.7 months 2.4 months No significant difference 0.0 months Trifluridine-tipiracil plus bevacizumab Capecitabine plus bevacizumab No significant difference in progression-free survival (9.4 months vs. 9.3 months; HR 0.87, 95% CI 0.75 to 1.02) Secondary outcomes No significant difference in overall response rate (36% vs. 42%; RR 0.86, 95% CI -0.14 to 1.86) No significant difference in disease control rates (86% vs. 85%; RR 1.01, 95% CI -2.9 to 4.92) Safety outcomes No significant difference in treatment-related deaths. Significant differences in grade 3 treatment-emergent adverse events (52% vs. 1%), decreased neutrophil count (18% vs. < 1%), anemia (14% vs. 4%), hand-foot syndrome (0% vs. 15%). Conclusion In adult patients with histologically confirmed metastatic colorectal cancer, ineligible for full-dose doublet or triplet chemotherapy and curative resection, trifluridine-tipiracil plus bevacizumab was not superior to capecitabine plus bevacizumab with respect to a progression-free survival. Reference Thierry Andr , Alfredo Falcone, Yaroslav Shparyk et al. Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):133-144. Open reference URL https://web.pathway.md/studies/recYJJ7lhghVTCAKZ 2/2