Rebeca Ortiz Worthington, Dheepa Sekar, Melissa McNeil, Scott Rothenberger, Sarah Merriam
Development and Pilot Testing of a Longitudinal Skills-Based Feedback and Conflict Resolution Curriculum for Internal Medicine Residents
Academic medicine : journal of the Association of American Medical Colleges
destinybreast02 patients her2positive unresectable metastatic breast cancer received trastuzumab deruxtecan demonstrated superior progressionfree overall survival compared receiving treatment physicians choice present patientreported outcomes pros hospitalisation data randomised openlabel phase 3 trial conducted 227 clinical sites globally enrolled patients aged 18 years older her2positive unresectable metastatic breast cancer progressed trastuzumab emtansine eastern cooperative oncology group performance status 0 1 patients randomly assigned 21 using block randomisation block size 3 receive trastuzumab deruxtecan 54 mgkg intravenously every 21 days treatment physicians choice independent biostatistician using interactive webbased system patients investigators remained unmasked treatment treatment physicians choice either capecitabine 1250 mgm2 orally twice per day days 114 plus trastuzumab 8 mgkg intravenously day 1 6 mgkg per day capecitabine 1000 mgm2 plus lapatinib 1250 mg orally per day days 121 21day schedule primary endpoint progressionfree survival based blinded independent central review previously reported pros assessed full analysis set patients randomly assigned study using oncologyspecific european organisation research treatment cancer quality life questionnaire core 30 eortc qlqc30 breast cancerspecific eortc quality life questionnaire breast 45 qlqbr45 generic hrqol eq5d5l questionnaire analyses included change baseline time definitive deterioration pro variables interest hospitalisationrelated endpoints study registered clinicaltrialsgov nct03523585 closed recruitment sept 6 2018 dec 31 2020 608 patients randomly assigned receive either trastuzumab deruxtecan n406 two receive treatment treatment physicians choice n202 seven receive treatment overall 603 patients 99 female five 1 male median followup 215 months iqr 152284 trastuzumab deruxtecan group 186 months iqr 88260 treatment physicians choice group median treatment duration 113 months iqr 62205 trastuzumab deruxtecan group approximately 45 months treatment physicians choice group 44 months iqr 2587 trastuzumab 46 months 2189 capecitabine 45 months 21106 lapatinib baseline eortc qlqc30 global health status ghs scores similar trastuzumab deruxtecan n393 treatment physicians choice n187 remained stable clinically meaningful change defined 10point change baseline time median time definitive deterioration delayed trastuzumab deruxtecan compared treatment physicians choice primary pro variable eortc qlqc30 ghs 141 months 95 ci 104187 vs 59 months 4379 hr 05573 0437607099 p00001 prespecified pros eortc qlqc30 subscales eortc qlqbr45 arm breast symptoms eq5d5l visual analogue scale patient hospitalisation rates similar trastuzumab deruxtecan 92 23 406 treatment physicians choice 41 20 202 groups however median time hospitalisation 133 days iqr 56237 trastuzumab deruxtecan versus 83 days 30152 treatment physicians choice overall ghs quality life maintained treatment groups prespecified pro variables favouring trastuzumab deruxtecan treatment physicians choice suggesting despite longer treatment duration detrimental impact patient healthrelated quality life trastuzumab deruxtecan considered efficacy safety data destinybreast02 results support overall benefit trastuzumab deruxtecan patients her2positive unresectable metastatic breast cancer previously treated trastuzumab emtansine daiichi sankyo astrazeneca