Results: At primary analysis, 160 pts were randomised; all pts completed crossover tx; 44% completed continuation tx at cut-off (24-02-20). 136 pts (85%; 95% CI 79e90%) preferred SC; 22 (14%) preferred IV; 2 (1%) had no preference. Main reasons for SC preference: reduced clinic time (n¼119) and comfort during administration (n¼73). 141 (88%) were very satisfied or satisfied with SC vs. 108 (68%) with IV. 87% chose SC to complete HER2-targeted therapy. HCPs' perceptions on median pts' time in the tx room across cycles 1e6 for SC vs. IV admin were 33e50 vs. 130e300 min, respectively. The rates of serious adverse events (AEs) and grade 3 AEs were low; the most common AEs were as expected (table ).
Background: Biomarkers in clinical trials as well as the need for correlative studies have led to the massive incorporation of research biopsies and archival tissue collection, with potentially risks and no direct benefit for patients. In 2019, ASCO has released an ethical framework (Levit LA et al. JCO 2019) to provide guidance on incorporating research biopsies in clinical trials.
abstracts
Annals of OncologyVolume 31 -Issue S4 -2020 S497
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