participate. Overall, 251 pts were identified. At each center, up to 6 pts who started olaparib (400 mg bid, capsule formulation) between 03/2014 and 03/2017 were randomly selected and included. Medical records were reviewed for clinic and pathologic characteristics, survival outcomes and safety. Our primary objective was to assess efficacy of olaparib in real-world pts treated upon initial EMA label (pts EMA ) by evaluating progression free survival (PFS) from olaparib initiation.Results: Overall, 128 pts were included in the analysis and 89 were treated according to EMA label. Main reasons to be given olaparib off-label were absence of radiological response following platinum-based chemotherapy (n¼22) and non high-grade serous EOC subtype (n¼14). BRCA1/2 mutation was present in 126 pts (98%). Most pts (68%) received olaparib after 3 or more lines of platinum-based chemotherapy. Median follow up was 41.8 months. Median PFS in pts EMA was 17.0 months (95% CI: 14.7-21.3). Median PFS and overall survival (OS) in the whole population were 15.5 months (95% CI: 12.6-18.1) and 33.6 months (95% CI: 28.7; 40.3), respectively. Fourteen (11.2%) pts stopped olaparib for toxicity reason and 75 (58.6%) had at least one dose reduction or one dose interruption. Related myelodysplastic syndrome and second cancers were diagnosed in respectively n¼5 and n¼1 pts. Number of previous lines of systemic therapy 2 was associated with prolonged PFS.Conclusions: With an extended follow-up, efficacy and toxicity of olaparib in realworld cohort of pts are consistent with findings observed in study 19 and SOLO-2 trials.Clinical trial identification: NCT04152941.Legal entity responsible for the study: ARCAGY-GINECO.
Evaluation of oral nano-silymarin formulation efficacy on prevention of radiotherapy induced mucositis: A randomized, double-blinded, placebo-controlled clinical trial
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