Lancet oncol: ARIEL3 trial: An exploratory analysis of Rucaparib's maintenance treatment for platinum-sensitive recurrent ovarian cancer more than 2 years later
Last Update: 2020-06-16
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In the ARIEL3 trial (evaluating parP inhibitor rucaparib for recurrent ovarian cancer), rucaparib maintenance therapy significantly improved the patient's progression-free survival compared to placeboLedermann et alare publishing pre-determined, researcher-evaluated, exploratory progressendpoints, and updated security data in The Lancet OncologyThe ARIEL3 trial is an ongoing (recruitment completed), randomized placebo-controlled phase 3 trial that recruited patients over the age of 18 with platinum-sensitive high-level slurry or endometrial-like ovary, primary peritoneal or fallopian tube cancer, requiring ECOG to perform at 0 or 1 cent, having received at least two platinum-based chemotherapy sessions, and had been remissiond after the last platinum chemotherapySubjects were randomly divided into oral rucaparib (600 mg, 2/day) or a placebo for 28 daysThe non-progression survival period (the main node) assessed by the researchers has been reportedThe safety of no chemotherapy interval (CFI), first follow-up treatment start time (TFST), disease progression or death time after follow-up treatment (PFS2), second follow-up treatment start time (TSST) and updated is analyzedFrom 7 April 2014 to 19 July 2016, a total of 564 patients were recruited and randomly divided into the rucaparib group (375 persons) or the placebo group (189)Median follow-up 28.1 months (IQR 22.0-33.6)In the intended treatment population, the median CFI in the rucaparib group and the placebo group were 14.3 months (95% CI 13.0-17.4) and 8.8 month ;ps (8.0-10.3); 15.2) and 7.2 months (6.4-8.6; HR 0.43 (0.35-0.52) ;p 0.0001), median PFS2 is 21.0 months (18.9-23.6) and 16.5 months (15.2-18.4; HR 0.66 .0.53-0.82), respectively; p-0.0002), median TSST is 22.4 months (19.1-24.5) and 17.3 months (14.9-19.4; HR 0.68 (0.54-0.85); p-0.0007)CFI, TFST, PFS2 and TSST in the Rucaparib group were also significantly longer than in the placebo group for the co-carrier BRCA mutation and homologous recombinant fix defect queueThe most common adverse reactions requiring emergency treatment at level 3 and above were anemia or reduced hemoglobin (22% vs placebo group 1%) in the rucaparib groupAdverse reactions requiring severe emergency treatment were found in 22% of patients in the rucaparib group and 11% in the placebo groupTwo treatment-related deaths have been reported in the past;In this exploratory analysis of more than 2 years of median follow-up, rucaparib maintenance therapy significantly delayed the start of follow-up treatment, and there were significant statistical differences in the compared to placebo in all three of the study groupsThe latest security assessments are consistent with past reports
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