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The Phase 3 ARIEL3 study compared the clinical efficacy of rucaparib and placebo maintenance for the treatment of relapsed ovarian cancer, and showed that Rucapari had significant clinical benefits compared to placebo.
Oza and others conducted an ex post-mortem analysis of the trial to assess quality-corrected progress-free lifetime (QA-PFS) and asymptomatic or toxic time (Q-TWiST).
ARIEL3 were randomly assigned to the Rukapali group (600 mg 2/day) or placebo group in patients with platinum-sensitive, relapsed ovarian cancer.
as of April 15, 2017, the average QA-PFS in the Rukapali group (375) was significantly longer than in the placebo group (189) (a difference of 6.28 months); In the (HRD) queue (236 vs 118) and the patients with low BRCA wild or miscellaneous absence (LOH) (107 vs 54), the average QA-PFS in the Rukapali group was also significantly longer than in the placebo group (differences of 9.37 months, 7.93 months and 2.71 months, respectively).
the average Q-TWiST difference between the Rukapali group and the placebo group in the ITT population, BRCA mutation queue, HRD queue and BRCA wild type/LOH low patient group was 6.88 months, 9.73 months, 8.11 months and 3.35 months, respectively, using TOX defined by level 3 TEAE.
summary: The significant difference between QA-PFS and Q-TWiST between Rukapali and placebo proves that Rukapali's benefits are significantly better than that of placebo in all predetermined queues.
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