Introduction/Background* *: The poly(ADP-ribose) polymerase inhibitor olaparib has shown antitumor activity in patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer with or without BRCA1 or BRCA2 mutations. The aim of our study was to assess the efficacy and tolerability of Carboplatin in single agent therapy, followed by olaparib maintenance monotherapy, versus manteinance therapy bevacizumab in elderly patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer according to BRCA status.
Methodology In our retrospective study, old patients (median age 80) with platinum-sensitive, recurrent, high-grade serous ovarian cancer received carboplatin (area under the curve [AUC] 4 mg/mL per min, according to the Calvert formula, administered intravenously on day 1)followed by olaparib monotherapy (400 mg capsules twice daily, given continuously) or Bevacizumab 15 mg/kv ev on day 1 every 21 days until progression The primary endpoint was progression-free survival.
Result(s)*Between Feb 17 and July 30, 2020, 17 patients were eligible and were assigned to the two treatment groups (5 to the olaparib group and 12 to the bevacizumab group). BRCA mutation status was known for all patients (either at baseline or determined retrospectively): 5 of 17 had a BRCA mutation Progression-free survival was significantly longer in the olaparib group (median 24.2 months [95% CI 9.7-15.0]) than in the bevacizumab group (median 9.6 months [95% CI 9.1-9.7) (HR 0.51 [95% CI 0.34-0.77]; p=0.0012), especially in patients with BRCA mutations (HR 0.21 [0.08-0.55]; p=0.0015). Adverse events more commonly reported in the olaparib group than in the placebo group (by more than 10% of patients) were nausea (68% vs. 35%), fatigue (49% vs. 38%), vomiting (32% vs. 14%), and anemia (17% vs. 5%); the majority of adverse events were grade 1 or 2.
Conclusion* *: Carboplatin in monotherapy followed by olaparib in manteinance therapy significantly improved progression-free survival versus bevacizumab plus carboplatin alone, with the greatest clinical benefit in BRCA-mutated patients elderly patients and had an acceptable and manageable tolerability profile.
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