Ann Oncol: Issue 3 | Nirapali maintains efficacy in treating patients with platinum-sensitive relapse ovarian cancer in China

This study evaluated the maintenance effect of the PARP inhibitor Niraparib on patients with platinum-sensitive relapsed ovarian cancer.
The two-blind placebo-controlled Phase 3 trial, conducted in 30 centers in China, randomized two groups (2:1) of patients with platinum-sensitive relapsed ovarian cancer who had responded to the previous platinum chemotherapy and were taken or oral nirapali (300 mg/day) or matched placebo until the disease progressed or becoming unenforceable toxicity.
With the modification of the programme, the dose of the drug was changed to an individualized starting dose (ISD) of 200 mg/day for patients with a weight of 77 kg or plate plate count of 150×103/μL, and the remaining patients remained unchanged.
randomized through an interactive network response system and stratified according to BRCA mutations, relapse time after penultimate chemotherapy, and response to recent chemotherapy.
end point is progress-free lifetime (PFS).
between September 26, 2017 and February 2, 2019, a total of 265 patients were randomly divided into two groups: 177 in the Nirapali group, 88 in the placebo group, and 249 patients who received ISD (300 mg, n=14;200 mg, n=235) as a result of the programme.
in patients in the intended treatment group, the mid-level PFS in the Nirapali group was significantly longer than in patients in the placebo group: 18.3 vs. 5.4 months (risk ratio of 0.32) Similar PFS benefits were observed in patients treated with ISD, regardless of the BRCA mutation status, at 95% CI 0.23-0.45;p<0001.
Patients with BRCA mutation had no progression survival rate of no progression survival rate in patients without BRCA mutation, nirapali group and placebo group ≥ the risk of adverse events requiring emergency treatment at level 3 was 50.8% and 19.3%, respectively; the most common were a decrease in nexus cell count (20.3 vs 8.0%) and anemia (14.7 vs 2.3%).
, Nirapali maintenance therapy reduced the risk of disease progression or death in patients with platinum-sensitive relapsed ovarian cancer by 68 percent compared to placebo, while extending PFS.
addition, individualized dosing is effective and safe, or can be used as a standard therapy in such cases.