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There are few prospective studies comparing the efficacy of PARP inhibitors with chemotherapy in BRCA1 or BRCA2 mutated ovarian cancer
.
The aim of this study was to evaluate the efficacy of the PARP inhibitor lucaparib versus platinum-based and non-platinum-based chemotherapy in BRCA1/2-mutated ovarian cancer
To evaluate the efficacy of the PARP inhibitor lucaparib versus platinum-based and non-platinum-based chemotherapy in BRCA1/2-mutated ovarian cancer
This is an open-label, randomized, controlled Phase 3 study (ARIEL4) in 64 hospitals and cancer centers in multiple countries, recruiting BRCA1 or BRCA2 mutations in patients 18 years of age and older who have received at least 2 prior chemotherapy treatments of ovarian cancer patients
.
Patients were randomized (2:1) to receive oral lucaparib (600 mg, 2/day) or chemotherapy
In the efficacy analysis population, progression-free survival in both groups
In the efficacy analysis population, progression-free survival in both groupsBetween March 1, 2017, and September 24, 2020, a total of 930 patients were screened, of whom 349 eligible patients (median age 58 years, 95% white) were randomized to lucapa benefit group (n=233) or chemotherapy group (n=116)
.
As of September 30, 2020, the median follow-up was 25.
In the efficacy analysis population (220 in the rucaparib group and 105 in the chemotherapy group), the median progression-free survival was 7.
In the intention-to-treat population, progression-free survival in both groups
In the intention-to-treat population, progression-free survival in both groupsThe most common adverse reactions requiring urgent treatment were grade 1/2
.
The most common grade 3 or higher adverse reactions were anemia or hemoglobin reduction (lucaparib vs chemotherapy: 22% vs 5%)
The most common adverse reactions of grade 3 and above are anemia or decreased hemoglobin The most common adverse reactions of grade 3 and above are anemia or decreased hemoglobin
Taken together, the results of the ARIEL4 study support lucaparib as an alternative treatment option for chemotherapy in recurrent, BRCA1- or BRCA2-mutated ovarian cancer
Lucaparib as an alternative to chemotherapy in recurrent, BRCA1 or BRCA2-mutated ovarian cancer Lucaparib as an alternative to chemotherapy in recurrent, BRCA1 or BRCA2-mutated ovarian cancer
Original source:
Original source:Rebecca Kristeleit, et al.
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