NEW YORK (Reuters Health) - Results of the ARIEL4 study support the use of the PARP inhibitor rucaparib as an alternative to chemotherapy for patients with relapsed, BRCA1- or BRCA2-mutated ovarian cancer.
"To our knowledge, ARIEL4 is the first study to compare a PARP inhibitor with standard-of-care platinum and non-platinum-based chemotherapy in patients with germline or somatic BRCA1 or BRCA2 mutations and relapsed ovarian carcinoma," researchers report in The Lancet Oncology.
"Our patient population is also distinct from that of previous studies because it included patients with platinum-resistant, partially platinum-sensitive, and fully platinum-sensitive disease. In this broad population, rucaparib significantly improved progression-free survival versus chemotherapy," they add.
The open-label study enrolled 349 patients with relapsed, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, with 233 randomly allocated to rucaparib (600 mg twice daily) and 116 to chemotherapy (administered per institutional guidelines).
Weekly paclitaxel was given to patients who were platinum resistant or partially sensitive and platinum-based chemotherapy monotherapy or doublet regimen was given to those who were fully sensitive to platinum.
Seventy-four patients in the chemotherapy group (64%) who had disease progression crossed over to the rucaparib group.
In the efficacy population (220 on rucaparib and 105 on chemotherapy), median progression-free survival (PFS) was significantly longer with rucaparib than chemotherapy (7.4 vs. 5.7 months; hazard ratio: 0.64; 95% CI, 0.49 to 0.84).
