QUADRA Trial: Niraparib Active in Late-Line Ovarian Cancer
Posted: Tuesday, May 14, 2019
For some women with heavily pretreated ovarian cancer, a fourth- or later-line treatment with the PARP inhibitor niraparib may make sense, according to results from the phase II QUADRA trial, published in The Lancet Oncology. In patients with homologous recombination deficiency (HRD)–positive tumors who were sensitive to their last platinum-based therapy, the response rate to niraparib was 28%.
Kathleen N. Moore, MD, of the University of Oklahoma’s Stephenson Cancer Center, Oklahoma City, and colleagues enrolled women from 50 U.S. and Canadian treatment sites between 2015 and 2017. All patients had relapsed, high-grade serous (grade 2 or 3) epithelial ovarian, fallopian tube, or primary peritoneal cancer and had received at least 3 previous chemotherapy regimens.
A total of 189 women with HRD-positive and 230 with HRD-negative or -unknown disease were included the final PARP inhibitor–naive modified per-protocol population of 419 patients. Of those with HRD-positive disease, 47 were platinum-sensitive to their last treatment; 18 of these women had BRCA-mutated disease and 29 had BRCA wild-type disease. The trial’s primary endpoint, explained the authors, was investigator-assessed confirmed overall response among these 47 patients.
Ultimately, 13 of the 47 women achieved an overall response (28%; one-sided P = .00053). The median duration of response was 9.2 months (range, 5.9 to not estimable), and the median progression-free survival was 5.5 months (95% confidence interval = 3.5–8.2 months), noted Dr. Moore and colleagues.
In patients with late-line ovarian cancer, “a particularly challenging population to treat,” niraparib demonstrated “clinically relevant activity [with] no new safety signals,” the team concluded. Given the “current treatment landscape in this area of high unmet need…, niraparib could…be considered an alternative to established chemotherapy regimens” in these patients, especially those with HRD-positive disease, no matter what their BRCA status.
Disclosure: The study authors’ disclosure information may be found at thelancet.com.