Niraparib maintenance therapy prolonged the time without symptoms or toxicity compared with placebo among women with recurrent ovarian cancer, according to results of a randomized phase 3 trial presented at Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.
Researchers observed the benefit regardless of patients’ BRCA mutation status.
Previous studies demonstrated that niraparib (Zejula, Tesaro) — a poly(ADP-ribose) polymerase (PARP) inhibitor — significantly extended PFS among women with recurrent ovarian cancer.
“When patients with recurrent ovarian cancer enter into a remission following platinum-based treatment, they now have the option to prolong their [PFS] with a PARP inhibitor,” Ursula A. Matulonis, MD, director and chief of gynecologic oncology at Dana-Farber Cancer Institute, said in a press release. “It’s really important to demonstrate that, if we’re adding a maintenance therapy, we’re not significantly altering women’s quality of life.”
The study by Matulonis and colleagues specifically investigated the time without symptoms or toxicity among women who received niraparib as maintenance therapy compared with placebo.
The analysis included 203 women with germline BRCA mutations (niraparib, n = 138; placebo, n = 65) and 350 without germline BRCA mutations (niraparib, n = 234; placebo, n = 116).
Symptomatic adverse events included were grade 2 and higher fatigue, nausea and vomiting.
Researchers calculated toxicity time as the number of days a patient experienced an adverse event after randomization but prior to disease progression. They estimated time without symptoms or toxicity as the difference between mean PFS and mean toxicity time between niraparib and placebo. Alternative survival models for estimating mean PFS were used to explore uncertainty.
Among women with germline BRCA mutations, treatment with niraparib conferred a mean PFS benefit of 3.23 years and a mean toxicity time of 0.28 years compared with placebo, for a mean time without symptoms or toxicity benefit of 2.95 years.
Among women without BRCA mutations, niraparib treatment resulted in a mean PFS benefit of 1.44 years and a mean toxicity time of 0.1 years compared with placebo, for a mean symptoms/toxicity time benefit of 1.34 years.
“All of these maintenance studies have a quality-of-life component to the trials,” Matulonis said. “Quality of life is very important so that patients can take these drugs without experiencing unacceptable toxicities and keep their cancer in remission.” – by John DeRosier
Matulonis UA, et al. Abstract 1. Presented at: Society of Gynecologic Oncology Annual Meeting; March 16-19, 2019; Honolulu.
Disclosure s : HemOnc Today could not confirm the authors’ relevant financial disclosures at the time of reporting.