In an analysis of patient-reported outcomes (PROs), patients with newly diagnosed advanced ovarian cancer indicated that niraparib was well-tolerated by patients and was rated similarly to placebo. According to the lead study author, Bhavana Pothuri, MD, of the Gynecologic Oncology Group and Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health, these data suggest that treatment with niraparib has no detrimental effect on quality of life in this patient population.
Niraparib has led to improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer who responded to platinum-based chemotherapy. The drug works by slowing the growth of cancer cells, and is commonly used to treat ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
At the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer, Dr Pothuri and colleagues reported PROs from patients receiving niraparib and placebo in the double-blind, randomized, phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial.
In the study, 733 patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer were randomized to niraparib or placebo once daily for 36 months or until disease progression. All patients had demonstrated a complete or partial response to first-line platinum-based chemotherapy.
The primary end point of the trial was PFS assessed by blinded independent central review. PROs were a secondary end point, and data were collected every 8 weeks for 56 weeks, and then every 12 weeks thereafter while patients were still receiving treatment.
Once a patient discontinued treatment, PRO evaluations were performed at the time of discontinuation and then at approximately 4, 8, 12, and 24 weeks after the end of treatment, regardless of the status of subsequent treatment. The study utilized 4 validated PRO instruments: the Ovarian Symptom Index (FOSI), the European EQ-5D-5L tool, the European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30, and the EORTC-QLQ-OV28.
According to the investigators, niraparib-treated patients and those given placebo showed no difference in health-related quality-of-life scores, according to PRO outcomes from the EORTC-QLQ-C30 and EORTC-QLQ-OV28. Additionally, mean scores between the niraparib and placebo arms were similar at each time point.
SGO 2020 Annual Meeting on Women’s Cancer. Abstract 83.