The use of niraparib in women receiving treatment for platinum-sensitive recurrent ovarian cancer did not adversely affect quality of life (QoL), according to a study published in The Lancet Oncology.
An international team of researchers led by Amit M Oza, MD, from the Division of Medical Oncology and Hematology at Princess Margaret Cancer Centre, University Health Network, in Toronto, Ontario, Canada, conducted the ENGOT-OV16/NOVA trial (ClinicalTrials.gov Identifier: NCT01847274), a multicentre, double-blind, phase 3, randomized controlled trial that enrolled patients in 2 independent cohorts determined by germline BRCA (gBRCA) mutation status (gBRCAmut and non-gBRCAmut). Patients were at least 18 years of age and had been diagnosed with epithelial ovarian, fallopian tube, or peritoneal cancer. All patients demonstrated a complete or partially complete response to their penultimate platinum-based treatment regimen, with disease progression >6 months after completion of chemotherapy. Duration of progression-free survival was identified as the primary end point.
Each cohort were randomly assigned (2:1) to receive either niraparib 300 mg or placebo once per day until disease progression. Assignment was based on time to progression following the penultimate platinum-based regimen, previous use of bevacizumab, and best possible response to the last platinum-based regimen. Patient-reported outcomes questionnaires — the Functional Assessment of Cancer Therapy – Ovarian Symptoms Index (FOSI), the European QOL Scale, 5 dimension, 5 level (EQ-5D-5L), and the European QOL Visual Analogue Scale (EQ-VAS) — were used to assess both ovarian cancer symptoms and overall QoL.
The study was conducted from August 28, 2013, to June 1, 2015. A total of 138 patients in the gBRCAmut cohort and 234 in non-gBRCAmut cohort received niraparib; 65 in the gBRCAmut cohort and 116 in the non-gBRCAmut cohort received placebo. Median duration of follow-up was 16.9 months. Patients in the gBRCAmut cohort treated with niraparib had a reduced risk for disease progression (hazard ratio [HR] 0.27) compared with those in the non-gBRCAmut cohort (HR 0.45). Baseline mean FOSI values in both the gBRCAmut and non-gBRCAmut groups were similar (niraparib 25.1 vs 25.6 in placebo for gBRCAmut; niraparib 25.4 v 25.0 in placebo for non-gBRCAmut).
The most common symptoms reported were lack of energy (n=425, 79%) and pain (n=236, 44%), as well as nausea (n=118, 22%). The most frequently reported adverse events in those receiving niraparib included thrombocytopenia (n=124, 34%), anemia (n=93, 25%), and neutropenia (n=72, 20%). However, hematological toxicity did not adversely affect QoL in any cohort.
“The ENGOT-OV16/NOVA trial showed significant improvements in progression-free survival in patients with ovarian cancer for both cohorts, gBRCAmut and non-gBRCAmut,” the authors concluded. “It is important that toxic effects associated with maintenance treatment do not result in a substantial reduction in QoL that offsets the benefit associated with delaying the time to progression or death.”
Oza AM, Matulonis UA, Malander S, et al. Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomised controlled trial [published online July 16, 2018]. Lancet Oncol. doi: 10.1016/S1470-2045(18)30333-4