Are patient-reported outcomes (PROs) similar in the placebo and the niraparib groups, suggesting that over the course of treatment niraparib does not adversely affect patients’ quality of life? Results of the PRIMA/ENGOT-OV26/GOG-3012 trial begin to elucidate the answer to this question.
Bhavana Pothuri, MD, Professor, Obstetrics and Gynecology, at NYU Grossman School of Medicine, New York City, and Director, Gynecologic Oncology Clinical Trials, NYU Langone Medical Center, New York City, presented PROs from the PRIMA/ENGOT-OV26/GOG-3012 clinical trial at the European Society for Medical Oncology Virtual Congress 2020. This double-blind, placebo-controlled phase 3 study further explored the use of the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib, which has been approved for use in heavily pretreated patients as well as maintenance therapy with newly diagnosed or recurrent ovarian cancer patients responsive to platinum-based chemotherapy.
A total of 733 patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy were randomized to receive niraparib. For 36 months or until disease progression, patients received either niraparib therapy or placebo once daily. The primary end point was progression-free survival assessed by blinded independent central review. Secondary end points included PROs and were measured using validated instruments, including the Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index (FOSI), the European Quality of Life–5 Dimensions (EQ-5D-5L), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30), and the EORTC Quality of Life Questionnaire Ovarian Cancer module (EORTC-QLQ-OV28).
There was a high compliance rate with the use of these PRO instruments in the study. These secondary outcomes were assessed for 56 weeks at 8-week intervals then at 12-week intervals thereafter during ongoing treatment. PRO evaluations were administered at the time of treatment discontinuation, and were administered at approximately 4, 8, 12, and 24 weeks after treatment cessation, despite later treatment status.
A significant difference in health-related quality-of-life scores reported by patients receiving niraparib therapy or placebo were not demonstrated by these findings, as evidenced by EORTC-QLQ-C30 and EORTC-QLQ-OV28. At each given point in time, mean scores between the niraparib and placebo cohorts were similar. Highlighting the benefit of treatment, the health utility index of patients who received niraparib demonstrated a slight uptick, translating to a modest improvement trend.
Dr Pothuri concluded that PROs were similar in the placebo group and the niraparib group, suggesting that over the course of treatment niraparib did not negatively affect patients’ quality of life. These findings add to the growing body of evidence, including the PRIMA clinical trial in which patients did not experience decreased quality of life from niraparib treatment,1 and the NOVA study in which PROs indicated similar outcomes for those receiving niraparib and those receiving placebo.2 The PRIMA trial and the NOVA study data showed that patients in the niraparib group reported having a quality of life that was similar to that among patients receiving placebo. In addition, the ENGOT-OV16/NOVA clinical trial demonstrated no meaningful differences between niraparib and placebo in partial and complete response subgroups when they were observed with respect to PROs.3
Source: Pothuri B, et al. Ann Oncol. 2020;31(suppl 4). Abstract 810MO.
1. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381:2391-2402.
2. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154-2164.
3. del Campo JM, Matulonis UA, Malander S, et al. Niraparib maintenance therapy in patients with recurrent ovarian cancer after a partial response to the last platinum-based chemotherapy in the ENGOT-OV16/NOVA trial. J Clin Oncol. 2019;37:2968-2973.