Quality of life comparable between niraparib, placebo in advanced ovarian cancer
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Patients with gynecologic cancers that responded to first-line platinum-based chemotherapy receiving niraparib did not show lower health-related quality of life compared with placebo, according to data presented at ESMO Virtual Congress 2020.
Bhavana Pothuri, MD, of the Gynecologic Oncology Group and Perlmutter Cancer Center, NYU Langone Health, and colleagues examined patient-reported outcomes in 733 newly diagnosed patients who received niraparib and placebo in the PRIMA/ENGOT-OV26/GOG-3012 trial. Patients received niraparib (Zejula, GlaxoSmithKline) or placebo once daily for 3 years or until disease progression.
Researchers examined progression-free survival and patient-reported outcomes using four validated patient-reported outcomes instruments (FOSI, EQ5D-5L, EORTC-QLQ-C30 and EORTC-QLQ-OV28) collected every 8 weeks for 56 weeks, then every 12 weeks thereafter during ongoing treatment. Patient-reported outcomes evaluation were conducted at the time a patient discontinued treatment as well as at 4, 8, 12 and 24 weeks post-treatment, regardless of status of later treatment, according to the abstract.
Patient compliance rates were high — greater than 80% — across all PRO instruments, according to Pothuri.
Analysis of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 instruments indicated no difference in health-related quality of life scores among patients treated with niraparib compared with placebo.
“FOSI scores between niraparib and placebo were comparable,” Pothuri said in the presentation. “Quality of life were comparable between niraparib and placebo, as indicated by the EORTC-QLQ-C30 instrument. Abdominal/GI symptoms and other chemotherapy effects were comparable in both arms, as assessed by the EORTC-QLQ-OV28.”
Further, the investigators reported similar average scores between the niraparib and placebo arms at each time point and the overall health utility index demonstrated a slight improvement trend in patients who received niraparib compared with those who received placebo.
“Consistent with PRO results in the NOVA study, patients receiving niraparib in the PRIMA trial did not experience a decrement in quality of life compared with placebo during their treatment, despite AEs, including greater than grade 3 hematologic toxicity,” Pothuri concluded.
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Pothuri B, et al. Abstract 810MO. Presented at: European Society for Medical Oncology Virtual Congress 2020; Sept. 19-21, 2020.
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