Quality of life measures were similar to those taking placebo

The PARP inhibitor niraparib as maintenance following chemotherapy was well tolerated and was found to have no detrimental effect on quality of life for women with advanced ovarian cancer compared with placebo, according to an analysis of patient-reported outcomes from the PRIMA/ENGOT-OV26/GOG-3012 trial.

Niraparib “did not negatively impact quality of life, even though there were adverse events, including grade ≥ 3 hematologic toxicity,” lead author Bhavana Pothuri, MD, of the Gynecologic Oncology Group and Perlmutter Cancer Center, NYU Langone Health, New York, told BreakingMED in an email correspondence about the study.

It is crucial that the tolerability and impact on quality of life of cancer therapies be evaluated, emphasized Pothuri. “This is especially true of a maintenance therapy, where we are not actively treating cancer but trying to prevent or delay a recurrence,” she said.

For the phase III PRIMA/ENGOT-OV26/GOG-3012 trial, 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 or placebo once daily for 36 months or until disease progression. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review. As has been previously reported, niraparib improved PFS in both the homologous recombination deficiency and overall populations.

“[T]he median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months versus 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31-0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50-0.76; P<0.001),” Pothuri and colleagues reported in the New England Journal of Medicine. “At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44-1.11).”

For the current analysis, the researchers reported on the secondary endpoint of the trial — patient-reported outcomes, which were collected every 8 weeks for 56 weeks and then every 12 weeks thereafter while patients were receiving treatment. Once patients discontinued treatment, patient-reported outcomes evaluations were performed at the time of treatment discontinuation and then again at 4, 8, 12, and 24 weeks (± 1 week for each timepoint) after the end of treatment, regardless of the status of subsequent treatment. Patient-reported outcomes were measured using the following validated instruments: Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), which was scored from 0 to 32; the EuroQol 5-Dimension 5 (EQ-5D-5L), scored from 0 to 1 on each of 5 domains; and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ) C30, and OV28, each of which were scored from 0 to 100.

The findings were to be presented at the Society for Gynecologic Oncology 2020 annual meeting, planned to take place in Toronto, Canada, from March 28-31. The conference was cancelled due to the Covid-19 pandemic, but the study abstracts were subsequently released online.

“One of the strengths of this study is that the investigators used a number of different patient-reported outcome measurements… to assess quality of life,” Lisa Landrum, MD, PhD, from the Stephenson Cancer Center in Oklahoma City, told BreakingMED in an emailed comment on the study. Still, questions remain as to whether these measures are sensitive enough to detect differences in quality of life in the maintenance setting, where differences between treatment and placebo groups may be subtle. It also remains unclear whether quality of life parameters might vary by patient demographic factors such as ethnicity, socioeconomic status, and education.

Fundamentally, however, the news is good. “Most patients are very eager to complete their platinum-based chemotherapy following cytoreductive surgery as front-line therapy for advanced ovarian cancer,” said Landrum. “However, we can now counsel patients that niraparib can be used as a maintenance strategy to extend the time to recurrence without compromising quality of life compared to placebo.”

“Clinicians… can tell their patients that taking the drug is effective in preventing or delaying [cancer] recurrence, and… it will not affect their overall quality of life,” echoed Pothuri. “Despite some on the side effects patients may have with the drug, it did not impair patients in their daily lives, and their functional health status.”

  1. The use of niraparib as maintenance following platinum-based chemotherapy for newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer did not affect quality of life, compared with placebo.

  2. Use of niraparib in the maintenance setting can delay the time to cancer recurrence without compromising quality of life, despite producing some side effects.

Alison Palkhivala, Contributing Writer, BreakingMED™

Pothuri reports being on the executive steering committee for PRIMA/ENGOT-OV26/GOG-3012 and receiving clinical trial support for conducting this trial by GlaxoSmithKline/Tesaro at her institution.

This study was funded by GlaxoSmithKline.

Landrum reported no conflicts of interest.

Cat ID: 445

Topic ID: 78,445,730,445,692,192,356