In a study reported in The Lancet Oncology, Oza et al found that quality of life (QOL) based on patient-reported outcomes (PROs) was not worsened with niraparib (Zejula) maintenance vs placebo in the phase III ENGOT-OV16/NOVA trial in women with recurrent ovarian cancer who were in response to their last platinum-based chemotherapy. The trial showed that niraparib treatment resulted in significantly longer progression-free survival vs placebo, regardless of germline BRCA status.
In the trial, 553 patients were randomized to receive niraparib 300 mg/d (n = 138 in a germline BRCA-mutant [gBRCAmut] cohort, n = 234 in a non-gBRCAmut cohort) or placebo (n = 65 in the gBRCAmut cohort, n = 116 in the non-gBRCAmut cohort). PROs were assessed using the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI) and European QOL five-dimension five-level questionnaire (EQ-5D-5L).
Mean FOSI scores at baseline were similar between the two groups (25.0–25.6). Overall QOL scores remained stable during treatment and preprogression periods in the niraparib group, with no significant differences observed between the niraparib and placebo groups. Preprogression EQ-5D-5L scores did not differ significantly between niraparib patients and placebo patients in the gBRCAmut cohort (0.838 vs 0.834; 0.850 vs 0.847 at baseline) or non-gBRCAmut cohort (0.833 vs 0.815; 0.837 vs 0.824 at baseline).
Among FOSI symptoms, the most common adverse events reported at baseline among all patients were lack of energy (79%), pain (44%), and nausea (22%). Among these and bloating, cramping, and vomiting, all symptoms except nausea remained stable or improved in the niraparib group. The most common grade 3 or 4 adverse events in the niraparib group were the hematologic toxicities of thrombocytopenia (34%), anemia (25%), and neutropenia (20%); these adverse events had no significant effect on QOL vs patients without these adverse events in either the gBRCAmut cohort or non-gBRCAmut cohort in adjusted (histology, region, previous treatment, age, planned treatment, and baseline score) or unadjusted FOSI models.
The investigators concluded, “These PRO data suggest that women who receive niraparib as maintenance treatment for recurrent ovarian cancer after responding to platinum treatment are able to maintain QOL during their treatment when compared with placebo.”
The study was funded by TESARO.
Amit M. Oza, MD, of the Princess Margaret Cancer Centre, University Health Network, Toronto, is the corresponding author for The Lancet Oncology article.
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