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

Josep M Del Campo, Ursula A Matulonis, Susanne Malander, Diane Provencher, Sven Mahner, Philippe Follana, Justin Waters, Jonathan S Berek, Kathrine Woie, Amit M Oza, Ulrich Canzler, Marta Gil-Martin, Anne Lesoin, Bradley J Monk, Bente Lund, Lucy Gilbert, Robert M Wenham, Benedict Benigno, Sujata Arora, Sebastien J Hazard, Mansoor R Mirza, Josep M Del Campo, Ursula A Matulonis, Susanne Malander, Diane Provencher, Sven Mahner, Philippe Follana, Justin Waters, Jonathan S Berek, Kathrine Woie, Amit M Oza, Ulrich Canzler, Marta Gil-Martin, Anne Lesoin, Bradley J Monk, Bente Lund, Lucy Gilbert, Robert M Wenham, Benedict Benigno, Sujata Arora, Sebastien J Hazard, Mansoor R Mirza

Abstract

Purpose: In the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.

Patients and methods: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index.

Results: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.

Conclusion: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.

Figures

FIG 1.
FIG 1.
Study enrollment and outcomes. BRCA, breast cancer susceptibility gene. Reprinted with permission.
FIG 2.
FIG 2.
Kaplan-Meier curves for progression-free survival in patients with a partial response (PR) to their last platinum-based therapy in the (A) gBRCAmut and (B) non-gBRCAmut cohorts, and patients with a complete response (CR) to their last platinum-based therapy in the (C) gBRCAmut and (D) non-gBRCAmut cohorts. gBRCAmut, germline breast cancer susceptibility gene mutation; HR, hazard ratio.
FIG A1.
FIG A1.
Individual FOSI measures over time by best response to last platinum. BL, baseline; CR, complete response; PR, partial response.
FIG A1.
FIG A1.
(Continued).

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Source: PubMed

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