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Clinical Trial
. 2019 Nov 10;37(32):2968-2973.
doi: 10.1200/JCO.18.02238. Epub 2019 Jun 7.

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  1 , Ursula A Matulonis  2 , Susanne Malander  3 , Diane Provencher  4 , Sven Mahner  5 , Philippe Follana  6 , Justin Waters  7 , Jonathan S Berek  8 , Kathrine Woie  9 , Amit M Oza  10 , Ulrich Canzler  11 , Marta Gil-Martin  12 , Anne Lesoin  13 , Bradley J Monk  14 , Bente Lund  15 , Lucy Gilbert  16 , Robert M Wenham  17 , Benedict Benigno  18 , Sujata Arora  19 , Sebastien J Hazard  19 , Mansoor R Mirza  20
Affiliations
Clinical Trial

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 et al. J Clin Oncol. .

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.

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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).
See this image and copyright information in PMC

References

    1. Hanker LC, Loibl S, Burchardi N, et al. The impact of second to sixth line therapy on survival of relapsed ovarian cancer after primary taxane/platinum-based therapy. Ann Oncol. 2012;23:2605–2612. - PubMed
    1. Ledermann JA, Raja FA, Fotopoulou C, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24:vi24–vi32. - PubMed
    1. Tapia G, Diaz-Padilla I. Molecular mechanisms of platinum resistance in ovarian cancer , in Diaz-Padilla I (ed): Ovarian Cancer: A Clinical and Translational Update. Rijeka, Croatia, InTechOpen, 2013, pp 205-223 .
    1. Ledermann JA, Sessa N, Colombo N, et al. http://www.esmo.org/Guidelines/Gynaecological-Cancers/Newly-Diagnosed-an... eUpdate: Ovarian cancer treatment recommendations.
    1. National Comprehensive Cancer Network https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf Clinical practice guidelines in oncology: Ovarian cancer, version 2.2018.

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