ENGOT-OV16/NOVA trial of niraparib in recurrent ovarian cancer: Survival and long-term safety

IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY
Ursula A. Matulonis , Jørn Herrstedt , Amit Oza , Sven Mahner , Andrés Redondo , Dominique Berton , Jonathan S. Berek , Charlotte A. Haslund , Frederik Marmé , Antonio González-Martín , Stéphanie Bécourt , Anna V. Tinker , Jonathan A. Ledermann , Benedict Benigno , Gabriel Lindahl , Nicoletta Colombo , Izabela A. Malinowska , Wenlei Liu , Manjinder Bains , Bradley J. Monk , Mansoor R. Mirza
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引用次数: 0

Abstract

Objective

To evaluate secondary efficacy endpoints and safety for the ENGOT-OV16/NOVA (NCT01847274) trial of niraparib maintenance therapy after extended follow-up and vital-status-data retrieval. Previously reported analyses (data cutoff, October 1, 2020) indicated benefit of niraparib maintenance therapy beyond first progression, but overall survival (OS) analyses were limited by missing data.

Methods

Patients were randomized 2:1 to niraparib (300 mg once daily) or placebo. A vital status check was extended to retrieve last-known-alive status for patients with missing survival data. Prespecified secondary efficacy outcomes (OS, chemotherapy-free interval [CFI], time to first subsequent therapy [TFST], PFS2, time to second subsequent therapy [TSST]) and safety are reported based on the extended data cutoff (March 31, 2021).

Results

Survival status was available for 97.6% (540/553) of randomized patients (germline BRCA [gBRCA]-mutated, 203; non-gBRCA–mutated, 350). Median OS with niraparib and placebo was 40.9 and 38.1 months, respectively, in the gBRCA-mutated cohort (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.61–1.20) and 31.0 and 34.8 months, respectively, in the non-gBRCA–mutated cohort (HR, 1.06; 95% CI, 0.81–1.37). Medians for CFI, TFST, PFS2, and TSST numerically favored niraparib in both cohorts. No new safety signals were detected.

Conclusions

OS did not significantly differ between treatment arms. Prespecified secondary efficacy endpoints numerically favored niraparib. Long-term safety remained consistent with the established niraparib safety profile. Taken together with the significant improvements in PFS observed in the primary analysis, these data support a favorable overall benefit–risk profile for niraparib in the recurrent OC maintenance setting.
尼拉帕利治疗复发性卵巢癌的ENGOT-OV16/NOVA试验:生存期和长期安全性
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来源期刊
Gynecologic oncology
Gynecologic oncology 医学-妇产科学
CiteScore
8.60
自引率
6.40%
发文量
1062
审稿时长
37 days
期刊介绍: Gynecologic Oncology, an international journal, is devoted to the publication of clinical and investigative articles that concern tumors of the female reproductive tract. Investigations relating to the etiology, diagnosis, and treatment of female cancers, as well as research from any of the disciplines related to this field of interest, are published. Research Areas Include: • Cell and molecular biology • Chemotherapy • Cytology • Endocrinology • Epidemiology • Genetics • Gynecologic surgery • Immunology • Pathology • Radiotherapy
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