A phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO

IF 4.1 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Gynecologic oncology Pub Date : 2025-07-01 DOI:10.1016/j.ygyno.2025.06.014

Melissa M. Hardesty , Thomas C. Krivak , Gail S. Wright , Erika Hamilton , Evelyn L. Fleming , Jimmy Belotte , Shelby Gorman , Natalie Compton , Aine Clements , Heidi J. Gray , Gottfried E. Konecny , Richard G. Moore , Debra L. Richardson

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Abstract

Objective

To report long-term outcomes from the OVARIO trial of niraparib plus bevacizumab maintenance following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer.

Methods

The phase 2, single-arm, open-label trial enrolled adult patients with stage IIIB–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have attempted debulking surgery and have a complete or partial response or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was 18-month progression-free survival (PFS) rate, per RECIST. Secondary endpoints included PFS, overall survival (OS), safety, and health-related quality of life (HRQOL) as assessed by the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI). Final analysis cutoff date, August 12, 2024.

Results

The median duration of follow-up was 65.7 months. Among evaluable patients (N = 105), PFS results were consistent with the primary analysis. Median OS (95% CI) was 61.1 months (44.9 months–not evaluable [NE]; 52.4% maturity) in the overall population, NE (58.2 months–NE) in the homologous recombination-deficient, 38.7 months (21.9–63.8 months) in the homologous recombination-proficient, and 39.8 months (21.7 months–NE) in the homologous recombination status not determined subgroups. Most patients (73.3%) received subsequent anticancer therapy; 30.5% received subsequent PARP inhibitor therapy. No new safety signals were identified; safety remained consistent with the primary analysis. Per FOSI, HRQOL was not negatively affected.

Conclusion

In OVARIO, median OS was 61.1 months in the overall population. Safety was consistent with known safety profiles of niraparib and bevacizumab as monotherapies.

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一项尼拉帕尼加贝伐单抗维持治疗的2期试验，在贝伐单抗治疗晚期卵巢癌的一线铂基化疗后：OVARIO的最终分析和总生存结果

目的：报告在贝伐单抗治疗晚期卵巢癌的一线铂基化疗后，尼拉帕尼加贝伐单抗维持的OVARIO试验的长期结果。方法：这项2期、单臂、开放标签试验招募了IIIB-IV期上皮性卵巢癌、输卵管癌或原发性腹膜癌（NCT03326193）的成年患者。患者需要尝试减体积手术，并且在一线铂基化疗和贝伐单抗≥3个周期后有完全或部分缓解或无疾病证据。根据RECIST，主要终点是18个月无进展生存（PFS）率。次要终点包括PFS、总生存期（OS）、安全性和健康相关生活质量（HRQOL），由癌症治疗功能评估-卵巢症状指数（FOSI）评估。最终分析截止日期为2024年8月12日。结果中位随访时间为65.7个月。在可评估的患者（N = 105）中，PFS结果与初步分析一致。中位OS （95% CI）为61.1个月(44.9个月，不可评估[NE]；同源重组缺乏组NE(58.2个月- NE)，同源重组熟练组38.7个月（21.9-63.8个月），同源重组状态未确定组39.8个月（21.7个月- NE）。大多数患者（73.3%）接受了后续抗癌治疗；30.5%的患者接受了PARP抑制剂治疗。没有发现新的安全信号;安全性与初步分析一致。根据FOSI， HRQOL没有受到负面影响。结论OVARIO中位总生存期为61.1个月。安全性与已知的尼拉帕尼和贝伐单抗作为单一疗法的安全性一致。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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