Characteristics and real-world outcomes of patients with epithelial ovarian cancer who received niraparib plus bevacizumab first-line maintenance therapy in the COMB1NE study.

IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY International Journal of Gynecological Cancer Pub Date : 2024-12-02 DOI:10.1136/ijgc-2024-005611
Premal H Thaker, Tirza Areli Calderón Boyle, Sara Burns, Jonathan Lim, John Hartman, Linda V Kalilani, Jeanne M Schilder, Jean A Hurteau, Amanda K Golembesky
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Abstract

Objective: In the phase 2 OVARIO trial (NCT03326193) investigating niraparib-bevacizumab first-line maintenance, median progression-free survival was 14.2 months (95% confidence interval (CI) 8.6 to 16.8) for patients with homologous recombination (HR)-proficient (HRp) epithelial ovarian cancer, and 12.1 months (95% CI8.0-not evaluated) for patients with undefined HR status. However, real-world data are limited for patients who receive niraparib-bevacizumab first-line maintenance therapy. The COMB1NE study describes real-world clinical outcomes (time to treatment discontinuation; time to next treatment) in patients with epithelial ovarian cancer who received niraparib-bevacizumab first-line maintenance, regardless of first-line bevacizumab use.

Methods: This real-world, retrospective study used a US nationwide electronic health record-derived deidentified database. Eligible patients were 18 years or older at initial epithelial ovarian cancer diagnosis and initiated niraparib-bevacizumab first-line maintenance (January 1, 2017-September 2, 2022) following first-line treatment. The index date was the start of first-line maintenance. Patients were followed until death, last clinical activity, or end of study, whichever occurred first. Time to treatment discontinuation and time to next treatment, a proxy for real-world progression-free survival, were estimated using the Kaplan-Meier method.

Results: Among 59 included patients, the median age was 67 years (interquartile range (IQR) 61-76), and 81.4% had stage III/IV epithelial ovarian cancer at diagnosis. Overall, 83.1% of patients had BRCA wild-type with either HRp or HR status unknown disease. Median time to treatment discontinuation of first-line maintenance was 11.8 months (95% CI 8.7 to 13.5). Median time to next treatment was 14.1 months (95% CI 11.3 to 16.6). At 6 months after index, 77.9% of patients had not initiated second-line treatment; at 12 months, 61.3% had not.

Conclusion: In this real-world study of patients receiving niraparib-bevacizumab first-line maintenance, the majority of whom had HRp/HR status unknown, the median time to next treatment was consistent with observed progression-free survival in patients with similar HR status in the OVARIO study.

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在 COMB1NE 研究中接受尼拉帕利加贝伐珠单抗一线维持治疗的上皮性卵巢癌患者的特征和实际疗效。
研究目的在研究尼拉帕利-贝伐单抗一线维持治疗的 2 期 OVARIO 试验(NCT03326193)中,同源重组(HR)熟练(HRp)上皮性卵巢癌患者的中位无进展生存期为 14.2 个月(95% 置信区间(CI)8.6 至 16.8),HR 状态未定义的患者的中位无进展生存期为 12.1 个月(95% CI8.0-未评估)。然而,接受尼拉帕利-贝伐单抗一线维持治疗的患者的实际数据却很有限。COMB1NE研究描述了接受尼拉帕利-贝伐珠单抗一线维持治疗的上皮性卵巢癌患者的真实世界临床结果(治疗中止时间;下一次治疗时间),无论一线是否使用贝伐珠单抗:这项真实世界的回顾性研究使用了美国全国范围内的电子健康记录衍生去标识数据库。符合条件的患者在初次诊断上皮性卵巢癌时年满18岁,并在一线治疗后开始尼拉帕利-贝伐珠单抗一线维持治疗(2017年1月1日至2022年9月2日)。指标日期为一线维持治疗的开始日期。患者随访至死亡、最后一次临床活动或研究结束,以先发生者为准。采用 Kaplan-Meier 法估算了患者停止治疗的时间和接受下一次治疗的时间(即真实世界的无进展生存期):在59名纳入患者中,中位年龄为67岁(四分位间距(IQR)为61-76),81.4%的患者在确诊时为III/IV期上皮性卵巢癌。总体而言,83.1%的患者为BRCA野生型,HRp或HR状态未知。停止一线维持治疗的中位时间为11.8个月(95% CI为8.7至13.5)。下一次治疗的中位时间为 14.1 个月(95% CI 11.3 至 16.6)。指数测定后6个月,77.9%的患者尚未开始二线治疗;12个月时,61.3%的患者尚未开始二线治疗:在这项针对尼拉帕利-贝伐单抗一线维持治疗患者的真实世界研究中,大部分患者的HRp/HR状态不明,下一次治疗的中位时间与OVARIO研究中观察到的HR状态相似的患者的无进展生存期一致。
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来源期刊
CiteScore
6.60
自引率
10.40%
发文量
280
审稿时长
3-6 weeks
期刊介绍: The International Journal of Gynecological Cancer, the official journal of the International Gynecologic Cancer Society and the European Society of Gynaecological Oncology, is the primary educational and informational publication for topics relevant to detection, prevention, diagnosis, and treatment of gynecologic malignancies. IJGC emphasizes a multidisciplinary approach, and includes original research, reviews, and video articles. The audience consists of gynecologists, medical oncologists, radiation oncologists, radiologists, pathologists, and research scientists with a special interest in gynecological oncology.
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