Hardesty Melissa M, Krivak Thomas C, Wright Gail S, Hamilton Erika, Fleming Evelyn L, Belotte Jimmy, Gorman Shelby, Compton Natalie, Clements Aine, Gray Heidi J, Konecny Gottfried E, Moore Richard G, Richardson Debra L
Alaska Women's Cancer Center, Anchorage, AK, USA.
The Western Pennsylvania Hospital, Pittsburgh, PA, USA.
Gynecol Oncol. 2025 Aug;199:96-102. doi: 10.1016/j.ygyno.2025.06.014. Epub 2025 Jul 1.
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.
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.
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.
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.
报告在晚期卵巢癌患者中，尼拉帕利联合贝伐珠单抗一线铂类化疗加贝伐珠单抗维持治疗的长期疗效。
这项2期单臂开放标签试验纳入了年龄≥18岁、组织学类型为上皮性卵巢癌、输卵管癌或原发性腹膜癌、分期为IIIB-IV期的患者（NCT03326193）。患者需接受过减瘤手术，且在一线含铂化疗联合≥3个周期贝伐珠单抗治疗后获得完全缓解、部分缓解或疾病稳定。主要终点是根据RECIST标准评估的18个月无进展生存期（PFS）率。次要终点包括PFS、总生存期（OS）、安全性以及通过癌症治疗功能评估-卵巢症状指数（FOSI）评估的健康相关生活质量（HRQOL）。最终分析截止日期为2024年8月12日。
中位随访时间为65.7个月。在可评估患者（n = 105）中，PFS结果与初步分析一致。总体人群的中位OS（95% CI）为61.1个月（44.9个月-不可评估[NE]；52.4%成熟度），同源重组缺陷人群中为NE（58.2个月-NE），同源重组 proficient人群中为38.7个月（21.9-63.8个月），同源重组状态未确定亚组中为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%接受了后续PARP抑制剂治疗。未发现新的安全信号；安全性与初步分析一致。根据FOSI，HRQOL未受到负面影响。
在OVARIO试验中，总体人群的中位OS为61.1个月。安全性与尼拉帕利和贝伐珠单抗单药治疗已知的安全性特征一致。
