Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Division of Cancer Care and Epidemiology, Queen's University, Kingston, Ontario, Canada.
Gynecol Oncol. 2024 May;184:51-56. doi: 10.1016/j.ygyno.2024.01.027. Epub 2024 Jan 28.
The addition of bevacizumab to chemotherapy for platinum-resistant (PL-R) ovarian cancer (OC) improved progression-free (PFS) but not overall survival (OS) in clinical trials. We explored real-world outcomes in Ontario, Canada, and compared survival in the pre- and post-bevacizumab era.
Administrative databases were utilized to identify all patients treated with bevacizumab for PL-R OC. Time on treatment (ToT) was used as surrogate for PFS. Median OS was determined using the Kaplan-Meier method. Factors associated with ToT/OS were identified using a Cox proportional hazard model. A before and after comparative effectiveness analysis was performed to determine mOS for patients treated pre- and post-bevacizumab approval.
From 2017 to 2019, 176 patients received bevacizumab. Median ToT was 3 months and OS was 11 months. Sixty-four percent received liposomal doxorubicin and 34% received paclitaxel. ToT (6 vs 3 months; HR 0.44; p < 0.0001) and OS (14 vs 9 months; HR 0.45; p = 0.0089) were longer with bevacizumab/paclitaxel. OS was not significantly different pre- and post-bevacizumab funding (8 vs 9 months; HR 1.01; 0.937). Median OS increased for those receiving paclitaxel (6 vs 11 months), but those in the post group were younger, more likely to have undergone primary surgery and had less co-morbidities.
Real-world outcomes with bevacizumab in PL-R OC are inferior to those in the pivotal clinical trial. Survival has not significantly improved since funding became publicly available, indicating a substantial efficacy-effectiveness gap between trial and real-world outcomes. Median OS and ToT were significantly better when bevacizumab was given with paclitaxel.
贝伐珠单抗联合化疗治疗铂耐药(PL-R)卵巢癌(OC)可改善无进展生存期(PFS),但不能改善总生存期(OS),这在临床试验中已得到证实。本研究旨在探索加拿大安大略省的真实世界结局,并比较贝伐珠单抗治疗前后的生存情况。
利用行政数据库确定所有接受贝伐珠单抗治疗 PL-R OC 的患者。治疗时间(ToT)被用作 PFS 的替代指标。采用 Kaplan-Meier 法确定中位 OS。采用 Cox 比例风险模型确定与 ToT/OS 相关的因素。进行贝伐珠单抗批准前后的比较有效性分析,以确定接受贝伐珠单抗治疗前和批准后患者的 mOS。
2017 年至 2019 年,176 例患者接受了贝伐珠单抗治疗。中位 ToT 为 3 个月,OS 为 11 个月。64%的患者接受脂质体多柔比星治疗,34%的患者接受紫杉醇治疗。贝伐珠单抗/紫杉醇组的 ToT(6 个月 vs 3 个月;HR 0.44;p<0.0001)和 OS(14 个月 vs 9 个月;HR 0.45;p=0.0089)均较长。贝伐珠单抗资助前后 OS 无显著差异(8 个月 vs 9 个月;HR 1.01;0.937)。接受紫杉醇治疗的患者中位 OS 增加(6 个月 vs 11 个月),但后一组患者年龄较小,更有可能接受初次手术,合并症较少。
PL-R OC 中贝伐珠单抗的真实世界结局不如关键临床试验中的结局。自资金公开以来,生存状况并未显著改善,这表明试验和真实世界结局之间存在显著的疗效-有效性差距。当贝伐珠单抗与紫杉醇联合使用时,中位 OS 和 ToT 显著改善。