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贝伐珠单抗联合化疗治疗铂耐药卵巢癌的真实世界结局。

Real-world outcomes associated with bevacizumab combined with chemotherapy in platinum-resistant ovarian Cancer.

机构信息

Division of Medical Oncology, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.

Division of Cancer Care and Epidemiology, Queen's University, Kingston, Ontario, Canada.

出版信息

Gynecol Oncol. 2024 May;184:51-56. doi: 10.1016/j.ygyno.2024.01.027. Epub 2024 Jan 28.

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

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。

方法

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。

结果

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。

结论

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。

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