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贝伐珠单抗治疗转移性结直肠癌老年患者的疗效:四项随机研究的汇总分析。

Effect of bevacizumab in older patients with metastatic colorectal cancer: pooled analysis of four randomized studies.

机构信息

Cancer Research UK, Glasgow, UK.

出版信息

J Cancer Res Clin Oncol. 2010 May;136(5):737-43. doi: 10.1007/s00432-009-0712-3. Epub 2009 Nov 11.

Abstract

BACKGROUND

Bevacizumab is frequently combined with 5-fluorouracil-based chemotherapy for patients with metastatic colorectal cancer (mCRC). The relative benefit of bevacizumab in older patients has not been widely studied and is of interest.

PATIENTS AND METHODS

This retrospective analysis used data from three first-line randomized controlled studies and one second-line randomized controlled study of bevacizumab plus chemotherapy in medically fit (Eastern Cooperative Oncology Group performance status 0 or 1) patients with mCRC. Overall survival (OS) and on-treatment progression-free survival (PFS) were assessed in patients aged <65, > or =65, and > or =70 years. Results were compared using unstratified hazard ratios (HRs). Grade 3-5 adverse events were also assessed.

RESULTS

Bevacizumab statistically significantly improved PFS [HR 0.58; 95% confidence interval (CI) 0.49-0.68] and OS (HR 0.85; 95% CI 0.74-0.97) in patients aged > or =65 years; patients aged > or =70 years had similar improvements. Benefits were consistent across the studies, irrespective of setting, bevacizumab dose, or chemotherapy regimen. Increases in thromboembolic events were observed in patients aged > or =65 and > or =70 years in the bevacizumab group compared with the control group, mainly as a result of increases in arterial thromboembolic events. No other substantial age-related increases in grade 3-5 adverse events were observed.

CONCLUSIONS

In medically fit older patients, bevacizumab provides similar PFS and OS benefits as in younger patients.

摘要

背景

贝伐珠单抗常与 5-氟尿嘧啶为基础的化疗联合应用于转移性结直肠癌(mCRC)患者。贝伐珠单抗在老年患者中的相对益处尚未广泛研究,这是一个令人关注的问题。

患者和方法

本回顾性分析使用了贝伐珠单抗联合化疗一线治疗 3 项随机对照研究和二线治疗 1 项随机对照研究的数据,纳入了身体状况良好(东部肿瘤协作组体力状况 0 或 1)的 mCRC 患者。评估了年龄<65 岁、年龄≥65 岁和年龄≥70 岁患者的总生存(OS)和治疗期间无进展生存(PFS)。采用未分层的危险比(HRs)比较结果。同时评估了 3-5 级不良事件。

结果

贝伐珠单抗显著改善了年龄≥65 岁患者的 PFS[HR 0.58;95%置信区间(CI)0.49-0.68]和 OS[HR 0.85;95% CI 0.74-0.97];年龄≥70 岁患者也有类似的改善。在这些研究中,无论研究环境、贝伐珠单抗剂量或化疗方案如何,均观察到获益一致。与对照组相比,年龄≥65 岁和年龄≥70 岁的贝伐珠单抗组患者中观察到血栓栓塞事件增加,主要是由于动脉血栓栓塞事件增加。未观察到与年龄相关的 3-5 级不良事件的其他实质性增加。

结论

在身体状况良好的老年患者中,贝伐珠单抗提供了与年轻患者相似的 PFS 和 OS 获益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e80d/11828235/37606ef54ec9/432_2009_712_Fig1_HTML.jpg

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