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贝伐珠单抗治疗真实世界临床实践中的转移性结直肠癌。

Bevacizumab Treatment for Metastatic Colorectal Cancer in Real-World Clinical Practice.

机构信息

Department of Oncology, Fundeni Clinical Institute, 022328 Bucharest, Romania.

Department of Internal Medicine, Fundeni Clinical Institute, 022328 Bucharest, Romania.

出版信息

Medicina (Kaunas). 2023 Feb 13;59(2):350. doi: 10.3390/medicina59020350.

Abstract

Colorectal cancer (CRC) is a leading cause of cancer-related mortality and morbidity worldwide. Bevacizumab was approved for the treatment of metastatic colorectal cancer (mCRC) based on favorable benefit-risk assessments from randomized controlled trials, but evidence on its use in the real-world setting is limited. The aim of the current study is to evaluate the outcomes and safety profile of bevacizumab in mCRC in a real-world setting in Romania. This was an observational, retrospective, multicentric, cohort study conducted in Romania that included patients with mCRC treated with bevacizumab as part of routine clinical practice. Study endpoints were progression-free survival, overall survival, adverse events, and patterns of bevacizumab use. : A total of 554 patients were included in the study between January 2008 and December 2018. A total of 392 patients (71%) received bevacizumab in the first line and 162 patients (29%) in the second line. Bevacizumab was mostly combined with a capecitabine/oxaliplatin chemotherapy regimen (31.6%). The median PFS for patients treated with bevacizumab was 8.4 months (interquartile range [IQR], 4.7-15.1 months) in the first line and 6.6 months (IQR, 3.8-12.3 months) in the second line. The median OS was 17.7 months (IQR, 9.3-30.6 months) in the first line and 13.5 months (IQR, 6.7-25.2 months) in the second line. Primary tumor resection was associated with a longer PFS and OS. The safety profile of bevacizumab combined with chemotherapy was similar to other observational studies in mCRC. : The safety profile of bevacizumab was generally as expected. Although the PFS was generally similar to that reported in other studies, the OS was shorter, probably due to the less frequent use of bevacizumab after disease progression and the baseline patient characteristics. Patients with mCRC treated with bevacizumab who underwent resection of the primary tumor had a higher OS compared to patients with an unresected primary tumor.

摘要

结直肠癌(CRC)是全球癌症相关死亡率和发病率的主要原因。贝伐单抗基于随机对照试验的有利获益风险评估被批准用于转移性结直肠癌(mCRC)的治疗,但在真实环境中的使用证据有限。本研究的目的是评估贝伐单抗在罗马尼亚真实环境中治疗 mCRC 的结果和安全性概况。这是一项在罗马尼亚进行的观察性、回顾性、多中心队列研究,纳入了接受贝伐单抗治疗的 mCRC 患者,这些患者的治疗是基于常规临床实践。研究终点为无进展生存期、总生存期、不良事件和贝伐单抗使用模式。研究共纳入 2008 年 1 月至 2018 年 12 月间的 554 例患者。共有 392 例患者(71%)接受了一线贝伐单抗治疗,162 例患者(29%)接受了二线贝伐单抗治疗。贝伐单抗主要与卡培他滨/奥沙利铂化疗方案联合使用(31.6%)。一线治疗中接受贝伐单抗治疗的患者中位 PFS 为 8.4 个月(IQR,4.7-15.1 个月),二线治疗中为 6.6 个月(IQR,3.8-12.3 个月)。一线治疗中患者的中位 OS 为 17.7 个月(IQR,9.3-30.6 个月),二线治疗中为 13.5 个月(IQR,6.7-25.2 个月)。原发肿瘤切除术与更长的 PFS 和 OS 相关。贝伐单抗联合化疗的安全性与其他 mCRC 观察性研究相似。贝伐单抗的安全性与预期相符。尽管 PFS 总体上与其他研究报告的结果相似,但 OS 更短,可能是由于疾病进展后贝伐单抗的使用频率较低以及患者的基线特征所致。与未行原发肿瘤切除术的患者相比,行原发肿瘤切除术的 mCRC 患者的 OS 更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f390/9963555/b9f91fbdd581/medicina-59-00350-g001.jpg

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