贝伐珠单抗联合化疗一二线治疗不可手术转移性结直肠癌临床观察

中国临床药理学与治疗学 ›› 2014, Vol. 19 ›› Issue (9): 1037-1041.

贝伐珠单抗联合化疗一二线治疗不可手术转移性结直肠癌临床观察

朱利明¹, 周陈西², 赵亚珍¹, 刘鲁迎³, 徐琦¹, 应杰儿¹, 钟海均¹

¹ 浙江省肿瘤医院胃肠肿瘤内科,
² 药剂科,
³ 腹部放疗科,杭州 310022,浙江

收稿日期:2013-12-10 修回日期:2014-07-25 出版日期:2014-09-26 发布日期:2014-09-26
作者简介:朱利明,男,本科,副主任医师,研究方向:消化系统肿瘤的临床和基础。 Tel: 0571-88122162 E-mail: zjszlyy_zlm@163.com
基金资助:
浙江省公益技术研究社会发展项目(2013C33206)

Effect and safety of bevacizumab with chemotherapy as first-line and second-line therapy for metastatic colorectal cancer patients

ZHU Li-ming¹, ZHOU Chen-xi², ZHAO Ya-zhen¹, LIU Lu-ying³, XU Qi¹, YING Jie-er¹, ZHONG Hai-jun¹

¹ Department of Chemotherapy;
² Department of Pharmacy;
³ Department of Radiotherapy, Zhejiang Cancer Hospital, Hangzhou 310022, Zhejiang ,China

Received:2013-12-10 Revised:2014-07-25 Online:2014-09-26 Published:2014-09-26

摘要/Abstract

摘要： 目的评估现实治疗环境中贝伐珠单抗与化疗联合治疗转移性结直肠癌(mCRC)的疗效和毒性。方法收集2010年10月至2013年4月间接受贝伐珠单抗联合化疗治疗的mCRC患者资料,近期疗效评估采用实体瘤疗效评价标准 1.1 版;Kaplan-Meier法估计生存时间;毒性评估采用国立癌症研究所不良事件标准3.0版。结果 74例患者入组,男性40例,女性34例;年龄31~74岁,中位年龄 55.5 岁;结肠癌44例,直肠癌30例;一线和二线治疗各37例;63例患者有可测量病灶,一线、二线治疗的客观有效率(ORR)分别为 62.8%、28.6%;一线、二线治疗患者的中位无进展生存时间(PFS)和中位总生存时间(OS)分别为 8.7 个月、4.4 个月和 25.3 个月、14.6 个月;奥沙利铂及伊立替康为基础的化疗方案的中位PFS、中位OS分别为 8.1 个月、5.8 个月和21.9个月、17.1 个月,组间无统计学差异(P值分别为 0.592 和0.506)。全组各级高血压的发生率为 9.5%、蛋白尿 8.1%、静脉血栓形成 2.7%、胃肠穿孔 2.7%,伤口愈合综合症 4.1%,出血 17.6%。结论贝伐珠单抗联合化疗治疗mCRC有效,贝伐珠单抗相关毒性的总体发生率较低。

关键词: 结直肠癌, 贝伐珠单抗, 化疗, 疗效, 毒性

Abstract: AIM: After approval of bevacizumab in Chinese, postmarketing surveillance studies reported on efficacy and safety was rare. We evaluated the efficacy and safety of bevacizumab for metastatic colorectal cancer patients in daily practice. METHODS: All unresectable metastatic colorectal cancer patients who began receiving bevacizumab in participating facilities from October 2010 to April 2013 were retrospectively analyzed for efficacy and safety. Response Evaluation in Solid Tumors criteria,version 1.1, was used for the tumor response rate. The Kaplan-Meier method was used to determine PFS and OS. Adverse events were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events. RESULTS: A totalof 74 patients were assessed. Response rates were 62.8%, 28.6% overall among patients re-ceiving bevacizumab as first-,second-line therapy. Median progression-free survival was 8,7,4.4 months,and median overall survival was 25.3, 14.6 months, respectively. All grade adverse events related to bevacizumab included hypertendion in 9.5%, proteinuria in 8.1%, thrombosis in 2.7%,gastrointestinal perforation in 2.7%,poor wound healing in 4.1% and bleeding in 17.6%. CONCLUSION: Although the sample size was small and there were several study limitations, these results suggest that colorectal cancer patients in our center benefit from bevacizumab in combination with chemotherapy and might safely in daily practice.

Key words: colorectal neoplasms, bevacizumab, chemotherapy, efficacy, safety

中图分类号:

R735.3

朱利明, 周陈西, 赵亚珍, 刘鲁迎, 徐琦, 应杰儿, 钟海均. 贝伐珠单抗联合化疗一二线治疗不可手术转移性结直肠癌临床观察[J]. 中国临床药理学与治疗学, 2014, 19(9): 1037-1041.

ZHU Li-ming, ZHOU Chen-xi, ZHAO Ya-zhen, LIU Lu-ying, XU Qi, YING Jie-er, ZHONG Hai-jun. Effect and safety of bevacizumab with chemotherapy as first-line and second-line therapy for metastatic colorectal cancer patients[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2014, 19(9): 1037-1041.

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