贝伐珠单抗联合不同化疗方案治疗进展期结直肠癌54例分析

Bevacizumab in combination with various chemotherapy protocols for treatment of advanced colorectal cancer:a clinical evaluation

目的研究贝伐珠单抗(Bev)联合化疗治疗进展期结直肠癌的疗效和安全性。方法对2005年11月至2011年3月北京大学肿瘤医院接受Bev联合化疗治疗进展期结直肠癌54例进行分析。Bev 5 mg/kg静脉输注每2周1次或7.5 mg/kg静脉输注每3周1次,联合以奥沙利铂为基础的化疗,以伊立替康为基础的化疗,或以氟尿嘧啶类为基础的化疗进行治疗。按实体肿瘤疗效评价标准(RECIST)评价疗效,每6周评价1次。按美国癌症研究所常见毒性判定标准(NCI-CTC)3.0版评价不良反应。结果 54例中男26例,女28例;中位年龄50(24～73)岁。初治22例,21例可评价疗效,有效率(RR)为33.3%(7/21),疾病控制率(DCR)为100%(21/21);中位疾病无进展(PFS)时间11.3个月,总生存时间(OS)20.9个月。全部54例中,部分缓解(PR)12例(23.5%),稳定(SD)32例(62.7%),进展(PD)7例(13.5%),3例无法评价疗效;中位PFS 8.4个月,中位OS 15.5个月。主要3～4度不良反应为白细胞减少9例(16.7%),粒细胞减少13例(24.1%),粒细胞减少性发热1例(1.9%);3度恶心、呕吐2例(3.8%),3度腹泻3例(5.7%)。与贝伐珠单抗相关的不良反应为蛋白尿2例(3.8%),血压升高1例,鼻衄2例,痔疮出血2例,但均为1～2度。结论贝伐珠单抗联合化疗治疗进展期结直肠癌对于初治患者疗效较好,且未加重化疗的不良反应。

Objective To determine the efficacy and safety of Bevacizumab （Bev） in combination with various chemothera- py protocols in patients with advanced colorectal cancer （mCRC）. Methods Intravenous Bey （5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks） was used in combination with oxaliplatin-, irinotecan- and fluoropyrimidine-based regimens, re- spectively. The therapeutic efficacy was assessed every 6 months based on Response Evaluation Criterion for Solid Tumors （RECIST） , and the adverse events were evaluated according to National Cancer Institute-Common Toxicity Criterion for Ad- verse Events （ NCI-CTC AE） Ed 3.0. Results Of 54 patients （26 males and 28 females） aged 24 - 73 （ median ： 50 ） years who underwent the combination chemotherapy, 16 received oxaliplatin-based regimen, 32 were given irinotecan-based regimen, and 6 were treated with fluoropyrimidine-based regimen. Initial chemotherapy was performed in 22 of the patients. The therapeutic efficacy was assessable in 21 cases,among whom the response rate （RR） was 33. 3% （7/21） ,disease con- trol rate （DCR） 100% （21/21）, median progression-free survival （PFS） time 11.3 months and overall survival （OS） du- ration 20. 9 months. In all of the 54 cases which included 12 （23.5%） of partial remission （PR） ,disease stability （SD） and disease progression （PD） and efficacy not applicable was found in,32 （62. 7% ） ,7 （13.5%） and 3 cases,respectively. The median PFS time was 8.4 months and median OS duration was 15.5 months. The major grade 3/4 adverse events were leucocytopenia （9 cases, 16. 7% ）, neutropenia （ 13 cases,24. 1% ）, neutropenic febrile （ 1 case, 1.9% ）. 2 cases （3.8%） were reported as having grade 3 nausea/vomiting, and 3 cases （5.7%）, grade 3 diarrhea. Grade 1/2 Bev-associated adverse events were proteinuria （2 cases, 3.8 % ）, hypertension （ 1 case, 1.9 % ）, rhinorrhagia （ 2 cases, 3.8 % ）, hemorrhagic hemorrhoid （1 case, 1.9% ）. Conclusion Bev in combination with various chemotherapy protocols is effective and is not associated with worsening of adverse events in patients with mCRC.