贝伐珠单抗与化疗药物联合治疗转移性结直肠癌的近期疗效和安全性

Efficacy and safety of bevacizumab （BEV）plus chemotherapeutic agents in the treatment of metastatic colorectal cancer （mCRC）

目的 观察贝伐珠单抗与化疗药物联合治疗转移性结直肠癌的近期疗效和安全性。方法应用贝伐珠单抗联合5-氟尿嘧啶类、奥沙利铂、伊立替康为基础的化疗方案治疗转移性结直肠癌患者77例，观察其临床疗效和贝伐珠单抗相关的不良反应。至少2个周期贝伐珠单抗治疗后评估疗效，每周期治疗后记录不良反应。结果77例患者平均接受贝伐珠单抗联合化疗治疗5．2个周期，有64例患者可评估疗效，其中部分缓解（PR）12例，疾病稳定（SD）36例，疾病进展（PD）16例，有效率为18．8％（12／64），疾病控制率为75．0％（48／64）。一线治疗患者27例，有效率为37．0％（10／27），疾病控制率为85．2％（23／27）。4例患者肝转移灶由潜在可切除变成可切除病灶，并成功接受了肝转移灶的R0切除术。二线治疗患者25例，有效率为8．0％（2／25），疾病控制率为76．0％（19／25）。所有患者均可进行不良反应评估，与贝伐珠单抗治疗相关的不良反应主要为高血压、蛋白尿和出血等，绝大多数为1—2级。结论贝伐珠单抗联合化疗治疗转移性结直肠癌的一线治疗效果较好，疾病控制率高；二线及以上治疗的疗效欠佳，但疾病控制率尚可。与贝伐珠单抗治疗相关的不良反应较轻，患者的耐受性较好。

Objective To assess the efficacy and safety of bevacizumab （BEV） plus chemotherapeutic agents in the treatment of metastatic colorectal cancer （mCRC）. Methods Seventy-seven mCRC patients received BEV plus 5-Fu type, oxaliplatin or irinotecan-based chemotherapy. The clinical efficacy and bevacizumab-related adverse reactions were observed. The efficacy assessment was conducted after at least 2 cycles of BEV therapy. The adverse reactions were recorded in each therapy cycle. Among the 77 cases, 64 patients had finished the efficacy assessment. The adverse reactions in all patients were assessed. Results The overall response rate （ORR） of BEV plus chemotherapy regimen was 18.75% （12/64）, and the disease control rate （DCR） was 75.0% （48/64）. In 27 patients who received the regimen as first-line treatment, the ORR reached 37.0% （ 10/27 ）, while the DCR was 85.2%. Four patients with potentially resectable lesions became resectable after the regimen and received R0 resection of the liver metastases successfully. Twenty-five patients who received the regimen as second line therapy had poor result with ORR 8.0% and DCR 76.0%. Hypertension was observed in 12 cases, with 8 cases of grade 1, 3 cases of grade 2, 1 case of grade 3. Various bleedings occurred in 24/77 cases （31.2%）, all were of grade 1-2, including 17 cases of epistaxis, grade 1 hemorrhoid bleeding in one case, hematuria in 3 case （2 of grade 1, 1 of grade 2）, GI bleeding in 2 cases, hemoptysis in 1 case （ grade 2）, and proteinuria in 4 cases （ grade 1 ）. Intestinal perforation occurred in 1 case （0.3 % ）. In two patients who had incomplete intestinal obstruction history appeared exacerbated intestinal obstruction symptoms after the application of BEV plus CPTll regimen. Conclusions BEV plus chemotherapy regimen as first-line treatment can improve the ORR and DCR of mCRC patients. When it was used as secondor later-line therapy, it may display satisfied DCR, although with a poor efficacy. The bevacizumab-related toxicity is mild and can be well tolerated.