贝伐珠单抗联合双周方案治疗45例转移性结直肠癌的临床疗效观察

Eicacy of bevacizumab plus bi-weekly chemotherapy in 45 patients with metastatic colorectal cancer

目的:评价贝伐珠单抗联合标准双周方案化疗对转移性结直肠癌(metastatic colorectal cancer,mCRC)的临床疗效及安全性。方法:收集45例2010年9月—2011年12月,在佛山市第一人民医院和中山大学附属第六医院进行贝伐珠单抗联合标准双周方案化疗的mCRC患者的资料,回顾性分析了贝伐珠单抗联合FOLFIRI(20例)或FOLFOX(25例)方案在一线治疗mCRC中的疗效及不良反应的情况。其中31例患者采用焦磷酸测序法检测K-ras基因的突变情况,并分析其突变与近期疗效的相关性。结果:贝伐珠单抗联合FOLFIRI或FOLFOX方案的总有效率为62.2%,疾病控制率为82.2%,中位无进展生存期(progression-free survival,PFS)为9.0个月。疗效预测方面,K-ras基因的突变与近期疗效无明显相关性;K-ras基因野生型患者和应用FOLFIRI方案组患者的PFS略优,分别是11.5个月对9.0个月和9.0个月对8.5个月,但Log-rank检验结果显示,差异无统计学意义(P值分别为0.71和0.65)。与贝伐珠单抗相关的严重不良反应主要为昏迷(4.4%)和肠穿孔(2.2%),但未出现治疗相关性的死亡病例。结论:贝伐珠单抗联合化疗治疗mCRC疾病控制率高,且疾病控制时间较长,但仍需进一步寻找其疗效预测因子;少见病例有严重的不良反应,仍需加强对患者的筛选和监控。

Objective： To evaluate the efficacy and safety of bevacizumab combined with bi-weekly chemotherapy in mCRC （metastatic colorectal cancer）. Methods： The clinical data from 45 patients with mCRC, who received bevacizumab combined with standard bi-weekly chemotherapy at Foshan First People＇s Hospital and Sixth Subsidiary Sun Yat-sen University Hospital between September 2010 and December 2011, were collected and reviewed. The short-term efficacy and safety of bevacizumab combined with FOLFIRI （20 cases） or FOLFOX （25 cases） regimen were analyzed. The relationship between K-ras gene status and treatment outcome was analyzed in 31 patients whose K-ras gene mutation status was examined. Results： The ORR （overall response rate） of bevacizumab combined with FOLFIRI or FOLFOX regimen was 62.2%, and the disease control rate was 82.2%. The median PFS （progression-free survival） time was 9.0 months. K-ras gene mutation status was not associated with short-term response. The cases carrying wild-type K-ras gene have a longer PFS time （11.5 vs 9.0 months, P = 0.71）. The PFS of 20 cases receiving FOLFIRI regimen was better than the 25 cases receiving FOLFOX regimen （9.0 vs 8.5 months）, but the difference was not significant （P = 0.65）. The most serious adverse events related to bevacizumab were coma （4.4%） and enterobrosis （2.2%）, but no treatment-related deaths occurred. Conclusion： Bevacizumab-FOLFIRI and bevacizumab-FOLFOX regimens are effective as the first-line treatment for patients with mCRC with less but serious adverse events. The regimens should be used in the selected patients under rigorous monitoring, and the biomarkers of clinical outcome still need further study.