贝伐单抗联合伊立替康为主方案一线治疗转移性结直肠癌的临床评价

目的 评价贝伐单抗联合伊立替康(CPT-11)为主方案一线治疗转移性结直肠癌的疗效和安全性,分析治疗前后血清肿瘤标志物的变化.方法 将67例转移性结直肠癌患者分为IFL组、IFL+贝伐单抗组和FOLFIRI组.IFL组采用CPT-11(每周125 mg/m2)+亚叶酸钙(CF,每周20mg/m2)+5-氟尿嘧啶(5-Fu,每周500 mg/m2);IFL+贝伐单抗组采用贝伐单抗(每2周5 mg/kg)+IFL方案(CPT-11每周125 mg/m2,CF每周20 mg/m2,5-Fu每周500 mg/m2);FOLFIRI组采用CPT-11(180 mg/m2)+CF(200 mg/m2)+5-Fu(1000 mg/m2).3组患者均持续治疗至病情进展或毒性不能耐受.结果 67例患者均可评价疗效和毒性.IFL组、IFL+贝伐单抗组和FOLFIRI组的治疗有效率分别为16.0%(4/25)、35.0%(7/20)和18.2%(4/22;x2=6.026,P=0.049),中位无疾病进展时间(PFS)分别为3.7、7.5和4.0个月(x2=11.97 P=0.003).全组患者的1年生存率为47.0%,2年生存率为27.0%,中位生存时间为13.0个月,总生存期在3组间差异无统计学意义(x2=3.42,P=0.18).3组患者治疗前后血清肿瘤标记物均有所下降,但差异无统计学意义(P＞0.05).IFL组和FOLFIRI组的主要不良反应为迟发性腹泻和中性粒细胞减少,IFL+贝伐单抗组增加的不良反应主要有高血压、出血、心脏毒性和伤口愈合延迟.结论 以CPT-11为基础方案的化疗联用贝伐单抗提高了晚期结直肠癌患者治疗的有效率,并延长了PFS,不良反应患者可耐受.

Evaluation of bevacizumab combined with irinotecan-based regimen as the first-line treatment for patients with metastatic colorectal cancer

Objective To assess the efficacy and safety of bevacizumab plus irinotecan-based regimen for the first line treatment in metastatic colorectal cancer (mCRC) patients, and to investigate the correlation between serum tumor markers including CEA and CA19-9 and response as well as prognosis.Methods From May 2007 to July 2008, 67 previously untreated mCRC patients received treatment of IFL ( n = 25 ), IFL plus Bevacizumab ( n = 20) or FOLFIRI ( n = 22). The treatment continued until disease progression or unacceptable toxicity. The data were retrospectively analyzed. Results All patients were evaluable for response, survival and toxicity analysis. The objective response rate of IFL, IFL plus Bevacizumab or FOLFIRI regimen groups was 16.0%(4/25), 35.0%(7/20) and 18.2%(4/22),respectively (x2 = 6.026, P = 0.049 ). The median progression-free survival (PFS) of IFL plus bevacizumab group was 7.5 months, significantly improved as compared with 3.7 months in the IFL group and 4 months in FOLFIRI group (x2 = 11.97, P = 0.003 ) . Of all 67 cases, the one-year survival rate was 47.0%, twoyear survival rate was 27.0%, and the median overall survival (OS) was 13.0 months, with no significant difference among the three treatment groups (x2 = 3.42, P = 0.18). The serum CEA and CA19-9 levels were decreased after treatment, but with no significant difference among the three groups (P ＞ 0.05). The common toxicity profiles of IFL and FOLFIRI regimens were diarrhea and neutropenia, while the toxicity related to bevacizumab was consistent with that documented in previous literature, such as hypertension,hemorrhage, cardiac toxicity and delayed wound healing. Conclusion The addition of bevacizumab to irinotecan-based regimen significantly improves the response rate and PFS in first-line treatment for patients with mCRC and its toxicity is well tolerated.