Cao Ranhua, Zhang Shuai, Ma Dedong, Hu Likuan
Department of Radiation Oncology, Qilu Hospital of Shandong University, Jinan, 250012, Shandong Province, China.
Med Oncol. 2015 Jan;32(1):325. doi: 10.1007/s12032-014-0325-9. Epub 2014 Dec 7.
Bevacizumab is an anti-VEGF human monoclonal antibody suitable for chemotherapy for patients with metastatic colorectal cancer (mCRC). This study investigated the efficacy and safety of using bevacizumab plus irinotecan, 5-fluorouracil, and leucovorin (FOLFIRI) as second-line chemotherapy option for patients with mCRC in China. Patients with mCRC, who had been previously treated with oxaliplatin-based chemotherapy, but not bevacizumab, were randomly assigned to two groups to receive bevacizumab plus FOLFIRI (FOLFIRI-B) or FOLFIRI alone. In FOLFIRI-B group, patients were given 10 mg/kg bevacizumab plus FOLFIRI every 2 weeks. The primary endpoints were response rates and survival rates. Between June 2010 and May 2014, 65 patients were assigned to FOLFIRI-B group and 77 to FOLFIRI alone group. The median progression-free survivals were 8.5 months (95 % CI 5.8-10.5 months) for FOLFIRI-B and 5.1 months (95 % CI 2.7-9.8 months) for FOLFIRI alone; median overall survivals were 15.2 months (95 % CI 11.8-19.4 months) for FOLFIRI-B and 11.3 months (95 % CI 6.7-16.5 months) for FOLFIRI alone. Incidence rates of grade 3 and 4 adverse events were observed and comparable between FOLFIRI-B and FOLFIRI alone groups. Chinese patients with mCRC treated with second-line chemotherapy of FOLFIRI-B had better survivals than those patients treated with FOLFIRI alone.
贝伐单抗是一种抗血管内皮生长因子(VEGF)的人源单克隆抗体,适用于转移性结直肠癌(mCRC)患者的化疗。本研究调查了在中国使用贝伐单抗联合伊立替康、5-氟尿嘧啶和亚叶酸钙(FOLFIRI)作为mCRC患者二线化疗方案的疗效和安全性。曾接受过基于奥沙利铂的化疗但未使用过贝伐单抗的mCRC患者被随机分为两组,分别接受贝伐单抗联合FOLFIRI(FOLFIRI-B)或单纯FOLFIRI治疗。在FOLFIRI-B组中,患者每2周接受10mg/kg贝伐单抗联合FOLFIRI治疗。主要终点为缓解率和生存率。2010年6月至2014年5月期间,65例患者被分配至FOLFIRI-B组,77例患者被分配至单纯FOLFIRI组。FOLFIRI-B组的中位无进展生存期为8.5个月(95%CI 5.8 - 10.5个月),单纯FOLFIRI组为5.1个月(95%CI 2.7 - 9.8个月);FOLFIRI-B组的中位总生存期为15.2个月(95%CI 11.8 - 19.4个月),单纯FOLFIRI组为11.3个月(95%CI 6.7 - 16.5个月)。观察到3级和4级不良事件的发生率,FOLFIRI-B组和单纯FOLFIRI组之间具有可比性。接受FOLFIRI-B二线化疗的中国mCRC患者的生存期优于接受单纯FOLFIRI治疗的患者。