Suenaga Mitsukuni, Mizunuma Nobuyuki, Matsusaka Satoshi, Shinozaki Eiji, Ueno Masashi, Yamaguchi Toshiharu
Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Asia Pac J Clin Oncol. 2014 Dec;10(4):322-9. doi: 10.1111/ajco.12094. Epub 2013 Aug 5.
Past reports have suggested that the addition of bevacizumab (BV) to oxaliplatin combined with 5-fluorouracil (5-FU) and folinic acid (leucovorin) (FOLFOX4) provides a limited survival benefit in metastatic colorectal cancer (mCRC). Our study aimed to evaluate the survival benefits of a FOLFOX4 + BV regimen.
Patients with mCRC who started treatment between April 2005 and July 2008 were evaluated in this retrospective cohort study. Patients received FOLFOX4, or FOLFOX4 + BV after the approval of BV in 2007. The two cohorts treated before and after BV approval were compared. Primary end-points were progression-free survival (PFS), overall survival (OS) and response rate (RR).
A total of 213 patients received either FOLFOX4 (n = 128) or FOLFOX4 + BV (n = 85). For FOLFOX4 and FOLFOX4 + BV respectively, median PFS was 9.9 and 17.0 months (HR, 0.58; 95% CI, 0.42-0.82; P = 0.002), median OS was 20.5 and 38.8 months (HR, 0.49; 95% CI, 0.34-0.71; P < 0.001), respectively. Patients who received 5-fluorouracil plus leucovorin (FL) as maintenance therapy during oxaliplatin suspension in both FOLFOX4 (n = 6) and FOLFOX4 + BV (n = 46) groups showed a trend to improved median PFS and median OS.
The additive effect and potential survival benefits of adding BV to the FOLFOX4 regimen in first-line treatment of mCRC were demonstrated. Maintenance FL during suspension of oxaliplatin appeared to be an important factor in better survival.
既往报告表明，在奥沙利铂联合5-氟尿嘧啶（5-FU）和亚叶酸钙（甲酰四氢叶酸）（FOLFOX4）方案中添加贝伐单抗（BV），在转移性结直肠癌（mCRC）中生存获益有限。本研究旨在评估FOLFOX4 + BV方案的生存获益。
在这项回顾性队列研究中，对2005年4月至2008年7月开始治疗的mCRC患者进行评估。2007年BV获批后，患者接受FOLFOX4或FOLFOX4 + BV治疗。比较BV获批前后的两个队列。主要终点为无进展生存期（PFS）、总生存期（OS）和缓解率（RR）。
共有213例患者接受了FOLFOX4（n = 128）或FOLFOX4 + BV（n = 85）治疗。FOLFOX4组和FOLFOX4 + BV组的中位PFS分别为9.9个月和17.0个月（HR，0.58；95%CI，0.42 - 0.82；P = 0.002），中位OS分别为20.5个月和38.8个月（HR，0.49；95%CI，0.34 - 0.71；P < 0.001）。在FOLFOX4组（n = 6）和FOLFOX4 + BV组（n = 46）中，在奥沙利铂停用期间接受5-氟尿嘧啶加亚叶酸钙（FL）作为维持治疗的患者，其PFS和OS的中位数有改善趋势。
在mCRC一线治疗中，FOLFOX4方案添加BV的附加效应和潜在生存获益得到证实。奥沙利铂停用期间维持FL治疗似乎是生存改善的一个重要因素。
