Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan ; Department of Medical Oncology, Hokkaido University Graduate School of Medicine, Sapporo, Hokkaido, Japan.
Department of Gastroenterology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Onco Targets Ther. 2015 Mar 3;8:529-37. doi: 10.2147/OTT.S77190. eCollection 2015.
A previous pivotal Phase III study (NO16966) demonstrated the benefit of the addition of bevacizumab (BV) to oxaliplatin-based regimens in metastatic colorectal cancer (MCRC). Our study evaluated the safety and efficacy of three oxaliplatin-based chemotherapy regimens (FOLFOX4 [intravenous twice-bolus and twice-infusional 5-fluorouracil/folinic acid plus oxaliplatin], mFOLFOX6 [intravenous once-bolus and once-infusional 5-fluorouracil/folinic acid plus oxaliplatin], and XELOX [capecitabine plus oxaliplatin]) plus BV in the first-line treatment of MCRC patients.
Patients with MCRC who started treatment between June 2007 and September 2010 were evaluated in this retrospective cohort study. We also evaluated early objective tumor response (EOTR) within 12 weeks, which was defined as a relative change of ≥30% in the sum of the longest diameters of target lesions when compared with baseline. The primary study endpoints were progression-free survival (PFS) and response rate.
A total of 185 patients received the following chemotherapy: FOLFOX4 + BV (FF4 arm, n=85), mFOLFOX6 + BV (FF6 arm, n=40), and XELOX + BV (XELOX arm, n=60). The overall response rates were 61.2%, 72.5%, and 75.0% (95% confidence interval: 50.6%-71.8%, 58.0%-87.0%, and 63.7%-86.3%). Median PFS was 18.0, 15.5, and 13.7 months, respectively (log-rank: P=0.254; data cut-off: May 2013). Patients with EOTR (n=117) had significantly better PFS than those without-EOTR (n=68) (17.5 versus 12.7 months, P=0.004).
This study suggests that these three BV plus oxaliplatin-based treatments might have comparable benefit in terms of tumor response and PFS. Moreover, EOTR may be a predictive factor for PFS in patients with MCRC.
一项先前的关键 III 期研究（NO16966）表明，贝伐珠单抗（BV）联合奥沙利铂为基础的方案在转移性结直肠癌（MCRC）中具有获益。我们的研究评估了三种奥沙利铂为基础的化疗方案（FOLFOX4[静脉两次推注和两次输注 5-氟尿嘧啶/亚叶酸钙加奥沙利铂]、mFOLFOX6[静脉一次推注和一次输注 5-氟尿嘧啶/亚叶酸钙加奥沙利铂]和 XELOX[卡培他滨加奥沙利铂]）联合 BV 在 MCRC 患者一线治疗中的安全性和疗效。
本回顾性队列研究评估了 2007 年 6 月至 2010 年 9 月期间开始治疗的 MCRC 患者。我们还评估了 12 周内的早期客观肿瘤缓解（EOTR），其定义为与基线相比，目标病变最长直径总和的相对变化≥30%。主要研究终点为无进展生存期（PFS）和缓解率。
共 185 例患者接受以下化疗：FOLFOX4+BV（FF4 组，n=85）、mFOLFOX6+BV（FF6 组，n=40）和 XELOX+BV（XELOX 组，n=60）。总缓解率分别为 61.2%、72.5%和 75.0%（95%置信区间：50.6%-71.8%、58.0%-87.0%和 63.7%-86.3%）。中位 PFS 分别为 18.0、15.5 和 13.7 个月（对数秩检验：P=0.254；数据截止日期：2013 年 5 月）。EOTR（n=117）患者的 PFS 明显优于无 EOTR（n=68）患者（17.5 个月比 12.7 个月，P=0.004）。
本研究表明，这三种 BV 联合奥沙利铂的治疗方案在肿瘤缓解和 PFS 方面可能具有相似的获益。此外，EOTR 可能是 MCRC 患者 PFS 的预测因素。
