CAC Val d'Aurelle, Montpellier, France.
Oncologist. 2011;16(11):1557-64. doi: 10.1634/theoncologist.2011-0141. Epub 2011 Oct 20.
Triplet chemotherapy has demonstrated manageable toxicities and a favorable response rate. The addition of cetuximab to chemotherapy can increase treatment efficacy. We evaluated the efficacy and safety of cetuximab plus 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX), the ERBIRINOX regimen, as first-line treatment in patients with unresectable metastatic colorectal cancer (mCRC).
In a phase II study, treatment consisted of weekly cetuximab plus biweekly. Treatment was continued for a maximum of 12 cycles and tumor response was evaluated every four cycles. The primary efficacy criterion was the complete response (CR) rate.
From April 2006 to April 2008, 42 patients were enrolled. The median age was 60 years (range, 32-76 years). The median duration of treatment was 5.2 months (range, 0.7-8.5 months), and a median of nine cycles was given per patient (range, 1-12 cycles). Five patients (11.9%) showed a CR, with a median duration of 23.1 months (95% confidence interval [CI], 10.8-39.7 months). The objective response rate was 80.9% (95% CI, 65.9%-91.4%). The median overall and progression-free survival times were 24.7 months (95% CI, 22.6 months to not reached) and 9.5 months (95% CI, 7.6-10.4 months), respectively. The most frequent grade 3-4 adverse events were diarrhea (52%), neutropenia (38%), and asthenia (32%).
The ERBIRINOX regimen appears to be effective and feasible in first-line treatment of mCRC patients. These promising results led us to initiate a multicenter, randomized, phase II trial ([Research Partnership for Digestive Oncology] PRODIGE 14) in patients with potentially resectable mCRC.
三药联合化疗具有良好的耐受性和较高的缓解率。西妥昔单抗联合化疗可提高治疗效果。我们评估了西妥昔单抗联合氟尿嘧啶、亚叶酸钙、伊立替康和奥沙利铂（FOLFIRINOX），即 ERBIRINOX 方案，作为不可切除转移性结直肠癌（mCRC）患者一线治疗的疗效和安全性。
在一项 II 期研究中，每周给予西妥昔单抗联合每两周给予。治疗最多持续 12 个周期，每 4 个周期评估肿瘤反应。主要疗效标准为完全缓解（CR）率。
从 2006 年 4 月至 2008 年 4 月，共纳入 42 例患者。中位年龄为 60 岁（范围，32-76 岁）。中位治疗持续时间为 5.2 个月（范围，0.7-8.5 个月），中位每位患者接受 9 个周期的治疗（范围，1-12 个周期）。5 例患者（11.9%）出现 CR，中位持续时间为 23.1 个月（95%置信区间[CI]，10.8-39.7 个月）。客观缓解率为 80.9%（95%CI，65.9%-91.4%）。中位总生存期和无进展生存期分别为 24.7 个月（95%CI，22.6 个月至未达到）和 9.5 个月（95%CI，7.6-10.4 个月）。最常见的 3-4 级不良事件为腹泻（52%）、中性粒细胞减少（38%）和乏力（32%）。
ERBIRINOX 方案在 mCRC 患者的一线治疗中似乎是有效且可行的。这些有希望的结果促使我们在有潜在可切除 mCRC 的患者中启动了一项多中心、随机、II 期试验（[消化肿瘤研究合作]PRODIGE 14）。
