Laboratory of Tumor Cell Biology School of Medicine, University of Crete, Heraklion, Greece.
Br J Cancer. 2012 Dec 4;107(12):1932-7. doi: 10.1038/bjc.2012.509. Epub 2012 Nov 20.
We conducted an open-label, pilot phase II trial to evaluate the efficacy and safety of FOLFOXIRI plus cetuximab as first-line treatment of patients with metastatic colorectal cancer (mCRC).
Thirty patients with KRAS wild-type mCRC, <70 years and with performance status 0-1 were included in the trial.
Complete and partial responses were observed in 4 (13.3%) and 17 (56.7%) patients, respectively (overall response rate (ORR)=70%; 95% confidence interval (CI): 53.6%-86.4%); 8 patients (26.7%) had stable disease and 1 had progressive disease. The median time to tumour progression was 10.2 months (95% CI: 7.1-13.4) and the overall median survival time was 30.3 months (95% CI: 18.8-41.9). Secondary R0 resection was performed in 11 (37%) patients. Grade 3 or 4 diarrhoea and neutropenia were observed in 16 (53%) and 7 (23.3%) patients, respectively, and febrile neutropenia observed in 2 (6.6%) patients. Neurotoxicity grade 2 or 3 was reported in 7 (23.3%) and in 2 (6.7%) patients, respectively, and grade 3 rush was reported in 1 patient.
The FOLFOXIRI/cetuximab combination presented increased activity in terms of response rate and R0 secondary liver metastases resection, and merits further investigation, especially in patients with initially unresectable disease confined to the liver.
我们开展了一项开放标签、Ⅱ期临床试验，以评估 FOLFOXIRI 联合西妥昔单抗作为 KRAS 野生型转移性结直肠癌（mCRC）患者一线治疗的疗效和安全性。
共纳入 30 例 KRAS 野生型 mCRC 患者，年龄<70 岁，ECOG 体能状态 0-1 分。
完全缓解和部分缓解分别见于 4 例（13.3%）和 17 例（56.7%）患者（总缓解率[ORR]为 70%；95%CI：53.6%-86.4%）；8 例（26.7%）患者疾病稳定，1 例患者疾病进展。中位无进展生存期为 10.2 个月（95%CI：7.1-13.4），中位总生存期为 30.3 个月（95%CI：18.8-41.9）。11 例（37%）患者行二次 R0 切除术。16 例（53%）和 7 例（23.3%）患者分别发生 3/4 级腹泻和中性粒细胞减少症，2 例（6.6%）患者发生发热性中性粒细胞减少症。7 例（23.3%）和 2 例（6.7%）患者分别报告了 2/3 级神经毒性，1 例患者报告了 3 级皮疹。
FOLFOXIRI 联合西妥昔单抗方案在缓解率和 R0 肝转移灶切除方面具有更高的活性，值得进一步研究，尤其是在最初局限于肝脏且不可切除的患者中。
