U.O. Oncologia Medica 2 Universitaria, Polo Oncologico Area Vasta Nord-Ovest, Azienda Ospedaliero-Universitaria Pisana, Istituto Toscano Tumori, Pisa, Italy.
Clin Colorectal Cancer. 2012 Mar;11(1):71-6. doi: 10.1016/j.clcc.2011.06.013. Epub 2011 Sep 8.
FOLFOXIRI demonstrated higher efficacy compared to 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) as first-line treatment of metastatic colorectal cancer. We evaluated the outcome of second-line treatments among 196 patients treated with first-line FOLFOXIRI in three consecutive trials conducted by the Gruppo Oncologico Nord Ovest group.
One hundred seventy-two of 196 patients so far progressed and 136 (79%) received second-line therapies: 32 (24%) were rechallenged with FOLFOXIRI, 52 (38%) were treated with irinotecan- or oxaliplatin-based doublets, and 52 (38%) received fluoropyrimidine plus mytomicin C or single-agent chemotherapy. Only 10 patients received bevacizumab (3) or cetuximab (7) with chemotherapy. Activity and efficacy data were collected and subgroup analyses were performed according to the regimen administered.
Overall response rate (RR) was 23%; median progression-free survival (PFS) and overall survival (OS) were 5.9 and 13.2 months, respectively. At an exploratory subgroup analysis, retreatment with FOLFOXIRI was associated with longer PFS (8.2 versus 6.3 months; P = .003, hazard ratio [HR] = 0.61) and OS (19.3 versus 14.0 months; P = .02, HR = 0.57) compared with doublets; single-agent chemotherapy or fluoropyrimidine plus mytomicin C was significantly lower in terms of RR (8%), PFS (3.0 months), and OS (8.7 months) compared with FOLFOXIRI or doublets.
First-line FOLFOXIRI does not impair the efficacy of second-line treatments. In some patients rechallenge with FOLFOXIRI may represent a valid option, although potential imbalances in prognostic factors due to better patient selection should be considered.
FOLFOXIRI 作为转移性结直肠癌的一线治疗方案，其疗效优于氟尿嘧啶、亚叶酸钙、伊立替康（FOLFIRI）。我们评估了西北肿瘤协作组（Gruppo Oncologico Nord Ovest）连续三项试验中 196 例接受一线 FOLFOXIRI 治疗的患者的二线治疗结果。
196 例患者中，172 例患者目前已进展，其中 136 例（79%）接受二线治疗：32 例（24%）患者再次接受 FOLFOXIRI 治疗，52 例（38%）患者接受伊立替康或奥沙利铂为基础的双药治疗，52 例（38%）患者接受氟嘧啶加丝裂霉素 C 或单药化疗。仅有 10 例患者接受贝伐单抗（3 例）或西妥昔单抗（7 例）联合化疗。收集活性和疗效数据，并根据所使用的方案进行亚组分析。
总体缓解率（RR）为 23%；中位无进展生存期（PFS）和总生存期（OS）分别为 5.9 个月和 13.2 个月。在探索性亚组分析中，与双药治疗相比，FOLFOXIRI 再治疗患者的 PFS（8.2 个月比 6.3 个月；P=0.003，风险比[HR]为 0.61）和 OS（19.3 个月比 14.0 个月；P=0.02，HR 为 0.57）更长；与 FOLFOXIRI 或双药治疗相比，单药化疗或氟嘧啶加丝裂霉素 C 的 RR（8%）、PFS（3.0 个月）和 OS（8.7 个月）显著降低。
一线 FOLFOXIRI 不会损害二线治疗的疗效。在某些患者中，再次使用 FOLFOXIRI 可能是一种有效的选择，尽管由于更好的患者选择可能导致预后因素的潜在不平衡，应予以考虑。
