Phase II Trial of Alternating mFOLFOX6 and FOLFIRI Regimens in the First-Line Treatment for Unresectable or Metastatic Colorectal Cancer (KSCC0701)

作者：Oki Eiji^*; Emi Yasunori; Akagi Yoshito; Tokunaga Shoji; Sadanaga Noriaki; Tanaka Takaho; Ogata Yutaka; Saeki Hiroshi; Kakeji Yoshihiro; Baba Hideo; Nishimaki Tadashi; Natsugoe Shoji; Shirouzu Kazuo; Maehara Yoshihiko

来源：Oncology, 2013, 84(4): 233-239.

DOI：10.1159/000346690

• Colorectal cancer
• Oxaliplatin
• Irinotecan
• FOLFOX6
• FOLFIRI
• FIREFOX
• Neurotoxicity

Objective: This phase II study examined the efficacy and safety of alternating regimens of mFOLFOX6 and FOLFIRI as a first-line treatment for unresectable or metastatic colorectal cancer. Patients and Methods: Forty-eight patients were enrolled in this study. Patients received an alternating regimen of 4 cycles of mFOLFOX6 followed by 4 cycles of FOLFIRI. Results: The characteristics of the study population were as follows: males/females 34/12, median age 66 years (range 43-75) and Eastern Cooperative Oncology Group performance status 0/1/2 in 37/9/0 patients. The overall response rate was 58.7% [95% confidence interval (CI) 43.9-73.5]. The median progression-free survival was 10.3 months 95% CI 7.5-11.9), and the median overall survival was 28.4 months (95% CI 22.5-35.7). Among the 47 patients evaluated for toxicity, the most common grade 3-4 adverse events were leukopenia (26%), neutropenia (55%), anemia (4%), neurotoxicity (0%), diarrhea (2%), febrile neutropenia (4%), nausea (4%), vomiting (2%), and hypersensitivity (0%). Conclusions: The results of this phase II study indicate that this alternating schedule is effective and well tolerated as a first-line treatment for unresectable or metastatic colorectal cancer. The low rate of grade 3 neurotoxicity is also promising.

• 出版日期2013