• Yutaka Ogata, Shoji Tokunaga, Yasunori Emi, Eiji Oki, Hiroshi Saeki, Ken Shirabe, Hirofumi Hasegawa, Noriaki Sadanaga, Hironori Samura, Fumihiko Fujita, Takaho Tanaka, Masaki Kitazono, Manabu Yamamoto, Tatsuma Morikita, Masafumi Inomata, Yoshihiro Kakeji, Kazuo Shirouzu, Yoshihiko Maehara, and Kyushu Study Group of Clinical Cancer.
• Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
• Surg. Today. 2011 Jan 1; 41 (1): 84-90.

PurposeThis multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin, levoforinate, and infusional 5-fluorouracil (FOLFOX4) as a second-line therapy for Japanese patients with unresectable advanced or metastatic colorectal cancer.MethodsA total of 53 patients with progressive disease after first-line chemotherapy were enrolled in the study. The treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred, or the patient chose to discontinue the treatment.ResultsFour patients were ineligible and one did not receive the protocol therapy. Therefore, the response rate, overall survival (OS), and progression-free survival (PFS) were evaluated in 48 patients; toxicity was evaluated in 52 patients, excluding the patient who had not received the protocol therapy. A partial response was observed in 10 patients. The overall response rate was 20.8% (95% confidence interval [CI], 10.5%-35.0%). The median PFS was 5.6 months (95% CI, 4.1-7.0 months) and the median OS was 19.6 months (95% CI, 11.4-24.3 months). The most frequently encountered grade 3/4 hematological symptom was neutropenia (43.1%). The toxicity profile was generally predictable and manageable.ConclusionThe results showed good tolerability and efficacy for second-line FOLFOX4 in patients with advanced colorectal cancer, thus indicating the promise of this regimen as an effective second-line therapy for advanced colorectal cancer in the Japanese population.

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