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- Title
A multicenter phase II clinical study of oxaliplatin, folinic acid, and 5-fluorouracil combination chemotherapy as first-line treatment for advanced colorectal cancer: A Japanese experience.
- Authors
Baba, Hideo; Hayashi, Naoko; Emi, Yasunori; Kakeji, Yoshihiro; Egashira, Akinori; Oki, Eiji; Shirabe, Ken; Toyama, Tetsuo; Ohga, Takefumi; Yamamoto, Manabu; Hasegawa, Hirofumi; Kohakura, Fumiko; Higashi, Hidefumi; Niwa, Kiyoshi; Fujita, Fumihiko; Ogata, Yutaka; Kohnoe, Shunji; Inomata, Masafumi; Samura, Hironori; Tokunaga, Shoji
- Abstract
Purpose: This multicenter phase II study was designed to determine the efficacy and tolerability of oxaliplatin in combination with levofolinate and infusion 5-fluorouracil (FOLFOX4) as first-line therapy for Japanese patients with unresectable metastatic colorectal cancer. Methods: Sixty consecutive patients with histologically confirmed advanced or metastatic colorectal cancer were enrolled in the study. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity occurred. Results: Two patients were ineligible. Toxicity was evaluated in 60 patients, who had received a part or all of the protocol therapy. A partial response was observed in 20 patients. The overall response rate was 34.5% (95% CI, 22.5%-48.1%) and the tumor control rate (partial response + stable disease) was 82.8%. The median progression-free survival was 6.9 months (95% CI, 5.1-9.8 months), and the median overall survival was 31.5 months (95% CI, 18.1-40.1 months). There were no toxicity-related deaths. Grade 3 or 4 neutropenia occurred in 48.3% of patients and often caused a delay in the subsequent treatment course. Mild to moderate cumulative peripheral sensory neuropathy affected 71.7% of patients. Conclusion: The results showed good tolerability and efficacy for first-line FOLFOX4 in the treatment of patients with advanced colorectal cancer, indicating the promise of this regimen as first-line therapy for advanced colorectal cancer in the Japanese population.
- Subjects
JAPAN; COLON cancer; OXALIPLATIN; FOLINIC acid; FLUOROURACIL
- Publication
Surgery Today, 2011, Vol 41, Issue 12, p1610
- ISSN
0941-1291
- Publication type
Article
- DOI
10.1007/s00595-011-4589-9