統合腫瘍学ジャーナル

Multicenter Phase II Study of FOLFOX6 for Previously Untreated Unresectable Metastatic Colorectal Cancer

Abstract

Satoru Iwasa, Yasuhiro Shimada, Yoshitaka Inaba, Kiyomi Mera, Hisateru Yasui, Yutaka Ogata, Kenichi Sugihara, Tatsuhiro Arai, Kenji Katsumata, Satoshi Ikeda, Makoto Akaike, Takeshi Kato, Tetsuya Hamaguchi and Tomoyuki Kato

Background: This phase II study investigated the safety and efficacy of an oxaliplatin, fluorouracil, and lleucovorin regimen (FOLFOX6) in Japanese patients with previously untreated, unresectable metastatic colorectal cancer because oxaliplatin of FOLFOX6 was given at a previously untested dose of 100 mg/m2.
Methods: Patients with metastatic colorectal cancer received FOLFOX6, consisting of oxaliplatin at a dose of 100 mg/m2 in combination with l-leucovorin 200 mg/m2 over 2 hours, and fluorouracil 400 mg/m2 intravenous bolus followed by fluorouracil 2400 mg/m2 over a 46-hour infusion, with cycles every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was to evaluate the objective response rate.
Results: Among 49 patients enrolled, two patients were considered unsuitable against the inclusion criteria due to non-measurable lesion and prior treatment, and one patient was unable to start treatment due to clinical disease progression. Accordingly, safety and efficacy were assessed in 46 and 47 patients, respectively. There was one complete response and 22 partial responses, resulting in an overall response rate of 49% (95% CI 34–64%). The median progression-free survival time was 8.8 months, and the median survival time was 24.5 months. Grade 3 or higher neutropenia and thrombocytopenia occurred in 50% and 2% of patients, respectively, and febrile neutropenia occurred in one patient. Grade 3 sensory neuropathy occurred in 13% of patients.
Conclusion: FOLFOX6 with oxaliplatin at 100 mg/m2 was well-tolerated and effective in Japanese patients with unresectable metastatic colorectal cancer.