© 2007 Foundation for Promotion of Cancer Research
Phase II Study of Oxaliplatin in Japanese Patients with Metastatic Colorectal Cancer Refractory to Fluoropyrimidines
1 Division of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, Kashiwa, Chiba
2 Department of Clinical Research and Internal Medicine, National Hospital Organization Shikoku Cancer Center, Ehime
3 Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo
4 Department of Gastroenterology, Saku Central Hospital, Saku, Nagano
5 Department of Medical Oncology, Kinki University, Osakasayama, Osaka
6 Department of Gastrointestinal Oncology, Kobe University, Hyogo
7 Department of Medical Oncology, Japanese Foundation for Cancer Research, Tokyo
8 Department of Pharmacy, Keio University Hospital, Tokyo, Japan
For reprints and all correspondence: Narikazu Boku, Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 Japan. E-mail: n.boku{at}scchr.jp
Received December 22, 2006; accepted February 5, 2007
Background: Although oxaliplatin (L-OHP) combined with infusional 5-fluorouracil (5-FU) and leucovorin (LV) is one of the standard chemotherapy regimens for metastatic or recurrent colorectal cancer, its introduction to Japan has been delayed. Phase I studies of L-OHP monotherapy in Japan showed no dose-limiting toxicity at the internationally recommended dose of 130 mg/m2 every 3 weeks, as well as no racial differences in pharmacokinetics as compared with Western subjects. This study aimed to clarify the efficacy and safety of L-OHP monotherapy in patients with metastatic colorectal cancer refractory to fluoropyrimidines.
Methods: Patients with metastatic colorectal cancer who had failed to respond to fluoropyrimidine-based chemotherapy received L-OHP at a dose of 130 mg/m2 every 3 weeks.
Results: Sixty patients were enrolled. Two ineligible patients and one untreated patient were excluded from analysis. The median number of treatment cycles was 4 (range, 1–6). The overall response rate was 9% (5/57, 95% CI: 4–19%). The median time to progression was 2.7 months, and the median survival time was 11.1 months. Grade 3 major toxicity comprised thrombocytopenia (12%) and nausea (11%). There was no grade 4 toxicity. All patients experienced mild to moderate sensory neurotoxicity without functional impairment interfering with activities of daily living.
Conclusions: The efficacy and toxicity of L-OHP in Japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines is apparently similar to those in Western patients.
Key Words: oxaliplatin • monotherapy • colorectal cancer • phase II