Phase II study of oxaliplatin in japanese patients with metastatic colorectal cancer refractory to fluoropyrimidines.
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.
Boku
Narikazu
N
Division of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. n.boku@scchr.jp
Ohtsu
Atsushi
A
Hyodo
Ichinosuke
I
Shirao
Kuniaki
K
Miyata
Yoshinori
Y
Nakagawa
Kazuhiko
K
Tamura
Takao
T
Hatake
Kiyohiko
K
Tanigawara
Yusuke
Y
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use* / Q000633:toxicity; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004351:Drug Resistance; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000627:therapeutic use* / Q000633:toxicity; D000077150:Oxaliplatin
D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin