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.
Division of Gastrointestinal Oncology and Gastroenterology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan. n.boku@scchr.jp
Narikazu
N
Boku
Atsushi
A
Ohtsu
Ichinosuke
I
Hyodo
Kuniaki
K
Shirao
Yoshinori
Y
Miyata
Kazuhiko
K
Nakagawa
Takao
T
Tamura
Kiyohiko
K
Hatake
Yusuke
Y
Tanigawara
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