A pilot phase II study of capecitabine in advanced or recurrent colorectal cancer.
BACKGROUND
A pilot phase II study was conducted to evaluate the Japanese intermittent regimen of capecitabine in patients with advanced/recurrent colorectal cancer.


METHODS
Twenty-two patients received oral capecitabine in a dose of 828 mg/m(2) twice daily for 3 weeks every 4 weeks.


RESULTS
In the 20 patients evaluable for efficacy, the overall response rate was 25.0% (95% CI, 8.7-49.1%), rising to 33.0% in the subset of patients previously untreated for metastatic disease (n = 9). A further nine patients had stable disease. The median duration of response was 7.0 months. Five patients (22.7%) experienced grade 3/4 treatment-related adverse events, the most common being a bullous rash observed in two patients (9.1%).


CONCLUSIONS
The 3 weeks out of 4 intermittent regimen of capecitabine demonstrated good antitumor activity and tolerability in patients with advanced/refractory colorectal cancer, providing a clear rationale for conducting a larger phase II study in patients with advanced disease.
Kondo
Yukifumi
Y
Department of Surgery, Sapporo-Kosei General Hospital, Kita-3, Higashi-8, Chuo-ku, Sapporo, Hokkaido 060-0033, Japan. yuki.kondou@ja-hokkaidoukouseiren.or.jp
Terashima
Masanori
M
Sato
Atsushi
A
Taguchi
Tetsuo
T
D000284:Administration, Oral; D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003110:Colonic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D006932:Hyperbilirubinemia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012004:Rectal Neoplasms / Q000188:drug therapy* / Q000473:pathology
D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil