title: A phase II Japanese study of a modified capecitabine regimen for advanced or metastatic colorectal cancer.
abstract: This phase II study evaluated a modified Japanese capecitabine regimen as first-line treatment for advanced/metastatic colorectal cancer. Sixty patients received oral capecitabine 828 mg/m(2) twice daily for 3 weeks every 4 weeks. In the 56 efficacy-evaluable patients, the overall response rate was 26.8% (95% CI 15.8-40.3%) and 21 patients (37.5%) had stable disease. The median duration of response and overall survival times were 7.4 months (range 4.3-13.8) and 17.6 months (95% CI 14.1-20.5), respectively. The most frequent non-hematological treatment-related adverse events (all grades) were hand-foot syndrome (62.7%), anorexia (28.8%), diarrhea (22.0%) and fever (22.0%). There was no grade 3/4 diarrhea. The most common grade 3/4 laboratory abnormalities were lymphocytopenia (30.5%) and hyperbilirubinemia (35.6%). We conclude that the modified Japanese intermittent regimen of capecitabine is effective and well tolerated as first-line treatment for advanced colorectal cancer, and is worthy of further study in larger phase III studies.
authors.affiliation: Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Yoshidakanoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. sakamoto@pbh.med.kyoto-u.ac.jp
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Yukifumi
authors.initials: Y
authors.lastname: Kondo
authors.forename: Shoji
authors.initials: S
authors.lastname: Takemiya
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Sakamoto
authors.forename: Isamu
authors.initials: I
authors.lastname: Nishisho
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000069287:Capecitabine; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D018450:Disease Progression; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000031:analogs & derivatives; D005533:Foot Dermatoses / Q000139:chemically induced / Q000150:complications; D019983:Guideline Adherence; D006229:Hand Dermatoses / Q000139:chemically induced / Q000150:complications; D006801:Humans; D006932:Hyperbilirubinemia / Q000097:blood; D007564:Japan; D008231:Lymphopenia / Q000097:blood; D008875:Middle Aged; D018579:Patient Selection; D015996:Survival Rate; D013577:Syndrome; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil