[Optimal dosage of UFT + MMC combination chemotherapy for advanced colorectal cancer--phase I/II study of combination chemotherapy of MMC with 2-week intervals and intermittent UFT administration--Study Group of UFTM Therapy for Advanced Colorectal Cancer].
A combined phase I/II study (UFTM) of tegafururacil (UFT) and mitomycin C (MMC) was performed to find the optimal dosage for advanced colorectal cancer. The study consisted of two parts. The first part confirmed the safety of UFTM and determined the administered doses. The second part evaluated the clinical response of UFTM. Based on the first part, the dosage regimen in the second part was established as follows; the treatment course consisted of 4 weeks and a bolus dose of MMC 6 mg/m2 was given every 2 weeks with daily oral UFT 400 mg/m2 for 5 consecutive days followed by 2 drug-free days; MMC was not given in the third course, and the treatment cycle of the above-mentioned 3 courses was repeated thereafter. In the second part, 26 of 28 patients could be evaluated for toxicity. Grade 3 or 4 toxicities were: anorexia 2, nausea and vomiting 1, leukopenia 1, and 2 cases of thrombocytopenia. The clinical responses of UFTM showed 1 CR and 4 PR in the 21 patients who could be evaluated for response (23.8%). The response rate was 38.5% (5/13) in patients naive to chemotherapy. UFTM can be performed effectively at outpatient clinics as long-term chemotherapy.
Ikeda
E
E
Dept. of Surgery, Yamagata Prefectural Central Hospital.
Kodaira
S
S
Teramoto
T
T
Okuda
M
M
Takahashi
T
T
Kato
T
T
Yamamoto
Y
Y
Isomoto
H
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects
D004338:Drug Combinations; C096910:UFT(R) drug; D005641:Tegafur; D016685:Mitomycin; D014498:Uracil