Ikeda E, Kodaira S, Teramoto T, Okuda M, Takahashi T, Kato T, Yamamoto Y, Isomoto H
Dept. of Surgery, Yamagata Prefectural Central Hospital.
Gan To Kagaku Ryoho. 1996 Sep;23(10):1291-8.
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.
开展了一项替加氟尿嘧啶（UFT）与丝裂霉素C（MMC）联合的I/II期研究（UFTM），以寻找晚期结直肠癌的最佳剂量。该研究包括两个部分。第一部分确认了UFTM的安全性并确定给药剂量。第二部分评估了UFTM的临床反应。基于第一部分，第二部分的给药方案如下：疗程为4周，每2周给予一次MMC大剂量6 mg/m²，同时每日口服UFT 400 mg/m²，连续5天，随后休息2天；第三个疗程不给予MMC，此后重复上述3个疗程的治疗周期。在第二部分中，28例患者中有26例可评估毒性。3级或4级毒性反应为：厌食2例、恶心和呕吐1例、白细胞减少1例、血小板减少2例。在21例可评估反应的患者中，UFTM的临床反应显示1例完全缓解（CR）和4例部分缓解（PR）（23.8%）。初治化疗患者的缓解率为38.5%（5/13）。UFTM作为长期化疗可在门诊有效进行。
