Gan To Kagaku Ryoho. 1989 Mar;16(3 Pt 1):333-9.
In order to examine the efficacy of adjuvant chemotherapy employing mitomycin C (MMC) and carmofur (HCFU) for patients with noncuratively resected colorectal carcinoma, a cooperative study was performed by 54 institutions in the Kyushu and Chugoku areas of Japan. The criteria for patient selection were as follows: 1) Age of 75 years or less and not accompanied by any serious disease. 2) Macroscopic diagnosis as being noncuratively resected on completion of the surgical procedure. 3) Definitive diagnosis of colorectal carcinomas, histologically. 4) No synchronous or metachronous double cancer. The prospective randomized controlled study consisted of two groups. In Group A, the MMC group received bolus intravenous injections of 20 mg MMC on the day of operation and 10 mg the next day, followed by 10 mg every 4 weeks until a total of 100 mg had been administered. In Group B, the MMC + HCFU group received the same treatment in Group A, but with the addition of 600 mg/day of HCFU from the second week, orally for at least one year. Concerning the 69-month survival rate, a better result was observed in the MMC + HCFU group than in the MMC only group (generalized Wilcoxon test: p less than 0.05). Significantly better survival rates were obtained in those cases with disseminating peritoneal metastasis, hepatic metastasis and stage V cancer in the MMC + HCFU group as when compared with the MMC only group. No significant side effects due to the combined administration of HCFU were recognized. The combined administration of MMC and HCFU was suggested to be a safe and effective adjuvant chemotherapy for noncuratively resected cases of colorectal carcinoma.
为了研究丝裂霉素C(MMC)和卡莫氟(HCFU)辅助化疗对非根治性切除的结直肠癌患者的疗效,日本九州和中国地区的54家机构开展了一项合作研究。患者入选标准如下:1)年龄75岁及以下,且无任何严重疾病。2)手术完成后宏观诊断为非根治性切除。3)经组织学确诊为结直肠癌。4)无同时性或异时性双癌。这项前瞻性随机对照研究分为两组。A组为MMC组,在手术当天静脉推注20mg MMC,次日推注10mg,随后每4周推注10mg,直至总共给药100mg。B组为MMC+HCFU组,接受与A组相同的治疗,但从第二周起加用600mg/天的HCFU,口服至少一年。关于69个月生存率,MMC+HCFU组的结果优于单纯MMC组(广义Wilcoxon检验:p<0.05)。与单纯MMC组相比,MMC+HCFU组中出现弥漫性腹膜转移、肝转移和Ⅴ期癌症的患者生存率显著更高。未发现因联合使用HCFU而产生的明显副作用。MMC与HCFU联合给药被认为是一种安全有效的非根治性切除结直肠癌病例的辅助化疗方法。