Nakajima T, Miwa K, Ohmori Y, Sakabe T, Fujii M, Kajitani T
Gunma Cancer Center Tomo Hospital, Japan.
Gan To Kagaku Ryoho. 1996 Aug;23(9):1161-8.
A multi-center collaborative study was conducted in curatively resected gastric cancer patients at Stages II and III to compare oral 5-FU (Group A), oral Tegafur (Group B) and i.v. MMC + oral 5-FU (Group C). From May 1982 to April 1985, 1,012 cases were enrolled at 55 institutions. Some 138 (13.8%) were excluded, and 874 were analyzable. In the analysis of background factors, Group B had more cases with tumor of large diameter and advanced Stage. Adverse effects were relatively mild in all groups, and there was no problem in drug tolerance. Five-year survival rate was 67.6%, 62.4% and 68.6% in Groups A, B and C, respectively, reflecting no significant difference among them. It was 85.0%, 83.0% and 81.1% in Stage II and 52.5%, 51.0% and 59.0% in Stage III of Groups A, B and C, respectively. No significant difference was found, but Stage III of Group C showed a slightly higher survival rate. Supportive clinical study will be required to assess the usefulness of MMC as an introduction therapy. We found no difference in efficacy between 5-FU and Tegafur as maintenance therapy. The life-prolongation effect of fluoropyrimidines in comparison with surgery alone should be studied separately.
一项多中心协作研究在II期和III期接受根治性切除的胃癌患者中开展,以比较口服5-氟尿嘧啶(A组)、口服替加氟(B组)和静脉注射丝裂霉素+口服5-氟尿嘧啶(C组)的疗效。1982年5月至1985年4月,55家机构共纳入1012例患者。约138例(13.8%)被排除,874例可进行分析。在背景因素分析中,B组大直径肿瘤和晚期病例较多。所有组的不良反应相对较轻,药物耐受性方面没有问题。A、B、C组的5年生存率分别为67.6%、62.4%和68.6%,三组之间无显著差异。在II期,A、B、C组的5年生存率分别为85.0%、83.0%和81.1%;在III期,分别为52.5%、51.0%和59.0%。未发现显著差异,但C组III期的生存率略高。需要进行支持性临床研究以评估丝裂霉素作为诱导治疗的有效性。我们发现5-氟尿嘧啶和替加氟作为维持治疗的疗效没有差异。氟嘧啶与单纯手术相比的延长生命效果应单独研究。