Koyama S, Ozaki A, Iwasaki Y, Sakita T, Osuga T, Watanabe A, Suzuki M, Kawasaki T, Soma T, Tabuchi T
Cancer Immunol Immunother. 1986;22(2):148-54. doi: 10.1007/BF00199130.
We performed a randomized controlled study of postoperative adjuvant immunochemotherapy with Nocardia rubra cell wall skeleton (N-CWS) and Tegafur for gastric carcinoma between September 1979 and March 1983. A total of 309 patients were entered into this trial. Of the 309 patients, there were 98 evaluable patients in the chemotherapy group and 115 evaluable patients in the immunochemotherapy group. In both groups, Tegafur was given as chemotherapy at a daily dose of 400 to 800 mg, starting at 24-29 days after gastrectomy. In the immunochemotherapy group, 400 micrograms of N-CWS was injected i.d. within the 2nd postoperative week. It was given weekly during the first month and subsequently monthly for as long as practicable. The patients were surveyed for length of survival in March 1985. The postoperative survival rate was analyzed for all cases, and for patients with various histopathological stages of carcinoma for comparison between the two treatment groups. No statistical difference was detected between the two groups in terms of age, sex, surgical curability, or stage of carcinoma. The overall survival rate for all patients was significantly higher in the immunochemotherapy group than in the chemotherapy group (p less than 0.05). With stage III plus IV disease, 53 patients from the chemotherapy group and 61 patients from the immunochemotherapy group were included for the analysis. As a consequence, a highly significant survival rate was observed in patients with stage III plus IV carcinoma in the immunochemotherapy group (p less than 0.005) as compared to the chemotherapy group. The overall 5-year (1800 days) survival rate after surgical treatment was 60.2% for the chemotherapy group and 73.2% for the immunochemotherapy group. In patients with stage III plus IV disease, the 5-year survival rates of the two treatment groups were 28.8% and 52.4%, respectively. Accordingly, the 50% survival period of patients with stage III plus IV cancer was 1800 days or more in the immunochemotherapy group, whereas it was only 722 days in the chemotherapy group. These results emphasize the effectiveness of N-CWS as an adjuvant immunotherapeutic agent in postoperative gastric cancer patients. The main side effects of N-CWS were skin lesions in the injected sites and fever, but these were temporary and not serious.
1979年9月至1983年3月，我们对胃癌患者进行了一项关于红诺卡氏菌细胞壁骨架（N-CWS）联合替加氟术后辅助免疫化疗的随机对照研究。共有309例患者进入该试验。在这309例患者中，化疗组有98例可评估患者，免疫化疗组有115例可评估患者。两组均在胃切除术后24 - 29天开始给予替加氟化疗，每日剂量为400至800毫克。在免疫化疗组中，术后第2周内皮下注射400微克N-CWS。在第一个月每周注射一次，随后尽可能每月注射一次。1985年3月对患者的生存时间进行了调查。分析了所有病例的术后生存率，并对不同组织病理学分期的癌患者进行了分析，以比较两个治疗组。两组在年龄、性别、手术可治愈性或癌症分期方面均未检测到统计学差异。免疫化疗组所有患者的总生存率显著高于化疗组（p < 0.05）。对于III期加IV期疾病，化疗组纳入53例患者，免疫化疗组纳入61例患者进行分析。结果显示，与化疗组相比，免疫化疗组III期加IV期癌患者的生存率具有高度显著性（p < 0.005）。手术治疗后化疗组的总体5年（1800天）生存率为60.2%，免疫化疗组为73.2%。对于III期加IV期疾病的患者，两个治疗组的5年生存率分别为28.8%和52.4%。因此，免疫化疗组III期加IV期癌症患者的50%生存期为1800天或更长，而化疗组仅为722天。这些结果强调了N-CWS作为术后胃癌患者辅助免疫治疗药物的有效性。N-CWS的主要副作用是注射部位的皮肤病变和发热，但这些都是暂时的，并不严重。
