[Abstract] [Full Text PDF] (in Japanese / 4523KB) [Members Only And Two Factor Auth.]

J.Jpn. Surg. Soc.. 83(7): 635-648, 1982


Original article

RESULT OF RANDOMIZED CLINICAL TRIAL OF IMMUNOTHERAPY WITH NOCARDIA RUBRA-CWS ON POSTOPERATIVE GASTRIC CANCER PATIENTS

1) Department of Surgery, School of Medicine, Chiba University, Chiba
2) Department of Health Administration, School of Health Sciences, Faculty of Medicine, University of Tokyo, Tokyo

Hiroshi Sato1), Takenori Ochiai1), Hirotoshi Sato1), Ryosuke Hayashi11), Kazuo Watanabe1), Takehide Asano1), Kaichi Isono1), Tsuneo Tanaka2)

From September 1979 through March 1981, a total of 302 patients with gastric cancer undergoing gasterectomy at the Department of Surgery, Chiba University Hospital and its 14 affiliated hospitals were studied for clinical effectiveness of immunotherapy with Nocardia rubra cell wall skeleton (N-CWS). All the patients undergoing gasterectomy at these hospitals during the period were enrolled in the study. The subjects were stratified by gross stage of cancer and degree of operative curability. They were then randomly assinged to either chemotherapy group or chemotherapy plus immunotherapy group. Immunotherapy used was intradermal injection of 400μg of N-CWS, which was given weekly for the first month and monthly thereafter. After the specimen was examined microscopically, the patients were classified by radicality of surgical intervention into curative or non-curative group. The patients were surveyed for survival period in June 1981. No statistical difference was detected between the two treatment groups in age, sex or operative procedures that might influence the patient’s survival. As a result, statistical difference in survival rate was not seen in patients of curative group, probably due to short observation period so far. However, the difference in survival rate was statistically significant in patients of non-curative group (p<0.05). These results indicate the adjunctive effect of N-CWS as an immunotherapeutic agent in patients who undergone gasterectomy for gastric cancer.


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