title: Efficacy of adjuvant immunochemotherapy with OK-432 for patients with curatively resected gastric cancer: a meta-analysis of centrally randomized controlled clinical trials.
abstract: The benefit of immunochemotherapy employing a streptococcal preparation, OK-432 (Picibanil), in patients with curatively resected gastric cancer was reassessed by meta-analysis of data from 1,522 patients enrolled in six clinical trials with central randomization. All six trials began between 1985 and 1993, and patients were followed-up for at least 3 years after surgery and enrollment of the last patient. In these trials, standard chemotherapy was compared with the same chemotherapy plus OK-432. The endpoint was overall survival and intent-to-treat analysis was done without patient exclusion. Data were analyzed using the Mantel-Haenszel method. The 3-year survival rate for all eligible patients in the six trials was 67.5% in the immunochemotherapy group versus 62.6% in the chemotherapy group. The 3-year overall survival odds ratio was 0.81 (95% confidence interval: 0.65-0.99). The treatment effect was shown to be statistically significant (p = 0.044). The results of this meta-analysis suggest that immunochemotherapy after surgery with OK-432 can improve the survival of patients with curatively resected gastric cancer.
authors.affiliation: Department of Epidemiological & Clinical Research Information Management, Kyoto University, Graduate School of Medicine, Japan. sakamoto@pbh.med.kyoto-u.ac.jp
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nakazato
authors.forename: Yuji
authors.initials: Y
authors.lastname: Sato
authors.forename: Junichi
authors.initials: J
authors.lastname: Uchino
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Taguchi
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Ryoma
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D003131:Combined Modality Therapy; D006801:Humans; D007167:Immunotherapy; D016017:Odds Ratio; D010844:Picibanil / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D010844:Picibanil