Randomized controlled study of the effect of adjuvant immunotherapy with Picibanil on 51 malignant gliomas.
During the period from January 1981 to December 1983, two groups of a total of 51 patients (31 malignant astrocytomas, 17 glioblastomas, and 3 others) were treated with radioimmunochemotherapy using nimustine hydrochloride (ACNU) plus Picibanil (OK-432) (group A) and radiochemotherapy with ACNU only (group B) in a randomized controlled study. Group A consisted of 24 patients and group B of 27 patients. The differences in the background of the two groups were not statistically significant. Survival curves of both groups were shown by the Kaplan-Meier method. The postoperative survival rate at 1 year and 3 years was 70% and 30%, respectively, equal in both groups, and the differences between groups A and B were not statistically significant by the Cox-Mantel test. The side effects seen in group B were most prominent in the bone marrow, and severe leukopenia occurred. However, in group A leukopenia was suppressed after 2 months. Immunologic parameters, such as the purified protein derivative skin reaction test, did not change, but the streptococcus pyogenes Su-strain polysaccharide skin-reaction test became more positive after therapy in group A.
D000328:Adult; D000368:Aged; D001688:Biological Products / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D005260:Female; D005910:Glioma / Q000188:drug therapy / Q000532:radiotherapy / Q000628:therapy*; D006801:Humans; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D015376:Nimustine; D009607:Nitrosourea Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010844:Picibanil / Q000009:adverse effects / Q000627:therapeutic use*; D011897:Random Allocation; D012882:Skin Tests
D001688:Biological Products; D009607:Nitrosourea Compounds; D015376:Nimustine; D010844:Picibanil