[A double blind study to evaluate the optimal dose and its frequency for oral administration of OK-432 (picibanil) by immunological parameters (the 2nd report)].
The present study was designed to determine the optimal dose and frequency of oral administration of a biological response modifier, OK-432 (Picibanil), which has been used for cancer immunotherapy by injection. Ninety one stomach cancer patients were randomly assigned into 7 groups and were administered a placebo or OK-432 at a dose of 5, 20 or 40KE, once or 3 times a week before operation (5KE X 1/W, 20KE X 1/W, 40KE X 1/W, or X 3/W). Misregistration excluded 3 patients and the data of 88 patients were analysed. There was no significant difference in the background status of the patients in each group. In the 1st report, we already showed that 5KE X 3/W might be the optimal regimen to augment the natural killer (NK) activity of regional lymph node lymphocyte (RNL). In the 2nd report, we searched for the optimal regimen to augment the antitumor immunity of T lymphocytes. The proliferative response of RNL to SuPR (protein derived from OK-432) was augmented in all the groups administered OK-432. The responsiveness of PBL to autologous tumor extract enhanced by IL-2 was augmented by 5KE X 1/W, and that of RNL was augmented by 5KE X 3/W. The killer/suppressor (Leu2+15-/Leu2+15+) ratio in RNL increased in all the groups administered OK-432 especially in 20KE X 3/W group. Oral administration of OK-432 augmented both non-specific and the specific antitumor immunity of PBL as well as RNL, and 5KE X 3/W may be the optimal regimen to augment the antitumor immunity, especially of RNL.
1st Department of Surgery, Faculty of Medicine, Kyoto University.
T
T
Shiraishi
Y
Y
Nio
S
S
Imai
M
M
Tsubono
H
H
Morimoto
C C
CC
Tseng
T
T
Tobe
T
T
Tanaka
O
O
Kitamura
S
S
Sakanashi
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001688:Biological Products / Q000008:administration & dosage*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D006801:Humans; D007958:Leukocyte Count; D008213:Lymphocyte Activation; D008875:Middle Aged; D010844:Picibanil / Q000008:administration & dosage* / Q000627:therapeutic use; D013274:Stomach Neoplasms / Q000276:immunology* / Q000628:therapy; D013601:T-Lymphocytes / Q000276:immunology*
D001688:Biological Products; D010844:Picibanil