Postoperative chemotherapy including intraperitoneal and intradermal administration of the streptococcal preparation OK-432 for patients with gastric cancer and peritoneal dissemination: a prospective randomized study.
We studied the effects on survival time of postoperative immuno-chemotherapy, including the streptococcal preparation OK-432, in patients with gastric cancer and synchronous peritoneal dissemination. The patients were prospectively randomized and a valid statistical assessment could be made for 109. Patients randomized to group B received therapy that is widely used in Japan to treat patients with gastric cancer: mitomycin C (MMC) and UFT, a combination of tegafur and uracil in a molar ratio of 1:4, for 1 year. Patients randomized to group A received the same drugs as were given to group B patients plus OK-432 i.p. for 7 days, beginning on postoperative day 0, and OK-432 by intradermal injection for 1 year, at 2-week intervals. There were no differences between the two groups in any known prognostic factor or in the dose of any drug administered except for OK-432. There was no difference in the toxicity rate between the groups. In this negative trial, there was no improvement in survival time with the addition of OK-432 to MMC and UFT for patients with gastric cancer and peritoneal dissemination.
Sugimachi
K
K
Department of Surgery II, Kyushu University, Fukuoka, Japan.
Maehara
Y
Y
Akazawa
K
K
Kondo
Y
Y
Kunii
Y
Y
Kitamura
M
M
Yamaoka
H
H
Takahashi
Y
Y
Kito
T
T
Katou
M
M
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007271:Injections, Intradermal; D007274:Injections, Intraperitoneal; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010534:Peritoneal Neoplasms / Q000556:secondary / Q000628:therapy*; D010844:Picibanil / Q000627:therapeutic use*; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D016019:Survival Analysis; D016896:Treatment Outcome
D010844:Picibanil