Background. The preoperative intratumoral injection with OK‐432 (Picibanil, Chugai Pharmaceutical Co., Tokyo, Japan), an immunomodulatory agent prepared from an attenuated strain of streptococcus pyogenes, activates the regional immune system and causes degeneration of cancer tissue in carcinoma of the stomach.
Methods. A multi‐institutional randomized trial of OK‐432 to determine its clinical usefulness was conducted. Three hundred and ninety‐five patients with gastric cancer were assigned randomly either to receive or not to receive a preoperative intratumoral injection of OK‐432. Among them, 277 patients with advanced cancer were treated by common postoperative chemoimmunotherapy consisting of mitomycin C, tegafur, and OK‐432. All patients were followed for at least 5 years.
Results. The adverse effects of OK‐432 injected intratumorally predominantly were mild fever, anorexia, and abdominal pain, however, no treatment was required for these symptoms. Overall, there were no differences in outcome between the OK‐432 and control groups. However, analysis based on stage showed that a preoperative intratumoral injection of OK‐432 significantly improved the 5‐year survival rate of patients with Stage III cancer (P = 0.0229), at 47.7% for the OK‐432 group and 27.5% for the control group. In subset analysis, when the 5‐year survival of patients with and without tumor infiltrating lymphocytes (TIL) was compared, OK‐432 injected intratumorally had a significant positive effect on the group showing a moderate to marked number of TIL (P = 0.0438).
Conclusion. These results showed that the intratumoral injection of OK‐432 may improve survival of patients with Stage III gastric cancer.
Our results indicate that M-CSF at a high dose is a potent inhibitor of cytokine production and can potentially be used as an immunosuppressive agent for allograft rejection.
This investigation was intended to determine whether the natural killer (NK) activity of peripheral blood lymphocytes (PBL) correlated with the histopathological factor, which is thought to be a result of a balance between tumor aggression and host resistance. The NK activity of PBL from 60 patients with lung cancer was measured by the lysis of 51Cr-labelled K562 target cells. The activity was significantly decreased with advancing stages of the disease, and inversely correlated with increased immunosuppressive substance levels of the serum. Histopathological factors, such as low grade pleural invasion of the tumor and abundant lymphoid cell infiltration around the tumor, were significantly associated with the high NK activity of PBL. These results show that a decrease in NK activity may play a role in identifying those individuals with a greater risk of cancer development.
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