The Effects of Mesima-Ex, the Immunomodulator in Curatively Resected Gastric Cancer

Cho, Se Haeng; Kim, Joo Hang; Park, Byung Kyu; Park, Soo Jin; Ahn, Sang Hun; Jung, Hyun Chul; Rho, Jae Kyung; Kim, Byung Soo; Rho, Sung Hun

Abstract

PURPOSE: The Mesima-Ex is a kind of biologic response modifier, which is extracted from a mushroom called Phellinus linteus. Mesima-Ex consists of various chemical compounds which include protein bound polysaccharide, mucoprotein, triterpenoid, and quinones. Mesima-Ex exerts its antitumor effects by augmenting host immune response without any toxic side effects. In vitro study, Mesima-Ex seems to potentiates antibody dependent cell mediated cytotoxicity (ADCC) and cell mediated cytotoxicity (CMI) against tumor cells. We initiated this study to verify antitumor effects of Mesima-Ex as an antineoplastic agent. MATERIALS AND METHOD: Gastric cancer patients who underwent curative resection with normal hepatic and renal function were eligible. They were divided into two groups by random number table. One group (N=30: Mesima-Ex group) received postoperative adjuvant chemotherapy with 5-FU (500 mg/m2 weekly), adriamycin (40 mg/m2 every 3 weeks) and Mesima-Ex (6 cap daily per Os). Another group (N=37: control group) received 5-FU and adriamycin only without Mesima-Ex. NK (natural killer cell) activity, ADCC (antibody dependent cell mediated cytotoxicity), CD4 , and CD8 cells were measured and an analysis of disease free survival rate of the two study groups was performed.
RESULTS
Sixty seven patients were enrolled in this study. Their median age was 55 years old. NK activity (basal activity: 25%) was enhanced significantly at the 2nd, and 4th months in the Mesima-Ex group (28.9%, 43.4%, p<0.05). ADCC was also enhanced from 37% to 42.1% at the 2nd month in the Mesima-Ex group (p<0.05). The control group did not show any significant change in NK activity or ADCC. The CD4 cell ratio was increased from 37% to 42.1% at the 2nd months in the Mesima-Ex group but not in the control group (p<0.05). There was no significant change in CD8 subsets (p>0.05). There were no toxic side effects more than grade III from Mesima-Ex administration. The two year disease free survival rate was higher in the Mesima-Ex group than that of the control group (77% vs 58%, p<0.05).
CONCLUSION
Mesima-Ex can be used safely as an immunomodulator with standard chemotherapeutic agents for purpose of adjuvant chemotherapy. Mesima-Ex was effective in augmenting host immune response in vitro. The Mesima-Ex group showed a higher two year disease free survival rate than that of the control group.