First clinical data of a natural immunomodulator in colorectal cancer.
OBJECTIVE
MSC (trade-name AVEMAR) is a per os applicable complex of multiple, biologically active molecules obtained from fermented wheat-germ extract. Preclinical studies suggest potent anti-metastatic activity and it has a favorable toxicity profile. It has been aimed in a pilot-scale, phase II clinical study to document whether or not MSC as a support to surgery or plus chemotherapy adds any therapeutic benefit compared to the same combination without MSC in colorectal cancer.


METHODS
From 1998 to June 1999, 18 control patients and 12 consecutive colorectal cancer patients respectively, were enrolled into this study. All patients underwent curative surgery. The control group (18 patients) received no other therapy or adjuvant chemotherapy alone. The MSC group (12 patients) received MSC alone or plus adjuvant chemotherapy. Until now, the median follow-up has been 9 months.


RESULTS
Interim data of the study document that in the MSC group no new metastases, neither hepatic nor other, have occurred, so far. On the contrary, several new metastases have developed in the control group.


CONCLUSIONS
Orally administered MSC is a potent candidate to be regarded as a supportive therapy to surgery or plus chemotherapy for colorectal cancer patients.
Jakab
F
F
Department of Surgery, Uzsoki Teaching Hospital, Budapest, Hungary.
Mayer
A
A
Hoffmann
A
A
Hidvégi
M
M
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D037102:Lectins / Q000009:adverse effects / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*
D000276:Adjuvants, Immunologic; C113915:Avemar; D037102:Lectins; D010936:Plant Extracts