ACTIVATED (HLA-DR-LYMPHOCYTE SUBSETS IN CERVICAL-CARCINOMA AND EFFECTS OF RADIOTHERAPY AND IMMUNOTHERAPY WITH SIZOFIRAN ON CELL-MEDIATED-IMMUNITY AND SURVIVAL() T)

A prospective randomized trial on 312 patients with locally advanced c ervical carcinoma (FIGO stages IB-IV) was carried out. The 5-year surv ival in 90 patients treated with radiotherapy and antitumor polysaccha ride sizofiran, an extract from the culture broth of Schizophyllum com mune Fries, in combination was significantly (P = 0.045) better than t hat in 82 patients treated with radiotherapy alone. Treatment with siz ofiran and 5-fluorouracil in combination improved (P = 0.003) the 5-ye ar survival in 60 patients treated with radiotherapy. In 244 cervical carcinoma patients, the percentage of activated CD8 + (CD8 + HLA-DR ) T cells in the CD8 + T-cell subsets in peripheral lymphocytes increa sed significantly as the disease progressed. A similar tendency was ob served in the percentage of activated CD4 + (CD4 + HLA - DR +) T cells in the CD4 + T-cell subsets. These immunologic parameters were signif icantly increased by radiotherapy, but not by surgery. Sizofiran accel erated a recovery in the activated CD8 + T cells in the CD8 + T-cell s ubsets compared with that of sizofiran nontreated patients after radio therapy. Our data show that possible immune impairment in cervical car cinoma may be caused by disturbances in cell-mediated immunity, and th at sizofiran is an effective immunotherapeutic agent for cervical carc inoma because it stimulates a rapid recovery of the immunologic parame ters impaired by radiotherapy. (C) 1995 Academic Press, Inc.