THYMOSTIMULIN IN ASSOCIATION WITH CHEMOTHERAPY IN BREAST-CANCER PATIENTS WITH BONE METASTASES

40 patients with predominantly osteolytic bone metastases from breast cancer, in whom first-line chemotherapy had failed, were randomly allo cated to 2 groups: 20 patients received chemotherapy plus thymostimuli n (CHT + Th), and 20 patients received chemotherapy alone (CHT). The o ccurrence of infections, response rate, bone markers and bone pain wer e evaluated after 3 and 6 months of treatment. The infection rate was lower in the CHT + Th group than in the CHT group (p < 0.05). At the 6 th month the average administered dose intensity was significantly hig her in the CHT + Th group (p < 0.05). Pain, as assessed by a visual an alogue scale, showed a significant reduction in both groups. The hydro xyproline/ creatinine ratio showed a significant reduction (p < 0.05) only in CHT + Th treated patients. After 6 months of treatment, a part ial response was observed in 6 of 19 evaluable patients in the CHT + T h group and in 4 of 17 evaluable patients in the CHT group. Our findin gs suggest that the addition of thymostimulin to chemotherapy in breas t cancer patients with bone metastases reduces the infection rate and allows for the administration of the planned dose intensity.