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 allocated to 2 groups: 20 patients received chemotherapy plus thymostimulin (CHT + Th), and 20 patients received chemotherapy alone (CHT). The occurrence of infections, response rate, bone markers and bone pain were 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 6th month the average administered dose intensity was significantly higher in the CHT + Th group (p<0.05). Pain, as assessed by a visual analogue scale, showed a significant reduction in both groups. The hydroxyproline/creatinine ratio showed a significant reduction (p<0.05) only in CHT + Th treated patients. After 6 months of treatment, a partial response was observed in 6 of 19 evaluable patients in the CHT + Th group and in 4 of 17 evaluable patients in the CHT group. Our findings suggest that the addition of thymostimulin to chemotherapy in breast cancer patients with bone metastases reduces the infection rate and allows for the administration of the planned dose intensity. © 1995, Adis International Limited. All rights reserved.