HIGH-DOSE CHEMOTHERAPY AND AUTOLOGOUS PER IPHERAL HEMATOPOIETIC PROGENITOR CELLS TRANSPLANTATION IN BREAST-CANCER - STUDY OF INITIAL RESULTS, TOXICITY AND SUPPORTIVE THERAPY

BACKGROUND: In the last years high dose chemotherapy (HDC) schedules h ave been developed with autologous bone marrow transplantation (ABMT) which are very effective in breast cancer. Expectation has been raised concerning the cure of a subgroup of patients with metastatic breast cancer and the improvement of prognosis in high risk stages II and III . METHODS: CTCb (cyclophosphamide 6 g/m(2), thiotepa 500 mg/m(2) and c arboplatin 800 mg/m(2)) was administered with autologous peripheral he matopoietic progenitor cells transplantation (TACPHP) and granulocytic colony stimulating factor (G-CSF) 5 mu g/kg/day to 27 patients with b reast cancer: 9 in stage IV in complete remission, 12 in stage II with greater than or equal to 10 affected lymph nodes and 6 in stage III. RESULTS: No toxic deaths were reported. The median time to achieve gre ater than or equal to 0.5 x 10(9) neutrophils/l was 8 days, to greater than or equal to 20 x 10(9) platelets/l 9 days and to greater than or equal to 50 x 10(9) platelets/l 12 days. Fever was observed in 85% of the patients although its median duration was of only one day, Extrah ematologic toxicity was moderate with grade III nausea/vomiting in 48% of patients, grade III mucositis in 22%, grade III hepatitis in 19%, and grade III diarrhea in 4%. No grade IV toxicity was observed. The m edian follow-up is still short (10 months, range: 2-25). All the patie nts maintain normal hematologic peripheral blood counts and only 4 (in stage IV) have relapsed. CONCLUSIONS: The slight extrahematologic tox icity observed in the high dose chemotherapy with cyclophosphamide, th iotepa and carboplatin, and the rapid hematologic recovery provided by the TACPHP and G-CSF allow the above schedule to be administered with moderate toxicity and no mortality. This low toxic profile leads to t he possibility of future trials with this chemotherapy schedule in oth er subgroups of patients with breast cancer.