Results of a prospective study with high-dose etoposide, thiotepa and carboplatin and peripheral blood stem cell rescue for high-risk stage II-IIIA and selected stage IV breast cancer patients

Aims and background: To investigate the safety and efficacy of a high-dose chemotherapy regimen with etoposide, carboplatin and thiotepa in high-risk stage Il-IIIA breast cancer and in responsive metastatic patients. Study design: From April 1992 to December 1998, 24 patients with high-risk stage Il-IIIA breast cancer (greater than or equal to9 positive nodes) and 9 responsive metastatic patients were enrolled in the trial. After inductio n chemotherapy with an anthracycline-based regimen, peripheral blood stem c ells were mobilized with cyclophosphamide (7 g/m(2)) and G-CSF (5-16 mug/kg /sc/day). The high-dose chemotherapy regimen consisted of etoposide (1000 m g/m(2)), carboplatin (800 mg/m(2)) and thiotepa (500 mg/m(2)). At the end o f the high-dose chemotherapy, all stage II-IIIA patients received radiother apy to the breast or chest wall and draining nodes; stage IV patients were irradiated to sites of disease, if feasible. All ER+ and/or PgR+ patients w ere treated with hormone therapy. Results: For stage II-IIIA high-risk patients, the median followup was 4.36 years (range, 1.93-6.94), end the Kaplan-Meier estimate at 5 years of dise ase-free survival and overall survival was 54.8 +/- 11% SE and 76.73 +/- 9. 4% SE, respectively, For metastatic patients, the median follow-up was 4.93 years (range, 4.15-7.95), and the Kaplan-Meier estimate at 5 years of prog ression-free survival and overall survival was 22.2 +/- 13.9% SE and 76.2 /- 14.8% SE, respectively. No treatment-related deaths were observed. Conclusions: Our results are comparable to those obtained in other high-dos e chemotherapy trials but do not seem to be superior to conventional-dose t herapy given to similar patients.