Front-line treatment of advanced breast cancer with docetaxel and epirubicin: A multicenter phase II study

Purpose: In a previous phase I trial we evaluated the toxicity and determin ed the maximum tolerated doses of the docetaxel (D)-epirubicin (Epi) combin ation. We conducted a multicenter phase II study to evaluate the efficacy a nd tolerability of this regimen as front-line treatment in women with advan ced breast cancer (ABC). Patients and methods: Fifty-four women with ABC stage IIIB (4 patients) or IV (50 patients) received front-line treatment with Epi 70 mg/m(2) on day 1 and D 90 mg/m(2) on day 2. The median age was 55 years, performance status (WHO) was 0-1 in 49 patients and visceral disease was present in 45 (83%). Results: All patients were evaluable for toxicity and 50 for response. In a n intent-to-treat analysis complete remission was observed in 5(9%) patient s, partial remission in 31 (57%) (overall response rate 66%, 95% confidence interval: 54%-79%), stable disease in 9 (17%) and disease progression in 9 (17%). After a median follow-up of 11.5 months, the median duration of res ponses was 8 months, the median time to disease progression 11.5 months and the median survival has not yet been reached. The probability of one-year survival was 65%. Three hundred six cycles of treatment were administered ( median 6 cycles per patient). Grade 3 and 4 neutropenia was observed in 8 ( 15%) and 31 (57%) patients, respectively, and febrile neutropenia in 19 (35 %). Prophylactic rh-G-CSF was used in 45 (83%) patients or 226 (74%) cycles . Other hematologic or non-hematologic toxicities were usually mild. In fiv e (9%) patients the left ventricular ejection fraction (LVEF) was decreased by more than 10% with the treatment. Two patients died during the treatmen t of respiratory failure without associated neutropenia. Conclusions: The combination of docetaxel-epirubicin is an effective and we ll tolerated front-line treatment in patients with ABC.