A phase II trial of cyclophosphamide, epirubicin and vinorelbine in the treatment of advanced breast cancer

Background. Vinorelbine (Navelbin(R); N) has proven to be active in patient s with advanced breast cancer (ABC) and cyclophosphamide (C) and epirubicin (Epiadriamycin(R): E) are still among the main cytostatic agents against t his tumor. On this basis was carried out a study to determine the activity and toxicity of the combination of these three agents (CEN). Patients and method. From April 1996 to March 1998, 59 patients with ABC we re recruited of whom 56 were found eligible and evaluable for toxicixty and 55 for activity. The treatment regimen was C: 400 mg/m(2), E: 30 mg/m(2) a nd N: 25 mg/m(2) administered intravenously on days 1 and 8 of a 28-day cyc le. Results. The median number of cycles administered was 6 (range: 1-16). The most common hematological toxicity was grade (G) 3 and 4 neutropenia occurr ing in 36% of patients, associated with fever in 7% of them. Grade 3-4 thro mbocytopenia and anemia occurred in 5% and 7%, respectively. Other G2-G3 no n hematologic toxicities were: N/vomiting in 34%, alopecia in 73% and mucos itis in 11% of patients. An objective response was achieved in 28 of 56 pat ients (50%) (95% confidence interval (CI): 37-63%): complete response (CR) in 9%, partial response (PR) in 41%. The median duration of response, time to progression and overall survival time was 54, 47 and 90 weeks, respectiv ely. Conclusion. The CEN combination at these doses and treatment schedule appea rs to have acceptable tolerability but there is no apparent improvement in therapeutic efficacy when compared to other regimens used as first line tre atment in ABC.