A phase III study of high-dose intensification without hematopoietic progenitor cells support for patients with high-risk primary breast carcinoma

Patients with more than nine ipsilateral lymph node involvement or inflamma tory breast cancer have a 5-year survival rate of approximately 50%. We stu died the efficacy of high-dose intensification comparing it with the standa rd dose chemotherapy for patients with high-risk primary breast cancer. Pat ients with inflammatory breast cancer or more than nine ipsilateral lymph n ode involvement without evidence of distant metastasis were randomized to r eceive either standard dose 5-fluorouracil, doxorubicin. and cyclophosphami de (FAC) every 3 weeks for nine courses (control) or six courses of FAC Fol lowed by two courses of cyclophosphamide (5.25 g/m(2)), etoposide (1,500 mg /m(2)), and cisplatin (165 mg/m(2)) (HDCVP). The study was terminated in 19 98 because of slow accrual of patients, Forty six patients were entered in the study. At 4 years, the overall survival was 72.8% (SE 11.9%) and 61.7% (SE 12.4%), and disease-free survival were 45.5% (SE 12.3%) and 33.7% (SE 1 1.9%) for the control and HDCVP groups, respectively (p = 0.757 and 0.720). With the small number of patients in our study, a small overall survival b enefit of high-dose intensification compared with the standard therapy cann ot be excluded. However, any substantial benefit is unlikely.