Comparative study of chemotherapeutic protocols for advanced breast cancer

Objective: To compare the efficacy and toxicity of epirubicin the two-dose levels with combination of standard chemotherapy drugs. Design: A single center trial conducted under the sponsorship of Pakistan oncology co-operative group (POCG). Place and Duration of Study: The trial was conducted at the Institute of Nuclear Medicine and Oncology Lahore (INMOL). The study started in October 1995 and patient accrual was completed in June 1997. Patients and Methods: Breast cancer patients presenting with distant metastases were randomized to receive either single agent epirubicin, 120 mg/ m/sup 2/ weekly (arm A), epirubicin 40 mg/m/sup 2/, (Arm B), standard CMF regimen (Arm C) or standard FEC regimen (Arm D). Efficacy of each regimen, its toxicity and the quality of life of the patients were the factors compared. Results: FEC showed a response rate of 68% with median duration of 14 months, CMF showed 57% response rate with median duration of 8 months. High dose epirubicin 120 mg/m/sup 2/ showed a response rate of 31% with response duration of 2.5 months, while epirubicin 40 mg/m/sup 2/ showed partial response (pr) in 17% of patients with response duration of 1.7 months. Both FEC and CMF arms were found to be more effective (p<0.05) than the epirubicin regimens. Conclusion: FEC regimen was most effective in producing long lasting palliation. Single agent regimens produced low response rare and intolerable toxicity amongst metastatic breast cancer patients. (author)