Prospective Dose Intensity Trials for Breast Cancer

Tannock et al. (7) evaluated the dose-intensity concept in a prospective setting for patients with metastatic breast cancer. Patients were randomly assigned to receive two dose levels of CMF chemotherapy every 3 wk: standard (cyclophosphamide 600

mg/mL, methotrexate 40 mg/mL, 5-fluorouracil 600 mg/mL) and low dose (cyclophosphamide 300 mg/mL, methotrexate 20 mg/mL, 5-fluorouracil 300 mg/mL). Response rates were higher for the standard-dose cohort (30% vs 11%, p = 0.3), but there was no statistical difference in overall survival (15.6 mo vs 12.8 mo, p = 0.12). Although the rates of toxicity (vomiting, alopecia, myelosuppression, and conjunctivitis) were higher in the standard-dose cohort, patients in the standard-dose cohort had an improved quality of life. Based on the increased response rate, trend to improved survival, and overall improvement in quality of life, the authors concluded that the rate of disease palliation was improved with higher dose therapy.

At the M.D. Anderson Cancer Center, Hortobagyi and colleagues (8) evaluated the impact of higher dose anthracycline therapy in metastatic breast cancer. Patients were randomly assigned to receive either standard 5-fluorouracil (F), doxorubicin (A), and cyclophosphamide (C) or 260% higher FAC. The median response durations and overall survival rates were not significantly different. Furthermore, hematologic, infection-related, and gastrointestinal complications were increased in the high-dose FAC group (8). The studies by Tannock et al. (7) and Hortobagyi et al. (8) seemed to indicate that a threshold dose existed for the treatment of breast cancer, but a large confirmatory trial was needed.

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