RESUMEN
A multicentric randomized study was conducted to compare the CNF regimen (cyclophosphamide at 600 mg/m2/iv, mitoxantrone at 10 mg/m2/iv, 5-fluorouracil at 600 mg/m2/iv) with the CMF regimen (methotrexate at 40 mg/m2/iv instead of mitoxantrone) administered every 3 weeks to previously untreated locally advanced or metastatic breast cancer patients. In 119 patients evaluable for therapeutic response, complete plus partial response rate was 44% for CNF and 29% for CMF (p>0.05; 95% C.I.: CNF=32%-56%, CMF=18%-40%). No statistically significant difference regarding time to progression, over survival or response to second-line chemotherapy with Epidoxorubicin was observed between the two regimens. Both regimens were well tolerated, but the percent of alopecia and leucopenia was significantly higher in the CNF patient group (31% versus 5% and 18% versus 0%, respectively; p<0.01). In conclusion, CNF was demonstrated to be slightly more toxic but more effective as compared to CMF (global response: 44% versus 29%, respectively). These findings should be taken into consideration when planning future studies of adjuvant chemotherapy.
RESUMEN
The incidence of stage IV breast cancer at diagnosis is low, representing about 8% of all new cases. We report on the results obtained with a new aromatase inhibitor, formestane (500 mg i.m. fortnightly), given as a first treatment to fifteen postmenopausal patients with metastatic breast cancer. The overall response rate was 40%, with one complete remission in a patient with soft tissue and bone lesions and five partial remissions. The drug was well. tolerated and no significant systemic or local side effects were observed. We conclude that first treatment of stage IV breast cancer appears to be feasible with a hormonal drug such as formestane.