The aim of the study was to define an effective regimen as induction treatment in chemotherapy naive patients with advanced breast cancer as preparation for ablative chemotherapy.
Patients and methods: Patients with locally advanced or metastatic breast cancer (AJCC stage IIIB or IV) received 5-fluorouracil, methotrexate with leucovorin rescue and prednisone, alternating with doxorubicin and vincristine for six cycles. Results One hundred and eleven patients were eligible. All patients were evaluable for toxicity and seventy were evaluable for response. Thirty patients achieved a complete remission (43%) and 24 a partial remission (34%). Hematological toxicity was acceptable, as in 7% of 602 treatment cycles patients were admitted for neutropenic fever. Patients with liver metastases had a higher incidence of leucopenic fever, 32% compared to 15% for all patients, and a 25% incidence of cerebellar neuropathy compared to 9% for all patients. Mucositis more severe than WHO grade I occurred in 8% of cycles. Nausea and vomiting were not severe and cardiac or renal toxicity did not occur. Thromboembolic events occurred in 7% of the patients.
Conclusions: This induction regimen carries a 43% complete and 77% overall remission rate, which is high compared to other conventional and even escalated regimens. The toxicity profile is acceptable except for the higher incidence of leucopenic fever and the reversible 5-FU cerebellar syndrome in patients with liver metastases.