COMBINATION THERAPY WITH MITOXANTRONE FLUOROURACIL, LEUCOVORIN, AND GRANULOCYTE-COLONY-STIMULATING FACTOR IN PATIENTS WITH ADVANCED BREAST-CANCER - A PHASE-II STUDY

The purpose of this study was to assess the efficacy of combination th erapy with mitoxantrone, fluorouracil, and high-dose leucovorin (MFL) and granulocyte colony-stimulating factor (G-CSF) in patients with met astatic breast cancer, From May 1994 to June 1997, 46 patients with st age IV breast cancer mere treated with MFL chemotherapy plus G-CSF, as needed. World Health Organization criteria were used to define object ive responses and toxicity. Thirty-eight (82.6%) of 46 patients mere a ssessable for response to therapy and toxicity, Median follow-up was 1 5.2 months (range, 4 to 34 months), Twelve (31.6%) of these patients d emonstrated a complete response and 16 (42.1%) a partial response, giv ing an overall response rate of 73.7%. A small number of patients had grade 3 and 4 neutropenia and/or anemia The results of this study usin g combination therapy with MFL plus G-CSF are encouraging, The overall response rate of 73.7% in the 38 assessable patients is noteworthy, b ecause all had stage TV breast cancer and 24 (63.2%) of 38 patients ha d visceral-dominant disease, We conclude that the combination of MFL a nd G-CSF is a well-tolerated, active regimen for use as first-line the rapy in patients with metastatic breast cancer.