A PRELIMINARY-REPORT OF A PILOT RANDOMIZED TRIAL COMPARING CYCLOPHOSPHAMIDE, METHOTREXATE AND 5-FLUOROURACIL WITH CYCLOPHOSPHAMIDE, MITOXANTRONE AND 5-FLUOROURACIL IN THE ADJUVANT THERAPY OF STAGE-II BREAST-CANCER WITH 4 OR MORE POSITIVE AXILLARY NODES

Thirty-eight patients with stage II breast cancer with four or more po sitive axillary lymph nodes were randomized to receive CMF (cyclophosp hamide, methotrexate and 5-fluorouracil, every 3 weeks) or CXF (cyclop hosphamide, mitoxantrone and 5-fluorouracil, every 3 weeks). Pretreatm ent characteristics were similar tor both groups. The actuarial 5 year disease-free survival (DFS) was 36% for the CMF group and 23% for the CXF group. The actuarial 5 year survival was 60% for the CMF arm and 66% for the CXF arm. These differences were not statistically signific ant. Partial alopecia was observed in 42% of patients in the CMF arm a nd in 100% of those receiving CXF (p = 0.0002). No episodes of leucope nic fever were observed in patients receiving CMF, while they were pre sent in 53% of patients treated with CXF (p = 0.0006). No stomatitis o ccurred in the CMF group, but it was observed in 90% of patients who r eceived CXF (p < 0.0001). Treatment with CXF had to be discontinued in two patients because of toxicity. In this small group of patients wit h poor prognosis, it seems that CXF at the doses given here is more to xic but not more effective than CMF, as represented by a similar DFS a nd survival.