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 positive axillary lymph nodes were randomized to receive CMF (cyclophosphamide, methotrexate and 5-fluorouracil, every 3 weeks) or CXF (cyclophosphamide, mitoxantrone and 5-fluorouracil, every 3 weeks). Pretreatment 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 significant. Partial alopecia was observed in 42% of patients in the CMF arm and in 100% of those receiving CXF (p = 0.0002). No episodes of leucopenic fever were observed in patients receiving CMF, while they were present in 53% of patients treated with CXF (p = 0.0006). No stomatitis occurred in the CMF group, but it was observed in 90% of patients who received CXF (p < 0.0001). Treatment with CXF had to be discontinued in two patients because of toxicity. In this small group of patients with poor prognosis, it seems that CXF at the doses given here is more toxic but not more effective than CMF, as represented by a similar DFS and survival.