ABSTRACT
This randomized trial examined whether a reduction in the duration of adjuvant CMF CT could be safely achieved in node-positive breast cancer without compromising its efficacy. Four hundred and fifty-nine eligible patients were randomized to 12 or 6 monthly cycles of CMF (Bonadonna regimen [6]) after primary surgery and exclusion of metastatic disease. Based on early results from the CMF vs. observation trial by the same group, which suggested that CMF did not benefit postmenopausal women [6], randomization of postmenopausal women was discontinued after the first year, instead allocating them all to 12 CMF for the following 12 months, and thereafter excluding them from the trial (last 14 months of accrual). At 59 months of follow-up, relapse-free survival which was the primary endpoint of the trial, was not significantly different in the 12-and 6-month CMF groups (59% vs. 65.6%, p 0.17, respectively), and no significant differences were observed when treatment assignment was examined in subgroups of 1-3 or 3 nodes for both the population as a whole and divided by menopausal status. Treatment at the time of relapse was uniform according to menopausal and estrogen receptor status, and overall survival was not significantly different in the two arms. Toxicity was similar in the two groups, although a description of any added toxicity with the longer CT course is not provided.
