Prospective meta-analysis of randomised trials of cyclophosphamide, methotrexate & fluorouracil (CMF) vs fluorouracil, epirubicin & cyclophosphamide (FEC) chemotherapy in early breast cancer

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Abstract
592 Background: Our previous study of node positive (N+) patients (Coombes: JCO 1996 14:35–45) compared FEC1/2 vs. CMF1/2 (see table below). At 4.5 years there was no difference in disease free survival (DFS), p=0.61; or overall survival (OS), p=0.31. However, subset analysis suggested that FEC2 was better than CMF2 (DFS:p=0.03;OS:p=0.02). Concurrently a study in node negative (N-) patients was conducted comparing FEC2 with CMF2. This paper updates the previous N+ study, reports N- study outcome, and a combined meta analysis (MA). Methods: Prospective MA of two international randomised trials of CMF vs. FEC chemotherapy in early breast cancer: 1) N+ premenopausal trial, 2 regime options (CMF1/FEC1, CMF2/FEC2). and 2) N- trial (CMF2/FEC2). Main endpoints are OS and DFS. Sample sizes are small by today's standards, hence the prospective MA. Results: N+ recruited 759 (180 CMF1, 180 FEC1, 199 CMF2, 200 FEC2) patients between 1984–1992, median follow-up 100 months. N- recruited 950 (477 CMF2, 473 FEC2) patients between 1990–2000, median follow-up 70 months. Median age was 44 (N+) and 48 (N-) years. Grade 3/4 toxicity (sore mouth, vomiting/nausea, diarrhoea, anorexia, alopecia) occurred twice as often with FEC (54%) than CMF (24%), p<0.001. Grade 3/4 toxicity in N+ (56%) was twice that of N- (25%) patients, p<0.001. MA hazard ratios showed that for OS, CMF was better 1.08 (95% CI 0.87 –1.35, p=0.49) but for DFS, FEC was better 0.97 (95% CI 0.82–1.16, p=0.76). Tests showed OS trial results were heterogeneous (p=0.04) with FEC1 better than CMF1 (p=0.04), and CMF2 better than FEC2 (p=0.06) for N+ but no difference for N- (p=0.87). Conclusions: MA showed no difference between the treatments in terms of OS or DFS. Individual trial results for OS were not homogeneous.

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