The Pharmaceutical Journal
Vol 277 No 7426 p567
11 November 2006

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Epirubicin plus CMF superior to CMF alone

Epirubicin plus CMF (cyclophosphamide, methotrexate and fluorouracil) is superior to CMF alone as adjuvant treatment for early breast cancer, according to researchers who combined the results of two trials involving 2,391 women (New England Journal of Medicine 2006;355:1851).

In the National Epirubicin Adjuvant Trial women received four cycles of epirubicin followed by four cycles of CMF or six cycles of CMF alone. In the BR9601 trial, women received four cycles of epirubicin followed by four cycles of CMF, or eight cycles of modified CMF given every three weeks. The median follow-up for both studies was 48 months.

Relapse-free and overall survival rates were higher in the epirubicin-CMF groups than in the CMF alone groups (two-year relapse free survival, 91 per cent versus 85 per cent; two-year overall survival 95 per cent versus 92 per cent; P<0.001 for all comparisons). The hazard ratio for relapse in the epirubicin-CMF groups compared with the CMF alone groups was 0.69 (95 per cent confidence interval 0.58–0.82; P<0.001) and for death from any cause was 0.67 (CI 0.55–0.82; P<0.001).

Women in the epirubicin-CMF groups experienced more treatment-related adverse effects, however, most treatment-related deaths occurred in the CMF alone groups (14 versus six). The researchers say they found no significant influence of oestrogen-receptor status or tumour grade.

The authors of an accompanying editorial (ibid, p1920) point out that the researchers did not include the number of patients who received adjuvant radiation or tamoxifen during follow-up, both of which can reduce the risk of recurrence and death from breast cancer.