vinorelbine in the adjuvant treatment of early breast cancer. Interim results based on 36 months of follow-up showed improvement in terms of recurrence-free survival (primary endpoint) for docetaxel compared with vinorelbine, and in HER2-positive disease for trastuzumab compared with no trastuzumab. This report published early online in the Journal of Clinical Oncology presents the final results of the trial.

The study involved 1010 women with axillary node–positive or high-risk node-negative breast cancer, randomised to receive 3 cycles of docetaxel or vinorelbine, followed in both groups by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC). Women with HER2-positive cancer (n = 232) were further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine (the authors note that in all other trials reported to date of adjuvant trastuzumab for early HER2-positive breast cancer, the duration of treatment was 12 months or longer).

The median follow-up time was 62 months after randomisation and the following findings were reported:

• Women on docetaxel had better distant disease–free survival (DDFS) than those assigned to vinorelbine (hazard ratio = 0.66; 95% CI, 0.49 to 0.91; p = 0.010).

• In the subgroup of HER2-positive disease, there was no statistically significant difference between patients treated with trastuzumab and those treated with chemotherapy only (0.65; 0.38 to 1.12; p= 0.12); when adjusted for presence of axillary nodal metastases, this difference became statistically significant (p = 0.047).

• In exploratory analyses, docetaxel, trastuzumab, and FEC improved DDFS compared with docetaxel plus FEC (p =0.029) and vinorelbine, trastuzumab, and FEC (p = 0.020).

• The median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during the 5-year follow-up; one woman treated with trastuzumab was diagnosed with heart failure.

The researchers conclude that docetaxel improves DDFS compared with vinorelbine as adjuvant treatment of node-positive or high-risk node-negative early breast cancer; and docetaxel administered concomitantly with trastuzumab is more effective than vinorelbine plus trastuzumab, each followed by FEC, as adjuvant treatment of HER2-positive early breast cancer.” They note that the “brief course of trastuzumab and chemotherapy has little cardiac toxicity with the drug dosages used within the first 5 years of follow-up.”