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Adjuvant trastuzumab: a milestone in the treatment of HER-2-positive early breast cancer Baselga J; Perez EA; Pienkowski T; Bell ROncologist 2006[]; 11 Suppl 1 (ä): 4-12Up to one fourth of women diagnosed with early breast cancer (EBC) have tumors that are human epidermal growth factor receptor 2 (HER-2) positive. This is associated with a high risk of relapse and death from meta-static disease. Trastuzumab, a monoclonal antibody directed against the extracellular domain of HER-2, improves survival and quality of life in women with HER-2-positive metastatic breast cancer receiving chemotherapy. Four major adjuvant trials-Herceptin Adjuvant (HERA), National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31, North Central Cancer Treatment Group (NCCTG) N9831, and Breast Cancer International Research Group (BCIRG) 006-including between them >13,000 women with HER-2-positive EBC, have investigated different adjuvant treatment approaches with trastuzumab. These trials have shown that trastuzumab reduces the 3-year risk of recurrence by about half in this population. The benefit was similar across the trials despite differences in patient populations, chemotherapy regimens, and sequencing of treatment. At a 2-year follow-up, interim results from the combined analysis of the NSABP B-31 and NCCTG N9831 trials showed a one third lower mortality for trastuzumab, and there was a trend toward an overall survival benefit in the HERA and BCIRG trials. A small Finnish trial, FinHer, investigating another regimen of trastuzumab, has also shown similarly positive results. Further follow-up of the major adjuvant trials will clarify the survival benefit for women receiving trastuzumab, as well as the optimal treatment duration (1 or 2 years). Notably, cardiac events in the trastuzumab-containing arms of these trials have remained within acceptable levels, with a slightly higher (0.6%-3.3%) incidence of congestive heart failure that mostly responded to treatment. Further follow-up will provide information on long-term cardiac safety. Overall, results from clinical trials are sufficiently compelling to consider 1 year of adjuvant trastuzumab treatment for women with HER-2-positive EBC based on the risk:benefit ratio demonstrated in these studies.|Antibodies, Monoclonal, Humanized[MESH]|Antibodies, Monoclonal/administration & dosage/adverse effects/*therapeutic use[MESH]|Antineoplastic Agents/administration & dosage/adverse effects/*therapeutic use[MESH]|Antineoplastic Combined Chemotherapy Protocols/therapeutic use[MESH]|Breast Neoplasms/*drug therapy/epidemiology/metabolism/pathology[MESH]|Chemotherapy, Adjuvant[MESH]|Disease-Free Survival[MESH]|Female[MESH]|Heart Diseases/epidemiology/physiopathology[MESH]|Humans[MESH]|Multicenter Studies as Topic[MESH]|Neoplasm Recurrence, Local/prevention & control[MESH]|Neoplasm Staging[MESH]|Randomized Controlled Trials as Topic[MESH]|Receptor, ErbB-2/biosynthesis/*drug effects[MESH]|Stroke Volume/drug effects[MESH]|Trastuzumab[MESH] |
