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Trastuzumab in the adjuvant treatment of early-stage breast cancer: a systematic review and meta-analysis of randomized controlled trials Dahabreh IJ; Linardou H; Siannis F; Fountzilas G; Murray SOncologist 2008[Jun]; 13 (6): 620-30BACKGROUND: We performed a systematic review and meta-analysis to compare treatment outcomes for human epidermal growth factor receptor (HER)-2-positive breast cancer patients receiving adjuvant chemotherapy with or without trastuzumab. METHODS: We identified randomized clinical trials comparing adjuvant chemotherapy with or without trastuzumab in patients with resectable breast cancer. Fixed-effects meta-analysis was used to combine data. RESULTS: Five eligible trials were identified, reporting outcomes on 13,493 women. Fixed-effects analysis showed disease-free survival to be superior for trastuzumab-treated patients (risk ratio [RR], 0.62; 95% confidence interval [CI], 0.56-0.68). Superiority was also observed for patients receiving trastuzumab with respect to mortality (RR, 0.66; 95% CI, 0.57-0.77), locoregional recurrence (RR, 0.58; 95% CI, 0.43-0.77), and distant recurrence (RR, 0.60; 95% CI, 0.52-0.68). Patients receiving trastuzumab with chemotherapy had a higher risk for congestive heart failure (RR, 7.60; 95% CI, 4.07-14.18) and left ventricular ejection fraction decline (RR, 2.09; 95% CI, 1.84-2.37). A higher risk for central nervous system metastasis as the first recurrence event (RR, 1.60; 95% CI, 1.06-2.40) was also noted in patients receiving trastuzumab. CONCLUSIONS: The use of trastuzumab should be considered an integral part of the adjuvant therapy of HER-2-positive breast cancer patients.|*Randomized Controlled Trials as Topic[MESH]|Antibodies, Monoclonal, Humanized[MESH]|Antibodies, Monoclonal/*therapeutic use[MESH]|Antineoplastic Agents/*therapeutic use[MESH]|Breast Neoplasms/*drug therapy/metabolism/mortality[MESH]|Chemotherapy, Adjuvant[MESH]|Disease-Free Survival[MESH]|Female[MESH]|Gene Amplification[MESH]|Humans[MESH]|Immunoenzyme Techniques[MESH]|Neoplasm Staging[MESH]|Receptor, ErbB-2/genetics/metabolism[MESH]|Survival Rate[MESH]|Trastuzumab[MESH]|Treatment Outcome[MESH] |