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BACKGROUND The authors have previously reported 2 consecutive phase 2 trials in patients with early breast cancer that overexpresses human epidermal growth factor receptor 2 ( HER2) to assess the feasibility of incorporating anti-HER2 therapies into dose-dense (dd) chemotherapy regimens. The incidence of congestive heart failure (CHF) at a median follow-up of 2 years was 1.4% and 3.2%, respectively. METHODS In trial A, patients received dd doxorubicin and cyclophosphamide (AC)→paclitaxel (T) (each given every 2 weeks) × 4 with trastuzumab (H) given × 1 year. In trial B, weekly T (weekly × 12) was substituted for ddT and lapatinib × 1 year was added. Herein, the authors report the longer-term incidence of CHF and distant disease-free survival (DDFS). RESULTS From January 2005 to May 2008, 165 patients enrolled (median age, 46 years, with a median left ventricular ejection fraction of 68% [range, 52%-81%]), 17%of whom had previous hypertension. With a median follow-up of 84 months (trial A) and 57 months (trial B), 1 additional patient developed CHF. Therefore, the cumulative incidence of CHF was 1.4% (95% confidence interval [95% CI], 1.36%-7.7%) for trial A and 4.2% (95% CI, 4.2%-10.4%) for trial B. The 5-year DDFS for trials A and B was 92% (95% CI, 83%-97%) and 89% (95% CI, 81%-94%), respectively. CONCLUSIONS Longer follow-up of these 2 studies has demonstrated that ddAC→TH only or with lapatinib is associated with a low risk of CHF and promising DDFS in patients with early breast cancer. Cancer 2013;119:3943-3951. © 2013 American Cancer Society. [ABSTRACT FROM AUTHOR]

BACKGROUND: Patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer have a higher risk of locoregional recurrence (LRR), even in the setting of early stage, lymph node-negative disease. In this sequential, retrospective study, the authors evaluated whether adjuvant trastuzumab was associated with reduced LRR in women with lymph node-negative, HER2-positive disease who received breast-conservation therapy (BCT). METHODS: By using an institutional database, 197 women were identified who had lymph node-negative, HER2-positive breast cancer measuring ≤5 cm diagnosed between 2002 and 2008 and who received BCT, including whole-breast irradiation. Two cohorts were compared: 70 women who did not receive trastuzumab (the no-trastuzumab cohort) and 102 women who did receive trastuzumab (the trastuzumab cohort). Kaplan-Meier methods were used to estimate LRR-free survival. RESULTS: The 2 cohorts were similar in age, tumor size, histology, and hormone receptor status. Chemotherapy was received by 73% of the no-trastuzumab cohort and by 100% of the trastuzumab cohort. In both groups, 99% of patients completed radiotherapy with a median dose of 60 Gray. The median recurrence-free follow-up was 86 months for the no-trastuzumab cohort and 47 months for the trastuzumab cohort. The 3-year LRR-free survival rate was 90% (95% confidence interval, 83%-97%) for the no-trastuzumab cohort and 99% (95% confidence interval, 97%-100%) for the trastuzumab cohort. In the no-trastuzumab cohort, LRR occurred in 7 patients (median time to LRR, 14 months). In the trastuzumab cohort, there was 1 LRR at 14 months. CONCLUSIONS: Even among women with lower risk breast cancer, the relatively high locoregional failure rates associated with positive HER2 status could be reduced markedly with adjuvant trastuzumab chemotherapy. Within 3 years, a 10% LRR rate without trastuzumab and a 1% LRR rate with trastuzumab were observed in women with lymph node-negative disease who received BCT. Cancer 2012. © 2011 American Cancer Society. [ABSTRACT FROM AUTHOR]