Long‐term cardiac safety and outcomes of dose‐dense doxorubicin and cyclophosphamide followed by paclitaxel and trastuzumab with and without lapatinib in patients with early breast cancer. Issue 22 (26th August 2013)

• Record Type: Journal Article
• Authors: Morris, Patrick G.; Iyengar, Neil M.; Patil, Sujata; Chen, Carol; Abbruzzi, Alyson; Lehman, Robert; Steingart, Richard; Oeffinger, Kevin C.; Lin, Nancy; Moy, Beverley; Come, Steven E.; Winer, Eric P.; Norton, Larry; Hudis, Clifford A.; Dang, Chau T.
• Is Part Of: Cancer. Volume 119:Issue 22(2013)
• Page Start: 3943
• Page End: 3951
• Publication Date: 2013-08-26
• Subjects: cardiac safety -- dose‐dense chemotherapy -- early breast cancer -- efficacy -- lapatinib -- trastuzumab; Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.28284
• Languages: English
• ISSNs: 0008-543X

Abstract

Abstract : 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 : The authors conducted 2 consecutive phase 2 trials for early breast cancer that overexpresses human epidermal growth factor receptor‐2 (HER2) and concluded that, with up to 7 years of follow‐up, dose‐dense, anthracycline‐based chemotherapy can be safely combined with sequential anti‐HER2 therapy with acceptable cardiac toxicity. Furthermore, disease control rates in these studies appear to be encouraging.