• J. Clin. Oncol. · Dec 2017

    Randomized Controlled Trial Multicenter Study

    Long-Term Follow-Up of Cardiac Function and Quality of Life for Patients in NSABP Protocol B-31/NRG Oncology: A Randomized Trial Comparing the Safety and Efficacy of Doxorubicin and Cyclophosphamide (AC) Followed by Paclitaxel With AC Followed by Paclitaxel and Trastuzumab in Patients With Node-Positive Breast Cancer With Tumors Overexpressing Human Epidermal Growth Factor Receptor 2.

    • Patricia A Ganz, Edward H Romond, Reena S Cecchini, Priya Rastogi, Charles E Geyer, Sandra M Swain, Jong-Hyeon Jeong, Louis Fehrenbacher, Howard M Gross, Adam M Brufsky, Patrick J Flynn, Tanya A Wahl, Thomas E Seay, James L Wade, David D Biggs, James N Atkins, Jonathan Polikoff, John L Zapas, Eleftherios P Mamounas, and Norman Wolmark.
    • All authors: National Surgical Adjuvant Breast and Bowel Project/NRG Oncology; Reena S. Cecchini, Priya Rastogi, Jong-Hyeon Jeong, and Adam M. Brufsky, University of Pittsburgh; Priya Rastogi and Adam M. Brufsky, Magee-Womens Hospital; Norman Wolmark, Allegheny Health Network Cancer Institute, Pittsburgh, PA; Patricia A. Ganz, University of California at Los Angeles, Los Angeles; Louis Fehrenbacher, Kaiser Permanente, Vallejo; Jonathan Polikoff, Kaiser Permanente, San Marco, CA; Edward H. Romond, University of Kentucky, Lexington, KY; Charles E. Geyer Jr, Virginia Commonwealth University, Richmond, VA; Sandra M. Swain and John L. Zapas, MedStar Washington Hospital Center, Washington, DC; Howard M. Gross, Dayton National Cancer Institute Community Oncology Research Program (NCORP), Dayton, OH; Patrick J. Flynn, Metro-Minnesota Community Clinical Oncology Program (CCOP), Woodbury, MN; Tanya A. Wahl, Fred Hutchinson Cancer Research Center, Seattle, WA; Thomas E. Seay, Atlanta Regional CCOP, Atlanta, GA; James L. Wade III, Heartland NCORP, Decatur, IL; David D. Biggs, Christiana Care Health System, Newark, DE; James N. Atkins, Southeast Clinical Oncology Research Consortium NCORP, Goldsboro, NC; and Eleftherios P. Mamounas, Orlando Health, Orlando, FL.
    • J. Clin. Oncol. 2017 Dec 10; 35 (35): 3942-3948.

    AbstractPurpose Early cardiac toxicity is a risk associated with adjuvant chemotherapy plus trastuzumab. However, objective measures of cardiac function and health-related quality of life are lacking in long-term follow-up of patients who remain cancer free after completion of adjuvant treatment. Patients and Methods Patients in NSABP Protocol B-31 received anthracycline and taxane chemotherapy with or without trastuzumab for adjuvant treatment of node-positive, human epidermal growth factor receptor 2-positive early-stage breast cancer. A long-term follow-up assessment was undertaken for patients who were alive and disease free, which included measurement of left ventricular ejection fraction by multigated acquisition scan along with patient-reported outcomes using the Duke Activity Status Index (DASI), the Medical Outcomes Study questionnaire, and a review of current medications and comorbid conditions. Results At a median follow-up of 8.8 years among eligible participants, five (4.5%) of 110 in the control group and 10 (3.4%) of 297 in the trastuzumab group had a > 10% decline in left ventricular ejection fraction from baseline to a value < 50%. Lower DASI scores correlated with age and use of medications for hypertension, cardiac conditions, diabetes, and hyperlipidemia, but not with whether patients had received trastuzumab. Conclusion In patients without underlying cardiac disease at baseline, the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy does not result in long-term worsening of cardiac function, cardiac symptoms, or health-related quality of life. The DASI questionnaire may provide a simple and useful tool for monitoring patient-reported changes that reflect cardiac function.

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