Ganz Patricia A, Romond Edward H, Cecchini Reena S, Rastogi Priya, Geyer Charles E, Swain Sandra M, Jeong Jong-Hyeon, Fehrenbacher Louis, Gross Howard M, Brufsky Adam M, Flynn Patrick J, Wahl Tanya A, Seay Thomas E, Wade James L, Biggs David D, Atkins James N, Polikoff Jonathan, Zapas John L, Mamounas Eleftherios P, Wolmark Norman
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. doi: 10.1200/JCO.2017.74.1165. Epub 2017 Oct 26.
Purpose 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.
目的 早期心脏毒性是辅助化疗联合曲妥珠单抗相关的一种风险。然而，在辅助治疗完成后仍无癌症的患者的长期随访中，缺乏心脏功能和健康相关生活质量的客观测量方法。
患者与方法 NSABP协议B-31中的患者接受了含或不含曲妥珠单抗的蒽环类和紫杉类化疗，用于淋巴结阳性、人表皮生长因子受体2阳性早期乳腺癌的辅助治疗。对存活且无疾病的患者进行了长期随访评估，包括通过多门控采集扫描测量左心室射血分数，以及使用杜克活动状态指数（DASI）、医学结局研究问卷进行患者报告的结局评估，并审查当前用药和合并症情况。
结果 在符合条件的参与者中，中位随访8.8年，对照组110例中有5例（4.5%），曲妥珠单抗组297例中有10例（3.4%）左心室射血分数从基线下降超过10%至<50%。较低的DASI评分与年龄以及使用治疗高血压、心脏病、糖尿病和高脂血症的药物相关，但与患者是否接受曲妥珠单抗无关。
结论 在基线时无基础心脏病的患者中，在辅助蒽环类和紫杉类化疗中添加曲妥珠单抗不会导致心脏功能、心脏症状或健康相关生活质量的长期恶化。DASI问卷可为监测反映心脏功能的患者报告变化提供一个简单有用的工具。
