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美国《临床肿瘤杂志》：曲妥珠单抗（赫赛汀）对乳腺癌患者心脏功能的远期影响不大

2017年10月31日

来源：桓兴医讯

美国《临床肿瘤杂志》2017年10月26日在线先发

http://ascopubs.org/doi/full/10.1200/JCO.2017.74.1165#affiliationsContainer

对NSABP方案B-31试验/NRG肿瘤学组中患者心脏功能和生活质量的长期随访：在肿瘤过表达人表皮生长因子受体2、淋巴结阳性乳腺癌患者中比较阿霉素+环磷酰胺（AC方案）序贯紫杉醇方案与AC方案序贯紫杉醇+曲妥珠单抗的一项随机化临床试验

目的

早期心脏毒性是曲妥珠单抗+辅助化疗相关的一个风险，但在完成辅助治疗仍无肿瘤复发患者的长期随访中，缺乏心脏功能检查的客观指标和健康相关的生活质量结果。

患者与方法

NSABP方案B-31试验患者接受了蒽环类和紫杉类的化疗+或不+曲妥珠单抗，以作为淋巴结阳性、人表皮生长因子受体2阳性、早期乳腺癌的辅助治疗。我们对无瘤生存患者进行了长期随访评估，评估包括通过MUGA核素扫描测量左室射血分数，以及采用Duke活动指数、医疗转归研究调查问卷调查所获得的患者报告结果、当前所用药物和并存疾病情况。

结果

对符合条件的患者中位随访8.8年时，对照组110名患者中有5名（4.5%）、曲妥珠单抗组297名中有10名（3.4%）出现10%的左室射血分数下降，入组时的左室射血分数下降到<50%。较低的Duke活动指数与年龄、使用降压药、心脏状况、糖尿病、高脂血症相关，但与患者是否接受过曲妥珠单抗治疗无关。

结论

在入组时没有潜在心脏疾病的患者中，辅助蒽环类+紫杉类化疗方案加入曲妥珠单抗，并没有导致心脏功能、心脏症状或健康相关的生活质量的长期恶化。Duke活动指数问卷调查可以提供一简单实用的工具，用于监测患者报告的反映心脏功能的变化情况。

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

Purpose

Earlycardiac toxicity is a risk associated with adjuvant chemotherapy plustrastuzumab. However, objective measures of cardiac function and health-relatedquality of life are lacking in long-term follow-up of patients who remaincancer free after completion of adjuvant treatment.

Patients and Methods

Patientsin NSABP Protocol B-31 received anthracycline and taxane chemotherapy with orwithout trastuzumab for adjuvant treatment of node-positive, human epidermalgrowth factor receptor 2–positive early-stage breast cancer. A long-termfollow-up assessment was undertaken for patients who were alive and diseasefree, which included measurement of left ventricular ejection fraction bymultigated acquisition scan along with patient-reported outcomes using the DukeActivity Status Index (DASI), the Medical Outcomes Study questionnaire, and areview of current medications and comorbid conditions.

Results

At amedian follow-up of 8.8 years among eligible participants, five (4.5%) of 110in 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 forhypertension, cardiac conditions, diabetes, and hyperlipidemia, but not withwhether patients had received trastuzumab.

Conclusion

Inpatients without underlying cardiac disease at baseline, the addition oftrastuzumab to adjuvant anthracycline and taxane-based chemotherapy does notresult in long-term worsening of cardiac function, cardiac symptoms, orhealth-related quality of life. The DASI questionnaire may provide a simple anduseful tool for monitoring patient-reported changes that reflect cardiacfunction.

责任编辑：肿瘤资讯-Ruby

美国《临床肿瘤杂志》： 曲妥珠单抗（赫赛汀）对乳腺癌患者心脏功能的远期影响不大

目的

结果

结论

Purpose

Patients and Methods

Results

Conclusion

美国《临床肿瘤杂志》：曲妥珠单抗（赫赛汀）对乳腺癌患者心脏功能的远期影响不大