Zuazana Bielčiková, Luboš Petruželka, Renata Chloupková
Klin Onkol. 2018 Spring;31(3):191-199. doi: 10.14735/amko2018191.
Trastuzumab (Herceptin® - H) has been the standard-of-care for patients with HER2+ breast cancer (BC) since 2009 in the Czech Republic. Neoadjuvant application of H increases the number of patients who achieve pathological complete remission (pCR) and improves patients' outcomes.
This study aimed to assess the effect of neoadjuvant therapy (NAT) with H in patients with early HER2+ BC and to correlate the therapeutic outcome with overall survival (OS). We defined pCR as no invasive carcinoma (ypT0) or in situ residual carcinoma (ypTis) in breast tissue and no invasive carcinoma in axillary lymphatic nodes (ypN0). To correlate pCR with the hormone dependency of BC, we compared the number of patients who achieved pCR between those with hormone-dependent (estrogen receptor (ER) +) BC and those with hormone-negative (ER-) BC.
We evaluated data from 148 patients with HER2+ BC, most of whom were at stage II. Of these, 50.7% were premenopausal women and 45.9% had ER- BC. Most patients were treated with anthracyclines followed by taxanes and H. pCR was reported in 50% of patients (74/148). ER+ BC regressed more often to ypTis stage (24/35), ER- BC to ypT0ypN0 stage (26/39). The 1-year OS rate of patients who achieved pCR was significantly higher than that of patients who did not (100.0% vs. 95.3%, p = 0.009). Median OS was not achieved in pCR patients group.
Patients who achieved pCR had a better prognosis than patients who did not. Key words: neoadjuvant therapy - trastuzumab - early breast cancer - pathological complete remission - prognosis The authors declare they have no potential conflicts of interest concerning drugs, products, or services used in the study. The Editorial Board declares that the manuscript met the ICMJE recommendation for biomedical papers. Submitted: 14. 9. 2017 Accepted: 15. 2. 2018.
自2009年以来，曲妥珠单抗（赫赛汀® - H）一直是捷克共和国HER2阳性乳腺癌（BC）患者的标准治疗药物。H的新辅助应用增加了实现病理完全缓解（pCR）的患者数量，并改善了患者的预后。
本研究旨在评估H新辅助治疗（NAT）对早期HER2阳性BC患者的疗效，并将治疗结果与总生存期（OS）相关联。我们将pCR定义为乳腺组织中无浸润性癌（ypT0）或原位残留癌（ypTis），腋窝淋巴结中无浸润性癌（ypN0）。为了将pCR与BC的激素依赖性相关联，我们比较了激素依赖性（雌激素受体（ER）阳性）BC患者和激素阴性（ER阴性）BC患者中实现pCR的患者数量。
我们评估了148例HER2阳性BC患者的数据，其中大多数处于II期。其中，50.7%为绝经前女性，45.9%患有ER阴性BC。大多数患者先接受蒽环类药物治疗，然后接受紫杉烷类药物和H治疗。50%的患者（74/148）报告达到pCR。ER阳性BC更常退化为ypTis期（24/35），ER阴性BC退化为ypT0ypN0期（26/39）。实现pCR的患者1年OS率显著高于未实现pCR的患者（100.0%对95.3%，p = 0.009）。pCR患者组未达到中位OS。
实现pCR的患者比未实现pCR的患者预后更好。关键词：新辅助治疗 - 曲妥珠单抗 - 早期乳腺癌 - 病理完全缓解 - 预后 作者声明他们在研究中使用的药物、产品或服务方面没有潜在的利益冲突。编辑委员会声明该手稿符合ICMJE对生物医学论文的建议。提交日期：2017年9月14日 接受日期：2018年2月15日。
