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新辅助治疗中接受曲妥珠单抗治疗的HER2阳性乳腺癌患者的病理完全缓解

Pathologic Complete Response in HER2-Positive Breast Cancer Patients Receiving Trastuzumab in Neoadjuvant Setting.

作者信息

Sheikh Fareeha, Nazir Adil, Yasmeen Samia, Badar Farhana, Ahmad Usman, Siddiqui Neelam

机构信息

Department of Medical Oncology, Shaukat Khanum Memorial Cancer Hospital, Lahore, Pakistan.

Department of Biostatistics and Epidemiology, Shaukat Khanum Memorial Cancer Hospital, Lahore, Pakistan.

出版信息

J Coll Physicians Surg Pak. 2019 Feb;29(2):159-163. doi: 10.29271/jcpsp.2019.02.159.

Abstract

OBJECTIVE

To compare the pathological complete response in human epidermal growth factor receptor type 2 (HER-2) positive breast cancer patients getting neoadjuvant chemotherapy with or without trastuzumab.

STUDY DESIGN

Retrospective randomised double-arm observational study.

PLACE AND DURATION OF STUDY

Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, from 2008 to 2016.

METHODOLOGY

HER2-positive, lymph node positive, breast cancer patients receiving neoadjuvant chemotherapy (NACT) were retrospectively observed. Patients getting neoadjuvant trastuzumab, fulfilling the inclusion criteria were studied. The comparison group included randomly selected equal number of HER2-positive breast cancer patients having similar tumor characteristics, getting NACT only. Pathological complete response (pCR) was defined as no residual invasive or in situ residual tumor in breast tissue, or in the lymph nodes. One hundred and fifty-six patients were studied. Eighty-nine patients with HER2-positive disease received trastuzumab preoperatively. Sixty-four (n=64) patients received the complete standard dose of neoadjuvant trastuzumab along with chemotherapy. Almost equal number of patients (n=67) with HER2- positive disease were selected by random assortment for the reference group who did not receive trastuzumab before surgery.

RESULTS

The pathological complete response of study group was (n=32) 50%, which was 26.1% higher than the reference group (n=16) 23.9%; and this difference was statistically significant with a p-value of 0.002 (<0.05). The overall pCR was 36.6% (n=48).

CONCLUSION

Addition of trastuzumab to neoadjuvant chemotherapy doubled the pCR in HER2-positive breast cancer. Targeted therapy should be offered to all eligible patients with HER2-overexpressing breast cancer.

摘要

目的

比较接受或不接受曲妥珠单抗新辅助化疗的人表皮生长因子受体2(HER-2)阳性乳腺癌患者的病理完全缓解情况。

研究设计

回顾性随机双臂观察性研究。

研究地点和时间

2008年至2016年,拉合尔的沙卡特汗姆纪念癌症医院和研究中心。

方法

对接受新辅助化疗(NACT)的HER2阳性、淋巴结阳性乳腺癌患者进行回顾性观察。对符合纳入标准且接受新辅助曲妥珠单抗治疗的患者进行研究。对照组包括随机选择的数量相等、具有相似肿瘤特征且仅接受NACT的HER2阳性乳腺癌患者。病理完全缓解(pCR)定义为乳腺组织或淋巴结中无残留浸润性或原位残留肿瘤。共研究了156例患者。89例HER2阳性疾病患者术前接受曲妥珠单抗治疗。64例患者接受了新辅助曲妥珠单抗的完整标准剂量并联合化疗。通过随机分组选择了数量几乎相等(n = 67)的HER2阳性疾病患者作为未在手术前接受曲妥珠单抗治疗的参照组。

结果

研究组的病理完全缓解率为(n = 32)50%,比参照组(n = 16)的23.9%高26.1%;且该差异具有统计学意义,p值为0.002(<0.05)。总体pCR为36.6%(n = 48)。

结论

在新辅助化疗中添加曲妥珠单抗可使HER2阳性乳腺癌的pCR翻倍。应向所有符合条件的HER2过表达乳腺癌患者提供靶向治疗。

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