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新辅助多西他赛联合或不联合卡铂加双重HER2阻断治疗HER2阳性乳腺癌:一项回顾性多中心中国研究。

Neoadjuvant docetaxel with or without carboplatin plus dual HER2 blockade for HER2-positive breast cancer: a retrospective multi-center Chinese study.

作者信息

Lv Minhao, Guo Huihui, Wang Chao, Tian Peiqi, Ma Youzhao, Chen Xiuchun, Luo Suxia

机构信息

Department of Breast Disease, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.

Department of General Surgery, The Jiyuan People's Hospital, Jiyuan, China.

出版信息

Gland Surg. 2020 Dec;9(6):2079-2090. doi: 10.21037/gs-20-791.

Abstract

BACKGROUND

This study aimed to compare the real-world efficacy and safety of the TCbHP regimen (docetaxel, carboplatin, trastuzumab and pertuzumab) and the THP regimen (docetaxel, trastuzumab and pertuzumab) as neoadjuvant therapy for Chinese patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.

METHODS

We compared efficacy and safety outcomes from 72 Chinese patients with HER2-positive breast cancer who underwent neoadjuvant dual HER2 blockade plus TCb or T chemotherapy and surgery between March 2019 and June 2020.

RESULTS

All 72 patients were women (32-76 years old) and the overall pathological complete response (pCR) rate was 70.8% (51/72). The pCR rates were 76.1% (35/46) for the TCbHP regimen and 61.5% (16/26) for the THP regimen (P=0.28). Univariate analyses revealed that pCR was associated with clinical T classification (P=0.024), AJCC stage (P=0.042), estrogen receptor (ER) status (P=0.002), progesterone receptor (PR) status (P=0.035), Ki-67 index (P<0.001), and immunohistochemical HER2 status (P<0.001). Multivariate analyses revealed that pCR was independently predicted by ER status (OR: 0.227, 95% CI: 0.053-0.852; P=0.032) and immunohistochemical HER2 status (OR: 43.673, 95% CI: 6.801-875.86; P<0.001). The common adverse events for both regimens included neutropenia, anemia, thrombocytopenia, nausea, and diarrhea. Relative to the THP group, the TCbHP group had higher frequencies of grade 3-4 thrombocytopenia (17% 0%, P=0.044) and grade 3-4 diarrhea (15% 0%, P=0.044). Both regimens had very good cardiac safety.

CONCLUSIONS

These results suggest that both TCbHP and THP regimens may be useful neoadjuvant treatments for high-risk early or locally advanced HER2-positive breast cancer. Both regimens had generally good safety outcomes, although clinicians should be aware of the risks of grade 3-4 thrombocytopenia and diarrhea during TCbHP treatment. Elderly patients who require neoadjuvant therapy may benefit from 6 cycles of THP treatment, based on its good efficacy and mild adverse events.

摘要

背景

本研究旨在比较多西他赛、卡铂、曲妥珠单抗和帕妥珠单抗(TCbHP)方案与多西他赛、曲妥珠单抗和帕妥珠单抗(THP)方案作为中国表皮生长因子受体2(HER2)阳性乳腺癌患者新辅助治疗的真实世界疗效和安全性。

方法

我们比较了2019年3月至2020年6月期间72例接受新辅助双HER2阻断加TCb或T化疗及手术的中国HER2阳性乳腺癌患者的疗效和安全性结果。

结果

所有72例患者均为女性(32 - 76岁),总体病理完全缓解(pCR)率为70.8%(51/72)。TCbHP方案的pCR率为76.1%(35/46),THP方案的pCR率为61.5%(16/26)(P = 0.28)。单因素分析显示,pCR与临床T分类(P = 0.024)、美国癌症联合委员会(AJCC)分期(P = 0.042)、雌激素受体(ER)状态(P = 0.002)、孕激素受体(PR)状态(P = 0.035)、Ki-67指数(P < 0.001)和免疫组化HER2状态(P < 0.001)相关。多因素分析显示,pCR由ER状态(比值比:0.227,95%置信区间:0.053 - 0.852;P = 0.032)和免疫组化HER2状态(比值比:43.673,95%置信区间:6.801 - 875.86;P < 0.001)独立预测。两种方案的常见不良事件包括中性粒细胞减少、贫血、血小板减少、恶心和腹泻。相对于THP组,TCbHP组3 - 4级血小板减少(17%对0%,P = 0.044)和3 - 4级腹泻(15%对0%,P = 0.044)的发生率更高。两种方案的心脏安全性都非常好。

结论

这些结果表明,TCbHP和THP方案可能都是高危早期或局部晚期HER2阳性乳腺癌有用的新辅助治疗方法。两种方案的安全性结果总体良好,尽管临床医生应注意TCbHP治疗期间3 - 4级血小板减少和腹泻的风险。基于其良好的疗效和轻微的不良事件,需要新辅助治疗的老年患者可能从6周期的THP治疗中获益。

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