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新辅助化疗采用卡铂和多西他赛,不使用蒽环类药物,用于三阴性早期乳腺癌:病理完全缓解率和生存率的多中心分析

Neoadjuvant, anthracycline-free chemotherapy with carboplatin and docetaxel in triple-negative, early-stage breast cancer: a multicentric analysis of rates of pathologic complete response and survival.

作者信息

Kern Peter, Kalisch Anne, von Minckwitz Gunter, Pütter Carolin, Kolberg Hans-Christian, Pott Dirk, Kurbacher Christian, Rezai Mahdi, Kimmig Rainer

机构信息

a Universitat Duisburg-Essen, University Hospital of Essen, Women's Department , Düsseldorf , Germany.

b GBG Forschungs GmbH, German Breast Group , Neu-Isenburg , Germany.

出版信息

J Chemother. 2016 Jun;28(3):210-7. doi: 10.1179/1973947815Y.0000000061. Epub 2016 May 27.

Abstract

INTRODUCTION

Triple-negative breast cancer (TNBC) has the highest mortality rates of all subtypes. Anthracycline and taxane regimens yield unsatisfactorily low rates of pathologic complete response (pCR) and are often not feasible in cardiac comorbidity. This study seeks to increase pCR and survival by introducing platin agents.

PATIENTS AND METHODS

In this multicentric, open-label study with six cycles of docetaxel (75 mg/m(2)) and carboplatin AUC 6 q3w, patients were unwilling or unsuitable for anthracycline-based regimens. Primary endpoint was pCR (ypT0/ypTis ypN0) and survival.

RESULTS

pCR rate was 50%. After 2 and 5 years, overall survival (OS) was 96.7 and 89.7%, disease-free-survival (DFS) 96.7 and 85.7%, DDFS 96.7 and 89.6%. Grade 3/4 toxicities were rare. Ninety-three per cent of patients completed six cycles. No toxicity-related treatment discontinuation or febrile neutropaenia was recorded.

CONCLUSION

This regimen is highly effective and feasible in TNBC and may be combined with anthracyclines.

摘要

引言

三阴性乳腺癌(TNBC)是所有亚型中死亡率最高的。蒽环类和紫杉类方案产生的病理完全缓解(pCR)率低得不尽人意,并且在合并心脏疾病时往往不可行。本研究旨在通过引入铂类药物提高pCR率和生存率。

患者与方法

在这项多中心、开放标签的研究中,患者接受六个周期的多西他赛(75mg/m²)和卡铂AUC 6,每三周一次,这些患者不愿意或不适合接受基于蒽环类的方案。主要终点是pCR(ypT0/ypTis ypN0)和生存率。

结果

pCR率为50%。2年和5年后,总生存率(OS)分别为96.7%和89.7%,无病生存率(DFS)分别为96.7%和85.7%,远处无病生存率(DDFS)分别为96.7%和89.6%。3/4级毒性反应罕见。93%的患者完成了六个周期。未记录到与毒性相关的治疗中断或发热性中性粒细胞减少。

结论

该方案在TNBC中高效且可行,并且可与蒽环类药物联合使用。

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