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多西他赛、表柔比星和环磷酰胺联合作为局部晚期乳腺癌患者新辅助化疗方案的II期研究

A Phase II Study of Concurrent Docetaxel, Epirubicin and Cyclophosphamide as a Neoadjuvant Chemotherapy Regimen in Patients with Locally Advanced Breast Cancer.

作者信息

Yao Xin, Hosenpud Janet, Chitambar Christopher R, Charlson John, Cheng Yee Chung

机构信息

Division of Hematology and Oncology, Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.

出版信息

J Cancer. 2012;3:145-51. doi: 10.7150/jca.3980. Epub 2012 Apr 1.

DOI:10.7150/jca.3980
PMID:22481980
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3319980/
Abstract

BACKGROUND

Neoadjuvant chemotherapy with concurrent docetaxel, doxorubicin and cyclophosphamide is commonly used for patients with locally advanced breast cancer. Epirubicin is another anthracycline used in breast cancer but the concurrent use of epirubicin and taxane is not well-established. We conducted a single institution, phase II study to assess the efficacy and safety of concurrent docetaxel, epirubicin and cyclophosphamide (TEC) as a neoadjuvant chemotherapy regimen in breast cancer.

METHODS

Patients with newly diagnosed locally advanced breast cancer defined as T2 >3 cm, T3, T4 with any N, or any T with N1-3 were eligible. A chemotherapy regimen of docetaxel 75mg/m(2), epirubicin 75mg/m(2) and cyclophosphamide 600mg/m(2 )was given with filgrastim support every 3 weeks for 6 cycles. The primary end-point was pathologic complete response rate.

RESULTS

Twenty patients were enrolled from 2003 to 2006. The median age was 51 (29-70) year-old. Eight patients were premenopausal. Ten patients had positive hormone receptors. Four patients had HER2 positive receptor. Nineteen patients completed six cycles of TEC chemotherapy. The pathologic complete response rate was 25%. Eight of sixteen patients with N1-3 disease had pathological negative lymph nodes. With a median follow up of 57.5 (16-71) months, four patients relapsed including one death from recurrence. The estimated 5 year relapse-free survival was 79.3% and the 5-year overall survival was 94.7%. No patient had cardiac failure or death during treatment. The most common grade 3-4 toxicity was neutropenia (35%).

CONCLUSION

TEC regimen is a well- tolerated and effective neoadjuvant chemotherapy regimen for locally advanced breast cancer that results in a pathologic complete response rate of 25%.

摘要

背景

多西他赛、阿霉素与环磷酰胺联合的新辅助化疗常用于局部晚期乳腺癌患者。表柔比星是另一种用于乳腺癌治疗的蒽环类药物,但表柔比星与紫杉烷联合使用的效果尚未明确。我们开展了一项单机构II期研究,以评估多西他赛、表柔比星与环磷酰胺(TEC)联合作为乳腺癌新辅助化疗方案的疗效与安全性。

方法

新诊断的局部晚期乳腺癌患者符合入组条件,定义为T2>3cm、T3、T4伴任何N分期,或任何T分期伴N1-3。给予多西他赛75mg/m²、表柔比星75mg/m²和环磷酰胺600mg/m²的化疗方案,每3周一次,共6个周期,并给予非格司亭支持。主要终点为病理完全缓解率。

结果

2003年至2006年共入组20例患者。中位年龄为51岁(29-70岁)。8例患者为绝经前。10例患者激素受体阳性。4例患者HER2受体阳性。19例患者完成了6个周期的TEC化疗。病理完全缓解率为25%。16例N1-3期疾病患者中有8例病理淋巴结阴性。中位随访57.5个月(16-71个月),4例患者复发,其中1例因复发死亡。估计5年无复发生存率为79.3%,5年总生存率为94.7%。治疗期间无患者发生心力衰竭或死亡。最常见的3-4级毒性为中性粒细胞减少(35%)。

结论

TEC方案是一种耐受性良好且有效的局部晚期乳腺癌新辅助化疗方案,病理完全缓解率为25%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4614/3319980/4a0587ba1b2c/jcav03p0145g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4614/3319980/538d0d911d77/jcav03p0145g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4614/3319980/4a0587ba1b2c/jcav03p0145g02.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4614/3319980/538d0d911d77/jcav03p0145g01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4614/3319980/4a0587ba1b2c/jcav03p0145g02.jpg

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