Pegylated liposomal doxorubicin (Lipo-Dox®) combined with cyclophosphamide and 5-fluorouracil is effective and safe as salvage chemotherapy in taxane-treated metastatic breast cancer: an open-label, multi-center, non-comparative phase II study

BMC Cancer

Research Article

Yung-Chang Lin¹  Jen-Shi Chen¹  Cheng-Hsu Wang²  Kuan-Der Lee³  Yen-Yang Chen⁴  Kun-Ming Rau⁴  Hsien-Kun Chang⁵ 

[1] College of Medicine, Chang Gung University, Tao-Yuan, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, LinKo Chang Gung Memorial Hospital, 5, Fushing St., Gueishan Township, 333, Taoyuan, Taiwan;College of Medicine, Chang Gung University, Tao-Yuan, Taiwan;Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Keelong, Keelong, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Chiayia, Chiayia, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, Chang Gung Memorial Hospital at Keelong, Keelong, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan;College of Medicine, Chang Gung University, Tao-Yuan, Taiwan;Division of Hematology-Oncology, Department of Internal Medicine, LinKo Chang Gung Memorial Hospital, 5, Fushing St., Gueishan Township, 333, Taoyuan, Taiwan;

关键词: Advanced breast cancer;    Pegylated liposomal doxorubicin;    Metastatic breast cancer;    Taxane failure;    Safety;   

DOI  :  10.1186/s12885-015-1433-4

 received in 2015-01-12, accepted in 2015-05-13,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundAnthracycline and taxane are classes of drugs that are frequently used in the adjuvant and palliative settings of metastatic breast cancer (MBC); however, treatment failure occurs in most cases. Limited data demonstrated favorable response in MBC after previous taxane-based treatment. The aim of this study was to evaluate the efficacy and safety of pegylated liposomal doxorubicin (Lipo-Dox®) used as part of a combination salvage therapy for patients with MBC whose tumors progressed during or after taxane-based treatment.MethodsPatients with MBC who failed to respond to previous taxane-based treatments were recruited. Treatment with pegylated liposomal doxorubicin (40 mg/m2), cyclophosphamide (500 mg/m2), and 5-fluorouracil (500 mg/m2) was administered every 3 weeks. Tumor response to treatment was determined by using the Response Evaluation Criteria in Solid Tumor criteria version 1.0, and left ventricular ejection fraction was measured before and after treatment using echocardiography. Each patient was followed for 30 days after the last dose of study medication or until resolution/stabilization of any drug-related adverse event.ResultsForty-five patients were recruited. As of December 2012, the median follow-up duration was 29.8 months, the overall response rate was 41.9 %, the median progression-free survival was 8.2 months, and the median overall survival was 36.6 months for all treated patients. Grade 3/4 neutropenia, leucopenia, and neutropenic fever were observed in 14 %, 9 %, and 1 % of the cycles, respectively. Other non-hematologic adverse effects were mild to moderate and were manageable. No decrease in left ventricular ejection function was noted.ConclusionThis regimen of combined of pegylated liposomal doxorubicin, cyclophosphamide, and 5-fluorouracil exhibited a promising overall response rate, progression-free survival rate, and overall survival rate, with a safe cardiac toxicity profile and manageable adverse effects. This regimen could be considered as a treatment option for patients with MBC whose tumors progressed during or after taxane-based treatment.

【 授权许可】

Unknown   
© Rau et al.; licensee BioMed Central. 2015. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.