Systematic Reviews
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Oncol. Aug 10, 2016; 7(4): 331-336
Published online Aug 10, 2016. doi: 10.5306/wjco.v7.i4.331
Sorafenib in breast cancer treatment: A systematic review and overview of clinical trials
Menelaos Zafrakas, Panayiota Papasozomenou, Christos Emmanouilides
Menelaos Zafrakas, Panayiota Papasozomenou, Research Laboratory for Mastology, Gynecology and Obstetrics, School of Health and Medical Care, Alexander Technological Institute of Thessaloniki, 57400 Thessaloniki, Greece
Menelaos Zafrakas, Christos Emmanouilides, Interbalkan European Medical Center of Thessaloniki, 57001 Thessaloniki, Greece
Author contributions: Zafrakas M and Emmanouilides C conceived the study; Zafrakas M and Papasozomenou P conducted the literature search; Zafrakas M and Papasozomenou P drafted the manuscript; Emmanouilides C revised the manuscript critically for important intellectual content; all authors have read and approved the final version of the manuscript.
Conflict-of-interest statement: The authors declare no relevant conflict of interest.
Data sharing statement: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Menelaos Zafrakas, FEBS (Breast Surgery), Professor of Obstetrics and Gynecology, Research Laboratory for Mastology, Gynecology and Obstetrics, School of Health and Medical Care, Alexander Technological Institute of Thessaloniki, Ethnikis Antistaseos 81, 57400 Thessaloniki, Greece. mzafrakas@gmail.com
Telephone: +30-2310-222792 Fax: +30-2310-222498
Received: April 23, 2016
Peer-review started: April 23, 2016
First decision: June 6, 2016
Revised: July 12, 2016
Accepted: July 20, 2016
Article in press: July 22, 2016
Published online: August 10, 2016
Processing time: 99 Days and 19.2 Hours
Abstract

AIM: To evaluate the current role of sorafenib, an oral multikinase inhibitor in the treatment of breast cancer.

METHODS: An extensive search of the literature until March 2016 was carried out in Medline and clinicaltrials.gov, by using the search terms “sorafenib” and “breast cancer”. Papers found were checked for further relevant publications. Overall, 21 relevant studies were found, 18 in advanced breast cancer (16 in stage IV and two in stages III-IV) and three in early breast cancer.

RESULTS: Among studies in advanced breast cancer, there were two trials with sorafenib as monotherapy, four trials of sorafenib in combination with taxanes, two in combination with capecitabine, one with gemcitabine and/or capecitabine, one with vinorelbine, one with bevacizumab, one with pemetrexed and one with ixabepilone, three trials of sorafenib in combination with endocrine therapy and two trials in women with brain metastases undergoing whole brain radiotherapy. In addition, there was one trial of sorafenib added to standard chemotherapy in the adjuvant setting, and two trials in the neoadjuvant setting. In general, sorafenib was well tolerated in breast cancer patients, though its dosage had to be adjusted in some trials, and discontinuation rates were high, particularly for the combination of sorafenib with anastrozole. Sorafenib monotherapy and combinations with taxanes, bevacizumab and ixabepilone showed inadequate efficacy, while efficacy results from combinations with gemcitabine and/or capecitabine and possibly tamoxifen were more promising.

CONCLUSION: At present, sorafenib should not be used for the treatment of breast cancer outside of clinical trials and more clinical data are needed in order to support its standard use in breast cancer therapy.

Keywords: Breast cancer; Sorafenib; Kinase inhibitors; BRAF; Mitogen-activated protein kinase

Core tip: In this systematic review of the literature, the role of sorafenib in the treatment of breast cancer has been evaluated. Regarding toxicity, sorafenib was generally well tolerated in breast cancer patients, while in terms of efficacy the most promising results came from clinical trials evaluating sorafenib in combination with gemcitabine and/or capecitabine and possibly tamoxifen. Efficacy was inadequate with sorafenib monotherapy and combinations with taxanes, bevacizumab and ixabepilone.