Off-label drug use in breast cancer therapy Review article
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Abstract
Breast cancer is one of the most common malignancies across the world, including Poland. Chemotherapy plays an important part in the treatment of the disease. Most of the available chemotherapy drugs and regimens have undergone randomized clinical studies and have been registered for that specific indication. However, a number of drugs are used in an off-label manner, i.e. outside the officially approved product specifications. The paper discusses the use of several off-label therapies in breast cancer in order to demonstrate that such treatment may be well-grounded and indeed turns out beneficial in many cases. It describes the use of liposomal doxorubicin in pre- and post-operative treatment, capecitabine for incomplete efficacy of preoperative treatment, and the administration of metronomic vinorelbine. Moreover, the paper is aimed at demonstrating the legal basis and the principles of marketing authorization of off-label drug use.
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright: © Medical Education sp. z o.o. This is an Open Access article distributed under the terms of the Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). License (https://creativecommons.org/licenses/by-nc/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
Address reprint requests to: Medical Education, Marcin Kuźma (marcin.kuzma@mededu.pl)
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