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Teraźniejszość i przyszłość leków biologicznych w terapii nowotworów głowy i szyi

Title variants
Biological agents in head and neck cancer: current and future considerations
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Zgodnie z definicją Europejskiej Agencji Leków leki biologiczne są farmaceutykami, których substancja aktywna wytwarzana jest przez żyjący organizm. Mechanizm ich działania polega na modulacji reakcji immunologicznych poprzez naśladowanie naturalnie występujących cząsteczek lub interakcji z ich szlakiem molekularnym. Największą grupę leków biologicznych stanowią przeciwciała monoklonalne. Cztery leki biologiczne zostały zaaprobowane przez zagraniczne towarzystwa onkologiczne (amerykańską Narodową Sieć Ośrodków Onkologicznych NCCN oraz Narodowy Instytut Zdrowia i Doskonałości Klinicznej Wielkiej Brytanii NICE) do terapii nowotworów płaskonabłonkowych głowy i szyi – cetuksymab, afatynib, pembrolizumab i niwolumab. W Polsce tylko pierwszy z nich jest dostępny w codziennej praktyce klinicznej, we wskazaniach ograniczonych ministerialnym programem lekowym. Kwalifikują się do niego chorzy poddawani radykalnej radioterapii, z przeciwwskazaniami do cisplatyny. Gwałtowny rozwój immunoterapii i leczenia celowanego w ostatnich dekadach sprawił, że obecnie toczą się setki badań klinicznych oceniających skuteczność leków biologicznych w terapii nowotworów rejonu głowy i szyi zarówno w leczeniu radykalnym (neoadjuwantowo, adjuwantowo lub w skojarzeniu z radioterapią) jak i paliatywnym (w monoterapii, skojarzeniu z chemioterapeutykami lub innymi lekami biologicznymi).
According to European Medicines Agency’s definition, biological agents are pharmaceuticals whose active substance is made by a living organism. Biologics modulate immunological response by mimicking endogenous proteins or interacting with signaling pathways. The vast majority of biologics used in oncology are monoclonal antibodies. Use of four biologics in treatment of head and neck cancers - cetuximab, afatinib, pembrolizumab, nivolumab, is supported by National Comprehensive Cancer Network (NCCN) and National Institute for Health and Care Excellence (NICE) guidelines. In Poland only cetuximab can be applied in everyday practice, with some limitations. Cetuximab should be administered concurrently with radical radiotherapy to patients with contraindications for cisplatin. Due to rapid development of immunotherapy and biologics in the last decades there are currently hundreds of clinical trials conducted, seeking for most optimal regimens of biological drugs in head and neck cancer treatment, both in radical treatment (neoadjuvant and adjuvant therapy or in combination with radiotherapy) and in paliative treatment (in monotherapy, in combination with chemotherapeutic agents or other biological agents).
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