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Naslov:Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN) : a retrospective analysis of patients treated through an access program
Avtorji:Illini, Oliver (Avtor)
Hochmair, Maximilian J (Avtor)
Fabikan, Hannah (Avtor)
Weinlinger, Christoph (Avtor)
Tufman, Amanda (Avtor)
Swalduz, Aurélie (Avtor)
Lamberg, Kristina (Avtor)
Hashemi, Sayed M. S. (Avtor)
Huemer, Florian (Avtor)
Vikström, Anders (Avtor)
Mohorčič, Katja (Avtor)
Jezik:Angleški jezik
Tipologija:1.01 - Izvirni znanstveni članek
Organizacija:Logo UKPBAG - Univerzitetna klinika za pljučne bolezni in alergijo Golnik
Povzetek:Introduction: Rearranged during transfection (RET) gene fusions are rare genetic drivers in non-small cell lung cancer (NSCLC). Selective RET-inhibitors such as selpercatinib have shown therapeutic activity in early clinical trials; however, their efficacy in the real-world setting is unknown. Methods: A retrospective efficacy and safety analysis was performed on data from RET fusio-%positive NSCLC patients who participated in a selpercatinib access program (named patient protocol) between August 2019 and January 2021. Results: Data from 50 patients with RET fusion-positive advanced NSCLC treated with selpercatinib at 27 centers in 12 countries was analyzed. Most patients were Non-Asian (90%), female (60%), never-smokers (74%), with a median age of 65 years (range, 38-89). 32% of the patients had known brain metastasis at the time of selpercatinib treatment. Overall, 13 patients were treatment-naïve, while 37 were pretreated with a median of three lines of therapy (range, 1-8). The objective response rate (ORR) was 68% [95% confidence interval (CI), 53-81] in the overall population. The disease control rate was 92%. The median progression-free survival was 15.6 months (95% CI, 8.8-22.4) after a median follow-up of 9 months. In patients with measurable brain metastases (n=8) intracranial ORR reached 100%. In total, 88% of patients experienced treatment-related adverse events (TRAEs), a large majority of them being grade 1 or 2. The most common grade >/=3 TRAEs were increased liver enzyme levels (in 10% of patients), prolonged QTc time (4%), abdominal pain (4%), hypertension (4%), and fatigue/asthenia (4%). None of patients discontinued selpercatinib treatment for safety reasons. No new safety concerns were observed, nor where there any treatment-related death. Conclusions: In this real-world setting, the selective RET-inhibitor selpercatinib demonstrated durable systemic and intracranial antitumor activity in RET fusion-positive NSCLC and was well tolerated.
Ključne besede:non-small cell lung carcinoma -- drug therapy -- genetics, molecular targeted therapy, real-world data, selpercatinib, targeted therapy, tyrosine kinase inhibitor
Leto izida:2021
Založnik:Sage Journals
Izvor:Velika Britanija
UDK:616-006
ISSN pri članku:1758-8359
COBISS_ID:66935555 Povezava se odpre v novem oknu
DOI:10.1177/17588359211019675 Povezava se odpre v novem oknu
Opombe:Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Katja Mohorčič; Opis vira z dne 14. 6. 2021;
Število ogledov:334
Število prenosov:134
Datoteke:.pdf PDF - Predstavitvena datoteka, prenos (777,25 KB)
.pdf PDF - Priloga, prenos (108,37 KB)
 
Nadgradivo:Ther. adv. med. oncol.
SAGE Publications
 
Metapodatki:XML RDF-CHPDL DC-XML DC-RDF
Avtorske pravice:© The Author(s), 2021.
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Licence

Licenca:CC BY-NC 4.0, Creative Commons Priznanje avtorstva-Nekomercialno 4.0 Mednarodna
Povezava:http://creativecommons.org/licenses/by-nc/4.0/deed.sl
Opis:Licenca Creative Commons, ki prepoveduje komercialno uporabo, vendar uporabniki ne rabijo upravljati materialnih avtorskih pravic na izpeljanih delih z enako licenco.
Začetek licenciranja:11.06.2021

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