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Title:Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN) : a retrospective analysis of patients treated through an access program
Authors:ID Illini, Oliver (Author)
ID Hochmair, Maximilian J (Author)
ID Fabikan, Hannah (Author)
ID Weinlinger, Christoph (Author)
ID Tufman, Amanda (Author)
ID Swalduz, Aurélie (Author)
ID Lamberg, Kristina (Author)
ID Hashemi, Sayed M. S. (Author)
ID Huemer, Florian (Author)
ID Vikström, Anders (Author)
ID Mohorčič, Katja, Klinika Golnik (Author)
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Language:English
Typology:1.01 - Original Scientific Article
Organization:Logo UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik
Abstract: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.
Keywords:non-small cell lung carcinoma -- drug therapy -- genetics, molecular targeted therapy, real-world data, selpercatinib, targeted therapy, tyrosine kinase inhibitor
Publication status:Published
Publication version:Version of Record
Place of publishing:Velika Britanija
Publisher:Sage Journals
Year of publishing:2021
Number of pages:str. 1-17
Numbering:Vol. 13
PID:20.500.12556/DiRROS-14130 New window
UDC:616-006
ISSN on article:1758-8359
DOI:10.1177/17588359211019675 New window
COBISS.SI-ID:66935555 New window
Copyright:© The Author(s), 2021.
Note:Nasl. z nasl. zaslona; Soavtorica iz Slovenije: Katja Mohorčič; Opis vira z dne 14. 6. 2021;
Publication date in DiRROS:16.06.2021
Views:1990
Downloads:1040
Metadata:XML DC-XML DC-RDF
:
ILLINI, Oliver, HOCHMAIR, Maximilian J, FABIKAN, Hannah, WEINLINGER, Christoph, TUFMAN, Amanda, SWALDUZ, Aurélie, LAMBERG, Kristina, HASHEMI, Sayed M. S., HUEMER, Florian, VIKSTRÖM, Anders and MOHORČIČ, Katja, 2021, Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN) : a retrospective analysis of patients treated through an access program. Therapeutic advances in medical oncology [online]. 2021. Vol. 13, p. 1–17. [Accessed 23 March 2025]. DOI 10.1177/17588359211019675. Retrieved from: https://dirros.openscience.si/IzpisGradiva.php?lang=eng&id=14130
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Record is a part of a journal

Title:Therapeutic advances in medical oncology
Shortened title:Ther. adv. med. oncol.
Publisher:SAGE Publications
ISSN:1758-8359
COBISS.SI-ID:519822105 New window

Licences

License:CC BY-NC 4.0, Creative Commons Attribution-NonCommercial 4.0 International
Link:http://creativecommons.org/licenses/by-nc/4.0/
Description:A creative commons license that bans commercial use, but the users don’t have to license their derivative works on the same terms.
Licensing start date:11.06.2021

Secondary language

Language:Undetermined
Keywords:nedrobnocelični karcinom pljuč -- terapija z zdravili -- genetika, molekularna tarčna terapija, podatki iz resničnega življenja, selperactinib, tarčna terapija, zaviralci tirozinskih kinaz


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