| Title: | Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN) : a retrospective analysis of patients treated through an access program |
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| Authors: | Illini, Oliver (Author)
Hochmair, Maximilian J (Author)
Fabikan, Hannah (Author)
Weinlinger, Christoph (Author)
Tufman, Amanda (Author)
Swalduz, Aurélie (Author)
Lamberg, Kristina (Author)
Hashemi, Sayed M. S. (Author)
Huemer, Florian (Author)
Vikström, Anders (Author)
Mohorčič, Katja (Author) |
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| Language: | English |
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| Tipology: | 1.01 - Original Scientific Article |
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| Organisation: |  UKPBAG - University Clinic of Respiratory and Allergic Diseases Golnik |
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| 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. |
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| Keywords: | non-small cell lung carcinoma -- drug therapy -- genetics, molecular targeted therapy, real-world data, selpercatinib, targeted therapy, tyrosine kinase inhibitor |
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| Year of publishing: | 2021 |
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| Publisher: | Sage Journals |
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| Source: | Velika Britanija |
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| COBISS_ID: | 66935555  |
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| UDC: | 616-006 |
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| ISSN on article: | 1758-8359 |
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| DOI: | 10.1177/17588359211019675 |
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| Note: | Nasl. z nasl. zaslona;
Soavtorica iz Slovenije: Katja Mohorčič;
Opis vira z dne 14. 6. 2021;
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| Views: | 695 |
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| Downloads: | 307 |
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| Files: |  PDF - Presentation file, download (777,25 KB)
PDF - Supplement, download (108,37 KB)
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| | | Journal: | Ther. adv. med. oncol.
SAGE Publications
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| | | Metadata: |     |
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| Rights: | © The Author(s), 2021. |
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