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Selpercatinib in RET fusion-positive non-small-cell lung cancer (SIREN) [Elektronski vir] : a retrospective analysis of patients treated through an access programIllini, Oliver ...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 fusion-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.Source: Therapeutic advances in medical oncology. - ISSN 1758-8359 (Vol. 13, 2021, str. 1-17)Type of material - e-article ; adult, seriousPublish date - 2021Language - englishCOBISS.SI-ID - 66935555
Author
Illini, Oliver |
Hochmair, Maximilian J |
Fabikan, Hannah |
Weinlinger, Christoph |
Tufman, Amanda |
Swalduz, Aurélie |
Lamberg, Kristina |
Hashemi, Sayed M. S. |
Huemer, Florian |
Vikström, Anders |
Mohorčič, Katja, 1978-
Topics
Carcinoma, non-small cell lung |
Drug therapy |
Genetics |
Molecular targeted therapy |
Nedrobnocelični karcinom pljuč |
Terapija z zdravili |
Genetika |
Molekularna tarčna terapija |
podatki iz resničnega življenja |
selperactinib |
tarčna terapija |
zaviralci tirozinskih kinaz |
real-world data |
selpercatinib |
targeted therapy |
tyrosine kinase inhibitor
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Database name | Field | Year |
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Illini, Oliver | |
Hochmair, Maximilian J | |
Fabikan, Hannah | |
Weinlinger, Christoph | |
Tufman, Amanda | |
Swalduz, Aurélie | |
Lamberg, Kristina | |
Hashemi, Sayed M. S. | |
Huemer, Florian | |
Vikström, Anders | |
Mohorčič, Katja, 1978- | 30985 |
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