A single-arm, multicenter, phase II trial of osimertinib in patients with epidermal growth factor receptor exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations.

Autor:	Villaruz LC; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh., Wang X; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham., Bertino EM; Division of Medical Oncology, The Ohio State University James Comprehensive Cancer Center, Columbus., Gu L; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham., Antonia SJ; Duke Cancer Institute, Durham, USA., Burns TF; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh., Clarke J; Duke Cancer Institute, Durham, USA., Crawford J; Duke Cancer Institute, Durham, USA., Evans TL; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh., Friedland DM; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh., Otterson GA; Division of Medical Oncology, The Ohio State University James Comprehensive Cancer Center, Columbus., Ready NE; Duke Cancer Institute, Durham, USA., Wozniak AJ; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh., Stinchcombe TE; Duke Cancer Institute, Durham, USA. Electronic address: Thomas.stinchcombe@duke.edu.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2023 Apr; Vol. 8 (2), pp. 101183. Date of Electronic Publication: 2023 Mar 09.
DOI:	10.1016/j.esmoop.2023.101183
Abstrakt:	Background: For patients with stage IV non-small-cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions and exon 21 L858R mutations, osimertinib is the standard of care. Investigating the activity and safety of osimertinib in patients with EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations is of clinical interest. Patients and Methods: Patients with stage IV non-small-cell lung cancer with confirmed EGFR exon 18 G719X, exon 20 S768I, or exon 21 L861Q mutations were eligible. Patients were required to have measurable disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, and adequate organ function. Patients were required to be EGFR tyrosine kinase inhibitor-naive. The primary objective was objective response rate, and secondary objectives were progression-free survival, safety, and overall survival. The study used a two-stage design with a plan to enroll 17 patients in the first stage, and the study was terminated after the first stage due to slow accrual. Results: Between May 2018 and March 2020, 17 patients were enrolled and received study therapy. The median age of patients was 70 years (interquartile range 62-76), the majority were female (n = 11), had a performance status of 1 (n = 10), and five patients had brain metastases at baseline. The objective response rate was 47% [95% confidence interval (CI) 23% to 72%], and the radiographic responses observed were partial response (n = 8), stable disease (n = 8), and progressive disease (n = 1). The median progression-free survival was 10.5 months (95% CI 5.0-15.2 months), and the median OS was 13.8 months (95% CI 7.3-29.2 months). The median duration on treatment was 6.1 months (range 3.6-11.9 months), and the most common adverse events (regardless of attribution) were diarrhea, fatigue, anorexia, weight loss, and dyspnea. Conclusions: This trial suggests osimertinib has activity in patients with these uncommon EGFR mutations. (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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