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Poster Display session

133TiP - Neoadjuvant osimertinib followed by sequential definitive radiotherapy and/or surgery in stage III EGFR-mutant NSCLC: An open-label, single-arm, phase II study

Date

31 Mar 2023

Session

Poster Display session

Presenters

Waleed Kian

Citation

Journal of Thoracic Oncology (2023) 18 (4S): S106-S115.
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Authors

W. Kian1, N. Peled2, L. C Roisman2, E. Levison3, J. Dudnik4, E. Chernomordikov3, E. Dudnik5, S. Keren-Rosenberg6, S. Tsuriel6, V. Hannes6, D. Hershkovitz6, R. Lichtenberg4, I. Granot2, B. Krayim2, W. Shalata3, A. M Allen2, P. Blumenfeld7, K. Lavrenkov3

Author affiliations

  • 1 Beer Sheva/IL
  • 2 Shaare Zedek Medical Center, Jerusalem/IL
  • 3 Soroka University Medical Center, Beer Sheva/IL
  • 4 Ben-Gurion University of the Negev, Beer Sheva/IL
  • 5 Ben-Gurion University of the Negev, Petah Tikva/IL
  • 6 Tel Aviv Sourasky Medical Center-(Ichilov), Tel Aviv/IL
  • 7 Hadassah University Hospital - Ein Kerem, Jerusalem/IL

Resources

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Abstract 133TiP

Background

The treatment of unresectable, locally advanced stage III non-small cell lung cancer (NSCLC) is concurrent chemoradiation therapy (CRT), followed by consolidation durvalumab. This study aims to evaluate the benefit of neoadjuvant osimertinib as an alternative therapy to this approach with the aim of reducing the radiation field.

Trial design

This investigation was a nonrandomized, open-label, single-arm, phase II prospective, proof-of-concept study. Eligible patients were treatment-naïve, nonoperable, stage III EGFR-mutant NSCLC patients. Patients received 80 mg oral osimertinib daily for 12 weeks prior to definitive radiotherapy (RT) and/or surgery. The response was assessed at week 6 and week 12. For responders, sequential definitive RT and/or surgery were planned. Nonresponders were started on standard CRT. After RT ± surgery or CRT, patients were followed for two years without adjuvant therapy. The primary endpoint was the objective response rate (ORR), with September 20, 2022 set as the cut-off for data collection. Secondary endpoints were safety and the gross tumour volume (GTV), planned tumour volume (PTV) and the percentage of total lung volume exceeding 20 Gy (V20%) before vs. after osimertinib. Exploratory analyses included assessments of the presence of plasma circulating tumour-free DNA (cfDNA) before osimertinib treatment, at weeks 6 and 12, at the end of RT, and 6 weeks post-RT.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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