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iSABR: Safety and Efficacy Results from a Phase II Study of SABR in Combination with Durvalumab for Early-Stage Medically Inoperable NSCLC by P. Lee; A. Stube; C. Felix; D. Oseguera; T. Romero; J. Goldman; E. Garon; J.M. Lee; J. Glaspy; A.E. Lisberg; C. G. Rusthoven Jr; D.R. Camidge; S. Siva; B. Solomon; A. Lee; S.E. Tenn; N. Shaverdian; M.L. Steinberg; A. Raldow is a Medicine article available to read on EtoBox.

What is iSABR: Safety and Efficacy Results from a Phase II Study of SABR in Combination with Durvalumab for Early-Stage Medically Inoperable NSCLC about?

Purpose/Objective(s) SABR is standard for medically inoperable early-stage NSCLC and results in excellent outcomes. However, rate of regional and distant failures is significant. Addition of immune check point inhibitors improve disease control and overall survival in stage III and IV NSCLC and may improve outcomes in early-stage NSCLC. We report safety and efficacy results of a phase II study of SABR with durvalumab (durva) in early-stage inoperable NSCLC. Materials/Methods Eligible patients had newly diagnosed, biopsy proven clinical stage I or IIA NSCLC defined by AJCC 7th edition. Patient had to be medically inoperable or refused surgery. There was a 15-patient safety lead-in cohort with pre-specified stopping rules based on incidence of grade 3 or 4 treatment-related toxicity. Patients were treated with one cycle of durva at the time of CT simulation, followed by SABR (54 Gy in 3, 50 Gy in 4, or 65 Gy in 10), then up to 4 cycles of durva (1500 mg Q4 wk). No stopping rules were met, but due to slow accrual, the study terminated prematurely in the randomized Phase II portion (1:1; SABR/durva: SABR). A total of 20 patients were enrolled from October 2017 - March 2020. Eighteen pa

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Author

P. Lee; A. Stube; C. Felix; D. Oseguera; T. Romero; J. Goldman; E. Garon; J.M. Lee; J. Glaspy; A.E. Lisberg; C. G. Rusthoven Jr; D.R. Camidge; S. Siva; B. Solomon; A. Lee; S.E. Tenn; N. Shaverdian; M.L. Steinberg; A. Raldow

Publisher

Elsevier BV

Published

2022

Language

EN

Field

Medicine (Health Sciences)