A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer

IntroductionFor unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter...

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Autores principales:	Alessio Bruni, Vieri Scotti, Paolo Borghetti, Stefano Vagge, Salvatore Cozzi, Elisa D’Angelo, Niccolò Giaj Levra, Alessandra Fozza, Maria Taraborrelli, Gaia Piperno, Valentina Vanoni, Matteo Sepulcri, Marco Trovò, Valerio Nardone, Elisabetta Lattanzi, Said Bou Selman, Federica Bertolini, Davide Franceschini, Francesco Agustoni, Barbara Alicja Jereczek-Fossa, Stefano Maria Magrini, Lorenzo Livi, Frank Lohr, Andrea Riccardo Filippi
Formato:	article
Lenguaje:	EN
Publicado:	Frontiers Media S.A. 2021
Materias:	chemoradiotherapy immunotherapy stage III unresectable NSCLC Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/c19bbcb997264bcc8021500369c7f78b
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spelling	oai:doaj.org-article:c19bbcb997264bcc8021500369c7f78b2021-11-16T07:59:43ZA Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer2234-943X10.3389/fonc.2021.744956https://doaj.org/article/c19bbcb997264bcc8021500369c7f78b2021-09-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fonc.2021.744956/fullhttps://doaj.org/toc/2234-943XIntroductionFor unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter, retrospective cohort.MethodsTwo hundred thirty-eight patients have been included. We collected data on systemic therapy, radiation therapy, the timing between CRT and durvalumab, number of durvalumab cycles, reasons for non-starting or discontinuation, incidence and grade of adverse events (AEs), and progression-free survival (PFS) and overall survival (OS).ResultsOne hundred fifty-five patients out of 238 (65.1%) received at least one durvalumab dose: 91 (58.7%) after concomitant CRT (cCRT) and 64 (41.3%) after sequential CRT (sCRT). Programmed-death ligand 1 (PD-L1) status was unknown in 7/155 (4.5%), negative in 14 (9.1%), and positive ≥1% in 134/155 (86.4%). The main reasons for non-starting durvalumab were progression (10.1%), PD-L1 negativity (7.5%), and lung toxicity (4.6%). Median follow-up time was 14 months (range 2–29); 1-year PFS and OS were 65.5% (95%CI: 57.6-74.4) and 87.9% (95%CI: 82.26.6-93.9), respectively. No significant differences in PFS or OS were detected for cCRT vs. sCRT, but the median PFS was 13.5 months for sCRT vs. 23 months for cCRT. Potentially immune-related AEs were recorded in 76/155 patients (49.0%). Pneumonitis was the most frequent, leading to discontinuation in 11/155 patients (7.1%).ConclusionsDurvalumab maintenenace after concurrent or sequential chemoradiation for unresectable, stage III NSCLC showed very promising short-term survival results in a large, multicenter, restrospective, real-world study. Durvalumab was the first drug obtaining a survival benefit over CRT within the past two decades, and the present study contributes to validating its use in clinical practice.Alessio BruniVieri ScottiPaolo BorghettiStefano VaggeSalvatore CozziElisa D’AngeloNiccolò Giaj LevraAlessandra FozzaMaria TaraborrelliGaia PipernoValentina VanoniMatteo SepulcriMarco TrovòValerio NardoneElisabetta LattanziSaid Bou SelmanFederica BertoliniDavide FranceschiniFrancesco AgustoniBarbara Alicja Jereczek-FossaBarbara Alicja Jereczek-FossaStefano Maria MagriniLorenzo LiviFrank LohrAndrea Riccardo FilippiFrontiers Media S.A.articlechemoradiotherapyimmunotherapystage IIIunresectableNSCLCNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENFrontiers in Oncology, Vol 11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	chemoradiotherapy immunotherapy stage III unresectable NSCLC Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	chemoradiotherapy immunotherapy stage III unresectable NSCLC Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Alessio Bruni Vieri Scotti Paolo Borghetti Stefano Vagge Salvatore Cozzi Elisa D’Angelo Niccolò Giaj Levra Alessandra Fozza Maria Taraborrelli Gaia Piperno Valentina Vanoni Matteo Sepulcri Marco Trovò Valerio Nardone Elisabetta Lattanzi Said Bou Selman Federica Bertolini Davide Franceschini Francesco Agustoni Barbara Alicja Jereczek-Fossa Barbara Alicja Jereczek-Fossa Stefano Maria Magrini Lorenzo Livi Frank Lohr Andrea Riccardo Filippi A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
description	IntroductionFor unresectable stage III non-small cell lung cancer (NSCLC), the standard therapy consists of chemoradiotherapy (CRT) followed by durvalumab maintenance for responding patients. The present study reports on the safety and outcome of durvalumab use after CRT in a real-world, multicenter, retrospective cohort.MethodsTwo hundred thirty-eight patients have been included. We collected data on systemic therapy, radiation therapy, the timing between CRT and durvalumab, number of durvalumab cycles, reasons for non-starting or discontinuation, incidence and grade of adverse events (AEs), and progression-free survival (PFS) and overall survival (OS).ResultsOne hundred fifty-five patients out of 238 (65.1%) received at least one durvalumab dose: 91 (58.7%) after concomitant CRT (cCRT) and 64 (41.3%) after sequential CRT (sCRT). Programmed-death ligand 1 (PD-L1) status was unknown in 7/155 (4.5%), negative in 14 (9.1%), and positive ≥1% in 134/155 (86.4%). The main reasons for non-starting durvalumab were progression (10.1%), PD-L1 negativity (7.5%), and lung toxicity (4.6%). Median follow-up time was 14 months (range 2–29); 1-year PFS and OS were 65.5% (95%CI: 57.6-74.4) and 87.9% (95%CI: 82.26.6-93.9), respectively. No significant differences in PFS or OS were detected for cCRT vs. sCRT, but the median PFS was 13.5 months for sCRT vs. 23 months for cCRT. Potentially immune-related AEs were recorded in 76/155 patients (49.0%). Pneumonitis was the most frequent, leading to discontinuation in 11/155 patients (7.1%).ConclusionsDurvalumab maintenenace after concurrent or sequential chemoradiation for unresectable, stage III NSCLC showed very promising short-term survival results in a large, multicenter, restrospective, real-world study. Durvalumab was the first drug obtaining a survival benefit over CRT within the past two decades, and the present study contributes to validating its use in clinical practice.
format	article
author	Alessio Bruni Vieri Scotti Paolo Borghetti Stefano Vagge Salvatore Cozzi Elisa D’Angelo Niccolò Giaj Levra Alessandra Fozza Maria Taraborrelli Gaia Piperno Valentina Vanoni Matteo Sepulcri Marco Trovò Valerio Nardone Elisabetta Lattanzi Said Bou Selman Federica Bertolini Davide Franceschini Francesco Agustoni Barbara Alicja Jereczek-Fossa Barbara Alicja Jereczek-Fossa Stefano Maria Magrini Lorenzo Livi Frank Lohr Andrea Riccardo Filippi
author_facet	Alessio Bruni Vieri Scotti Paolo Borghetti Stefano Vagge Salvatore Cozzi Elisa D’Angelo Niccolò Giaj Levra Alessandra Fozza Maria Taraborrelli Gaia Piperno Valentina Vanoni Matteo Sepulcri Marco Trovò Valerio Nardone Elisabetta Lattanzi Said Bou Selman Federica Bertolini Davide Franceschini Francesco Agustoni Barbara Alicja Jereczek-Fossa Barbara Alicja Jereczek-Fossa Stefano Maria Magrini Lorenzo Livi Frank Lohr Andrea Riccardo Filippi
author_sort	Alessio Bruni
title	A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
title_short	A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
title_full	A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
title_fullStr	A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
title_full_unstemmed	A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer
title_sort	real-world, multicenter, observational retrospective study of durvalumab after concomitant or sequential chemoradiation for unresectable stage iii non-small cell lung cancer
publisher	Frontiers Media S.A.
publishDate	2021
url	https://doaj.org/article/c19bbcb997264bcc8021500369c7f78b
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A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer

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