PMID- 34650927 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220427 IS - 2234-943X (Print) IS - 2234-943X (Electronic) IS - 2234-943X (Linking) VI - 11 DP - 2021 TI - A Real-World, Multicenter, Observational Retrospective Study of Durvalumab After Concomitant or Sequential Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer. PG - 744956 LID - 10.3389/fonc.2021.744956 [doi] LID - 744956 AB - INTRODUCTION: For 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. METHODS: Two 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). RESULTS: One 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%). CONCLUSIONS: Durvalumab 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. CI - Copyright (c) 2021 Bruni, Scotti, Borghetti, Vagge, Cozzi, D'Angelo, Giaj Levra, Fozza, Taraborrelli, Piperno, Vanoni, Sepulcri, Trovo, Nardone, Lattanzi, Bou Selman, Bertolini, Franceschini, Agustoni, Jereczek-Fossa, Magrini, Livi, Lohr and Filippi. FAU - Bruni, Alessio AU - Bruni A AD - Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. FAU - Scotti, Vieri AU - Scotti V AD - Department of Oncology, Radiation Therapy Unit, Careggi University Hospital, Florence, Italy. FAU - Borghetti, Paolo AU - Borghetti P AD - Radiation Oncology Department, Spedali Civili and University of Brescia, Brescia, Italy. FAU - Vagge, Stefano AU - Vagge S AD - Department of Radiation Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Martino, Genova, Italy. FAU - Cozzi, Salvatore AU - Cozzi S AD - Radiation Therapy Department, Arcispedale di Santa Maria Nuova IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico), Reggio Emilia, Italy. FAU - D'Angelo, Elisa AU - D'Angelo E AD - Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. FAU - Giaj Levra, Niccolo AU - Giaj Levra N AD - Advanced Radiation Oncology Department, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Sacro Cuore Don Calabria Hospital, Verona, Italy. FAU - Fozza, Alessandra AU - Fozza A AD - Department of Radiation Oncology, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Martino, Genova, Italy. FAU - Taraborrelli, Maria AU - Taraborrelli M AD - Radiation Oncology Department, SS. Annunziata Hospital, "G. D'Annunzio" University of Chieti, Chieti, Italy. FAU - Piperno, Gaia AU - Piperno G AD - Division of Radiotherapy, European Institute of Oncology (IEO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) European Institute of Oncology, Milan, Italy. FAU - Vanoni, Valentina AU - Vanoni V AD - Radiation Oncology Department, S. Chiara Hospital, Trento, Italy. FAU - Sepulcri, Matteo AU - Sepulcri M AD - Radiation Oncology Unit, Veneto Institute of Oncology Istituto Oncologico Veneto (IOV), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italy. FAU - Trovo, Marco AU - Trovo M AD - Radiation Oncology Department, Azienda Sanitaria Universitaria Integrata, Udine, Italy. FAU - Nardone, Valerio AU - Nardone V AD - Radiotherapy Unit, "Ospedale del Mare", Naples, Italy. FAU - Lattanzi, Elisabetta AU - Lattanzi E AD - Radiotherapy Unit, University Hospital of Parma, Parma, Italy. FAU - Bou Selman, Said AU - Bou Selman S AD - Department of Radiotherapy, Bolzano Hospital, Bolzano, Italy. FAU - Bertolini, Federica AU - Bertolini F AD - Medical Oncology Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. FAU - Franceschini, Davide AU - Franceschini D AD - Department of Radiotherapy and Radiosurgery, Humanitas Research Hospital, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)-Humanitas Research Hospital, Milan, Italy. FAU - Agustoni, Francesco AU - Agustoni F AD - Medical Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, Pavia, Italy. FAU - Jereczek-Fossa, Barbara Alicja AU - Jereczek-Fossa BA AD - Division of Radiotherapy, European Institute of Oncology (IEO), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) European Institute of Oncology, Milan, Italy. AD - Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. FAU - Magrini, Stefano Maria AU - Magrini SM AD - Radiation Oncology Department, Spedali Civili and University of Brescia, Brescia, Italy. FAU - Livi, Lorenzo AU - Livi L AD - Department of Oncology, Radiation Therapy Unit, Careggi University Hospital, Florence, Italy. FAU - Lohr, Frank AU - Lohr F AD - Radiotherapy Unit, Department of Oncology and Hematology, University Hospital of Modena, Modena, Italy. FAU - Filippi, Andrea Riccardo AU - Filippi AR AD - Department of Radiation Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo and University of Pavia, Pavia, Italy. LA - eng PT - Journal Article DEP - 20210928 PL - Switzerland TA - Front Oncol JT - Frontiers in oncology JID - 101568867 EIN - Front Oncol. 2021 Nov 16;11:802949. PMID: 34869046 PMC - PMC8507147 OTO - NOTNLM OT - *NSCLC OT - *chemoradiotherapy OT - *immunotherapy OT - *stage III OT - *unresectable COIS- AB: speakers' bureau from Astra Zeneca, MSD, Tecnologie Avanzate; and advisory role for Astra Zeneca. VS: speakers' bureau for Astra Zeneca, Roche, Accuray Int.; and advisory role for Astra Zeneca. PB: speakers' bureau for Astra Zeneca. SV: speakers' bureau for Astra Zeneca, Roche, Accuray Int. ED'A: speaker's bureau from Nestle, MSD, Astra Zeneca; travel expenses: IPSEN; and expert testimony: Nestle. NG: speakers' bureau for Astra Zeneca. DF: speakers' bureau for Astra Zeneca; and advisory role for AstraZeneca. FA: speakers' bureau for Astra Zeneca, Roche, BMS, Boehringer Ingelheim, MSD; and advisory role for Boehringer Ingelheim, MSD. BJ-F: personal fees from Janssen, Roche, Astra Zeneca, and Accuray, and institutional grants from AIRC, FIEO-CCM and Accuray Int., all outside of the submitted work. ARF: speakers' bureau for Astra Zeneca, MSD, Roche, Ipsen; advisory role for Astra Zeneca, Roche; institutional research funding: Astra Zeneca; and honoraria for study conduction (not related to the present study): Astra Zeneca. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2021/10/16 06:00 MHDA- 2021/10/16 06:01 PMCR- 2021/01/01 CRDT- 2021/10/15 06:38 PHST- 2021/07/21 00:00 [received] PHST- 2021/09/06 00:00 [accepted] PHST- 2021/10/15 06:38 [entrez] PHST- 2021/10/16 06:00 [pubmed] PHST- 2021/10/16 06:01 [medline] PHST- 2021/01/01 00:00 [pmc-release] AID - 10.3389/fonc.2021.744956 [doi] PST - epublish SO - Front Oncol. 2021 Sep 28;11:744956. doi: 10.3389/fonc.2021.744956. eCollection 2021.