Treatment Characteristics and Real-World Progression-Free Survival in Patients With Unresectable Stage III NSCLC Who Received Durvalumab After Chemoradiotherapy: Findings From the PACIFIC-R Study.

Autor:	Girard N; Institut du Thorax Curie Montsouris, Institut Curie, Paris, France and UVSQ, Paris Saclay, Versailles, France. Electronic address: nicolas.girard2@curie.fr., Bar J; Institute of Oncology, Sheba Medical Centre, Ramat Gan, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel., Garrido P; Medical Oncology Department, Hospital Ramón y Cajal, Universidad de Alcalá, Madrid, Spain., Garassino MC; Department of Hematology/Oncology, The University of Chicago, Chicago, Illinois., McDonald F; Lung Unit, The Royal Marsden NHS Foundation Trust, London, United Kingdom., Mornex F; Department of Radiation Oncology, Centre Hospitalier Universitaire de Lyon, Lyon, France., Filippi AR; Radiation Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo and University of Pavia, Pavia, Italy., Smit HJM; Department of Pulmonary Diseases, Rijnstate Hospital, Arnhem, The Netherlands., Peters S; Department of Oncology, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland., Field JK; Roy Castle Lung Cancer Research Programme, Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, United Kingdom., Christoph DC; Department of Medical Oncology/Hematology, Evang. Kliniken Essen-Mitte, Evang. Huyssens-Stiftung Essen-Huttrop, Essen, Germany., Sibille A; Department of Pneumology and Allergology, Centre Hospitalier Universitaire de Liège, Liège, Belgium., Fietkau R; Department of Radiation Oncology, Universitätsklinikums Erlangen, Erlangen, Germany., Haakensen VD; Department of Oncology and Institute for Cancer Research, Oslo University Hospital, Oslo, Norway., Chouaid C; Service de Pneumologie, Centre Hospitalier Intercommunal de Créteil, Créteil, France., Markman B; Cabrini Hospital and Monash University, Melbourne, Victoria, Australia., Hiltermann TJN; University of Groningen, Department of Pulmonary Diseases, University Medical Center Groningen, Groningen, The Netherlands., Taus A; Department of Medical Oncology, Hospital del Mar-CIBERONC, Barcelona, Spain., Sawyer W; AstraZeneca, Cambridge, United Kingdom., Allen A; AstraZeneca, Gaithersburg, Maryland., Chander P; AstraZeneca, Gaithersburg, Maryland., Licour M; AstraZeneca, Courbevoie, France., Solomon B; Department of Medical Oncology, Peter MacCallum Cancer Centre and University of Melbourne, Victoria, Australia.
Jazyk:	angličtina
Zdroj:	Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] 2023 Feb; Vol. 18 (2), pp. 181-193. Date of Electronic Publication: 2022 Oct 25.
DOI:	10.1016/j.jtho.2022.10.003
Abstrakt:	Introduction: The phase 3 PACIFIC trial established consolidation therapy with durvalumab as standard of care for patients with unresectable, stage III NSCLC and no disease progression after definitive chemoradiotherapy (CRT). The observational PACIFIC-R study assesses the real-world effectiveness of durvalumab in patients from an early access program. Here, we report treatment characteristics and a preplanned analysis of real-world progression-free survival (rwPFS). Methods: PACIFIC-R (NCT03798535) is an ongoing, international, retrospective study of patients who started durvalumab (intravenously; 10 mg/kg every 2 wk) within an early access program between September 2017 and December 2018. The primary end points are investigator-assessed rwPFS and overall survival (analyzed by Kaplan-Meier method). Results: As of November 30, 2020, the full analysis set comprised 1399 patients from 11 countries (median follow-up duration, 23.5 mo). Patients received durvalumab for a median of 11.0 months. Median rwPFS was 21.7 months (95% confidence interval: 19.1-24.5). RwPFS was numerically longer among patients who received concurrent versus sequential CRT (median, 23.7 versus 19.3 mo) and among patients with programmed cell death-ligand 1 expression greater than or equal to 1% versus less than 1% (22.4 versus 15.6 mo). Overall, 16.5% of the patients had adverse events leading to treatment discontinuation; 9.5% of all patients discontinued because of pneumonitis or interstitial lung disease. Conclusions: Consolidation durvalumab after definitive CRT was well tolerated and effective in this large, real-world cohort study of patients with unresectable, stage III NSCLC. As expected, rwPFS was longer among patients who received concurrent versus sequential CRT and patients with higher programmed cell death-ligand 1 expression. Nevertheless, favorable rwPFS outcomes were observed regardless of these factors. (Copyright © 2022 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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