Health-Related Quality of Life Outcomes in Patients with Resected Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer Who Received Adjuvant Osimertinib in the Phase III ADAURA Trial
Majem, Margarita (Institut d'Investigació Biomèdica Sant Pau)
Goldman, Jonathan W. (David Geffen School of Medicine. University of California Los Angeles)
John, Thomas (Department of Medical Oncology. Austin Health)
Grohe, Christian (Klinik fur € Pneumologie-Evangelische Lungenklinik Berlin Buch)
Laktionov, Konstantin (N.N. Blokhin National Medical Research Center of Oncology (Rússia))
Kim, Sang-We (Department of Oncology. Asan Medical Center)
Kato, Terufumi (Depart-ment of Thoracic Oncology. Kanagawa Cancer Center)
Vu, Huu Vinh (Department of Thoracic Surgery. Choray Hospital)
Lu, Shun (Lung Cancer Center. Shanghai Chest Hospital. Shanghai Jiao Tong University)
Li, Shanqing (Department of Thoracic Surgery. Peking Union Medical College Hospital. Chinese Academy of Medical Sciences)
Lee, Kye Young (Pre-cision Medicine Lung Cancer Center. Konkuk University Medical Center)
Akewanlop, Charuwan (Division of Medical Oncology. Faculty of Medicine. Siriraj Hospital)
Yu, Chong-Jen (Department of Internal Medicine. National Taiwan University Hospital Hsinchu Branch. National Taiwan University College of Medicine)
De Marinis, Filippo (Thoracic Oncology Division. European Institute of Oncology (IEO). IRCCS)
Bonanno, Laura (Medical Oncology 2. Istituto Oncologico Veneto (IOV). IRCCS)
Domine, Manuel (Hospital Universitario Fundacion Jimenez Díaz. Servicio de Oncología)
Shepherd, Frances A. (Department of Medical Oncology and Hematology. University Health Network. Princess Margaret Cancer Center. the University of Toronto)
Atagi, Shinji (Department of Thoracic Oncology. National Hospital Organization Kinki-Chuo Chest Medical Center)
Zeng, Lingmin (Late Oncology Statistics. AstraZeneca)
Kulkarni, Dakshayini (Late Oncology R&D. AstraZeneca)
Medic, Nenad (AstraZeneca Oncology Business Unit. Academy House)
Tsuboi, Masahiro (Department of Thoracic Surgery and Oncology. National Cancer Center Hospital East)
Herbst, Roy S. (Medical Oncology. Yale School of Medicine. Yale Cancer Center)
Wu, Yi-Long (Guangdong Lung Cancer Institute)

Fecha:	2022
Resumen:	Purpose: In the phase III ADAURA trial, adjuvant treatment with osimertinib versus placebo, with/without prior adjuvant chemotherapy, resulted in a statistically significant and clinically meaningful disease-free survival benefit in completely resected stage IB-IIIA EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). We report health-related quality of life (HRQoL) outcomes from ADAURA. Patients and Methods: Patients randomized 1:1 received oral osimertinib 80 mg or placebo for 3 years or until recurrence/ discontinuation. HRQoL (secondary endpoint) was measured using the Short Form-36 (SF-36) health survey at baseline, 12, and 24 weeks, then every 24 weeks until recurrence or treatment completion/ discontinuation. Exploratory analyses of SF-36 score changes from baseline until week 96 and time to deterioration (TTD) were performed in the overall population (stage IB-IIIA; N ¼ 682). Clinically meaningful changes were defined using the SF-36 manual. Results: Baseline physical/mental component summary (PCS/ MCS) scores were comparable between osimertinib and placebo (range, 46-47) and maintained to Week 96, with no clinically meaningful differences between arms; difference in adjusted least squares (LS) mean [95% confidence intervals (CI), -1. 18 (-2. 02 to -0. 34) and -1. 34 (-2. 40 to -0. 28), for PCS and MCS, respectively. There were no differences between arms for TTD of PCS and MCS; HR, 1. 17 (95% CI, 0. 82-1. 67) and HR, 0. 98 (95% CI, 0. 70-1. 39), respectively. Conclusions: HRQoL was maintained with adjuvant osimertinib in patients with stage IB-IIIA EGFRm NSCLC, who were disease-free after complete resection, with no clinically meaningful differences versus placebo, further supporting adjuvant osimertinib as a new treatment in this setting.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Materia:	Acrylamides ; Adjuvants, Immunologic ; Aniline Compounds ; Carcinoma, Non-Small-Cell Lung ; ErbB Receptors ; Humans ; Lung Neoplasms ; Mutation ; Quality of Life ; Small Cell Lung Carcinoma
Publicado en:	Clinical Cancer Research, Vol. 28 Núm. 11 (january 2022) , p. 2286-2296, ISSN 1557-3265

DOI: 10.1158/1078-0432.CCR-21-3530
PMID: 35012927

11 p, 421.8 KB

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Documentos de investigación > Documentos de los grupos de investigación de la UAB > Centros y grupos de investigación (producción científica) > Ciencias de la salud y biociencias > Institut de Recerca Sant Pau
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