Postoperative Chemotherapy Use and Outcomes From ADAURA

Introduction: Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in pat...

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Detalles Bibliográficos
Autores: Wu, Yi-Long|||0000-0002-3611-0258, John, Thomas|||0000-0003-3399-5342, Grohe, Christian, Majem Tarruella, Margarita|||0000-0002-9919-7485, Goldman, Jonathan W., Kim, Sang-We, Kato, Terufumi, Laktionov, Konstantin, Vu, Huu Vinh, Wang, Zhije, Lu, Shun|||0000-0001-8833-7262, Lee, Kye Young, Akewanlop, Charuwan|||0000-0003-1022-3745, Yu, Chong-Jen|||0000-0001-5664-9392, De Marinis, Filippo, Bonanno, Laura|||0000-0001-5218-4970, Dómine Gómez, Manuel|||0000-0003-1634-9832, Shepherd, Frances A., Zeng, Lingmin, Atasoy, Ajlan, Herbst, Roy S.|||0000-0003-2535-5847, Tsuboi, Masahiro
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:290606
Acceso en línea:https://ddd.uab.cat/record/290606
https://dx.doi.org/urn:doi:10.1016/j.jtho.2021.10.014
Access Level:acceso abierto
Palabra clave:Adjuvant chemotherapy
EGFR
EGFR-TKI
NSCLC
Osimertinib
Descripción
Sumario:Introduction: Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA. Methods: Patients with resected stages IB to IIIA EGFRm NSCLC were randomized 1:1 to receive osimertinib or placebo for 3 years. Adjuvant chemotherapy before randomization was not mandatory, per physician and patient choice. DFS in the overall population (IB-IIIA), with and without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included the following: adjuvant chemotherapy use by patient age, disease stage, and geographic location; DFS by adjuvant chemotherapy use and disease stage. Results: Overall, 410 of 682 patients (60%) received adjuvant chemotherapy (osimertinib, n = 203; placebo, n = 207) for a median duration of 4.0 cycles. Adjuvant chemotherapy use was more frequent in patients: aged less than 70 years (338 of 509; 66%) versus more than or equal to 70 years (72 of 173; 42%); with stages II to IIIA (352 of 466; 76%) versus stage IB (57 of 216; 26%); and enrolled in Asia (268 of 414; 65%) versus outside of Asia (142 of 268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS hazard ratio = 0.16, 95% confidence interval: 0.10-0.26) and without adjuvant chemotherapy (hazard ratio = 0.23, 95% confidence interval: 0.13-0.40), regardless of disease stage. Conclusions: These findings support adjuvant osimertinib as an effective treatment for patients with stages IB to IIIA EGFRm NSCLC after resection, with or without previous adjuvant chemotherapy.

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