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Randomized Controlled Trial
. 2022 Mar;17(3):423-433.
doi: 10.1016/j.jtho.2021.10.014. Epub 2021 Nov 2.

Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC

Yi-Long Wu  1 , Thomas John  2 , Christian Grohe  3 , Margarita Majem  4 , Jonathan W Goldman  5 , Sang-We Kim  6 , Terufumi Kato  7 , Konstantin Laktionov  8 , Huu Vinh Vu  9 , Zhijie Wang  10 , Shun Lu  11 , Kye Young Lee  12 , Charuwan Akewanlop  13 , Chong-Jen Yu  14 , Filippo de Marinis  15 , Laura Bonanno  16 , Manuel Domine  17 , Frances A Shepherd  18 , Lingmin Zeng  19 , Ajlan Atasoy  20 , Roy S Herbst  21 , Masahiro Tsuboi  22
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Free article
Randomized Controlled Trial

Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC

Yi-Long Wu et al. J Thorac Oncol. 2022 Mar.
Free article

Abstract

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.

Keywords: Adjuvant chemotherapy; EGFR; EGFR-TKI; NSCLC; Osimertinib.

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  • The Magic of ADAURA?
    Camidge DR. Camidge DR. J Thorac Oncol. 2022 Mar;17(3):348-350. doi: 10.1016/j.jtho.2021.11.019. J Thorac Oncol. 2022. PMID: 35216729 No abstract available.

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