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

2022

Wu, Yi-Long

John, Thomas

Grohe, Christian

Majem, Margarita

Goldman, Jonathan W

Kim, Sang-We

Kato, Terufumi

Laktionov, Konstantin

Vu, Huu Vinh

Wang, Zhijie

Lu, Shun

Lee, Kye Young

Akewanlop, Charuwan

Yu, Chong-Jen

de Marinis, Filippo

Bonanno, Laura

Domine, Manuel

Shepherd, Frances A

Zeng, Lingmin

Atasoy, Ajlan

Herbst, Roy S

Tsuboi, Masahiro

Adjuvant chemotherapy

EGFR

EGFR-TKI

NSCLC

Osimertinib

Journal Article

10.1016/j.jtho.2021.10.014

Adjuvant chemotherapy is recommended in patients with resected stage IIꟷIIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase III, ADAURA study (NCT02511106), osimertinib demonstrated a highly statistically significant improvement in disease-free survival (DFS) in patients with resected stage IBꟷIIIA EGFRm NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA. Patients with resected stage IBꟷIIIA 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 (IBꟷIIIA), with/without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included: adjuvant chemotherapy use by patient age, disease stage and geographical location; DFS by adjuvant chemotherapy use and disease stage. Overall, 410/682 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 <70 years (338/509; 66%) versus ≥70 years (72/173; 42%); with stage II-IIIA disease (352/466; 76%) versus stage IB (57/216; 26%); enrolled in Asia (268/414; 65%) versus outside of Asia (142/268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS HR = 0.16, 95% CI: 0.10ꟷ0.26) and without adjuvant chemotherapy (HR = 0.23, 95% CI: 0.13ꟷ0.40), regardless of disease stage. These findings support adjuvant osimertinib as an effective treatment for patients with stage IB-IIIA EGFRm NSCLC after resection, with or without prior adjuvant chemotherapy.

link

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2022; 17(3): 423-433

Journal of Thoracic Oncology