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Two ADAURA Analyses Support the Use of Osimertinib in Patients With Surgically Resected NSCLC


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Two presentations based on data from the ADAURA clinical trial advanced previous research that demonstrated improved disease-fee survival outcomes for patients with surgically resected non–small cell lung cancer (NSCLC) receiving osimertinib, while also maintaining quality of life. The data were reported at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore, which was moved to a virtual format and held January 28–31, 2021, in light of the COVID-19 pandemic.

Osimertinib is a third-generation, irreversible, central nervous system–active, epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. ADAURA is a randomized phase III trial comparing adjuvant osimertinib with placebo in patients with surgically resected stage IB to IIIA (AJCC 7th edition; pathologic stage) NSCLC that harbors an activating EGFR mutation with either an exon 19 deletion or exon 21 L858R substitution.

Postoperative chemotherapy was allowed, per physician and patient choice. Adult patients were randomly assigned 1:1 and treated with osimertinib at 80 mg once daily orally or placebo for 3 years or until disease recurrence.

Health-Related Quality of Life

In one analysis presented by Margarita Majem, MD, of the Department of Medical Oncology at the Hospital de la Santa Creu i Sant Pau, Barcelona, adjuvant osimertinib, with or without prior adjuvant chemotherapy, provided a significant disease-free survival benefit without affecting health-related quality of life, a secondary endpoint of the study, in completely resected and disease-free patients with stage IB to IIIA EGFR-mutated NSCLC (Abstract OA06.03).

Health-related quality of life was assessed with the short form-36 (SF-36) health survey, which consisted of eight domains and two aggregated summary scores—physical (PCS) and mental (MCS) component summary—and was completed by patients at random assignment, 12 weeks, and 24 weeks, then every 24 weeks until treatment completion or discontinuation.

The SF-36 T-scoring system assesses different physical and mental health parameters. Higher T scores indicate better health. Survey compliance was high, at ≥ 85% among both the treatment and placebo arms.

Analysis of the survey data showed that patients treated with adjuvant osimertinib maintained their quality of life, with no clinically meaningful differences in the physical or mental health scores between the osimertinib and placebo arms (PCS = −1.18, 95% confidence interval [CI] = −2.02 to 0.34]; MCS -1.34, 95% CI = −2.40 to −0.28]. There were no differences in time to deterioration of PCS (hazard ratio [HR] = 1.17) or MCS (HR = 0.98).

“The effect of adjuvant treatment on health-related quality of life is an important clinical consideration for patients who, following surgery with curative intent, are disease-free and require long-term treatment to reduce the risk of disease recurrence,” concluded Dr. Majem.

Disease-Free Survival Outcomes

In another analysis, Yi-Long Wu, MD, of Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital & Guangdong Academy of Medical Sciences, Guangzhou/China, presented data that adjuvant osimertinib demonstrated a highly statistically significant improvement in disease-free survival vs placebo in patients with resected stage IB to IIIA EGFR-mutant NSCLC (Abstract OA06.04). Quality of life was maintained during osimertinib treatment, with no clinically meaningful differences observed between arms.

Dr. Wu and colleagues randomly assigned patients with resected stage IB to IIIA (AJCC 7th edition; pathologic stage) EGFR-mutated NSCLC to receive 80 mg of daily osimertinib or to placebo for 3 years (study completion) or until disease recurrence. Disease staging was based on electronic case report forms for baseline characteristics data, and interactive voice response system for efficacy data (per statistical analysis plan).

In ADAURA, 60% (410 of 682) of all patients randomly assigned received adjuvant chemotherapy for a median duration of four cycles, balanced across treatment arms. Overall, 409 patients received platinum-based chemotherapy, most with stage II/IIIA (II = 71% [165 of 231]; IIIA = 80% [187 of 235]), and fewer with stage IB (26% [57 of 216]) disease. Across disease stages, the overall proportion of patients who received chemotherapy was 66% in patients aged younger than 70 (338 of 509), compared with 42% (72 of 173) in patients aged 70 or older and 27% (21 of 78) in patients aged 75 or older.

The group that received chemotherapy (n = 230) experienced 22 disease-free survival events (11%), and the placebo group (n = 207) experienced 103 disease-free survival events (50%). The treatment arm that received osimertinib without chemotherapy (n = 136) experienced 15 disease-free survival events (11%), while the placebo group that did not receive chemotherapy experienced 56 disease-free survival evenrts (40%).

Dr. Wu reported that disease-free survival benefit with osimertinib vs placebo for patients who received prior chemotherapy was similar to that for patients who had not received prior chemotherapy, regardless of disease stage.

“These data further support adjuvant osimertinib as a new treatment strategy in this setting, with significant disease-free survival benefit and maintained quality of life,” concluded Dr. Wu.

Disclosure: For full disclosures of the study authors, visit wclc2020.iaslc.org/disclosures.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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