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Majem, Margarita; Goldman, Jonathan W.; John, Thomas; Grohe, Christian; Laktionov, Konstantin; Kim, Sang-We; Kato, Terufumi; Vu, Huu Vinh; Lu, Shun; Li, Shanqing; Lee, Kye Young; Akewanlop, Charuwan; Yu, Chong-Jen; de Marinis, Filippo; Bonanno, Laura; Domine, Manuel; Shepherd, Frances A.; Atagi, Shinji; Zeng, Lingmin; Kulkarni, Dakshayini; Medic, Nenad; Tsuboi, Masahiro; Herbst, Roy S.; Wu, Yi-Long

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

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  • Medientyp: E-Artikel
  • Titel: 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
  • Beteiligte: Majem, Margarita; Goldman, Jonathan W.; John, Thomas; Grohe, Christian; Laktionov, Konstantin; Kim, Sang-We; Kato, Terufumi; Vu, Huu Vinh; Lu, Shun; Li, Shanqing; Lee, Kye Young; Akewanlop, Charuwan; Yu, Chong-Jen; de Marinis, Filippo; Bonanno, Laura; Domine, Manuel; Shepherd, Frances A.; Atagi, Shinji; Zeng, Lingmin; Kulkarni, Dakshayini; Medic, Nenad; Tsuboi, Masahiro; Herbst, Roy S.; Wu, Yi-Long
  • Erschienen: American Association for Cancer Research (AACR), 2022
  • Erschienen in: Clinical Cancer Research
  • Sprache: Englisch
  • DOI: 10.1158/1078-0432.ccr-21-3530
  • ISSN: 1078-0432; 1557-3265
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:title>Abstract</jats:title> <jats:sec> <jats:title>Purpose:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Patients and Methods:</jats:title> <jats:p>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 = 682). Clinically meaningful changes were defined using the SF-36 manual.</jats:p> </jats:sec> <jats:sec> <jats:title>Results:</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions:</jats:title> <jats:p>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.</jats:p> <jats:p>See related commentary by Patil and Bunn, p. 2204</jats:p> </jats:sec>
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