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
Por:
Majem, M, Goldman, JW, John, T, Grohe, C, Laktionov, K, Kim, SW, Kato, T, Vu, HV, Lu, S, Li, SQ, Lee, KY, Akewanlop, C, Yu, CJ, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Atagi, S, Zeng, LM, Kulkarni, D, Medic, N, Tsuboi, M, Herbst, RS, Wu, YL
Publicada:
1 jun 2022
Resumen:
Purpose: 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.
Patients and Methods: 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.
Results: 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.
Conclusions: 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.
Filiaciones:
Majem, M:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona, Spain
Goldman, JW:
Univ Calif Los Angeles, David Geffen Sch Med, Los Angeles, CA 90095 USA
John, T:
Austin Hlth, Dept Med Oncol, Melbourne, Vic, Australia
Grohe, C:
Evangel Lungenklin Berlin Buch, Klin Pneumol, Berlin, Germany
Laktionov, K:
Minist Hlth Russian Federat NN Blokhin NMRCO, NN Blokhin Natl Med Res Ctr Oncol, Fed State Budgetary Inst, Moscow, Russia
Kim, SW:
Asan Med Ctr, Dept Oncol, Seoul, South Korea
Kato, T:
Kanagawa Canc Ctr, Dept Thorac Oncol, Yokohama, Kanagawa, Japan
Vu, HV:
Choray Hosp, Dept Thorac Surg, Ho Chi Minh City, Vietnam
Lu, S:
Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Lung Canc Ctr, Shanghai, Peoples R China
Li, SQ:
Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Thorac Surg, Beijing, Peoples R China
Lee, KY:
Konkuk Univ, Med Ctr, Precis Med Lung Canc Ctr, Seoul, South Korea
Akewanlop, C:
Siriraj Hosp, Div Med Oncol, Fac Med, Bangkok, Thailand
Yu, CJ:
Natl Taiwan Univ Hosp, Hsinchu Branch, Dept Internal Med, Taipei, Taiwan
Natl Taiwan Univ, Coll Med, Taipei, Taiwan
de Marinis, F:
European Inst Oncol IEO, Thorac Oncol Div, IRCCS, Milan, Italy
Bonanno, L:
Ist Oncol Veneto IOV, IRCCS, Med Oncol 2, Padua, Italy
Domine, M:
Hosp Univ Fdn Jimenez Diaz IIS FJD, Dept Oncol, Madrid, Spain
Shepherd, FA:
Univ Hlth Network, Princess Margaret Canc Ctr, Dept Med Oncol & Hematol, Toronto, ON, Canada
Univ Toronto, Toronto, ON, Canada
Atagi, S:
Natl Hosp Org Kinki Chuo Chest Med Ctr, Dept Thorac Oncol, Osaka, Japan
Zeng, LM:
AstraZeneca, Late Oncol Stat, Gaithersburg, MD USA
Kulkarni, D:
AstraZeneca, Late Oncol R&D, Cambridge, England
Medic, N:
AstraZeneca, Oncol Business Unit, Acad House, Cambridge, England
Tsuboi, M:
Natl Canc Ctr Hosp East, Dept Thorac Surg & Oncol, Kashiwa, Chiba, Japan
Herbst, RS:
Yale Sch Med, Med Oncol, New Haven, CT USA
Yale Canc Ctr, New Haven, CT USA
Wu, YL:
Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, 106 Zhongshan 2nd Rd, Guangzhou 510080, Peoples R China
Guangdong Acad Med Sci, 106 Zhongshan 2nd Rd, Guangzhou 510080, Peoples R China
hybrid, Hybrid Gold
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