Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC
Por:
Wu, YL, John, T, Grohe, C, Majem, M, Goldman, JW, Kim, SW, Kato, T, Laktionov, K, Vu, HV, Wang, ZJ, Lu, S, Lee, KY, Akewanlop, C, Yu, CJ, de Marinis, F, Bonanno, L, Domine, M, Shepherd, FA, Zeng, LM, Atasoy, A, Herbst, RS, Tsuboi, M
Publicada:
1 mar 2022
Ahead of Print:
1 feb 2022
Resumen:
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. (C) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc.
Filiaciones:
Wu, YL:
Guangdong Prov Peoples Hosp, Guangdong Lung Canc Inst, 106 Zhongshan Er Rd, Guangzhou 510080, Peoples R China
Guangdong Acad Med Sci, 106 Zhongshan Er Rd, Guangzhou 510080, Peoples R China
John, T:
Austin Hlth, Dept Med Oncol, Melbourne, Vic, Australia
Grohe, C:
Evangelische Lungenklin, Dept Resp Dis, Berlin, Germany
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
Kim, SW:
Univ Ulsan, Asan Med Ctr, Dept Oncol, Coll Med, Seoul, South Korea
Kato, T:
Kanagawa Canc Ctr, Dept Thorac Oncol, Yokohama, Kanagawa, Japan
Laktionov, K:
Minist Hlth Russian Federat, NN Blokhin Natl Med Res Ctr Oncol, Fed State Budgetary Inst, NN Blokhin NMRCO, Moscow, Russia
Vu, HV:
Choray Hosp, Dept Thorac Surg, Ho Chi Minh City, Vietnam
Wang, ZJ:
Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, State Key Lab Mol Oncol,Natl Canc,Dept Med Oncol, Beijing, Peoples R China
Lu, S:
Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Lung Canc Ctr, Shanghai, Peoples R China
Lee, KY:
Konkuk Univ, Precis Med Lung Canc Ctr, Med Ctr, Seoul, South Korea
Akewanlop, C:
Siriraj Hosp, Fac Med, Div Med Oncol, Bangkok, Thailand
Yu, CJ:
Natl Taiwan Univ Hosp, Dept Internal Med, Hsinchu Branch, Taipei, Taiwan
Natl Taiwan Univ, Coll Med, Taipei, Taiwan
de Marinis, F:
IRCCS, Thorac Oncol Div, European Inst Oncol IEO, Milan, Italy
Bonanno, L:
IRCCS, Med Oncol 2, Ist Oncol Veneto IOV, Padua, Italy
Domine, M:
Inst Invest Sanitaria Fdn Jimenez Diaz, Oncol Dept, Madrid, Spain
Shepherd, FA:
Univ Hlth Network, Princess Margaret Canc Ctr, Dept Med Oncol & Hematol, Toronto, ON, Canada
Univ Toronto, Toronto, ON, Canada
Zeng, LM:
AstraZeneca, Late Oncol Stat, Gaithersburg, MD USA
Atasoy, A:
AstraZeneca, Late Oncol Res & Dev, Cambridge, England
Herbst, RS:
Yale Sch Med, Med Oncol, New Haven, CT USA
Yale Canc Ctr, New Haven, CT USA
Tsuboi, M:
Natl Canc Ctr Hosp East, Dept Thorac Surg & Oncol, Kashiwa, Chiba, Japan
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