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Alectinib in Resected ALK-Positive Non-Small-Cell Lung Cancer.
Wu, Yi-Long; Dziadziuszko, Rafal; Ahn, Jin Seok; Barlesi, Fabrice; Nishio, Makoto; Lee, Dae Ho; Lee, Jong-Seok; Zhong, Wenzhao; Horinouchi, Hidehito; Mao, Weimin; Hochmair, Maximilian; de Marinis, Filippo; Migliorino, M Rita; Bondarenko, Igor; Lu, Shun; Wang, Qun; Ochi Lohmann, Tania; Xu, Tingting; Cardona, Andres; Ruf, Thorsten; Noe, Johannes; Solomon, Benjamin J.
Afiliação
  • Wu YL; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Dziadziuszko R; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Ahn JS; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Barlesi F; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Nishio M; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Lee DH; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Lee JS; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Zhong W; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Horinouchi H; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Mao W; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Hochmair M; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • de Marinis F; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Migliorino MR; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Bondarenko I; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Lu S; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Wang Q; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Ochi Lohmann T; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Xu T; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Cardona A; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Ruf T; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Noe J; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
  • Solomon BJ; From the Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou (Y.-L.W., W.Z.), the Institute of Basic Medicine and Cancer, Chinese Academy of Sciences, Hangzhou (W.M.), and the Department of Medical On
N Engl J Med ; 390(14): 1265-1276, 2024 Apr 11.
Article em En | MEDLINE | ID: mdl-38598794
ABSTRACT

BACKGROUND:

Platinum-based chemotherapy is the recommended adjuvant treatment for patients with resectable, ALK-positive non-small-cell lung cancer (NSCLC). Data on the efficacy and safety of adjuvant alectinib as compared with chemotherapy in patients with resected ALK-positive NSCLC are lacking.

METHODS:

We conducted a global, phase 3, open-label, randomized trial in which patients with completely resected, ALK-positive NSCLC of stage IB (tumors ≥4 cm), II, or IIIA (as classified according to the seventh edition of the Cancer Staging Manual of the American Joint Committee on Cancer and Union for International Cancer Control) were randomly assigned in a 11 ratio to receive oral alectinib (600 mg twice daily) for 24 months or intravenous platinum-based chemotherapy in four 21-day cycles. The primary end point was disease-free survival, tested hierarchically among patients with stage II or IIIA disease and then in the intention-to-treat population. Other end points included central nervous system (CNS) disease-free survival, overall survival, and safety.

RESULTS:

In total, 257 patients were randomly assigned to receive alectinib (130 patients) or chemotherapy (127 patients). The percentage of patients alive and disease-free at 2 years was 93.8% in the alectinib group and 63.0% in the chemotherapy group among patients with stage II or IIIA disease (hazard ratio for disease recurrence or death, 0.24; 95% confidence interval [CI], 0.13 to 0.45; P<0.001) and 93.6% and 63.7%, respectively, in the intention-to-treat population (hazard ratio, 0.24; 95% CI, 0.13 to 0.43; P<0.001). Alectinib was associated with a clinically meaningful benefit with respect to CNS disease-free survival as compared with chemotherapy (hazard ratio for CNS disease recurrence or death, 0.22; 95% CI, 0.08 to 0.58). Data for overall survival were immature. No unexpected safety findings were observed.

CONCLUSIONS:

Among patients with resected ALK-positive NSCLC of stage IB, II, or IIIA, adjuvant alectinib significantly improved disease-free survival as compared with platinum-based chemotherapy. (Funded by F. Hoffmann-La Roche; ALINA ClinicalTrials.gov number, NCT03456076.).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Compostos de Platina / Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
Imprimir
XML
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Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Compostos de Platina / Carcinoma Pulmonar de Células não Pequenas / Neoplasias Pulmonares / Antineoplásicos Limite: Humans Idioma: En Ano de publicação: 2024 Tipo de documento: Article