000			02708nam a2200301 4500
001			ESSALUD
005			20260804150724.0
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040			_aBMG
041			_aeng
100			_aYue, Dongsheng _eAutor _953711
245			_aEnsartinib in resected ALK-positive non–small-cell lung cancer
300			_apáginas: 151-161
520			_aBackground: Anaplastic lymphoma kinase (ALK) inhibitors have emerged as promising agents for patients with resectable ALK-positive non–small-cell lung cancer (NSCLC). Whether ensartinib, a second-generation ALK inhibitor, is safe and effective in such patients is unknown. Methods: In this phase 3, double-blind, randomized trial involving patients with completely resected, ALK-positive stage IB to IIIB NSCLC after adjuvant chemotherapy, we randomly assigned patients in a 1:1 ratio to receive ensartinib at a dose of 225 mg once daily or placebo for 24 months. The primary end point was disease-free survival in patients with stage II to IIIB NSCLC. The key secondary end point was disease-free survival in the overall patient population. Results: A total of 274 patients were randomly assigned to receive ensartinib or placebo (137 patients in each group). At 24 months, the percentage of patients with stage II to IIIB disease who were alive and disease-free was 86.4% in the ensartinib group and 53.5% in the placebo group (hazard ratio for disease recurrence or death, 0.20; 95% confidence interval [CI], 0.11 to 0.38; P<0.001). In the overall patient population, the percentage of patients who were alive and disease-free was 87.3% in the ensartinib group and 57.2% in the placebo group (hazard ratio, 0.20; 95% CI, 0.10 to 0.37; P<0.001). Overall survival data were immature. Adverse events of grade 3 or higher occurred in 35.8% of the patients who received ensartinib (most commonly rash) and in 18.2% of those who received placebo. Conclusions: Among patients with completely resected stage IB to IIIB ALK-positive NSCLC, the percentage of patients who were alive and disease-free at 24 months was significantly higher with ensartinib than with placebo.
650			_aCANCER DE PULMÓN _953712
650			_aNEUMOLOGÍA _925628
650			_aCUIDADOS INTENSIVOS _95208
650			_aTRATAMIENTO EN ONCOLOGÍA _953713
700			_aHuang, Meijuan _953714
700			_aSong, Pingping _953715
700			_aChen, Yuejun _953716
700			_aLi, Bin _953717
700			_aFu, Junke _953718
700			_aGuo, Jianji _953719
773	0		_022717 _922635 _dMassachusetts NEJM Group _oNEJM002 _tThe New England Journal of Medicine _wESSALUD _x0028-4793
942			_cARTICULOS _e2026-07-30 _zsqb
999			_c22732 _d22732