000 03490nam a2200349 4500
001 ESSALUD
005 20260821122750.0
007 ta
008 t pe ||||| |||| 00| 0 spa d
040 _aBMG
041 _aeng
100 _aZhou, Caicun
_eAutor
_954258
245 _aFirst-line sunvozertinib in NSCLC with EGFR exon 20 insertion mutations
300 _apáginas: 765-775
520 _aBackground: Sunvozertinib received accelerated approval for use in later lines of therapy for patients with advanced non–small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Data are needed on the efficacy and safety of sunvozertinib as a first-line treatment for NSCLC. Methods: In this phase 3, international trial, we randomly assigned, in a 1:1 ratio, patients with advanced nonsquamous NSCLC with EGFR exon 20 insertions to receive sunvozertinib or chemotherapy (carboplatin–pemetrexed). The primary end point was progression-free survival as assessed by blinded independent central review. Crossover to the sunvozertinib group was allowed after disease progression was confirmed. Secondary end points included overall survival, investigator-assessed progression-free survival, objective response (complete or partial response), change in tumor size, and duration of response. Results: A total of 324 patients were randomly assigned to receive sunvozertinib (163 patients) or chemotherapy (161 patients). Treatment with sunvozertinib led to significantly longer median progression-free survival than chemotherapy (10.3 vs. 7.5 months; hazard ratio for disease progression or death, 0.65; 95% confidence interval, 0.50 to 0.85; P<0.001). At 12 months, progression-free survival was reported in 46.1% of the patients in the sunvozertinib group and in 26.7% of those in the chemotherapy group; the data for overall survival were immature (38.9% maturity). The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group; the median best percentage change in tumor size was −42.1% and −24.7% respectively, and the median duration of response was 11.2 and 7.1 months. Grade 3 or higher adverse events were reported in 75.5% of the patients in the sunvozertinib group and in 56.7% of those in the chemotherapy group. In the sunvozertinib group, the most common adverse events of grade 3 or higher included increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to adverse events considered by the investigators to be related to sunvozertinib. Conclusions: The efficacy of sunvozertinib was superior to that of chemotherapy as first-line treatment for advanced NSCLC with EGFR exon 20 insertions.
650 _aCÁNCER DE PULMÓN
_953712
650 _aNEUMOLOGÍA
_925628
650 _aCUIDADOS INTENSIVOS GENERAL
_954115
650 _aTRATAMIENTOS EN ONCOLOGÍA
_953734
700 _aGreillier, Laurent
_954259
700 _aLiu, Geoffrey
_954260
700 _aJohn, Thomas
_954261
700 _aXing, Ligang
_954262
700 _aKowalski, Dariusz
_954263
700 _aMemmott, Regan M.
_954264
700 _aYazici, Ozan
_954265
700 _aSun, Meili
_954266
700 _aShu, Catherine A.
_954267
700 _aPons-Tostivint, Elvire
_954268
773 0 _022717
_922650
_dMassachusetts NEJM Group
_oNEJM12
_tThe New England Journal of Medicine
_wESSALUD
_x0028-4793
942 _cARTICULOS
_e2026-08-21
_zsqb
999 _c22854
_d22854