000 03675nam a2200361 4500
001 ESSALUD
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007 ta
008 t pe ||||| |||| 00| 0 spa d
040 _aBMG
041 _aeng
100 _aShitara, Kohei
_eAutor
_954397
245 _aZanidatamab with and without Tislelizumab in HER2-Positive Gastroesophageal Cancer
300 _apáginas: 2002-2014
520 _aBackground: Zanidatamab, a dual human epidermal growth factor receptor 2 (HER2)–targeted bispecific antibody, plus chemotherapy both with and without tislelizumab (anti–programmed death 1), showed encouraging efficacy and safety as first-line therapy in phase 2 studies involving patients with HER2-positive gastroesophageal adenocarcinoma. Methods: In an open-label, phase 3 trial, we randomly assigned, in a 1:1:1 ratio, patients with previously untreated, centrally confirmed HER2-positive advanced gastroesophageal adenocarcinoma to receive zanidatamab and tislelizumab plus chemotherapy, zanidatamab plus chemotherapy, or trastuzumab plus chemotherapy. The two primary end points were progression-free survival and overall survival. Results: At a median follow-up of 25.9 months, progression-free survival was longer with zanidatamab–tislelizumab–chemotherapy (median among 302 patients, 12.4 months) and zanidatamab–chemotherapy (median among 304 patients, 12.4 months) than with trastuzumab–chemotherapy (median among 308 patients, 8.1 months) (hazard ratio for progression or death with zanidatamab–tislelizumab–chemotherapy, 0.63 [95% confidence interval {CI}, 0.51 to 0.78]; hazard ratio with zanidatamab–chemotherapy, 0.65 [95% CI, 0.52 to 0.81]; P<0.001 for both comparisons). Overall survival was longer with zanidatamab–tislelizumab–chemotherapy than with trastuzumab–chemotherapy (median, 26.4 vs. 19.2 months; hazard ratio for death, 0.72; 95% CI, 0.57 to 0.90; P=0.004). At this interim analysis, overall survival did not differ significantly between zanidatamab–chemotherapy (median, 24.4 months) and trastuzumab–chemotherapy (hazard ratio, 0.80; 95% CI, 0.64 to 1.01; P=0.06). The incidence of grade 3 or higher adverse events was 83.3% with zanidatamab–tislelizumab–chemotherapy, 73.8% with zanidatamab–chemotherapy, and 74.5% with trastuzumab–chemotherapy; diarrhea was the most common such event, in 24.8%, 20.0%, and 12.9% of patients, respectively. Conclusions: Zanidatamab plus chemotherapy, both with and without tislelizumab, led to longer progression-free survival than trastuzumab plus chemotherapy among patients with HER2-positive advanced gastroesophageal adenocarcinoma. At this interim analysis, overall survival was longer with zanidatamab–tislelizumab–chemotherapy than with trastuzumab–chemotherapy; further analyses are planned to assess zanidatamab–chemotherapy. Diarrhea was a common adverse event.
650 _aCÁNCER DEL TRACTO GASTROINTESTINAL
_953776
650 _aGASTROENTEROLOGÍA
_912562
650 _aHEMATOLOGÍA
_97422
650 _aONCOLOGÍA
_912240
650 _aTRATAMIENTOS EN ONCOLOGÍA
_953734
700 _aElimova, Elena
_954398
700 _aLiu, Tianshu
_954399
700 _aTabernero, Josep
_954400
700 _aLee, Keun-Wook
_954401
700 _aSchenker, Michael
_954402
700 _aTebbutt, Niall C.
_954403
700 _aAjani, Jaffer
_954404
700 _aSalimin, Norhidayu
_954405
700 _aKu, Geoffrey
_954406
700 _aKim, Jong Gwang
_954407
773 0 _022717
_922665
_dMassachusetts NEJM Group
_oNEJM013
_tThe New England Journal of Medicine
_wESSALUD
_x0028-4793
942 _cARTICULOS
_e2026-08-28
_zsqb
999 _c22887
_d22887