| 000 | 03675nam a2200361 4500 | ||
|---|---|---|---|
| 001 | ESSALUD | ||
| 005 | 20260902144423.0 | ||
| 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 |
||