Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial

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dc.contributor.authorShitara, Kohei
dc.contributor.authorVan Cutsem, Eric
dc.contributor.authorBang, Yung-Jue
dc.contributor.authorFuchs, Charles
dc.contributor.authorWyrwicz, Lucjan
dc.contributor.authorLee, Keun-Wook
dc.contributor.authorKudaba, Iveta
dc.contributor.authorGarrido, Marcelo
dc.contributor.authorChung, Hyun Cheol
dc.contributor.authorLee, Jeeyun
dc.contributor.authorCastro, Hugo Raul
dc.contributor.authorMansoor, Wasat
dc.contributor.authorBraghiroli, Maria Ignez
dc.contributor.authorKaraseva, Nina
dc.contributor.authorCaglevic, Christian
dc.contributor.authorVillanueva, Luis
dc.contributor.authorGoekkurt, Eray
dc.contributor.authorSatake, Hironaga
dc.contributor.authorEnzinger, Peter
dc.contributor.authorAlsina, Maria
dc.contributor.authorBenson, Al
dc.contributor.authorChao, Joseph
dc.contributor.authorKo, Andrew H.
dc.contributor.authorWainberg, Zev A.
dc.contributor.authorKher, Uma
dc.contributor.authorShah, Sukrut
dc.contributor.authorKang, S. Peter
dc.contributor.authorTabernero, Josep
dc.date.accessioned2025-01-23T19:48:17Z
dc.date.available2025-01-23T19:48:17Z
dc.date.issued2020
dc.description.abstractIMPORTANCE Safe and effective therapies for untreated, advanced gastric/gastroesophageal junction (G/GEJ) cancer remain an unmet need.
dc.description.abstractOBJECTIVE To evaluate the antitumor activity of pembrolizumab, pembrolizumab plus chemotherapy, or chemotherapy alone in patients with untreated, advanced G/GEJ cancer with programmed cell death ligand l(PD-L1) combined positive score (CP5) of lor greater.
dc.description.abstractDESIGN, SETTING. AND PARTICIPANTS The phase 3 KEYNOTE -062 randomized, controlled, partially blinded interventional trial enrolled 763 patients with untreated, locally advanced/unresectable or metastatic G/GEJ cancer with PD-L1CPS of lor greater from 200 centers in 29 countries between September 18, 2015, and May 26, 2017.
dc.description.abstractINTERVENTIONS Patients were randomized 1:1:1to pembrolizumab 200 mg, pembrolizumab plus chemotherapy (cisplatin 80 mg/m2/d on day 1plus fluorouracil 800 mg/m2/d on days 1 to 5 or capecitabine 1000 mg/m2twice daily), or chemotherapy plus placebo, every 3 weeks.
dc.description.abstractMAIN OUTCOME ABD MEASURES Primary end points were overall survival (OS) and progression -free survival (PFS) in patients with PD-L1CPS of lor greater or 10 or greater. RE.5).K.Ts A total of 763 patients were randomized to pembrolizumab (n = 256), pembrolizumab plus chemotherapy (n = 257), or chemotherapy (n = 250). The median (range) age of all patients in the study cohort was 62 (20-87) years; 554 of 763 (72.6%) were men. At final analysis, after a median (range) follow-up of 29.4 (22.0-41.3) months, pembrolizumab was noninferior to chemotherapy for OS in patients with CPS of lor greater (median, 10.6 vs 11.1months; hazard ratio [HR], 0.91; 99.2% CI, 0.69-1]8). Pembrolizumab monotherapy was not superior to chemotherapy in patients with CPS of lor greater. Pembrolizumab prolonged OS vs chemotherapy in patients with CPS of 10 or greater (median, 17.4 vs 10.8 months; HR, 0.69; 95% CI, 0.49-0.97), but this difference was not statistically tested. Pembrolizumab plus chemotherapy was not superior to chemotherapy for OS in patients with CP5 of lor greater (12.5 vs 11.1 months; HR, 0.85; 95% CI, 0.70-1.03; P =.05) or CP5 of 10 or greater (12.3 vs 10.8 months; HR, 0.85; 95% CI, 0.62-1.17; P =.16) or for PFS in patients with CPS of lor greater (6.9 vs 6.4 months; HR, 0.84; 95% Cl, 0.70-1.02; P =.04). Grade 3 to 5 treatment-related adverse event rates for pembrolizumab, pembrolizumab plus chemotherapy, and chemotherapy were 17%, 73%, and 69%, respectively.
dc.description.abstractCONCLUSIONS AND RELEVANCE This phase 3 randomized clinical trial found that among patients with untreated, advanced G/GEJ cancer, pembrolizumab was noninferior to chemotherapy, with fewer adverse events observed. Pembrolizumab or pembrolizumab plus chemotherapy was not superior to chemotherapy for the OS and PFS end points tested.
dc.description.funderMerck Sharp Dohme Corp
dc.fuente.origenWOS
dc.identifier.doi10.1001/jamaoncol.2020.3370
dc.identifier.eissn2374-2445
dc.identifier.issn2374-2437
dc.identifier.urihttps://doi.org/10.1001/jamaoncol.2020.3370
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/100435
dc.identifier.wosidWOS:000583209400011
dc.issue.numero10
dc.language.isoen
dc.pagina.final1580
dc.pagina.inicio1571
dc.revistaJama oncology
dc.rightsacceso restringido
dc.subject.ods03 Good Health and Well-being
dc.subject.odspa03 Salud y bienestar
dc.titleEfficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer: The KEYNOTE-062 Phase 3 Randomized Clinical Trial
dc.typeartículo
dc.volumen6
sipa.indexWOS
sipa.trazabilidadWOS;2025-01-12
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