Abstract
Over the past decade, immune checkpoint inhibitors (ICIs) have shown incredible durable responses in an increasing number of patients with metastatic cancer. In patients with gastric and esophageal adenocarcinomas (GEAs), however, only modest responses to ICIs have been observed when used as later-line treatment and in unselected patient populations. 1 Shitara K. Özgüroğlu M. Bang Y.J. et al. Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial. Lancet. 2018; 392: 123-133 Abstract Full Text Full Text PDF PubMed Scopus (667) Google Scholar , 2 Kang Y.K. Boku N. Satoh T. et al. Nivolumab in patients with advanced gastric or gastro-oesophageal junction cancer refractory to, or intolerant of, at least two previous chemotherapy regimens (ONO-4538-12, ATTRACTION-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017; 390: 2461-2471 Abstract Full Text Full Text PDF PubMed Scopus (1184) Google Scholar , 3 Kato K. Cho B.C. Takahashi M. et al. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019; 20: 1506-1517 Abstract Full Text Full Text PDF PubMed Scopus (397) Google Scholar , 4 Shah M.A. Kojima T. Hochhauser D. et al. Efficacy and safety of pembrolizumab for heavily pretreated patients with advanced, metastatic adenocarcinoma or squamous cell carcinoma of the esophagus: the phase 2 KEYNOTE-180 study. JAMA Oncol. 2019; 5: 546-550 Crossref PubMed Scopus (228) Google Scholar , 5 Fuchs C.S. Doi T. Jang R.W. et al. Safety and efficacy of pembrolizumab monotherapy in patients with previously treated advanced gastric and gastroesophageal junction cancer: phase 2 clinical KEYNOTE-059 trial. JAMA Oncol. 2018; 4: e180013 Crossref PubMed Scopus (909) Google Scholar As durable responses have been demonstrated in some GEA patients, reliable biomarkers to select these patients for immunotherapeutic strategies are highly needed. Molecular determinants of clinical outcomes with pembrolizumab versus paclitaxel in a randomized, open-label, phase III trial in patients with gastroesophageal adenocarcinomaAnnals of OncologyVol. 32Issue 9PreviewIn the phase III KEYNOTE-061 trial (NCT02370498), pembrolizumab did not significantly improve overall survival versus paclitaxel as second-line therapy for gastric/gastroesophageal junction (GEJ) adenocarcinoma with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 tumors. The association of tissue tumor mutational burden (tTMB) status and clinical outcomes was determined, including the relationship with CPS and microsatellite instability-high (MSI-H) status. Full-Text PDF Open Access
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