Tislelizumab Plus Chemotherapy as First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma and Gastric/Gastroesophageal Junction Adenocarcinoma

• DOI: 10.1158/1078-0432.ccr-19-3561
• Publication Date: 2020-06-19T18:52:12Z
• Authors: Jianming Xu; Yuxian Bai; Nong Xu; Enxiao Li; Buhai Wang; Jin Wang; Xiang Li; Xin Wang; Xianglin Yuan
• Keywords: Tolerability

This phase II study (NCT03469557) assessed safety/tolerability and antitumor activity of first-line tislelizumab, a monoclonal antibody against programmed cell death-1, plus chemotherapy in patients with locally advanced/metastatic esophageal squamous carcinoma (ESCC) or gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.Patients ESCC received tislelizumab [200 mg i.v. every 3 weeks (Q3W)] cisplatin (80 mg/m² Q3W for ≤6 cycles) fluorouracil (800 mg/m²/day i.v., Days 1-5 cycles); G/GEJ adenocarcinoma (200 Q3W) oxaliplatin (130 up to six oral capecitabine (1,000 twice daily, 1-14 Q3W). The profile combination therapy was the primary endpoint; secondary endpoints included objective response rate (ORR), duration (DoR), disease control (DCR), progression-free survival per RECIST v1.1. Exploratory overall potential predictive biomarkers.As March 31, 2019, 30 (n = 15 cohort) were enrolled. Most common adverse events considered related and/or anemia 18), decreased appetite 17), nausea 16), asthenia 15). One patient experienced fatal hepatic dysfunction, confounded by progressive underlying hepatitis, attributed treatment investigator. Confirmed ORRs DCRs 46.7% 80%, respectively, both adenocarcinoma. In ESCC, median DoR 12.8 months (95% confidence interval, 3.5-12.8); not yet mature cohort.Tislelizumab demonstrated durable responses manageable tolerability advanced