SHR-1316, an anti-PD-L1 antibody, plus chemotherapy as the first-line treatment for advanced esophageal squamous cell carcinoma: A multicentre, phase 2 study.

Abstract

BACKGROUND:

This multicentre, open-label study evaluated the efficacy and safety of antiprogrammed death ligand 1 antibody SHR-1316 plus liposomal irinotecan and 5-fluorouracil as the first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC).

METHODS:

Eligible patients received SHR-1316 (10 mg/kg), liposomal irinotecan (60 mg/m2 for the first cycle, 80 mg/m2 thereafter), and 5-fluorouracil (2400 mg/m2 ) every 14 days until disease progression, intolerable toxicity or withdrawal of consent. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.

RESULTS:

We enrolled 23 patients between 11 March 2019 and 31 May 2019. The median follow-up duration was 15.2 months (95% CI 14.2-16.2). The median PFS was 8.5 months (95% CI 1.2-15.8), and ORR and DCR were 52.2% (95% CI 30.1-74.3) and 73.9% (95% CI 54.5-93.3), respectively. The median OS was 11.6 months (95% CI 6.7-16.6). The most common treatment-related grade 3-4 adverse events (AEs) were neutropenia (17.4%), nausea (13.0%), and anorexia (13.0%). Treatment-related serious AEs occurred in two patients. No treatment-related deaths occurred.

CONCLUSIONS:

SHR-1316 plus liposomal irinotecan and 5-fluorouracil has a promising efficacy and manageable safety profile, and could be a new first-line treatment approach for patients with unresectable locally advanced or distant metastatic ESCC.

• Authors: Lan Mu, Yan Song, Kuaile Zhao, Ying Liu, Qingxia Fan, Xi Wang, Qun Li, Xiaopeng Wang, Jing Huang
• Journal: Thoracic cancer (Thorac Cancer) Vol. 12 Issue 9 Pg. 1373-1381 (05 2021) ISSN: 1759-7714 [Electronic] Singapore
• PMID: 33760397 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2021 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

Chemical References

• Antibodies, Monoclonal

Topics

• Adolescent
• Adult
• Aged
• Antibodies, Monoclonal (pharmacology, therapeutic use)
• Antineoplastic Combined Chemotherapy Protocols (pharmacology, therapeutic use)
• Esophageal Squamous Cell Carcinoma (drug therapy, mortality, pathology)
• Female
• Humans
• Male
• Middle Aged
• Progression-Free Survival
• Prospective Studies
• Young Adult