Encouraging efficacy of sintilimab combined with nanoparticle albumin-bound paclitaxel and platinum as the first-line treatment for metastatic esophageal squamous cell carcinoma: A retrospective study.

Abstract

e16013 Background: Esophageal squamous cell carcinoma (ESCC) is one of the common malignancies worldwide and associated with poor prognosis. More recently, immunotherapy, especially monoclonal antibodies of programmed death receptor 1 (PD-1) and its ligand (PD-L1), has provided new treatment options for patients with various tumors. But there was no study to investigate the efficacy and safety of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and platinum as the first line treatment of metastatic ESCC. Methods: This was a retrospective study, the eligible metastatic ESCC patients were given sintilimab in combination with Nab-PTX and cisplatin or nedaplatin for up to 4-6 cycles (every 3 weeks). After immunochemtherapy, patients without progressive disease (PD) continued to receive sintilimab every three weeks as maintenance treatment until unacceptable toxicity, PD, withdrawal of consent, or for up to 2 years. The primary end point was objective response rate (ORR), the secondary end points included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Results: A total of 22 patients diagnosed as metastatic ESCC were enrolled, one patient reached a complete response (CR), 15 patients reached a partial response (PR), 4 patients stable disease (SD) and 2 patients PD. The ORR was 72.7% (16/22), the DCR was 90.9% (20/22). The time to response (TTR) was 1.9 months (95% CI:1.7-2.2 months). The median PFS was 7.0 months (95% CI, 6.0-9.3 month), median OS was not reached (6.5 months to not reached). Treatment related adverse events (AEs) occurred in 21 patients (95.5%), and most of them were grade 1 and 2. AEs of grade 3 or 4 occurred in 10 (45.5%) patients, there was no treatment-related death in this study. Conclusions: The preliminary results of this study suggest that sintilimab combine with Nab-PTX and platinum for patients with metastatic ESCC had significant high ORR and encouraging median PFS, and the safety profile is manageable. Clinical trial information: ChiCTR2100051909.