PMID- 37603519
OWN - NLM
STAT- MEDLINE
DCOM- 20230823
LR  - 20230824
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 102
IP  - 33
DP  - 2023 Aug 18
TI  - The efficacy and safety of sintilimab combined with chemotherapy as the 
      first-line treatment for metastatic esophageal squamous cell carcinoma.
PG  - e34794
LID - 10.1097/MD.0000000000034794 [doi]
LID - e34794
AB  - Immunotherapy is a new treatment option for patients with esophageal squamous 
      cell carcinoma (ESCC). However, no study has investigated the efficacy and safety 
      of sintilimab combined with nanoparticle albumin-bound paclitaxel (Nab-PTX) and 
      platinum as first-line treatment for metastatic ESCC. In this retrospective 
      study, eligible patients with metastatic ESCC were administered sintilimab plus 
      Nab-PTX, cisplatin, or nedaplatin for up to 4 to 6 cycles. Subsequently, patients 
      without progressive disease (PD) continued to receive sintilimab every 3 weeks as 
      maintenance treatment until unacceptable toxicity, PD, withdrawal of consent, or 
      for up to 2 years. The primary endpoint was the objective response rate (ORR) and 
      the secondary endpoints were progression-free survival (PFS), overall survival 
      (OS), disease control rate (DCR), and safety. A total of 22 patients diagnosed 
      with metastatic ESCC were enrolled, 1 patient reached a complete response (CR), 
      15 patients achieved a partial response (PR), 4 patients had stable disease, and 
      2 had PD. The ORR was 72.7% (16/22) and the DCR was 90.9% (20/22). The time to 
      response was 1.9 months (95% confidence interval [CI]:1.7-2.2 months). The median 
      PFS was 8.9 months (95% CI, 7.1-10.7 months), and the median OS was 19.0 months. 
      Exploratory biomarker analysis revealed that lactic dehydrogenase (LDH) was a 
      potential marker for OS, and patients with high LDH levels had shorter mOS (13.0 
      months, 95% CI:7.5-18.5 months). Treatment-related adverse events (AEs) occurred 
      in 21 patients (95.5%), most of which were grade 1 or 2. No treatment-related 
      deaths occurred in this study. The results of this study suggested that 
      sintilimab combined with Nab-PTX and platinum in patients with metastatic ESCC 
      had a significantly high ORR and encouraging mPFS and mOS. LDH was a potential 
      marker for OS, and the safety profile was manageable.
CI  - Copyright (c) 2023 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Zhao, Zheng
AU  - Zhao Z
AD  - Department of Oncology, Henan Provincial People's Hospital & People's Hospital of 
      Henan University, Zhengzhou, Henan, P.R. China.
FAU - Yin, Ming-Mei
AU  - Yin MM
FAU - Zhao, Wei-Feng
AU  - Zhao WF
FAU - Wang, Chao-Jie
AU  - Wang CJ
AUID- ORCID: 0000-0002-2863-2785
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 8FU7FQ8UPK (sintilimab)
RN  - 49DFR088MY (Platinum)
SB  - IM
MH  - Humans
MH  - *Esophageal Squamous Cell Carcinoma/drug therapy
MH  - *Esophageal Neoplasms/drug therapy
MH  - Platinum
MH  - Retrospective Studies
PMC - PMC10443762
COIS- The authors have no conflicts of interest to disclose.
EDAT- 2023/08/21 18:42
MHDA- 2023/08/23 06:42
PMCR- 2023/08/18
CRDT- 2023/08/21 13:03
PHST- 2023/08/23 06:42 [medline]
PHST- 2023/08/21 18:42 [pubmed]
PHST- 2023/08/21 13:03 [entrez]
PHST- 2023/08/18 00:00 [pmc-release]
AID - 00005792-202308180-00021 [pii]
AID - 10.1097/MD.0000000000034794 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2023 Aug 18;102(33):e34794. doi: 
      10.1097/MD.0000000000034794.