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Effectiveness and safety of toripalimab, camrelizumab and sintilimab in a real-world cohort of hepatitis B virus associated hepatocellular carcinoma patients
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  • Guosheng Yuan,
  • Xiaoyun Hu,
  • Qi Li,
  • Wencong Dai,
  • Xiao Cheng,
  • Pengfei Ying,
  • Mian Chen,
  • Wenxuan Yu,
  • Yabing Guo,
  • Jinzhang Chen
Guosheng Yuan
Southern Medical University Nanfang Hospital
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Xiaoyun Hu
Southern Medical University Nanfang Hospital
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Qi Li
Southern Medical University Nanfang Hospital
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Wencong Dai
Southern Medical University Nanfang Hospital
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Xiao Cheng
Southern Medical University Nanfang Hospital
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Pengfei Ying
Southern Medical University Nanfang Hospital
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Mian Chen
Churchill Hospital
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Wenxuan Yu
Southern Medical University Nanfang Hospital
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Yabing Guo
Southern Medical University Nanfang Hospital
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Jinzhang Chen
Southern Medical University Nanfang Hospital
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Abstract

Aims: The investigation regarding the clinical significance of programmed cell death protein-1 (PD-1)-targeted immunotherapy in Chinese patients is rare. This study evaluated safety and efficacy of PD-1 with Toripalimab, Camrelizumab or Sintilimab for Chinese Hepatocellular carcinoma (HCC) patients in a real-life cohort. Methods: We retrospectively analyzed HBV associated HCC patients treated with Toripalimab, Camrelizumab or Sintilimab in a retrospective cohort from Nov 2018 to Dec 2019. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP) and overall survival (OS). Results: Seventy eight patients were finally included in the analysis: 26 for Toripalimab, 36 for Camrelizumab, and 16 for Sintilimab. Mean duration of follow-up was 22.7 ± 12.6 weeks and the mean Cycles of PD-1 at cut-off were 4.8 ± 2.7 for all patients. The ORR and DCR for the whole cohort were 17.9% and 73.1%, respectively. Overall, 21 (26.9%) patients had radiological disease progression and 6 (7.7%) patients died during follow-up. Median PFS was 40.7 (95% CI, 34.7-46.7) weeks, median TTP was 45.7 (95% CI, 40.5-60.0) weeks, and median OS was 51.1 (95% CI, 46.4-55.9) weeks. Most frequent drug-related AEs were Rash (19.2%), Hypertension (15.4%), Fatigue (12.8%), Paraesthesia (12.8%), and Diarrhoea (10.3%). Conclusions: Our findings suggest that: 1. PD-1-targeted immunotherapy with Toripalimab, Camrelizumab or Sintilimab yielded a promising outcome in Chinese HBV patients with HCC; 2. Immunotherapy was well tolerated generally and had manageable side effects, which is worth of popularization and application in clinical practice.

Peer review status:ACCEPTED

04 May 2020Submitted to British Journal of Clinical Pharmacology
06 May 2020Submission Checks Completed
06 May 2020Assigned to Editor
15 May 2020Reviewer(s) Assigned
06 Jun 2020Review(s) Completed, Editorial Evaluation Pending
07 Jun 2020Editorial Decision: Revise Major
08 Jun 20201st Revision Received
09 Jun 2020Submission Checks Completed
09 Jun 2020Assigned to Editor
09 Jun 2020Review(s) Completed, Editorial Evaluation Pending
09 Jun 2020Reviewer(s) Assigned
26 Jun 2020Editorial Decision: Accept