Journal of Hepatocellular Carcinoma (Mar 2022)

Regorafenib Combined with PD-1 Blockade Immunotherapy versus Regorafenib as Second-Line Treatment for Advanced Hepatocellular Carcinoma: A Multicenter Retrospective Study

  • Huang J,
  • Guo Y,
  • Huang W,
  • Hong X,
  • Quan Y,
  • Lin L,
  • Zhou J,
  • Liang L,
  • Zhang Y,
  • Zhou J,
  • Cai M,
  • Zhu K

Journal volume & issue
Vol. Volume 9
pp. 157 – 170

Abstract

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Jingjun Huang,1,* Yongjian Guo,1,* Wensou Huang,1,* Xiaotao Hong,2 Yi Quan,3 Liteng Lin,1 Jingwen Zhou,1 Licong Liang,1 Yaqin Zhang,4 Juan Zhou,5 Mingyue Cai,1 Kangshun Zhu1 1Department of Minimally Invasive Interventional Radiology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou City, Guangdong Province, People’s Republic of China; 2Department of Interventional Medical Center, Jieyang People’s Hospital, Jieyang City, Guangdong Province, People’s Republic of China; 3Department of Oncology Medical Center, The First People’s Hospital of Zhaoqing, Zhaoqing City, Guangdong Province, People’s Republic of China; 4Department of Radiology, The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai City, Guangdong Province, People’s Republic of China; 5Department of Pharmacy, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou City, Guangdong Province, People’s Republic of China*These authors contributed equally to this workCorrespondence: Kangshun Zhu; Mingyue Cai, Department of Minimally Invasive Interventional Radiology, the Second Affiliated Hospital of Guangzhou Medical University, 250 East Changgang Road, Guangzhou City, Guangdong, 510260, People’s Republic of China, Tel +86-20-34156205, Fax +86-20-34153709, Email [email protected]; [email protected]: To evaluate the safety and efficacy of regorafenib combined with anti-PD-1 antibody sintilimab (rego-sintilimab) as a second-line treatment for advanced hepatocellular carcinoma (HCC).Methods: This multicenter retrospective study evaluated consecutive patients with advanced HCC who received rego-sintilimab (rego-sintilimab group) or regorafenib alone (regorafenib group) as a second-line treatment from January 2019 to December 2020. Adverse events, objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were compared between the two groups. Uni- and multi-variable analyses of prognostic factors for OS and PFS were performed using Cox proportional hazard regression models.Results: In total, 113 patients were included in the study: 58 received rego-sintilimab and 55 received regorafenib. The rego-sintilimab group had higher ORR (36.2% vs 16.4%, P = 0.017), longer PFS (median 5.6 vs 4.0 months; P = 0.045), and better OS (median 13.4 vs 9.9 months; P = 0.023) than the regorafenib group. Regorafenib alone, Child-Pugh B, and neutrophil-to-lymphocyte ratio (NLR) > 3.6 were independent prognostic factors for poor OS. Regorafenib alone, α-fetoprotein level, and NLR > 3.6 were independent prognostic factors for poor PFS. Subgroup analyses showed a survival benefit of rego-sintilimab in patients with NLR ≤ 3.6 (hazard ratio 0.518 [95% CI, 0.257– 0.955]) but not in those with NLR > 3.6 (0.852 [0.461– 1.572]); P = 0.002 for interaction. The difference in incidence of grade 3/4 adverse events between the two groups was not statistically significant (39.7% vs 30.9%; P = 0.331).Conclusion: Rego-sintilimab was tolerated and led to better OS than regorafenib as a second-line treatment for advanced HCC patients, especially in those with NLR ≤ 3.6.Keywords: liver cancer, regorafenib, anti-PD-1 antibody, second-line treatment, overall survival, neutrophil-to-lymphocyte ratio

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