Abstract
BackgroundHepatocellular carcinoma (HCC) is a highly aggressive malignancy with poor prognosis. Immunotherapy has gained great interest for various solid tumors due to its promising clinical efficacy. Targeted therapy also plays a crucial role in anticancer treatment. However, studies on the combination of immunotherapy and targeted therapy for advanced HCC are limited. Thus, the objective of this study was to investigate the efficacy and safety of camrelizumab combined with sorafenib in the treatment of advanced HCC.MethodsFrom January 2019 to January 2021, 100 consecutive patients with advanced HCC in our hospital were enrolled for this study. Patients were assigned into two groups: a combined-therapy group (camrelizumab + sorafenib) and a sorafenib-only group. Progression-free survival (PFS), overall survival (OS), treatment response, and relevant adverse effects (AEs) were evaluated and recorded.ResultsOf a total of 100 patients, 35 received a combination of camrelizumab and sorafenib, and 65 were treated with sorafenib alone. After 1:1 propensity score matching (PSM), each group had 34 patients. The overall response rate (ORR) of the combined-therapy group was statistically significantly higher than that of the sorafenib-only group (before PSM, p = 0.037; after PSM, p = 0.010). However, there was no significant difference in disease control rate (DCR) between the two groups (before PSM, p = 0.695; after PSM, p = 1.000). Patients who received the combination therapy had significantly longer PFS than those who received the sorafenib monotherapy (before PSM, p = 0.041; after PSM, p = 0.043). However, the two groups exhibited comparable median OS (before PSM, p = 0.135; after PSM, p = 0.105). Although the combined-therapy group showed a higher incidence of AEs such as thrombocytopenia than the sorafenib-only group after PSM, most of these AEs were easily controlled after treatment.ConclusionCamrelizumab plus sorafenib showed favorable efficacy and manageable toxicity for patients with advanced HCC. However, more prospective randomized trials are necessary to further verify the potential clinical benefits of this combination therapy.
Highlights
Hepatocellular carcinoma (HCC), one of the most lethal malignancies globally, is the fourth-ranked cause of cancer mortality worldwide [1]
Inclusion criteria were as follows: [1] male or female patients aged over 18 years; [2] HCC diagnosis was based on histological examination or the criteria of the American Association for the Study of Liver Diseases (AASLD) guidelines [2]; [3] those who had Child‐Pugh liver function class A or B; [4] those who had Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; [5] those with the presence of unresectable or metastatic lesions; [6] those with acceptable heart, hepatic, renal, and hematologic functions; [7] those who had estimated life expectancy ≥12 weeks; and [8] at least one measurable target lesion based on the modified Response Evaluation Criteria in Solid Tumors [19]
There was no significant difference in age, sex, hepatitis B virus (HBV) carrier, liver cirrhosis, ECOG performance score, Child-Pugh stage, Barcelona Clinic Liver Cancer (BCLC) stage, AFP, TB, ALB, aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count (PLT), white blood cell (WBC), prothrombin time (PT), tumor size, tumor number, macrovascular invasion, extrahepatic metastasis, or previous local regional therapy between the two groups before Propensity score matching (PSM) or after PSM
Summary
Hepatocellular carcinoma (HCC), one of the most lethal malignancies globally, is the fourth-ranked cause of cancer mortality worldwide [1]. Multitarget tyrosine kinase inhibitors (TKIs) play a vital role in the clinical management of patients with various types of solid tumors [5]. Sorafenib is the first-line targeted agent for advanced HCC patients that can lead to a median overall survival (OS) of 6.5–10.7 months and a median time to progression of 2.8–5.5 months [9, 10]. Other molecular targeted drugs have been developed, the efficacy of targeted therapy in advanced HCC remains a serious concern. Studies on the combination of immunotherapy and targeted therapy for advanced HCC are limited.
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