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Abstract
Purpose
Comparing the efficacy and safety of programmed cell death protein-1 (PD-1) inhibitors combined with tyrosine kinase inhibitors (TKIs) with or without hepatic artery infusion chemotherapy (HAIC) in HBV-related advanced HCC and exploring prognostic predictors of the combined regimen.
Patients and Methods
A total of 194 patients diagnosed with HBV-related advanced HCC between 2020 and 2022 were included in the study, including 99 in the HAIC combined with PD-1 inhibitors plus TKIs (HPT group) and 95 in the PD-1 inhibitors plus TKIs (PT group). The efficacy was evaluated according to the tumor response rate and survival, and the safety was evaluated according to the adverse events.
Results
The HPT group showed higher overall response rate and disease control rate than the PT group. The median overall survival (OS) of the HPT group and the PT group were 18.10 months and 12.57 months, respectively, and the difference was statistically significant (hazard ratio (HR) = 0.519, 95% confidence interval (CI): 0.374–0.722, P < 0.001). The median progression-free survival (PFS) was 9.20 months in the HPT group and 6.33 months in the PT group (HR = 0.632, 95% CI: 0.470–0.851, P = 0.002). In addition, albumin bilirubin (ALBI) and systemic inflammatory response index (SIRI) are independent prognostic factors affecting HAIC combined with targeted immunotherapy and can be used as prognostic predictors. Almost all patients included in the study experienced treatment-related adverse events (TRAEs) of varying degrees of severity, with grade 1–2 adverse events predominating.
Conclusion
The HPT group had better OS and PFS than the PT group in patients with HBV-related advanced HCC. In addition, high ALBI and high SIRI were associated with poor prognosis in the HAIC combined group.
Data Sharing Statement
The datasets generated during the current study are available from the corresponding author on reasonable request.
Ethics Approval
The study followed the World Medical Association Declaration of Helsinki and was approved by the Ethics Committee of Harbin Medical University Cancer Hospital before implementation (approval number: KY2022-14). The study participants provided written informed consent, agreeing to release any potentially recognizable images or data contained in this article. All patients included in this study signed the Second Use Informed Consent for Historical Data/Biospecimens at Harbin Medical University-affiliated Oncology Hospital.
Author Contributions
Dazhen Wang and Zhengfeng Zhang contributed equally to this work and should be considered co-first authors. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting or writing, substantially revising or critically reviewing the article; gave final approval of the version to be published; reviewed and agreed on all versions of the article before submission, during revision, the final version accepted for publication, and any significant changes introduced at the proofing stage; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare no competing financial interest.