| Objective: To explore the safety and efficacy of Hepatic Arterial Infusion Chemotherapy(HAIC)combined with Targeted and Immunotherapy in the treatment of unresectable hepatocellular carcinoma.Methods: The information of patients who received HAIC combined with Targeted and Immunotherapy or received only Targeted and Immunotherapy to treat unresectable hepatocellular carcinoma in our hospital from January 2021 to October 2022 was collected.86 patients were analyzed in the study.56 patients received HAIC combined with Targeted and Immunotherapy.And 30 patients only received Targeted and Immunotherapy.The objective response rate(ORR),disease control rate(DOR),surgical conversion rate,progression free survival(PFS)and overall survival(OS)were calculated and compared.The independent effective factor of the therapy was analyzed by single and multiple factor Cox analysis.And the safety of the study was evaluated by descriptive analysis.Results: The ORR of HAIC combined therapy group and targeted and immunotherapy group were 33.93%(19/56)and 13.33%(4/30).There was statistically significant difference in ORR between two groups(P=0.04).And the ORR of the HAIC combined therapy group was obviously higher than that of the targeted and immunotherapy group.The DCR of two groups were 60.71%(34/56)and 46.67(14/30).There was no statistically significant difference(P=0.66).The median PFS of the two groups were5.0±0.7 months and 4.0±1.1 months,and there was no statistically significant difference(P=0.133).The median OS of two groups was 11.0±3.1 months and 6.0±1.3 months,showing statistically significant difference(P=0.018).The median OS of the HAIC combined therapy group was obviously higher than that of the targeted and immunotherapy group.Subgroup analysis showed that the ORR of the group receiving1-2 times of HAIC combined therapy and the group receiving 3 or more times of HAIC combined therapy were 16.67%(4/24)and 46.88%(15/32),showing obviously statistically significant difference(P=0.02).The DCR of two groups was 41.67%(10/24)and 75.00%(24/32),and there was statistically significant difference(P=0.04).The ORR and DCR of the 3 or more times HAIC combined therapy group were obviously higher than those of the 1-2 times HAIC combined therapy group.The ORR(P<0.01)and DCR(P=0.02)were statistically different between the targeted and immunotherapy group and the 3 or more times HAIC combined therapy group,and the ORR and DCR of the 3 or more times HAIC combined therapy group were obviously higher compared with the targeted and immunotherapy group.The independent effective factor of PFS was AFP(<400ng/ml: ≥400ng/ml,HR=0.335,95%CI: 0.146-0.769,P=0.010).The independent effective factor of OS was PIVKA(<3000m AU/ml: ≥3000m AU/ml,HR=0.284,95%CI:0.126-0.638,P=0.002).No patient had grade 5 adverse event.There were 31 patients(55.36%)in the HAIC combined therapy group,Including 1 patient(1.79%)had grade 4adverse event related to surgical operation,which was femoral artery aneurysm after removal of femoral artery infusion port.Other grade 3-4 adverse event contained 2(3.57%)for gastrointestinal bleeding,14(25.00%)for white blood cell count declining,and 14(25.00%)for platelet count declining.In the targeted and immunotherapy group,12 patients(40.00%)had grade 3-4 adverse event,including 1(3.33%)for gastrointestinal bleeding.6(20.00%)for white blood cell count declining,and 5(16.67%)for platelet count declining.No statistically significant difference was found between the rate of grade 3-4 adverse event in two groups(P=0.175).Conclusion: The results of this study indicated that FOLFOX chemotherapy HAIC combined with targeted immunotherapy was efficient in unresectable hepatocellular carcinoma.Increasing the times of HAIC combined with targeted and immunotherapy could improve the PFS and OS.Compared with targeted and immunotherapy,FOLFOX chemotherapy HAIC combined with targeted and immunotherapy showed obviously higher ORR and OS.The process of treatment was safe,and the adverse reactions were controllable. |
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