| Objective:To investigate the safety and efficacy of lenvatinib in combination with tirelizumab in the treatment of patients with progressive hepatocellular carcinoma.Methods:This study retrospectively analyzed patients with clinical and pathological diagnosis of progressed hepatocellular carcinoma who presented at the First People’s Hospital of Yunnan Province Hospital from June 2021 to June 2022.After a rigorous clinical evaluation,no surgical indications were identified,and patients were enrolled after screening according to the inclusion and exclusion criteria.20 patients in group A were in the lenvatinib group;20 patients in group B were in the lenvatinib combined with tirelizumab group;11 males and 9 females in group A;15 males and 5 females in group B;a total of 40 patients were included in this study according to baseline and 4follow-ups(the first follow-up 6 weeks after the first treatment and every 8 weeks thereafter A total of 40 patients were included in the study according to the baseline and 4 follow-up visits(6 weeks after the first treatment and every 8 weeks thereafter).Patients’ baseline data and routine blood,liver and renal function and imaging data at the four follow-up visits were recorded and analysed.The length of malignant target lesions was measured separately according to the modified Response Evaluation Criteria in Solid Tumours(m RECIST),the number of patients with complete remission,partial remission,stable disease and disease progression in the total response was recorded and the median progression-free survival achieved in both groups was analysed.The median progression-free survival(Kaplan-Meier method),objective remission rate,disease control rate,change in the total length of malignant target lesions,the number of patients with grade 3 or higher adverse events,and the changes in bone marrow suppression and liver and kidney function before and after drug treatment were analysed.Results:1.Median progression-free survival: Group A 210.5 ± 25.7 days(95% CI,195.1-254.7 days),Group B 265.2±10.0 days(95% CI,210.5-336.2 days);P = 0.225 for comparison between the two analyses.2.Objective remission rates at four followups: Group A: 10%,40%,30%,25%;Group B: 20%,45%,50%,45%;P > 0.05 for both groups compared during the four follow-ups.3.Disease control rate at four followups: Group A: 95%,80%,65%,50%;Group B: 95%,85%,70%,65%;P > 0.05 for both groups compared during the four follow-ups.4.Change in total length of target lesion: 10 patients in Group A(In group A,10 patients(50%)had a reduction in the total length of the tumour target lesion,and 5 patients(25%)had a reduction in the total length of the tumour target lesion of more than 30% to achieve partial remission.13patients(65%)in group B had a reduction in the total length of the tumour target lesion,and 6 patients(30%)had a reduction in the total length of the tumour target lesion of more than 30% to achieve partial remission.P > 0.05 for the analysis of total length of tumour target lesions in both groups.5.Grade 3 and above adverse events: 10 cases(25%)occurred in all patients,none of them had fatal adverse events.4 cases(20.0%)in group A,hypertension(20%),proteinuria(10%)and hand-foot reaction(10%)were common.6 cases(30%)in group B,hypertension(30%),abnormalities of liver function(10%)and thyroid reaction were common.abnormalities(10%),hypothyroidism(10%),and fatigue(10%).P > 0.05 for the analysis of grade 3 and above adverse events in both groups.6.The treatment in both groups had a transient effect on bone marrow suppression,liver function impairment and no significant effect on renal function.Conclusions:1.The median progression-free survival,objective remission rate,disease control rate and reduction in total length of target lesions of lenvatinib combined with tirelizumab in the treatment of progressive hepatocellular carcinoma are better than those of lenvatinib monotherapy.2.Grade 3 and above adverse events in lenvatinib combined with tirelizumab in the treatment of progressive hepatocellular carcinoma are mainly hypertension,abnormalities in liver function,hypothyroidism and fatigue.3.Lenvatinib in combination with tirelizumab has a good safety profile... |
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