scholarly journals Comparative Analysis of Lenvatinib and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multi-Center, Propensity Score Study

2021 ◽  
Vol 10 (18) ◽  
pp. 4045
Author(s):  
Jaejun Lee ◽  
Ji-Won Han ◽  
Pil-Soo Sung ◽  
Soon-Kyu Lee ◽  
Hyun Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Propensity Score ◽  
Cox Regression ◽  
Objective Response ◽  
Hepatic Artery Infusion ◽  
Eligibility Criteria ◽  
Historical Cohort ◽  
Infusion Chemotherapy ◽  
Unresectable Hepatocellular Carcinoma ◽  
Hepatic Artery Infusion Chemotherapy

The comparative efficacy and safety between lenvatinib and hepatic artery infusion chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC) is still unclear. This multicenter historical cohort study enrolled 244 patients who were treated with HAIC (n = 173) or lenvatinib (n = 71) between 2012 and 2020. Propensity score matching (PSM) was performed, and 52 patients were selected per group. Clinical outcomes and safety were compared. Objective response rate (ORR) was not different between the two groups (26.0% vs. 23.1%, p = 0.736). Before PSM, the HAIC group had a higher proportion of Child-Pugh B and portal vein tumor, whereas the lenvatinib group had more patients with extrahepatic metastases, which was adjusted after PSM. There were no differences in progression-free survival (PFS) and overall survival (OS) after PSM (HAIC vs. lenvatinib, median PFS, 3.6 vs. 4.0 months, p = 0.706; median OS 10.8 vs. 7.9 months, p = 0.106). Multivariate Cox-regression showed that alpha-fetoprotein ≤1000 ng/mL was only an associated factor for OS after PSM in all patients (hazard ratio = 0.421, p = 0.011). Subgroup analysis for patients with a high tumor burden beyond the REFLECT eligibility criteria revealed that the HAIC group (n = 29) had a significantly longer OS than did the lenvatinib group (n = 30) (10.0 vs. 5.4 months, p = 0.004). More patients in the HAIC group achieved better liver function than those in the lenvatinib group at the time of best responses. There was no difference in the incidence of grade 3 and 4 adverse events between the two groups. Therefore, lenvatinib is comparable to HAIC in terms of ORR and OS in unresectable HCC meeting REFLECT eligibility criteria.

scholarly journals Comparative Analysis of Lenvatinib and Hepatic Arterial Infusion Chemotherapy in Unresectable Hepatocellular Carcinoma: A Multi-Center, Propensity Score Study

2021 ◽  
Author(s):  
Jaejun Lee ◽  
Ji Won Han ◽  
Pil Soo Sung ◽  
Soon Kyu Lee ◽  
Hyun Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Propensity Score ◽  
Cox Regression ◽  
Objective Response ◽  
Hepatic Artery Infusion ◽  
Eligibility Criteria ◽  
Historical Cohort ◽  
Infusion Chemotherapy ◽  
Unresectable Hepatocellular Carcinoma ◽  
Hepatic Artery Infusion Chemotherapy

The comparative efficacy and safety between lenvatinib and hepatic artery infusion chemotherapy (HAIC) in patients with unresectable hepatocellular carcinoma (HCC) are still unclear. This multicenter historical cohort study enrolled 244 patients who were treated with HAIC (n = 173) or lenvatinib (n = 71) between 2012 and 2020. Propensity score matching (PSM) was performed, and 52 patients were selected per group. Clinical outcomes and safety were compared. Objective response rate (ORR) was not different between the two groups (26.0% vs. 23.1%, P = 0.736). Before PSM, HAIC group had a higher proportion of Child-Pugh B and portal vein tumor, whereas lenvatinib group had more patients with extrahepatic metastases, which was adjusted after PSM. There were no differences in progression-free survival (PFS) and overall survival (OS) after PSM (HAIC vs. lenvatinib, median PFS, 3.6 vs. 4.0 months, P = 0.706; median OS 10.8 vs. 7.9 months, P = 0.106). Multivariate Cox-regression showed that alpha-fetoprotein ≤ 1000 ng/mL was only associated factor for OS after PSM in all patients (hazard ratio = 0.421, P = 0.011). Subgroup analysis for patients with high tumor burden beyond the REFLECT eligibility criteria revealed that HAIC group (n = 29) had a significantly longer OS than did lenvatinib group (n = 30) (10.0 vs. 5.4 months, P=0.004). More patients in HAIC group achieved better liver function than those in lenvatinib group at the time of best responses. There was no difference in the incidence of grade 3 and 4 adverse events between the two groups. Therefore, lenvatinib is comparable to HAIC in terms of ORR and OS in unresectable HCC meeting REFLECT eligibility criteria.

Hepatic artery infusion chemotherapy combined with apatinib and toripalimab in advanced hepatocellular carcinoma: Real-world data from a single center.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16602-e16602
Author(s):  
Yang-Kui Gu ◽  
Tian-Qi Zhang ◽  
Zi-Lin Huang ◽  
Zhi-Jun Geng ◽  
Chen Chen ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Objective Response ◽  
Hepatic Artery Infusion ◽  
Antiangiogenic Agents ◽  
Advanced Hepatocellular Carcinoma ◽  
Triple Combination Therapy ◽  
Advanced Hcc ◽  
Infusion Chemotherapy ◽  
Hepatic Artery Infusion Chemotherapy

e16602 Background: Outcomes remain poor for patients with advanced hepatocellular carcinoma (HCC). Hepatic arterial infusion chemotherapy (HAIC), antiangiogenic agents, and immune checkpoint inhibitors (ICIs) are available monotherapy options. Considering different anti-malignancy mechanisms, combining these three modalities may improve outcomes. We aimed to assess the efficacy and safety in a small cohort treated with HAIC combined with Apatinib and ICI (Toripalimab) for advanced HCC patients. Methods: We performed a retrospective study included patients with advanced HCC treated in the Sun Yat-sen University Cancer Center. Patients received 6 treatment cycles of 21 days, with HAIC given over an initial period of 50 hours (oxaliplatin 85 mg/m2, then folinic acid 400 mg/m2, then fluorouracil 2500 mg/m2). Patients also received apatinib (250 mg daily, starting day 8 of cycle 1), toripalimab (240 mg on day 4 of each cycle, starting with cycle 2), both continuing after the HAIC cycles until disease progression. Disease control was assessed using the RECIST 1.1 and mRECIST criteria. Safety was assessed using the CTCAE 5.0. Blood biomarkers (AFP and PIVKA-II) were log transferred and compared at baseline and last follow-up. Results: From April to August 2019, 6 patients (5 males, 51.7±11.6 years) were included. All patients finished 6 cycles of HAIC. After a median follow-up of 7.0 (range, 3.9-8.3) months, all patients remained objective response (6 PR by RECIST; 3 CR and 3 PR by mRECIST). Median time to response was 1.3 (range, 0.7-2.0) months. Blood logAFP (baseline: 3.2±1.6, last follow-up: 1.3±1.4; p = 0.029) and logPIVKA-II (baseline: 4.4±0.6, last follow-up: 2.0±1.4; p = 0.006) levels were significantly decreased after treatment. The most common adverse events (AEs) included hypertension, palmar-plantar erythrodysesthesia syndrome, and anorexia, observed in all patients. Four patients had Grade 3 AEs (myelosuppression in 2; palmar-plantar erythrodysesthesia, hypothyroidism, anorexia, hyperbilirubinemia and hypokalemia in 1). No Grade 4/5 AEs occurred. Conclusions: In patients with advanced HCC, treatment with strategically timed triple combination therapy of HAIC, apatinib, and toripalimab shows promising clinical benefit and safety. [Table: see text]

scholarly journals Efficacy and Safety of Lenvatinib Therapy for Unresectable Hepatocellular Carcinoma in a Real-World Practice in Korea

Liver Cancer ◽  
2021 ◽  
pp. 1-11
Author(s):  
Myung Ji Goh ◽  
Joo Hyun Oh ◽  
Yewan Park ◽  
Jihye Kim ◽  
Wonseok Kang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Prognostic Factors ◽  
Disease Progression ◽  
Real World ◽  
Medical Center ◽  
Objective Response ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Eligibility Criteria ◽  
Unresectable Hepatocellular Carcinoma

<b><i>Background:</i></b> Lenvatinib has been recently approved as a first-line treatment option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We aimed to study the efficacy and safety of lenvatinib therapy in a real-world practice and to find prognostic factors related to survival and disease progression. <b><i>Methods:</i></b> A hospital-based retrospective study was conducted on 111 consecutive patients who had unresectable HCC and were treated with lenvatinib at Samsung Medical Center from October 2018 to March 2020. Efficacy was determined using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated in 116 HCC patients including 5 patients who discontinued lenvatinib due to adverse events (AEs) before 1st tumor assessment using Common Terminology Criteria for AEs version 5.0. <b><i>Results:</i></b> A total of 111 patients with a median age of 59 years were analyzed during a median follow-up duration of 6.2 (4.4–9.0) months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the median progression-free survival was 6.2 months. Based on mRECIST criteria, the objective response rate was 18.9% and disease control rate was 75.7%. AEs developed in 86/116 (74.1%) patients, and grade ≥3 AEs developed in 16/116 (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, and anorexia were identified as the AEs with the highest frequencies of any grade. REFLECT eligibility criteria including tumor extent ≥50% liver occupation or inadequate bone marrow function and occurrence of anorexia were prognostic factors for survival, and occurrence of diarrhea was a favorable factor for disease progression. <b><i>Conclusion:</i></b> Lenvatinib therapy showed a favorable efficacy and safety in a real-world practice. The REFLECT eligibility criteria and specific AEs could be one of the prognostic markers.

scholarly journals Hepatic Arterial Infusion Chemotherapy Combined With PD-1 Inhibitors Plus Lenvatinib Versus PD-1 Inhibitors Plus Lenvatinib for Advanced Hepatocellular Carcinoma

2021 ◽  
Vol 11 ◽  
Author(s):  
Jie Mei ◽  
Yu-Hao Tang ◽  
Wei Wei ◽  
Ming Shi ◽  
Lie Zheng ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Hepatic Arterial Infusion ◽  
Progression Free Survival ◽  
Good Survival ◽  
Hepatic Artery Infusion ◽  
Advanced Hepatocellular Carcinoma ◽  
Advanced Hcc ◽  
Infusion Chemotherapy ◽  
Hepatic Artery Infusion Chemotherapy ◽  
Cell Death Protein

BackgroundLenvatinib combined with programmed cell death protein-1 (PD-1) inhibitors has resulted in good survival outcomes in the treatment of unresectable hepatocellular carcinoma (HCC). Hepatic artery infusion chemotherapy (HAIC) has also attracted attention due to its high response rates and favorable survival for advanced HCC patients. The present study aimed to compare the efficacy of HAIC combined with PD-1 inhibitors plus lenvatinib (HPL) and PD-1 inhibitors plus lenvatinib (PL) in patients with advanced HCC.MethodsBetween July 2018 and December 2019, patients diagnosed with advanced HCC who initially received HPL or PL treatment were reviewed for eligibility. Efficacy was evaluated according to tumor response and survival.ResultsIn total, 70 patients met the criteria and were included in the present study, and they were divided into the HPL group (n = 45) and PL group (n = 25). The overall response rate (40.0 vs. 16.0%, respectively; p = 0.038) and disease control rate (77.6 vs. 44.0%, respectively; p &lt; 0.001) were higher in the HPL group than in the PL group. The median overall survival was 15.9 months in the HPL group and 8.6 months in the PL group (p = 0.0015; HR = 0.6; 95% CI 0.43–0.83). The median progression-free survival was 8.8 months in the HPL group and 5.4 months in the PL group (p = 0.0320; HR = 0.74; 95% CI 0.55–0.98).ConclusionCompared to PL, HPL was associated with a significantly better treatment response and survival benefits for patients with advanced HCC.

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