Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice

Aim. To determine lenvatinib treatment outcomes in patients with advanced unresectable hepatocellular carcinoma (uHCC) in real clinical practice.Patients and methods. A multicenter retrospective observational study included 58 patients with a confirmed uHCC diagnosis receiving lenvatinib. At baselin...

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Main Authors: V. V. Petkau, A. V. Sultanbaev, K. V. Menshikov, A. S. Antipin, M. V. Volkonsky, V. M. Filippova, Yu. V. Vasilyeva, A. A. Tarkhanov, M. R. Mukhitova, M. Zh. Murzalina, A. R. Safarova
Format: Article
Language:Russian
Published: Gastro LLC 2022-12-01
Series:Российский журнал гастроэнтерологии, гепатологии, колопроктологии
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Online Access:https://www.gastro-j.ru/jour/article/view/723
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author V. V. Petkau
A. V. Sultanbaev
K. V. Menshikov
A. S. Antipin
M. V. Volkonsky
V. M. Filippova
Yu. V. Vasilyeva
A. A. Tarkhanov
M. R. Mukhitova
M. Zh. Murzalina
A. R. Safarova
author_facet V. V. Petkau
A. V. Sultanbaev
K. V. Menshikov
A. S. Antipin
M. V. Volkonsky
V. M. Filippova
Yu. V. Vasilyeva
A. A. Tarkhanov
M. R. Mukhitova
M. Zh. Murzalina
A. R. Safarova
author_sort V. V. Petkau
collection DOAJ
description Aim. To determine lenvatinib treatment outcomes in patients with advanced unresectable hepatocellular carcinoma (uHCC) in real clinical practice.Patients and methods. A multicenter retrospective observational study included 58 patients with a confirmed uHCC diagnosis receiving lenvatinib. At baseline, ECOG, Child-Pugh and BCLC scores were assessed. The objective response rate (ORR), disease control rate (DCR), median overall survival (OS) and median progression-free survival (PFS) rates were assessed. In addition, adverse effects (AE) during treatment were monitored.Results. The median OS and PFS comprised 14.6 (95 % CI 10.6–18.6) and 11.1 months (95 % CI 8.31–13.8), respectively. The ORR amounted to 32.8 %, while DCR reached the level of 79.3 %. The levels of ORR and DCR were not statistically significantly different between the patients with stages B and C according to the BCLC staging system, with grades 0 and 1 according to ECOG, with classes A and B according to the Child-Pugh score, with viral and non-viral HCC etiology, with and without extrahepatic spread, and with and without portal vein invasion. Patients with alpha-fetoprotein (AFP) blood levels <200 ng/mL showed significantly higher ORR and DCR compared to those with AFP levels >200 ng/mL (44.4 % vs. 13.6 %, p = 0.015; and 88.9 % vs. 63.6 %, p = 0.021, respectively). The uHCC stage according to BCLC, ECOG functional status, Child-Pugh class, presence or absence of extrahepatic spread and viral etiology had no effect on the OS and PFS median levels. Patients with macroscopic portal vein invasion had a significantly lower PFS compared with those lacking this complication: 3.97 (0.00-8.07) vs. 11.1 (8.46-13.7), p = 0.053. AFP levels ≥200 ng/mL adversely affected survival rates: median OS comprised 12.0 (5.95-18.9) months in the group of patients with AFP ≥200 ng/mL vs. 16.1 (8.73-23.5) months in the group of patients having AFP <200 ng/mL, p = 0.020. AEs were registered in 81.0% (n = 47) of patients. Among the most common AEs were arterial hypertension (32.8 %), weakness (24.1 %), weight loss (12.1 %) and appetite loss (10.3 %). Due to AEs, Lenvatinib was withdrawn in 5 (8.6 %) patients.Conclusion. Lenvatinib confirmed its efficacy and safety in patients with uHCC in real clinical practice. The treatment outcome might be affected by AFP levels and the presence of macroscopic portal vein invasion. Further comparative studies into treatment regimens applied in real clinical practice are required.
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spelling doaj-art-63c0b6ac5e87423bbeab0b4c7ffae6722025-02-10T16:14:37ZrusGastro LLCРоссийский журнал гастроэнтерологии, гепатологии, колопроктологии1382-43762658-66732022-12-01324758810.22416/1382-4376-2022-32-4-75-88481Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical PracticeV. V. Petkau0A. V. Sultanbaev1K. V. Menshikov2A. S. Antipin3M. V. Volkonsky4V. M. Filippova5Yu. V. Vasilyeva6A. A. Tarkhanov7M. R. Mukhitova8M. Zh. Murzalina9A. R. Safarova10Sverdlovsk Regional Oncological Dispensary; Ural State Medical UniversityRepublican Clinical Oncological DispensaryRepublican Clinical Oncological Dispensary; Bashkir State Medical UniversityChelyabinsk Regional Clinical Center of Oncology and Nuclear MedicineMoscow City Oncological Hospital No. 62Moscow City Oncological Hospital No. 62Moscow City Oncological Hospital No. 62Sverdlovsk Regional Oncological DispensaryM.Z. Sigal Republican Clinical Oncological DispensaryOrenburg Regional Clinical Oncology CenterM.Z. Sigal Republican Clinical Oncological DispensaryAim. To determine lenvatinib treatment outcomes in patients with advanced unresectable hepatocellular carcinoma (uHCC) in real clinical practice.Patients and methods. A multicenter retrospective observational study included 58 patients with a confirmed uHCC diagnosis receiving lenvatinib. At baseline, ECOG, Child-Pugh and BCLC scores were assessed. The objective response rate (ORR), disease control rate (DCR), median overall survival (OS) and median progression-free survival (PFS) rates were assessed. In addition, adverse effects (AE) during treatment were monitored.Results. The median OS and PFS comprised 14.6 (95 % CI 10.6–18.6) and 11.1 months (95 % CI 8.31–13.8), respectively. The ORR amounted to 32.8 %, while DCR reached the level of 79.3 %. The levels of ORR and DCR were not statistically significantly different between the patients with stages B and C according to the BCLC staging system, with grades 0 and 1 according to ECOG, with classes A and B according to the Child-Pugh score, with viral and non-viral HCC etiology, with and without extrahepatic spread, and with and without portal vein invasion. Patients with alpha-fetoprotein (AFP) blood levels <200 ng/mL showed significantly higher ORR and DCR compared to those with AFP levels >200 ng/mL (44.4 % vs. 13.6 %, p = 0.015; and 88.9 % vs. 63.6 %, p = 0.021, respectively). The uHCC stage according to BCLC, ECOG functional status, Child-Pugh class, presence or absence of extrahepatic spread and viral etiology had no effect on the OS and PFS median levels. Patients with macroscopic portal vein invasion had a significantly lower PFS compared with those lacking this complication: 3.97 (0.00-8.07) vs. 11.1 (8.46-13.7), p = 0.053. AFP levels ≥200 ng/mL adversely affected survival rates: median OS comprised 12.0 (5.95-18.9) months in the group of patients with AFP ≥200 ng/mL vs. 16.1 (8.73-23.5) months in the group of patients having AFP <200 ng/mL, p = 0.020. AEs were registered in 81.0% (n = 47) of patients. Among the most common AEs were arterial hypertension (32.8 %), weakness (24.1 %), weight loss (12.1 %) and appetite loss (10.3 %). Due to AEs, Lenvatinib was withdrawn in 5 (8.6 %) patients.Conclusion. Lenvatinib confirmed its efficacy and safety in patients with uHCC in real clinical practice. The treatment outcome might be affected by AFP levels and the presence of macroscopic portal vein invasion. Further comparative studies into treatment regimens applied in real clinical practice are required.https://www.gastro-j.ru/jour/article/view/723liver cancerhepatocellular carcinomahcctargeted therapylenvatinibreal clinical practice
spellingShingle V. V. Petkau
A. V. Sultanbaev
K. V. Menshikov
A. S. Antipin
M. V. Volkonsky
V. M. Filippova
Yu. V. Vasilyeva
A. A. Tarkhanov
M. R. Mukhitova
M. Zh. Murzalina
A. R. Safarova
Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
Российский журнал гастроэнтерологии, гепатологии, колопроктологии
liver cancer
hepatocellular carcinoma
hcc
targeted therapy
lenvatinib
real clinical practice
title Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
title_full Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
title_fullStr Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
title_full_unstemmed Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
title_short Lenvatinib Therapy in Patients with Unresectable Hepatocellular Carcinoma in Real Clinical Practice
title_sort lenvatinib therapy in patients with unresectable hepatocellular carcinoma in real clinical practice
topic liver cancer
hepatocellular carcinoma
hcc
targeted therapy
lenvatinib
real clinical practice
url https://www.gastro-j.ru/jour/article/view/723
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