Validation of the easy-to-use lenvatinib prognostic index to predict prognosis in advanced hepatocellular carcinoma patients treated with lenvatinib.
hepatocellular carcinoma
lenvatinib
prognostic factors
Journal
Hepatology research : the official journal of the Japan Society of Hepatology
ISSN: 1386-6346
Titre abrégé: Hepatol Res
Pays: Netherlands
ID NLM: 9711801
Informations de publication
Date de publication:
Dec 2022
Dec 2022
Historique:
revised:
11
07
2022
received:
12
06
2022
accepted:
27
07
2022
pubmed:
13
8
2022
medline:
13
8
2022
entrez:
12
8
2022
Statut:
ppublish
Résumé
The identification of new prognostic factors able to stratify hepatocellular carcinoma patients candidate to first-line therapy is urgent. In the present work we validated the prognostic value of the lenvatinib prognostic index. Data of Eastern and Western patients treated with lenvatinib as first-line for Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma were recollected. The lenvatinib prognostic index was composed by three classes of risk according with our previous study. The "low risk" group includes patients with prognostic nutritional index (PNI) >43.3 and with previous transarterial chemoembolization. The "medium risk" group includes patients with PNI >43.3, but without previous transarterial chemoembolization and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage B. The "high risk" group includes patients with PNI <43.3, albumin-bilirubin grade 2, and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage C. A total of 717 patients were included. The median overall survival was 20.7 months (95% CI 16.1-51.6) in patients with low risk (n = 223), 16.7 months (95% CI 13.3-47.0) in patients with medium risk (n = 264), and 10.7 months (95% CI 9.3-12.2) in patients with high risk (n = 230; HR 1, 1.29, and 1.92, respectively; p < 0.0001). Median progression-free survival was 7.3 months (95% CI 6.3-46.5) in patients with low risk, 6.4 months (95% CI 5.3-8.0) in patients with medium risk ,and 4.9 months (95% CI 4.3-5.5) in patients with high risk (HR 1, 1.07, 1.47 respectively; p = 0.0009). The lenvatinib prognostic index confirms its prognostic value on an external cohort of hepatocellular carcinoma patients treated with Lenvatinib.
Types de publication
Journal Article
Langues
eng
Pagination
1050-1059Informations de copyright
© 2022 The Authors. Hepatology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Hepatology.
Références
Llovet JM, Kelley RK, Villanueva A, Singal AG, Pikarsky E, Roayaie S, et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2021 Jan 21;7(1):6. PMID: 33479224. https://doi.org/10.1038/s41572-020-00240-3
Llovet JM, Zucman-Rossi J, Pikarsky E, Sangro B, Schwartz M, Sherman M, et al. Hepatocellular carcinoma. Nat Rev Dis Primers. 2016 Apr 14;2(1):16018. PMID: 27158749. https://doi.org/10.1038/nrdp.2016.18
Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. PMID: 18650514. https://doi.org/10.1056/NEJMoa0708857
Cheng AL, Kang YK, Chen Z, Tsao CJ, Qin S, Kim JS, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jan;10(1):25-34. Epub 2008 Dec 16. PMID: 19095497. https://doi.org/10.1016/S1470-2045(08)70285-7
Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Piscaglia F, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018;391(10126):1163-73. https://doi.org/10.1016/s0140-6736(18)30207-1
Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, et al. IMbrave150 investigators. Atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma. N Engl J Med. 2020 May 14382(20):1894-905. PMID: 32402160. https://doi.org/10.1056/NEJMoa1915745
Abou-Alfa G, Chan SL, Kudo M, et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. In: Presented at: 2022 gastrointestinal cancers symposium; January 20-22, 2022; San Francisco, California.
Kelley RK, Rimassa L, Cheng AL, Kaseb A, Qin S, Zhu AX, et al. Cabozantinib plus atezolizumab versus sorafenib for advanced hepatocellular carcinoma (COSMIC-312): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Aug;23(8):995-1008. https://doi.org/10.1016/S1470-2045(22)00326-6. Epub 2022 Jul 4. PMID: 35798016.
Casadei-Gardini A, Dadduzio V, Rovesti G, Cabibbo G, Vukotic R, Rizzato MD, et al. Utility of neutrophil-tolymphocyte ratio to identify long-term survivors among HCC patients treated with sorafenib. Medicine (Baltimore). 2020;99(22):e19958. https://doi.org/10.1097/md.0000000000019958
Liu L, Gong Y, Zhang Q, Cai P, Feng L. Prognostic roles of blood inflammatory markers in hepatocellular carcinoma patients taking sorafenib. A systematic review and meta-analysis. Front Oncol. 2020;9:1557. https://doi.org/10.3389/fonc.2019.01557
Zhong B.-Y, Yan Z.-P, Sun J.-H, Zhang L, Hou ZH, Yang MJ, et al. Prognostic performance of albumine bilirubin grade with artificial intelligence for hepatocellular carcinoma treated with transarterial chemoembolization combined with sorafenib. Front Oncol. 2020;10:525461. https://doi.org/10.3389/fonc.2020.525461
Caputo F, Dadduzio V, Tovoli F, Bertolini G, Cabibbo G, Cerma K, et al. The role of PNI to predict survival in advanced hepatocellular carcinoma treated with sorafenib. PLoS One. 2020;15(5):e0232449. https://doi.org/10.1371/journal.pone.0232449
Conroy G, Salleron J, Belle A, Bensenane M, Nani A, Ayav A, et al. The prognostic value of inflammation-based scores in advanced hepatocellular carcinoma patients prior to treatment with sorafenib. Oncotarget. 2017;8(56):95853-64. https://doi.org/10.18632/oncotarget.21401
Hiraoka A, Kumada T, Atsukawa M, Hirooka M, Tsuji K, Ishikawa T, et al. Prognostic factor of lenvatinib for unresectable hepatocellular carcinoma in real-world conditions - multicenter analysis. Cancer Med. 2019;8(8):3719-28. https://doi.org/10.1002/cam4.2241
Hiraoka A, Kumada T, Kariyama K, Tada T, Tani J, Fukunishi S, et al. Clinical importance of muscle volume in lenvatinib treatment for hepatocellular carcinoma: analysis adjusted with inverse probability weighting. J Gastroenterol Hepatol. 2020;36(7):1812-19. https://doi.org/10.1111/jgh.15336
Hiraoka A, Kumada T, Tada T, Fukunishi S, Atsukawa M, Hirooka M, et al. Nutritional index as prognostic indicator in patients receiving lenvatinib treatment for unresectable hepatocellular carcinoma. Oncology. 2020;98(5):295-302. https://doi.org/10.1159/000506293
Rimini M, Shimose S, Lonardi S, Tada T, Masi G, Iwamoto H, et al. Lenvatinib versus Sorafenib as first-line treatment in hepatocellular carcinoma: a multi-institutional matched case-control study. Hepatol Res. 2021 Dec;51(12):1229-41. Epub 2021 Oct 21. PMID: 34591334. https://doi.org/10.1111/hepr.13718
Burgio V, Iavarone M, Di Costanzo GG, Marra F, Lonardi S, Tamburini E, et al. Real-life clinical data of lenvatinib versus sorafenib for unresectable hepatocellular carcinoma in Italy. Cancer Manag Res. 2021 Dec 24;13:9379-89. PMID: 34992463; PMCID: PMC8713715. https://doi.org/10.2147/CMAR.S330195
Rapposelli IG, Tada T, Shimose S, Burgio V, Kumada T, Iwamoto H, et al. Adverse events as potential predictive factors of activity in patients with advanced hepatocellular carcinoma treated with lenvatinib. Liver Int. 2021 Dec;41(12):2997-3008. Epub 2021 Jul 22. PMID: 34250737. https://doi.org/10.1111/liv.15014
Casadei-Gardini A, Scartozzi M, Tada T, Yoo C, Shimose S, Masi G, et al. Lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: an inverse probability of treatment weighting analysis. Liver Int. 2021 Jun;41(6):1389-97. Epub 2021 Feb 20. PMID: 33547848. https://doi.org/10.1111/liv.14817
Rimini M, Kudo M, Tada T, Shigeo S, Kang W, Suda G, et al. Nonalcoholic steatohepatitis in hepatocarcinoma: new insights about its prognostic role in patients treated with lenvatinib. ESMO Open. 2021 Dec;6(6):100330. Epub 2021 Nov 27. PMID: 34847382; PMCID: PMC8710492. https://doi.org/10.1016/j.esmoop.2021.100330
Rapposelli IG, Shimose S, Kumada T, Okamura S, Hiraoka A, Di Costanzo GG, et al. Identification of lenvatinib prognostic index via recursive partitioning analysis in advanced hepatocellular carcinoma. ESMO Open. 2021 Aug;6(4):100190. Epub 2021 Jun 16. PMID: 34144271; PMCID: PMC8219999. https://doi.org/10.1016/j.esmoop.2021.100190
Casadei-Gardini A, Rimini M, Rimassa L, Burgio V, Kudo M, Tada T, et al. Atezolizumab plus bevacizumab versus lenvatinib or sorafenib in non-viral unresectable hepatocellular carcinoma: an international study. J Clin Oncol. 2022;40(16):4069. https://doi.org/10.1200/jco.2022.40.16_suppl.4069
Shimose S, Kawaguchi T, Tanaka M, Iwamoto H, Miyazaki K, Moriyama E, et al. Lenvatinib prolongs the progression-free survival time of patients with intermediate-stage hepatocellular carcinoma refractory to transarterial chemoembolization: a multicenter cohort study using data mining analysis. Oncol Lett. 2020;20(3):2257-65. https://doi.org/10.3892/ol.2020.11758
Shimose S, Iwamoto H, Tanaka M, Niizeki T, Shirono T, Noda Y, et al. Alternating lenvatinib and trans-arterial therapy prolongs overall survival in patients with intermediate stage hepato cellular carcinoma: a propensity score matching study. Cancers (Basel). 2021;13(1):160. https://doi.org/10.3390/cancers13010160
Casadei-Gardini A, Scartozzi M, Tada T, Yoo C, Shimose S, Masi G, et al. Lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: an inverse probability of treatment weighting analysis. Liver Int. 2021 Jun;41(6):1389-97. Epub 2021 Feb 20. PMID: 33547848. https://doi.org/10.1111/liv.14817
European Association for the Study of the Liver. Electronic address: easloffice@easloffice.eu; European Association for the Study of the Liver. EASL clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):182-236. Epub 2018 Apr 5. Erratum in: J Hepatol. 2019 Apr;70(4):817. PMID: 29628281. https://doi.org/10.1016/j.jhep.2018.03.019
Pinter M, Ulbrich G, Sieghart W, Kolblinger C, Reiberger T, Li S, et al. Hepatocellular carcinoma: a phase II randomized controlled double-blind trial of transarterial chemoembolization in combination with biweekly intravenous administration of bevacizumab or a placebo. Radiology. 2015;277(3):903-12. https://doi.org/10.1148/radiol.2015142140
Smolka S, Chapiro J, Manzano W, Treilhard J, Reiner E, Deng Y, et al. The impact of antiangiogenic therapy combined with Transarterial Chemoembolization on enhancement based quantitative tumor response assessment in patients with hepatocellular carcinoma. Clin Imaging. 2017 Nov-Dec;46:1-7. Epub 2017 Jun 7. PMID: 28668723; PMCID: PMC5720941. https://doi.org/10.1016/j.clinimag.2017.05.007
Meyer T, Fox R, Ma YT, Ross PJ, James MW, Sturgess R, et al. Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2017;2(8):565-75. https://doi.org/10.1016/s2468-1253(17)30156-5
Lencioni R, LLovet JM, Tak WY, Yang J, Guglielmi A, et al. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: the SPACE trial. J Hepatol. 2016;64(5):1090-8. https://doi.org/10.1016/j.jhep.2016.01.012
Kudo M, Han G, Poon RT, Blanc JF, Yan L, et al. Brivanib as adjuvant therapy to transarterial chemoembolization in patients with hepatocellular carcinoma: a randomized phase III trial. Hepatology. 2014;60(5):1697-707. https://doi.org/10.1002/hep.27290
Kudo M, Cheng AL, Liang PC, Hidaka H, et al. Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebocontrolled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2018;3(1):37-46. https://doi.org/10.1016/s2468-1253(17)30290-x
Kudo M, Imanaka K, Nakachi K, Tak WY, Takayama T, et al. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011;47(14):2117-27. https://doi.org/10.1016/j.ejca.2011.05.007
Kudo M, Ueshima K, Torimura T, Tanabe N, Aikata H, et al. Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Gut. 2019;69(8):1492-501. https://doi.org/10.1136/gutjnl-2019-318934
Peng Z, Fan W, Zhu B, et al. Lenvatinib combined with transarterial chemoembolization as first-line treatment of advanced hepatocellular carcinoma: a phase 3, multicenter, randomized controlled trial. In: Presented at ASCO GI 2022; January 20-22; 2022. Abstract 380.