دورية أكاديمية
أعرض في EDS

The Evolving Scenario in the Assessment of Radiological Response for Hepatocellular Carcinoma in the Era of Immunotherapy: Strengths and Weaknesses of Surrogate Endpoints.

التفاصيل البيبلوغرافية
العنوان: The Evolving Scenario in the Assessment of Radiological Response for Hepatocellular Carcinoma in the Era of Immunotherapy: Strengths and Weaknesses of Surrogate Endpoints.
المؤلفون: Giuffrida P; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Celsa C; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy.; Department of Surgical, Oncological, and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90127 Palermo, Italy., Antonucci M; Section of Radiology, Department of Biomedicine, Neuroscience and Advanced Diagnostics (BiND), University of Palermo, 90127 Palermo, Italy., Peri M; Department of Surgical, Oncological, and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90127 Palermo, Italy., Grassini MV; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Rancatore G; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Giacchetto CM; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Cannella R; Section of Radiology, Department of Biomedicine, Neuroscience and Advanced Diagnostics (BiND), University of Palermo, 90127 Palermo, Italy., Incorvaia L; Department of Surgical, Oncological, and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90127 Palermo, Italy., Corsini LR; Department of Surgical, Oncological, and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90127 Palermo, Italy., Morana P; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., La Mantia C; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Badalamenti G; Department of Surgical, Oncological, and Oral Sciences (Di.Chir.On.S.), University of Palermo, 90127 Palermo, Italy., Brancatelli G; Section of Radiology, Department of Biomedicine, Neuroscience and Advanced Diagnostics (BiND), University of Palermo, 90127 Palermo, Italy., Cammà C; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy., Cabibbo G; Section of Gastroenterology & Hepatology, Department of Health Promotion Sciences Maternal and Infant Care, Internal Medicine and Medical Specialties, PROMISE, University of Palermo, 90127 Palermo, Italy.
المصدر: Biomedicines [Biomedicines] 2022 Nov 06; Vol. 10 (11). Date of Electronic Publication: 2022 Nov 06.
نوع المنشور: Journal Article; Review
اللغة: English
بيانات الدورية: Publisher: MDPI AG Country of Publication: Switzerland NLM ID: 101691304 Publication Model: Electronic Cited Medium: Print ISSN: 2227-9059 (Print) Linking ISSN: 22279059 NLM ISO Abbreviation: Biomedicines Subsets: PubMed not MEDLINE
أسماء مطبوعة: Original Publication: Basel, Switzerland : MDPI AG, [2013]-
مستخلص: Hepatocellular carcinoma (HCC) is a challenging malignancy characterised by clinical and biological heterogeneity, independent of the stage. Despite the application of surveillance programs, a substantial proportion of patients are diagnosed at advanced stages when curative treatments are no longer available. The landscape of systemic therapies has been rapidly growing over the last decade, and the advent of immune-checkpoint inhibitors (ICIs) has changed the paradigm of systemic treatments. The coexistence of the tumour with underlying cirrhosis exposes patients with HCC to competing events related to tumour progression and/or hepatic decompensation. Therefore, it is relevant to adopt proper clinical endpoints to assess the extent of treatment benefit. While overall survival (OS) is the most accepted endpoint for phase III randomised controlled trials (RCTs) and drug approval, it is affected by many limitations. To overcome these limits, several clinical and radiological outcomes have been used. For instance, progression-free survival (PFS) is a useful endpoint to evaluate the benefit of sequential treatments, since it is not influenced by post-progression treatments, unlike OS. Moreover, radiological endpoints such as time to progression (TTP) and objective response rate (ORR) are frequently adopted. Nevertheless, the surrogacy between these endpoints and OS in the setting of unresectable HCC (uHCC) remains uncertain. Since most of the surrogate endpoints are radiology-based (e.g., PFS, TTP, ORR), the use of standardised tools is crucial for the evaluation of radiological response. The optimal way to assess the radiological response has been widely debated, and many criteria have been proposed over the years. Furthermore, none of the criteria have been validated for immunotherapy in advanced HCC. The coexistence of the underlying chronic liver disease and the access to several lines of treatments highlight the urgent need to capture early clinical benefit and the need for standardised radiological criteria to assess cancer response when using ICIs in mono- or combination therapies. Here, we review the most commonly used clinical and radiological endpoints for trial design, as well as their surrogacy with OS. We also review the criteria for radiological response to treatments for HCC, analysing the major issues and the potential future perspectives.
References: Hepatology. 2021 Jan;73 Suppl 1:158-191. (PMID: 32430997)
CA Cancer J Clin. 2021 May;71(3):209-249. (PMID: 33538338)
Ann Oncol. 2021 Jun;32(6):801-805. (PMID: 33716105)
J Hepatol. 2022 Oct 30;:. (PMID: 36323356)
J Hepatol. 2011 Dec;55(6):1309-16. (PMID: 21703196)
J Clin Oncol. 2013 Oct 1;31(28):3509-16. (PMID: 23980090)
N Engl J Med. 2008 Jul 24;359(4):378-90. (PMID: 18650514)
Lancet Oncol. 2019 Feb;20(2):282-296. (PMID: 30665869)
Eur J Cancer. 2009 Jan;45(2):228-47. (PMID: 19097774)
Nat Rev Clin Oncol. 2018 Oct;15(10):596-597. (PMID: 29970919)
J Comput Assist Tomogr. 2010 Jul;34(4):479-84. (PMID: 20657213)
Ann Oncol. 2013 Apr;24(4):965-73. (PMID: 23223331)
J Hepatol. 2022 Jul;77(1):128-139. (PMID: 35139400)
Lancet Oncol. 2022 Jan;23(1):77-90. (PMID: 34914889)
J Clin Oncol. 2016 May 1;34(13):1436-7. (PMID: 26951314)
Oncologist. 2008;13 Suppl 2:19-21. (PMID: 18434634)
Clin Cancer Res. 2022 Aug 15;28(16):3443-3451. (PMID: 34907081)
PLoS One. 2015 Jul 31;10(7):e0133488. (PMID: 26230853)
Stat Med. 1989 Apr;8(4):431-40. (PMID: 2727467)
Liver Int. 2017 Aug;37(8):1157-1166. (PMID: 28061016)
Lancet Oncol. 2009 Jan;10(1):25-34. (PMID: 19095497)
Hepatology. 2022 Aug 29;:. (PMID: 36037274)
Epidemiology. 2010 Jan;21(1):13-5. (PMID: 20010207)
J Hepatol. 2021 Oct;75(4):960-974. (PMID: 34256065)
Lancet. 2017 Jun 24;389(10088):2492-2502. (PMID: 28434648)
Hepatology. 2013 Dec;58(6):2023-31. (PMID: 23787822)
Hepatology. 2011 Dec;54(6):2055-63. (PMID: 21898496)
J Natl Cancer Inst. 2009 Dec 2;101(23):1642-9. (PMID: 19903805)
Cancers (Basel). 2020 Dec 30;13(1):. (PMID: 33396833)
BMC Res Notes. 2015 Oct 26;8:609. (PMID: 26502722)
J Hepatol. 2022 Sep 20;:. (PMID: 36341767)
J Clin Oncol. 2017 May 20;35(15):1686-1694. (PMID: 28375786)
J Hepatol. 2019 Aug;71(2):265-273. (PMID: 30959157)
Semin Liver Dis. 2021 Jan;41(1):1-8. (PMID: 33764480)
AJR Am J Roentgenol. 2022 Oct;219(4):533-546. (PMID: 35506555)
J Hepatol. 2018 Jun;68(6):1129-1136. (PMID: 29427727)
Eur J Nucl Med Mol Imaging. 2017 Dec;44(13):2310-2325. (PMID: 28815334)
J Hepatol. 2011 Apr;54(4):695-704. (PMID: 21147504)
J Hepatol. 2021 May;74(5):1225-1233. (PMID: 33582128)
J Clin Oncol. 2020 Jan 20;38(3):193-202. (PMID: 31790344)
N Engl J Med. 2018 Jul 05;379(1):54-63. (PMID: 29972759)
Liver Cancer. 2019 Mar;8(2):130-139. (PMID: 31019903)
Cancer. 2012 Jan 1;118(1):147-56. (PMID: 21713764)
Gut. 2016 May;65(5):861-9. (PMID: 25666192)
Br J Cancer. 2016 Nov 8;115(10):1201-1205. (PMID: 27736843)
Lancet. 2018 Mar 24;391(10126):1163-1173. (PMID: 29433850)
Lancet Oncol. 2022 Aug;23(8):995-1008. (PMID: 35798016)
Liver Cancer. 2018 Sep;7(3):215-224. (PMID: 30319981)
Hepatol Res. 2022 Apr;52(4):329-336. (PMID: 35077590)
Hepatology. 2010 Apr;51(4):1274-83. (PMID: 20112254)
Semin Liver Dis. 2010 Feb;30(1):52-60. (PMID: 20175033)
Am J Gastroenterol. 2016 Jan;111(1):70-7. (PMID: 26729544)
Hepat Oncol. 2017 Oct;4(4):129-137. (PMID: 30191059)
J Hepatol. 2022 Mar;76(3):681-693. (PMID: 34801630)
J Hepatol. 2020 Feb;72(2):288-306. (PMID: 31954493)
N Engl J Med. 2020 May 14;382(20):1894-1905. (PMID: 32402160)
JAMA Oncol. 2020 Nov 01;6(11):e204564. (PMID: 33001135)
JAMA Intern Med. 2019 May 1;179(5):642-647. (PMID: 30933235)
JAMA Oncol. 2022 May 1;8(5):679-680. (PMID: 35266952)
Nutr Metab Cardiovasc Dis. 2022 Oct;32(10):2279-2288. (PMID: 35970684)
Liver Int. 2021 Mar;41(3):585-597. (PMID: 33219585)
Lancet. 2017 Jan 7;389(10064):56-66. (PMID: 27932229)
J Hepatol. 2015 Nov;63(5):1118-25. (PMID: 26100495)
Hepatol Int. 2013 Jun;7(2):703-13. (PMID: 26201804)
Liver Int. 2021 May;41(5):891-893. (PMID: 33861895)
Liver Int. 2021 May;41(5):1105-1116. (PMID: 33587814)
JAMA Oncol. 2021 May 01;7(5):728-734. (PMID: 33764385)
Lancet Oncol. 2017 Mar;18(3):e143-e152. (PMID: 28271869)
J Immunother Cancer. 2020 Feb;8(1):. (PMID: 32107275)
Diagnostics (Basel). 2022 May 24;12(6):. (PMID: 35741118)
Liver Cancer. 2021 Nov 23;11(1):75-84. (PMID: 35222509)
J Hepatol. 2019 Jun;70(6):1262-1277. (PMID: 30943423)
J Natl Cancer Inst. 2008 May 21;100(10):698-711. (PMID: 18477802)
J Am Coll Cardiol. 2019 Oct 22;74(16):2102-2112. (PMID: 31623769)
J Hepatol. 2017 Jul;67(1):196-197. (PMID: 28315709)
Ann Hepatol. 2022 Jan;27 Suppl 1:100568. (PMID: 34699987)
Cancers (Basel). 2020 Jul 31;12(8):. (PMID: 32752060)
Gut. 2022 Mar;71(3):593-604. (PMID: 33741640)
J Clin Oncol. 2020 Dec 20;38(36):4317-4345. (PMID: 33197225)
Curr Treat Options Gastroenterol. 2005 Dec;8(6):457-66. (PMID: 16313863)
Gut. 2021 Dec 21;:. (PMID: 34933916)
J Thorac Dis. 2018 May;10(Suppl 13):S1564-S1580. (PMID: 29951307)
J Hepatol. 2017 Jun;66(6):1166-1172. (PMID: 28131794)
Cancer Manag Res. 2021 Dec 24;13:9379-9389. (PMID: 34992463)
Lancet Oncol. 2015 Jan;16(1):e32-42. (PMID: 25638553)
J Hepatol. 2001 Sep;35(3):421-30. (PMID: 11592607)
Biostatistics. 2000 Mar;1(1):49-67. (PMID: 12933525)
Dig Liver Dis. 2022 Apr;54(4):452-460. (PMID: 35131176)
Nat Clin Pract Gastroenterol Hepatol. 2009 Mar;6(3):159-69. (PMID: 19190599)
Clin Cancer Res. 2018 May 15;24(10):2268-2275. (PMID: 29326281)
Recenti Prog Med. 2021 Feb;112(2):110-116. (PMID: 33624623)
فهرسة مساهمة: Keywords: HCC; RECIST 1.1; endpoints; hepatocellular carcinoma; immunotherapy; mRECIST; radiological criteria; systemic therapy
تواريخ الأحداث: Date Created: 20221111 Latest Revision: 20221126
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC9687474
DOI: 10.3390/biomedicines10112827
PMID: 36359347
قاعدة البيانات: MEDLINE
الوصف
تدمد:2227-9059
DOI:10.3390/biomedicines10112827