Features of modified response evaluation criteria use in solid tumors in patients with hepatocellular carcinoma
https://doi.org/10.16931/1995-5464.2022-1-33-39
Abstract
The article reviews the key approaches to the use of modified response evaluation criteria in solid tumors (mRECIST) in patients with hepatocellular carcinoma and discusses its main strengths and features. According to the evaluation by mRECIST, complete response is defined as the disappearance of any intratumoral arterial enhancement in all target lesions. A partial response is defined as 30% decrease in the sum of the longest diameters of viable tumor target lesions compared with its baseline sum. Disease progression signifies a ≥20% increase in the sum of the longest diameters of viable tumor target lesions compared with nadir. Stable disease is defined as neither partial response nor progression.
Keywords
liver,
hepatocellular carcinoma,
MRI,
CT,
mRECIST,
complete response,
partial response,
tumor progression
About the Authors
B. M. Medvedeva
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
Bela M. Medvedeva – Doct. of Sci. (Med.), Head of the X-ray Diagnostic Department of the Research Institute of Clinical and Experimental Radiology
23, Kashirskoe shosse, Moscow, 115478
A. B. Lukianchenko
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
Aleksandr B. Lukiyanchenko – Doct. of Sci. (Med.), Professor, Leading Researcher of the X-ray Diagnostic Department of the Research Institute of Clinical and Experimental Radiology
23, Kashirskoe shosse, Moscow, 115478
V. V. Breder
N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Healthcare of the Russian Federation
Russian Federation
Russian Federation
Valeriy V. Breder – Doct. of Sci. (Med.), Leading Researcher of the Department of Chemotherapy
23, Kashirskoe shosse, Moscow, 115478
References
1. Zhou M., Wang H., Zeng X., Yin P., Zhu J., Chen W., Li X., Wang L., Wang L., Liu Y., Liu J., Zhang M., Qi J., Yu S., Afshin A., Gakidou E., Glenn S., Krish V.S., Miller-Petrie M.K., Mountjoy-Venning W.C., Mullany C.E., Redford S.B., Liu H., Naghavi M., Hay I.S., Wang L., Murray C.J.L., Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019; 394 (10204): 1145–1158. https://doi.org/10.1016/S0140-6736(19)30427-1
2. Bray F., Ferlay J., Siegel R.L., Torre L.A., Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 2018; 68 (6): 394–424. https://doi.org/10.3322/caac.21492
3. World Health Organization. Projections of mortality and causes of death, 2016 to 2060. Available from: https://www.who.int/ healthinfo/global_burden_disease/projections/en/ (accessed July 9, 2019). 4. International Agency for Research on Cancer. Global cancer observatory – cancer fact sheets. Available from: http://gco.iarc. fr/today/fact-sheets-cancers (accessed July 9, 2019).
4. European Association for the Study of the Liver. European Organisation for Research and Treatment of Cancer. EASLEORTC clinical practice guidelines: management of hepatocellular carcinoma. J. Hepatol. 2012; 56 (4): 908–943. https://doi.org/10.1016/j.jhep.2011.12.001
5. Morris-Stiff G., Gomez D., de Liguori Carino N., Prasad K.R. Surgical management of hepatocellular carcinoma: is the jury still out? Surg. Oncol. 2009; 18 (4): 298–321. https://doi.org/10.1016/j.suronc.2008.08.003
6. Imamura H., Matsuyama Y., Tanaka E., Ohkubo T., Hasegawa K., Miyagawa S., Sugawara Y., Minagawa M., Takayama T., Kawasaki S., Makuuchi M. Risk factors contributing to early and late phase intrahepatic recurrence of hepatocellular carcinoma after hepatectomy. J. Hepatol. 2003; 38 (2): 200–207. https://doi.org/10.1016/s0168-8278(02)00360-4
7. Zheng J., Chou J.F., Gönen M., Vachharajani N., Chapman W.C., Doyle M.B.M., Turcotte S., VandenbrouckeMenu F., Lapointe R., Buettner S., Koerkamp B.G., Ijzermans J.N.M., Chan C.Y., Goh B.K.P., Teo J.Y., Kam J.H., Jeyaraj P.R., Cheow P.C., Chung A.Y.F., Chow P.K.H., Ooi L.L.P.J., Balachandran V.P., Kingham T.P., Allen P.J., D'Angelica M.I., DeMatteo R.P., Jarnagin W.R., Lee S.Y. Prediction of hepatocellular carcinoma recurrence beyond Milan criteria after resection: validation of a clinical risk score in an international cohort. Ann. Surg. 2017; 266 (4): 693–701. https://doi.org/10.1097/SLA.0000000000002360
8. Famularo S., Di Sandro S., Giani A., Lauterio A., Sandini M., De Carlis R., Buscemi V., Uggeri F., Romano F., Gianotti L., De Carlis L. Recurrence patterns after anatomic or parenchymasparing liver resection for hepatocarcinoma in a western population of cirrhotic patients. Ann. Surg. Oncol. 2018; 25 (13): 3974–3981. https://doi.org/10.1245/s10434-018-6730-0
9. Boland P., Wu J. Systemic therapy for hepatocellular carcinoma: beyond sorafenib. Chin. Clin. Oncol. 2018; 7 (5): 50. https://doi.org/10.21037/cco.2018.10.10
10. Zhu A.X. Systemic therapy of advanced hepatocellular carcinoma: how hopeful should we be? Oncologist. 2006; 11 (7): 790–800. https://doi.org/10.1634/theoncologist.11-7-790
11. Gauthier A., Ho M. Role of sorafenib in the treatment of advanced hepatocellular carcinoma: an update. Hepatol. Res. 2013; 43 (2): 147–154. https://doi.org/10.1111/j.1872-034X.2012.01113.x
12. Llovet J.M., Ricci S., Mazzaferro V., Hilgard P., Gane E., Blanc J.-F., Cosme de Oliveira A., Santoro A., Raoul J.-L., Forner A., Schwartz M., Porta C., Zeuzem S., Bolondi L., Greten T.F., Galle P.R., Seitz J.-F., Borbath I., Häussinger D., Giannaris T., Shan M., Moscovici M., Voliotis D., Bruix J., SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N. Engl. J. Med. 2008; 359 (4): 378–390. https://doi.org/10.1056/NEJMoa0708857
13. Kudo M. Systemic therapy for hepatocellular carcinoma: 2017 update. Oncology. 2018; 10 (11): 412. https://doi.org/10.3390/cancers10110412
14. El-Khoueiry A.B., Sangro B., Yau T., Crocenzi T.S., Kudo M., Hsu C., Kim T.Y., Choo S.P., Trojan J., Welling T.H., Meyer T., Kang Y.K., Yeo W., Chopra A., Anderson J., Dela Cruz C., Lang L., Neely J., Tang H., Dastani H.B., Melero I. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMate 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017; 389 (10088): 2492–2502. https://doi.org/10.1016/S0140-6736(17)31046-2
15. Zhu A.X., Finn R.S., Edeline J., Cattan S., Ogasawara S., Palmer D., Verslype C., Zagonel V., Fartoux L., Vogel A., Sarker D., Verset G., Chan S.L., Knox J., Daniele B., Webber A.L., Ebbinghaus S.W., Ma J., Siegel A.B., Cheng A.L., Kudo M. KEYNOTE-224 investigators. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018; 19 (7): 940–952. https://doi.org/10.1016/S1470-2045(18)30351-6
16. Finn R.S., Ryoo B.Y., Merle P., Kudo M., Bouattour M., Lim H.Y., Breder V., Edeline J., Chao Y., Ogasawara S., Yau T., Garrido M., Chan S.L., Knox J., Daniele B., Ebbinghaus S.W., Chen E., Siegel A.B., Zhu A.X., Cheng A.L. KEYNOTE-240 investigators. Pembrolizumab as second-line therapy in patients with advanced hepatocellular carcinoma in KEYNOTE-240: a randomized, double-blind, phase III trial. J. Clin. Oncol. 2020; 38 (3): 193–202. https://doi.org/10.1200/JCO.19.01307
17. Zhu A.X., Galle P.R., Kudo M., Finn R.S., Yang L., Abada P., Llovet J.P. A randomized, double-blind, placebo-controlled phase 3 study of ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein (AFP) following first-line sorafenib (REACH-2). J. Clin. Oncol. 2017; 34 (15_suppl): TPS4145–TPS4145. https://doi.org/10.1200/JCO.2016.34.15_suppl.TPS4145
18. Breder V.V., Natrusova M.V., Dzhanyan I.A. Systemic therapy of hepatocellular carcinoma: reality and prospects. Annaly khirurgicheskoy gepatologii = Annals of HPB Surgery. 2020; 25 (2): 27–38. https://doi.org/10.16931/1995-5464.2020227-38 (In Russian)
19. European Association for the Study of the Liver. EASL clinical practice guidelines: management of hepatocellular carcinoma. J. Hepatol. 2018; 69 (1): 182–236. https://doi.org/10.1016/j.jhep.2018.03.019
20. Llovet J.M., Montal R., Villanueva A. Randomized trials and endpoints in advanced HCC: role of PFS as a surrogate of survival. J. Hepatol. 2019; 70 (6): 1262–1277. https://doi.org/10.1016/j.jhep.2019.01.028
21. Beaver J.A., Howie L.J., Pelosof L., Kim T., Liu J., Goldberg K.B., Sridhara R., Blumenthal G.M., Farrell A.T., Keega P., Pazdur R., Kluetz P.G. A 25-year experience of US food and drug administration accelerated approval of malignant hematology and oncology drugs and biologics. JAMA Oncol. 2018; 4 (6): 849–856. https://doi.org/10.1001/jamaoncol.2017.5618
22. Kemp R., Prasad V. Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused? BMC Med. 2017; 15 (1): 134. https://doi.org/10.1186/s12916-017-0902-9
23. Vogel A., Cervantes A., Chau I., Daniele B., Llovet J., Meyer T., Nault J.-C., Neumann U., Ricke J., Sangro B., Schirmacher P., Verslype C., Zech C.J., Arnold D., Martinelli E. Hepatocellular carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 2018; 29 (Suppl. 4): iv238–iv255. https://doi.org/10.1093/annonc/mdy308
24. Forner A., Ayuso C., Varela M., Rimola J., Hessheimer A.J., Rodriguez de Lope C., Reig M., Bianchi L., Llovet J.M., Bruix J. Evaluation of tumour response after locoregional therapies in hepatocellular carcinoma: are response evaluation criteria in solid tumours reliable? Cancer. 2009; 115 (3): 616– 623. https://doi.org/10.1002/cncr.24050
25. Lencioni R., Crocetti L., Della Pina M.C., Cioni D. Guidelines for imaging focal lesions in liver cirrhosis. Expert Rev. Gastroenterol. Hepatol. 2008; 2 (5): 697–703. https://doi.org/10.1586/17474124.2.5.697
26. Lencioni R., Llovet J.M. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin. Liver Dis. 2010; 30 (1): 52–60. https://doi.org/10.1055/s-0030-1247132
27. Fournier L.S., Ammari S., Thiam R., Cuénod C.-A. Imaging criteria for assessing tumour response: RECIST, mRECIST, Cheson. Diagn. Interv. Imaging. 2014; 95 (7–8): 689–703. https://doi.org/10.1016/j.diii.2014.05.002
28. Lencioni R., Llovet J.M., Han G., Tak W.Y., Yang J., Guglielmi A., Paik S.W., Reig M., Kim D.Y., Chau G.Y., Luca A., Ruiz Del Arbol L., Leberre M.A., Niu W., Nicholson K., Meinhardt G., Bruix J. Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC. The SPACE trial. J. Hepatol. 2016; 64 (5): 1090–1098. https://doi.org/10.1016/j.jhep.2016.01.012
29. Bruix J., Qin S., Merle P., Granito A., Huang Y.-H., Bodoky G. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib treatment (RESORCE): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017; 389 (10064): 56–66. https://doi.org/10.1016/S0140-6736(16)32453-9
30. Johnson P.J., Qin S., Park J.W., Poon R.T.P., Raoul J.-L., Philip P.A., Hsu C.H., Hu T.H., Heo J., Xu J., Lu L., Chao Y., Boucher E., Han K.-H., Paik S.-W., Robles-Aviña J., Kudo M., Yan L., Sobhonslidsuk A., Komov D., Decaens T., Tak W.-Y., Jeng L.-B., Liu D., Ezzeddine R., Walters I., Cheng A.-L. Brivanib versus sorafenib as first-line therapy in patients with unresectable, advanced hepatocellular carcinoma: results from the randomized phase III BRISK-FL study. J. Clin. Oncol. 2013; 31 (28): 3517–3524. https://doi.org/10.1200/JCO.2012.48.4410
31. Llovet J.M., Decaens T., Raoul J.L., Boucher E., Kudo M., Chang C., Kang Y.-K., Assenat E., Lim H.-Y., Boige V., Mathurin P., Fartoux L., Lin D.-Y., Bruix J., Poon R.T., Sherman M., Blanc J.-F., Finn R.S., Tak W.-Y., Chao Y., Ezzeddine R., Liu D., Walters I., Park J.-W. Brivanib in patients with advanced hepatocellular carcinoma who were intolerant to sorafenib or for whom sorafenib failed: results from the randomized phase III BRISK-PS study. J. Clin. Oncol. 2013; 31 (28): 3509–3516. https://doi.org/10.1200/JCO.2012.47.3009
32. Bruix J., Cheng A.-L., Meinhardt G., Nakajima K., De Sanctis Y., Llovet J. Prognostic factors and predictors of sorafenib benefit in patients with hepatocellular carcinoma: analysis of two phase 3 studies. J. Hepatol. 2017; 67 (5): 999– 1008. https://doi.org/10.1016/j.jhep.2017.06.026.
33. Lencioni R., Llovet J.M. Modified RECIST (mRECIST) assessment for hepatocellular carcinoma. Semin. Liver Dis. 2010; 30 (1): 52–60. https://doi.org/10.1055/s-0030-1247132
34. Eisenhauer E.A., Therasse P., Bogaerts J., Schwartz L.H., Sargent D., Ford R., Dancey J., Arbuck S., Gwyther S., Mooney M., Rubinstein L., Shankar L., Dodd L., Kaplan R., Lacombe D., Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur. J. Cancer. 2009; 45 (2): 228–247. https://doi.org/10.1016/j.ejca.2008.10.026
35. Cerny M., Chernyak V., Olivié D., Billiard J.-S., MurphyLavallée J., Kielar A.Z., Elsayes K.M., Bourque L., Hooker J.C., Sirlin C.B., An Tang. LI-RADS version 2018 ancillary features at MRI. RadioGraphics. 2018; 38 (7): 1973–2001. https://doi.org/10.1148/rg.2018180052
36. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Clinical trial imaging endpoint process standards. Guidance for industry. April 2018. https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/clinical-trialimaging-endpoint-process-standards-guidance-industry
37. Llovet J.M., Lencioni R. mRECIST for HCC: performance and novel refinements. J. Hepatol. 2020; 72 (2): 288–306. https://doi.org/10.1016/j.jhep.2019.09.026
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Medvedeva B.M., Lukianchenko A.B., Breder V.V. Features of modified response evaluation criteria use in solid tumors in patients with hepatocellular carcinoma. Annaly khirurgicheskoy gepatologii = Annals of HPB Surgery. 2022;27(1):33-39. (In Russ.) https://doi.org/10.16931/1995-5464.2022-1-33-39
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