Semin Liver Dis 2010; 30(1): 052-060
DOI: 10.1055/s-0030-1247132
© Thieme Medical Publishers

Modified RECIST (mRECIST) Assessment for Hepatocellular Carcinoma

Riccardo Lencioni1 , Josep M. Llovet2 , 3
  • 1Division of Diagnostic Imaging and Intervention, Department of Liver Transplantation, Hepatology, and Infectious Diseases, University of Pisa, Pisa, Italy
  • 2Barcelona Clinic Liver Cancer Group, Liver Unit, IDIBAPS, CIBERehd, Hospital Clínic, Barcelona, Spain
  • 3Mount Sinai Liver Cancer Program, Division of Liver Diseases, Mount Sinai School of Medicine, New York, New York
Further Information

Publication History

Publication Date:
19 February 2010 (online)

ABSTRACT

The endpoint in cancer research is overall survival. Nonetheless, other potential surrogate endpoints, such as response rate and time to progression, are currently used. Measurement of response rate in hepatocellular carcinoma (HCC) has become a controversial issue. The World Health Organization (WHO) criteria underestimate the actual response rate; thus, they were amended in 2000 by a panel of experts convened by the European Association for the Study of the Liver (EASL) to take into account treatment-induced tumor necrosis. Applying these guidelines, there was an association between response rate and outcome prediction. More recently, the Response Evaluation Criteria in Solid Tumors (RECIST) guideline was proposed as a method for measuring treatment response based on tumor shrinkage, which is a valuable measure of antitumor activity of cytotoxic drugs. This method was initially adopted by regulatory agencies, such as the U.S. Food and Drug Administration (FDA), for drug approval. However, anatomic tumor response metrics can be misleading when applied to molecular-targeted therapies or locoregional therapies in HCC. In 2008, a group of experts convened by the American Association for the Study of Liver Diseases (AASLD) developed a set of guidelines aimed at providing a common framework for the design of clinical trials in HCC and adapted the concept of viable tumor–tumoral tissue showing uptake in arterial phase of contrast-enhanced radiologic imaging techniques—to formally amend RECIST. These amendments conformed the AASLD-JNCI (Journal of the National Cancer Institute) guidelines and are summarized and clarified in the current article. They are referred to herein as the modified RECIST assessment (mRECIST). Further studies are needed to confirm the accuracy of this measurement compared with conventional gold standards such as pathologic studies of explanted livers.

REFERENCES

  • 1 Miller A B, Hoogstraten B, Staquet M, Winkler A. Reporting results of cancer treatment.  Cancer. 1981;  47(1) 207-214
  • 2 Therasse P, Arbuck S G, Eisenhauer E A et al.. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada.  J Natl Cancer Inst. 2000;  92(3) 205-216
  • 3 Llovet J M, Ricci S, Mazzaferro V SHARP Investigators Study Group et al. Sorafenib in advanced hepatocellular carcinoma.  N Engl J Med. 2008;  359(4) 378-390
  • 4 Forner A, Ayuso C, Varela M et al.. Evaluation of tumor response after locoregional therapies in hepatocellular carcinoma: are response evaluation criteria in solid tumors reliable?.  Cancer. 2009;  115(3) 616-623
  • 5 Bruix J, Sherman M, Llovet J M EASL Panel of Experts on HCC et al. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference.  J Hepatol. 2001;  35(3) 421-430
  • 6 Bruix J, Sherman M. Practice Guidelines Committee, American Association for the Study of Liver Diseases . Management of hepatocellular carcinoma.  Hepatology. 2005;  42(5) 1208-1236
  • 7 Llovet J M, Di Bisceglie A M, Bruix J Panel of Experts in HCC-Design Clinical Trials et al. Design and endpoints of clinical trials in hepatocellular carcinoma.  J Natl Cancer Inst. 2008;  100(10) 698-711
  • 8 D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies.  J Hepatol. 2006;  44(1) 217-231
  • 9 Llovet J M, Burroughs A, Bruix J. Hepatocellular carcinoma.  Lancet. 2003;  362(9399) 1907-1917
  • 10 Llovet J M, Bruix J. Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival.  Hepatology. 2003;  37(2) 429-442
  • 11 Eisenhauer E A, Therasse P, Bogaerts J et al.. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).  Eur J Cancer. 2009;  45(2) 228-247
  • 12 Bogaerts J, Ford R, Sargent D RECIST Working Party et al. Individual patient data analysis to assess modifications to the RECIST criteria.  Eur J Cancer. 2009;  45(2) 248-260
  • 13 Burrel M, Llovet J M, Ayuso C Barcelona Clínic Liver Cancer Group et al. MRI angiography is superior to helical CT for detection of HCC prior to liver transplantation: an explant correlation.  Hepatology. 2003;  38(4) 1034-1042

Riccardo LencioniM.D. 

Division of Diagnostic Imaging and Intervention, Cisanello University Hospital

Bldg. 30C, Suites 196-198, Via Paradisa 2, IT-56124 Pisa, Italy

Email: lencioni@med.unipi.it

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