Letters To The Editor
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Apr 7, 2017; 23(13): 2448-2452
Published online Apr 7, 2017. doi: 10.3748/wjg.v23.i13.2448
Tumor biopsy and patient enrollment in clinical trials for advanced hepatocellular carcinoma
Lorenza Rimassa, Maria Reig, Giovanni Abbadessa, Markus Peck-Radosavljevic, William Harris, Vittorina Zagonel, Davide Pastorelli, Elena Rota Caremoli, Camillo Porta, Nevena Damjanov, Hitendra Patel, Bruno Daniele, Maria Lamar, Brian Schwartz, Terri Goldberg, Armando Santoro, Jordi Bruix
Lorenza Rimassa, Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, 20089 Rozzano, Italy
Maria Reig, Jordi Bruix, Barcelona Clinic Liver Cancer Group, Liver Unit, Hospital Clinic, University of Barcelona, IDIBAPS, CIBERehd, 08036 Barcelona, Spain
Giovanni Abbadessa, Maria Lamar, Brian Schwartz, Clinical Development, ArQule, Inc, Burlington, MA 01803, United States
Markus Peck-Radosavljevic, Department of Gastroenterology, Hepatology, Endrocrinology, and Nephrology, Klinikum Klagenfurt am Wörthersee, 9020 Klagenfurt, Austria
William Harris, Department of Medicine, Oncology Division, University of Washington School of Medicine, Seattle, WA 98195, United States
Vittorina Zagonel, Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology-IRCCS, 35128 Padua, Italy
Davide Pastorelli, Department of Oncology, Santa Maria del Prato Hospital, 32032 Feltre, Italy
Elena Rota Caremoli, Department of Oncology, Papa Giovanni XXIII Hospital, 24125 Bergamo, Italy
Camillo Porta, Department of Oncology, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
Nevena Damjanov, Division of Gastrointestinal Oncology, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA 19104, United States
Hitendra Patel, Department of Medicine, The University of Arizona Cancer Center, Tucson, AZ 85724, United States
Bruno Daniele, Department of Oncology, G. Rummo Hospital, Via Dell’Angelo, 82100 Benevento, Italy
Terri Goldberg, Clinical Development, Daiichi Sankyo, Edison, NJ 08837, United States
Armando Santoro, Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Humanitas University, 20089 Rozzano, Italy
Author contributions: Rimassa L, Reig M, Abbadessa G, Santoro A and Bruix J wrote the manuscript; Peck-Radosavljevic M, Harris W, Zagonel V, Pastorelli D, Rota Caremoli E, Porta C, Damjanov N, Patel H, Daniele B, Lamar M, Schwartz B and Goldberg T contributed to the preparation, editing, and final approval of the manuscript.
Conflict-of-interest statement: Authors report no conflict of interest with the subject discussed in this article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Lorenza Rimassa, Deputy Director, Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center, Via Manzoni 56, 20089 Rozzano, Italy. lorenza.rimassa@cancercenter.humanitas.it
Telephone: +39-2-82244573 Fax: +39-2-82244590
Received: January 20, 2017
Peer-review started: January 22, 2017
First decision: February 10, 2017
Revised: February 24, 2017
Accepted: March 15, 2017
Article in press: March 15, 2017
Published online: April 7, 2017

Tumor biopsies may help to reliably distinguish hepatocellular carcinoma (HCC) from other tumors, mostly cholangiocarcinoma as well as to identify the patient populations who most benefit from target-driven HCC treatments, in order to improve the success rate of experimental therapies. Clarifying tumor biology may also lead to identify biomarkers with prognostic role and/or enabling to predict response or resistance to therapies. Recently, clinical trials have more efficiently included biomarker endpoints and increasingly collected tumor tissue from enrolled patients. Due to their frail status and sometimes fast-progressing disease, the performance status of patients with HCC progressing on first-line therapy can deteriorate quickly, preventing their enrollment in clinical trials. However, the challenge of identifying the proper patient at the proper time can be overcome by periodic inter-department meetings involving the key specialists taking care of HCC patients, and solid networks between research centers and referring institutions. An early planned biopsy would also facilitate timely inclusion of patients in biology-driven clinical trials. Ultimately, institution of multidisciplinary teams can optimize treatment choice, biopsy timing, and quick enrollment of patients in clinical trials, before their performance status deteriorates.

Keywords: Liver neoplasms, Biopsy, Biomarkers, Clinical trial, Tumor

Core tip: Despite the extensive research conducted in the last two decades, still only two agents have shown positive results in phase III clinical trials for advanced hepatocellular carcinoma, and clinicians have no way to predict which patient population will benefit more. Biomarker research and well-run clinical trials require biopsies and a multidisciplinary approach to manage patients with hepatocellular carcinoma.