TY - JOUR
T1 - A Real-World Observational Cohort of Patients with Hepatocellular Carcinoma
T2 - Design and Rationale for TARGET-HCC
AU - Cabrera, Roniel
AU - Singal, Amit G.
AU - Colombo, Massimo
AU - Kelley, R. Kate
AU - Lee, Hannah
AU - Mospan, Andrea R.
AU - Meyer, Tim
AU - Newell, Pippa
AU - Parikh, Neehar D.
AU - Sangro, Bruno
AU - Reddy, K. Rajender
AU - Watkins, Stephanie
AU - Zink, Richard C.
AU - Di Bisceglie, Adrian M.
N1 - Funding Information:
TARGET-HCC is a collaboration among academic and community investigators, the FDA, the pharmaceutical industry, and community advocates of patients with HCC. TARGET-HCC is sponsored by Target RWE. Target RWE thanks the study staff, nurses, health care providers, and patients at each study center for their contributions to this work.
Publisher Copyright:
© 2020 The Authors. Hepatology Communications published by Wiley Periodicals LLC on behalf of the American Association for the Study of Liver Diseases.
PY - 2021/3
Y1 - 2021/3
N2 - This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Conclusion: Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.
AB - This study describes the design of the TARGET-hepatocellular carcinoma (HCC) cohort and descriptive characteristics of the patient population at diagnosis among those who were enrolled in the cohort across academic and community clinical centers. TARGET-HCC is a 5-year, longitudinal, observational cohort of patients with HCC receiving care in usual clinical practice. Redacted clinical information, obtained from medical records, captures the natural history and management of the disease, including the safety and efficacy of treatment interventions used in usual clinical practice. Patients can complete patient-reported outcome measures and provide biological specimens for future translational studies. The TARGET-HCC study includes adults with histologic, cytologic, or radiologic diagnosis of HCC from academic and community centers in both the United States and Europe. A total of 1,841 participants were enrolled between January 9, 2017, and July 23, 2019, at 67 sites in the United States and Europe. To date, the most common liver disease etiology in the cohort continues to be hepatitis C, although nearly half had a nonviral etiology, including alcohol-related liver disease or nonalcoholic steatohepatitis. Most included patients were diagnosed at an early stage (Barcelona Clinic Liver Cancer Stage [BCLC] 0/A), but only approximately one third underwent curative treatment. Systemic therapy has been used in 7.3% of enrolled patients, including 45.7% of those with BCLC stage C tumors. Conclusion: Overall, the TARGET-HCC cohort allows for the assessment of patient characteristics and investigation of new treatment paradigms and sequencing with existing agents as well as novel regimens for HCC.
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U2 - 10.1002/hep4.1652
DO - 10.1002/hep4.1652
M3 - Article
C2 - 33681685
AN - SCOPUS:85103140269
SN - 2471-254X
VL - 5
SP - 538
EP - 547
JO - Hepatology Communications
JF - Hepatology Communications
IS - 3
ER -