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The efficacy and safety of sorafenib in older adults with advanced hepatocellular carcinoma: An analysis of a majority Hispanic cohort

Published:April 06, 2020DOI:https://doi.org/10.1016/j.jgo.2020.03.018
      The incidence of hepatocellular carcinoma (HCC) increases with advancing age in all populations, reaching a peak at 70 years of age [
      • El-Serag H.B.
      • Mason A.C.
      Rising incidence of hepatocellular carcinoma in the United States.
      ]. As a result, oncologists are caring for an increasing number of older adults with HCC. In the most recent HCC guidelines, disease staging includes tumor characteristics, underlying liver cirrhosis, and performance status, but the patient's age is not taken into account. As adults older than 65 years are underrepresented in clinical trials [
      • Arora S.P.
      • Liposits G.
      • Caird S.
      • Dunne R.F.
      • Moffat G.T.
      • Okonji D.
      • et al.
      Hepatocellular carcinoma in older adults: a comprehensive review by young International Society of Geriatric Oncology.
      ], treatment decisions in older adults with HCC are based on evidence from trials in younger patients. Further, prospective studies have not investigated the role of quality of life, functional age, and treatment tolerability in older adults with HCC, which is a cohort with underlying cirrhosis and other comorbidities resulting in vulnerability and frailty at younger ages. Therefore, there is a great need to understand further safety and efficacy of treatments in older adults with HCC. Currently, there are seven Food and Drug Administration (FDA)-approved treatments for HCC. Sorafenib, an oral multi-tyrosine kinase inhibitor, was the first to demonstrate survival benefits in patients with advanced HCC and continue a first-line treatment for HCC. The efficacy of sorafenib in HCC was established in Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) [
      • Llovet J.M.
      • Ricci S.
      • Mazzaferro V.
      • Hilgard P.
      • Gane E.
      • Blanc J.F.
      • et al.
      Sorafenib in advanced hepatocellular carcinoma.
      ] and Asian-Pacific studies [
      • Cheng A.L.
      • Kang Y.K.
      • Chen Z.
      • Tsao C.J.
      • Qin S.
      • Kim J.S.
      • et al.
      Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial.
      ]. However, these phase III studies are yet to publish further detailed analyses in the subgroup of older adults.

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