Systemic Therapy for Advanced Hepatocellular Carcinoma: ASCO Guideline.

Gordan, John D; Kennedy, Erin B; Abou-Alfa, Ghassan K; Beg, Muhammad Shaalan; Brower, Steven T; Gade, Terence P; Goff, Laura; Gupta, Shilpi; Guy, Jennifer; Harris, William P; Iyer, Renuka; Jaiyesimi, Ishmael; Jhawer, Minaxi; Karippot, Asha; Kaseb, Ahmed O; Kelley, R Kate; Knox, Jennifer J; Kortmansky, Jeremy; Leaf, Andrea; Remak, William M; Shroff, Rachna T; Sohal, Davendra P S; Taddei, Tamar H; Venepalli, Neeta K; Wilson, Andrea; Zhu, Andrew X; Rose, Michal G

PURPOSE To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with advanced hepatocellular carcinoma (HCC). METHODS ASCO convened an Expert Panel to conduct a systematic review of published phase III randomized controlled trials (2007-2020) on systemic therapy for advanced HCC and provide recommended care options for this patient population. RESULTS Nine phase III randomized controlled trials met the inclusion criteria. RECOMMENDATIONS Atezolizumab + bevacizumab (atezo + bev) may be offered as first-line treatment of most patients with advanced HCC, Child-Pugh class A liver disease, Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1, and following management of esophageal varices, when present, according to institutional guidelines. Where there are contraindications to atezolizumab and/or bevacizumab, tyrosine kinase inhibitors sorafenib or lenvatinib may be offered as first-line treatment of patients with advanced HCC, Child-Pugh class A liver disease, and ECOG PS 0-1. Following first-line treatment with atezo + bev, and until better data are available, second-line therapy with a tyrosine kinase inhibitor may be recommended for appropriate candidates. Following first-line therapy with sorafenib or lenvatinib, second-line therapy options for appropriate candidates include cabozantinib, regorafenib for patients who previously tolerated sorafenib, or ramucirumab (for patients with α-fetoprotein ≥ 400 ng/mL), or atezo + bev where patients did not have access to this option as first-line therapy. Pembrolizumab or nivolumab are also reasonable options for appropriate patients following sorafenib or lenvatinib. Consideration of nivolumab + ipilimumab as an option for second-line therapy and third-line therapy is discussed. Further guidance on choosing between therapy options is included within the guideline. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines.