title: Refining sorafenib therapy: lessons from clinical practice.
abstract: Understanding the best use of sorafenib is essential in order to maximize clinical benefit in hepatocellular carcinoma. Based on Phase III and noninterventional study data, as well as our extensive experience, we discuss dose modification in order to manage adverse events, disease response evaluation and how to maximize treatment benefit. Sorafenib should be initiated at the approved dose (400 mg twice daily) and reduced/interrupted as appropriate in order to manage adverse events. Dose modification should be considered before discontinuation. Appropriate tumor response assessment is critical. Focusing on radiologic response may result in premature sorafenib discontinuation; symptomatic progression should also be considered. If second-line therapies or trials are unavailable, continuing sorafenib beyond radiologic progression may provide a clinical benefit. Our recommendations enable the maximization of treatment duration, and hence clinical benefit, for patients.
authors.affiliation: Division of Internal Medicine, Department of Medical & Surgical Sciences, University of Bologna, S Orsola-Malpighi Hospital, Bologna, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Bolondi
authors.forename: Antonio
authors.initials: A
authors.lastname: Craxi
authors.forename: Franco
authors.initials: F
authors.lastname: Trevisani
authors.forename: Bruno
authors.initials: B
authors.lastname: Daniele
authors.forename: Giovan Giuseppe
authors.initials: GG
authors.lastname: Di Costanzo
authors.forename: Stefano
authors.initials: S
authors.lastname: Fagiuoli
authors.forename: Calogero
authors.initials: C
authors.lastname: Cammà
authors.forename: Paolo
authors.initials: P
authors.lastname: Bruzzi
authors.forename: Romano
authors.initials: R
authors.lastname: Danesi
authors.forename: Federico
authors.initials: F
authors.lastname: Spandonaro
authors.forename: Corrado
authors.initials: C
authors.lastname: Boni
authors.forename: Armando
authors.initials: A
authors.lastname: Santoro
authors.forename: Massimo
authors.initials: M
authors.lastname: Colombo
mesh_terms: D000367:Age Factors; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D018450:Disease Progression; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019233:Retreatment; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib
keywords: Child–Pugh B; adverse event management; dose modification; elderly; hepatocellular carcinoma; mRECIST; postprogression treatment; real-world data; response assessment; sorafenib