PMID- 26029452 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20150601 LR - 20220331 IS - 2078-6891 (Print) IS - 2219-679X (Electronic) IS - 2078-6891 (Linking) VI - 6 IP - 3 DP - 2015 Jun TI - Comparative dosing and efficacy of sorafenib in hepatocellular cancer patients with varying liver dysfunction. PG - 259-67 LID - 10.3978/j.issn.2078-6891.2015.005 [doi] AB - BACKGROUND: Sorafenib is the only FDA-approved systemic therapy for advanced hepatocellular carcinoma (HCC). In clinical practice, dose reductions are often required, although there are limited efficacy data related to dose modifications. Given the prevalence of HCC in South Texas, we assessed the efficacy and safety of sorafenib therapy in relation to dose and Child Pugh (CP) score. METHODS: A retrospective analysis was done of advanced HCC patients, starting sorafenib at 400 mg twice daily, or at physician discretion at 400 mg daily, with the goal of titrating to twice daily. Overall survival (OS) and progression-free survival (PFS) were assessed. RESULTS: Among 107 patients, median OS (mOS) was 10.2 months; median PFS (mPFS) was 5.2 months. mOS for sorafenib 400 mg/day was 6.6 vs. 800 mg/day was 12.8 months [hazard ratio (HR), 0.59; P=0.04]; mPFS was 3.5 vs. 5.9 months, respectively (HR, 0.66; P=0.07). For Child Pugh A class (CP-A) patients, mOS was 15.8 months for 400 mg/day vs. 12.8 months for 800 mg/day (HR, 1.48; P=0.35); mPFS was 9.0 vs. 5.9 months, respectively (HR, 1.23; P=0.56). For Child Pugh B class (CP-B) patients, mOS was 5.0 months for 400 mg/day vs. 11.2 months for 800 mg/day (HR, 0.33; P=0.002); mPFS was 2.1 vs. 5.6 months, respectively (HR, 0.41; P=0.006). No differences in adverse events (AEs) were observed in CP-A vs. CP-B. CONCLUSIONS: Patients with CP-A or CP-B advanced HCC should be offered sorafenib at 400 mg twice daily with optimal management of AEs in order to improve survival. FAU - Al-Rajabi, Raed AU - Al-Rajabi R AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Patel, Sukeshi AU - Patel S AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Ketchum, Norma S AU - Ketchum NS AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Jaime, Nicole A AU - Jaime NA AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Lu, Ting-Wei AU - Lu TW AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Pollock, Brad H AU - Pollock BH AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. FAU - Mahalingam, Devalingam AU - Mahalingam D AD - University of Texas Health Science Center San Antonio, San Antonio, TX 78229, USA. LA - eng PT - Journal Article PL - China TA - J Gastrointest Oncol JT - Journal of gastrointestinal oncology JID - 101557751 PMC - PMC4397242 OTO - NOTNLM OT - Child Pugh (CP) cirrhosis OT - Liver cancer OT - hepatobiliary OT - metastatic EDAT- 2015/06/02 06:00 MHDA- 2015/06/02 06:01 PMCR- 2015/06/01 CRDT- 2015/06/02 06:00 PHST- 2015/01/08 00:00 [received] PHST- 2015/01/13 00:00 [accepted] PHST- 2015/06/02 06:00 [entrez] PHST- 2015/06/02 06:00 [pubmed] PHST- 2015/06/02 06:01 [medline] PHST- 2015/06/01 00:00 [pmc-release] AID - jgo-06-03-259 [pii] AID - 10.3978/j.issn.2078-6891.2015.005 [doi] PST - ppublish SO - J Gastrointest Oncol. 2015 Jun;6(3):259-67. doi: 10.3978/j.issn.2078-6891.2015.005.