A multicenter randomized controlled trial established @entity2857 as a standard of care for @entity1 with @entity157 ( @entity157 ). Because the study was prematurely interrupted due to survival benefits in the @entity2857 arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice. Starting in 2008, all clinically compensated @entity1 with advanced @entity157 and those with an intermediate @entity157 who were unfit or failed to respond to ablative therapies were consecutively evaluated in six liver centers in Italy, for tolerability as well as radiologic and survival response to 800-mg/d @entity2857 therapy. Treatment was down-dosed or interrupted according to drug label. Two hundred ninety-six @entity1 (88% @entity1 -Pugh A, 75% Barcelona Clinic Liver Cancer [BCLC]-C, and 25% BCLC-B) received @entity2857 for 3.8 months (95% CI 3.3-4.4). Two hundred sixty-nine (91%) @entity1 experienced at least one adverse event (AE), whereas 161 (54%) had to reduce dosing. Treatment was interrupted in 103 (44%) for disease progression, in 95 (40%) for an AE, and in 38 (16%) for @entity1578 . The median survival was 10.5 months in the overall cohort, 8.4 months in BCLC-C versus 20.6 months in BCLC-B @entity1 (P < 0.0001), and 21.6 months in the 77 @entity1 treated for >70% of the time with a half dose versus 9.6 months in the 219 @entity1 treated for >70% of the time with a full dose. At month 2 of treatment, the overall radiologic response was 8%. Eastern Cooperative Oncology Group performance status, macrovascular invasion, extrahepatic spread of the @entity5 , radiologic response at month 2, and @entity2857 dosing were independent predictors of shortened survival. CONCLUSION: Overall, safety, effectiveness, and generalizability of @entity2857 therapy in @entity157 was validated in field practice. The effectiveness of half-dosed @entity2857 may have implications for tailored therapy.

Field-practice study of XXXX therapy for @entity157 : a prospective multicenter study in Italy.

@entity1 :: ('9606', 'Species') :: ['Child', 'patients'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity2857 :: ('MESH:C471405', 'Chemical') :: ['sorafenib'] @entity1578 :: ('MESH:D017093', 'Disease') :: ['liver deterioration'] @entity157 :: ('MESH:D006528', 'Disease') :: ['HCC', 'advanced hepatocellular carcinoma']
@entity2857 :: (MESH:C471405,Chemical) :: ['sorafenib']
