UNASSIGNED: 4115 Background: S is the only targeted agent that has been shown to improve survival in advanced @entity157 . It is not known whether a rebound phenomenon occurs after discontinuation of treatment after radiological progression ( @entity1726 ), or if continuation of treatment beyond this endpoint further delays @entity5 progression. The present trial was proposed to address this question. METHODS: This phase II randomized trial evaluated the feasibility and efficacy of increased-dose S (600 mg bid) after @entity1726 (RECIST criteria) on S 400 mg bid (standard dose). The primary aim was PFS from @entity1726 . @entity1 (pts) with histologically proven advanced @entity157 unsuitable for loco-regional therapies, @entity1 -Pugh class A/B @entity82 , were randomized 1:1 to increased-dose S + BSC vs BSC. Written informed consent was obtained from all pts. S was continued until disease progression or unacceptable @entity137 . RESULTS: From April 2007 to July 2008, 300 pts were prospectively treated with S 400 mg bid. At documented @entity1726 , 101 pts (34%) were randomized: 49 pts (48.5%) to increased-dose S (600 mg bid) + BSC and 52 pts (51.5%) to BSC. Baseline characteristics: male (83%), @entity1 -Pugh status A (93%), no extra hepatic spread (58%). In the S arm 41/49 (84%) pts were evaluable for drug exposure: 19 pts (46%) required no dose reduction, 15 pts (37%) received 75-99% of the planned dose, 3 pts (7%) 50-74% and 4 pts (10%) less than 50%. The table shows efficacy results. CONCLUSIONS: Increased-dose S in @entity157 @entity1 progressing on standard dose S is feasible. These promising results on PFS suggest that increased-dose S may be used as a control arm in phase II-III trials evaluating new drugs as second line therapy in @entity157 . [Table: see text].

Phase II randomized trial on dose-escalated sorafenib (S) versus best supportive care (BSC) in XXXX with @entity157 ( @entity157 ) with disease progression on prior S treatment.

@entity1 :: ('9606', 'Species') :: ['Child', 'Patients', 'patients'] @entity82 :: ('MESH:D005355', 'Disease') :: ['cirrhosis'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity1726 :: ('OMIM:168600', 'Disease') :: ['PD'] @entity157 :: ('MESH:D006528', 'Disease') :: ['HCC']
@entity1 :: (9606,Species) :: ['patients']
