UNASSIGNED: 465^ Background: Multiple targeted therapies have become available for @entity1358 over the past decade. @entity2857 is an orally active multikinase inhibitor which has been shown to improve progression free survival in low-risk and intermediate-risk status advanced clear-cell @entity1358 after previous systemic therapy. METHODS: Between May 2006 and December 2010, @entity1 with advanced @entity1358 with either clear cell or non-clear cell histopathology who had progressed on prior systemic chemotherapy or were treatment na  ve, ECOG performance status 0-2, commenced treatment with @entity2857 (400-mg twice daily continuously) through an expanded access clinical trial in two tertiary centres in Sydney and Melbourne. We report the pooled outcomes of these two studies. RESULTS: Total 47 @entity1 with metastatic @entity1358 were treated with @entity2857 . The median overall survival of advanced @entity1358 was 11.9 months. After median follow up of 51.3 months, the median PFS was 6.5 months. 38 @entity1 died by the time of analysis. Overall 1 @entity1 showed complete response (CR), 6 @entity1 (13%) had partial response (PR), and 29 @entity1 (62%) had stable disease (SD) as the best response. 8 (17%) had non-clear cell histopathology and 5 (10%) had sarcomatoid features. In non-clear cell cohort, 5 @entity1 (62.5%) showed SD. 23 (49%) @entity1 were treatment na  ve; 1/23 showed CR, 5/23 had PR and 13/23 had SD (clinical benefit: 83%). Overall 14 (30%) and 22 (47%) @entity1 had high risk status according to MSKCC and Heng prognostic scores, respectively. Median PFS for poor prognostic @entity1 was 5.1 and 4.2 months based on MSKCC and Heng scores, respectively. In MSKCC poor prognostic group, 1 @entity1 had CR, 2/14 showed PR and 8/14 had SD (clinical benefit: 79%). In Heng poor prognostic group, one @entity1 had CR, 2/22 showed PR and 13/22 had SD (clinical benefit: 73%). @entity2857 -related serious adverse events were seen in 10 @entity1 . The most common adverse events were @entity8566 (53%), @entity1910 (47%), @entity1295 (42%), @entity390 (40%), and @entity294 (32%). CONCLUSIONS: This study confirms the efficacy and tolerability of @entity2857 in a different spectrum of advanced @entity1358 @entity1 including non-clear cell histology, poor prognostic status and as first-line treatment. CLINICAL TRIAL INFORMATION: ACTRN12606000140550.

Efficacy of @entity2857 in advanced @entity1358 ( XXXX ) independent of prior treatment, histology, or prognostic group.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhoea'] @entity2857 :: ('MESH:C471405', 'Chemical') :: ['sorafenib', 'Sorafenib'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity1358 :: ('MESH:D002292', 'Disease') :: ['RCC'] @entity8566 :: ('MESH:D060831', 'Disease') :: ['hand-foot syndrome']
@entity1358 :: (MESH:D002292,Disease) :: ['RCC']
