Abstract
e15150 Background: This study evaluated the rates of and reasons for trx modifications and occurrence of adverse events (AEs) amongst pts treated with the angiogenesis inhibitor (AI) SU in UK clinical practice. Methods: Data from medical records were retrospectively abstracted at three large UK oncology centers for advanced RCC pts who were ≥18 years and received SU (N=132) as 1st-line AI trx from 1/1/2005 to 11/15/2010; prior cytokine therapy was permitted. The proportion of pts and reasons for trx modification, i.e. discontinuation, interruption, or dose change were determined. Timing of trx modifications and the proportion of pts with all grade and grade 3/4 AEs were also determined. Data on clinician assessed response rates were collected. Results: 91% of pts had not received cytokine therapy. Mean daily dose over initial cycle was 31.23 mg; 73.5% of pts started trx with dosing of 50 mg QD 4/2. Tumor response assessments were available for 96 pts among which 38.5% had an objective response (complete or partial response). 85.6% of pts treated experienced AEs (grades 3/4 24.2%). The 3 most commonly reported all grade AEs were mucositis/stomatitis (42.4%), diarrhea (38.6%), and fatigue (28.0%). 87.1% of pts experience ≥1 trx modification. Among pts who discontinued trx, 34.5% discontinued within 18 weeks (w), 14.8% within 0-6 w, 6.6% in 7-12 w, and 13.1% in 13-18 w. Median 1st-line AI trx duration was 6.5 months among those who discontinued trx. Conclusions: This study of 132 advanced RCC pts treated with SU revealed that a large proportion of pts experienced AEs and trx modifications due to AEs. Dose reduction was the most commonly used form of trx modification for AEs in comparison to trx interruption or trx discontinuation. The results from this study suggest that SU tolerability is a challenge for clinicians in the treatment of advanced RCC pts. Validation of these results using a larger sample is warranted. Trx patterns, n (%) SU N=132 Pts with trx discontinuation 61 (46.2) Due to progressive disease 27 (20.5) Due to AEs 25 (18.9) Pts with trx interruption 48 (36.4) Due to AEs 34 (25.8) Pts with dose reduction 63 (47.7) Due to AEs 56 (42.4) Pts with ≥1 any of the above trx modifications due to AEs 82 (62.1)
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