Abstract

383 Background: This study evaluated rates of trx modifications and reasons for these changes among pts treated with angiogenesis inhibitors in Irish clinical practice. Methods: Data from medical records were retrospectively reviewed at 3 large oncology centers in Ireland for mRCC pts who were ≥ 18 years and received sunitinib (SU) (n=54), sorafenib (n=9), bevacizumab (n=6), or temsirolimus (n=7) as first-line trx from 1/1/2005 to 8/31/2010. Proportions of pts with trx discontinuation (d/c), interruption, or dose change, and reasons for modifications and time to modifications were determined. Results: Due to small sample sizes in other groups, only results for SU are summarized. 1.9% of pts had prior cytokine therapy. Median first-line trx duration for SU was 8.7 months (mo), while median progression-free survival was 13.8 mo. 87% of patients treated with first-line SU experienced adverse events (AEs); 18.5% experienced grade 3/4 AEs. AEs led to trx modifications in 42.6% of pts. 94.4% of pts started trx on 50 mg QD 4/2 dosing; 33.3% of them were dose reduced to 37.5 mg QD 4/2 with median time to reduction 2.7 mo. Among pts who discontinued trx, 31.6% discontinued within 18 weeks (w) (15.8% within 0-6 w, 7.9% in 7-12 w, and 7.9% in 13-18 w). Among pts who discontinued trx within 18 w, 66.7% discontinued due to AEs. Conclusions: Over three-quarters of SU pts experienced trx modifications, more than half due to AEs. About 24% of txt discontinuations occurred within the first two cycles. This real-world practice study suggests that treatment tolerability is a challenge for physicians in the clinical care of mRCC pts. [Table: see text] [Table: see text]

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