PMID- 23510293 OWN - NLM STAT- MEDLINE DCOM- 20140331 LR - 20130619 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 12 IP - 4 DP - 2013 Jul TI - Safety and treatment patterns of angiogenesis inhibitors in patients with advanced renal cell carcinoma in Spain. PG - 455-63 LID - 10.1517/14740338.2013.781581 [doi] AB - OBJECTIVE: To examine real-world safety and treatment patterns of angiogenesis inhibitors for advanced renal cell carcinoma (aRCC) using observational data from two Spanish hospitals. METHODS: A retrospective medical record review was performed for 93 patients with a histological diagnosis of aRCC who received sunitinib, sorafenib, bevacizumab or temsirolimus as first-line angiogenesis inhibitor therapy, between January 2005 and September 2010 at two Spanish hospitals. Data were collected on adverse events (AEs), dosing to calculate relative dose intensity (RDI), treatment modifications and reasons for modifications. RESULTS: Sixty patients received sunitinib, 23 received sorafenib, 6 received bevacizumab, 1 received temsirolimus and 3 received a bevacizumab-temsirolimus combination. 91.7 and 100.0% of patients receiving sunitinib and sorafenib, respectively, experienced >/= 1 AE; 40.0% and 43.5% had >/= 1 grade 3/4 AE. Mean RDI for sunitinib and sorafenib were 0.866 (standard deviation (std) = 0.903) and 0.798 (std = 2.154), respectively. Among patients receiving sunitinib, 15.0% discontinued treatment, 43.3% had an interruption and 33.3% had a reduction due to AEs. For sorafenib, these rates were 4.3, 56.5 and 34.8%, respectively. CONCLUSIONS: High rates of AEs were observed which resulted in high rates of treatment interruptions and dose reductions. These results suggest the need for additional treatment options for aRCC with improved tolerability. FAU - Castellano, Daniel AU - Castellano D AD - Hospital Universitario 12 de Octubre, Madrid, Spain. FAU - Duh, Mei Sheng AU - Duh MS FAU - Korves, Caroline AU - Korves C FAU - Suthoff, Ellison Dial AU - Suthoff ED FAU - Neary, Maureen AU - Neary M FAU - Hernandez Pastor, Luis Javier AU - Hernandez Pastor LJ FAU - Bellmunt, Joaquim AU - Bellmunt J LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20130320 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Angiogenesis Inhibitors) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/adverse effects/*therapeutic use MH - Carcinoma, Renal Cell/*blood supply/*drug therapy MH - Female MH - Humans MH - Kidney Neoplasms/*blood supply/*drug therapy MH - Male MH - Middle Aged MH - Retrospective Studies MH - Spain EDAT- 2013/03/21 06:00 MHDA- 2014/04/01 06:00 CRDT- 2013/03/21 06:00 PHST- 2013/03/21 06:00 [entrez] PHST- 2013/03/21 06:00 [pubmed] PHST- 2014/04/01 06:00 [medline] AID - 10.1517/14740338.2013.781581 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2013 Jul;12(4):455-63. doi: 10.1517/14740338.2013.781581. Epub 2013 Mar 20.