PMID- 25045157 OWN - NLM STAT- MEDLINE DCOM- 20150923 LR - 20211021 IS - 2045-7634 (Electronic) IS - 2045-7634 (Print) IS - 2045-7634 (Linking) VI - 3 IP - 6 DP - 2014 Dec TI - Impact of adverse events, treatment modifications, and dose intensity on survival among patients with advanced renal cell carcinoma treated with first-line sunitinib: a medical chart review across ten centers in five European countries. PG - 1517-26 LID - 10.1002/cam4.302 [doi] AB - Angiogenesis inhibitors have become standard of care for advanced and/or metastatic renal cell carcinoma (RCC), but data on the impact of adverse events (AEs) and treatment modifications associated with these agents are limited. Medical records were abstracted at 10 tertiary oncology centers in Europe for 291 patients >/= 18 years old treated with sunitinib as first-line treatment for advanced RCC (no prior systemic treatment for advanced disease). Logistic regression models were estimated to compare dose intensity among patients who did and did not experience AEs during the landmark periods (18, 24, and 30 weeks). Cox proportional hazard models were used to explore the possible relationship of low-dose intensity (defined using thresholds of 0.7, 0.8, and 0.9) and treatment modifications during the landmark periods to survival. 64.4% to 67.9% of patients treated with sunitinib reported at least one AE of any grade, and approximately 10% of patients experienced at least one severe (grade 3 or 4) AE. Patients reporting severe AEs were statistically significantly more likely to have dose intensities below either 0.8 or 0.9. Dose intensity below 0.7 and dose discontinuation during all landmark periods were statistically significantly associated with shorter survival time. This study of advanced RCC patients treated with sunitinib in Europe found a significant relationship between AEs and dose intensity. It also found correlations between dose intensity and shorter survival, and between dose discontinuation and shorter survival. These results confirm the importance of tolerable treatment and maintaining dose intensity. CI - (c) 2014 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. FAU - Porta, Camillo AU - Porta C AD - IRCCS San Matteo University Hospital Foundation, Pavia, Italy. FAU - Levy, Antonin AU - Levy A FAU - Hawkins, Robert AU - Hawkins R FAU - Castellano, Daniel AU - Castellano D FAU - Bellmunt, Joaquim AU - Bellmunt J FAU - Nathan, Paul AU - Nathan P FAU - McDermott, Ray AU - McDermott R FAU - Wagstaff, John AU - Wagstaff J FAU - Donnellan, Paul AU - Donnellan P FAU - McCaffrey, John AU - McCaffrey J FAU - Vekeman, Francis AU - Vekeman F FAU - Neary, Maureen P AU - Neary MP FAU - Diaz, Jose AU - Diaz J FAU - Mehmud, Faisal AU - Mehmud F FAU - Duh, Mei Sheng AU - Duh MS LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20140718 PL - United States TA - Cancer Med JT - Cancer medicine JID - 101595310 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Indoles) RN - 0 (Pyrroles) RN - V99T50803M (Sunitinib) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/*administration & dosage/*adverse effects MH - Carcinoma, Renal Cell/blood supply/*drug therapy/pathology MH - Cohort Studies MH - Europe MH - Female MH - Humans MH - Indoles/*administration & dosage/*adverse effects MH - Kidney Neoplasms/blood supply/*drug therapy/pathology MH - Male MH - Middle Aged MH - Pyrroles/*administration & dosage/*adverse effects MH - Retrospective Studies MH - Sunitinib MH - Survival Analysis PMC - PMC4298378 OTO - NOTNLM OT - Angiogenesis OT - clinical observations OT - statistical methods OT - urological oncology EDAT- 2014/07/22 06:00 MHDA- 2015/09/24 06:00 PMCR- 2014/12/01 CRDT- 2014/07/22 06:00 PHST- 2014/02/20 00:00 [received] PHST- 2014/06/17 00:00 [revised] PHST- 2014/06/24 00:00 [accepted] PHST- 2014/07/22 06:00 [entrez] PHST- 2014/07/22 06:00 [pubmed] PHST- 2015/09/24 06:00 [medline] PHST- 2014/12/01 00:00 [pmc-release] AID - 10.1002/cam4.302 [doi] PST - ppublish SO - Cancer Med. 2014 Dec;3(6):1517-26. doi: 10.1002/cam4.302. Epub 2014 Jul 18.