PMID- 21435216 OWN - NLM STAT- MEDLINE DCOM- 20110801 LR - 20220318 IS - 1471-2407 (Electronic) IS - 1471-2407 (Linking) VI - 11 DP - 2011 Mar 24 TI - Safety and treatment patterns of multikinase inhibitors in patients with metastatic renal cell carcinoma at a tertiary oncology center in Italy. PG - 105 LID - 10.1186/1471-2407-11-105 [doi] AB - BACKGROUND: Multikinase inhibitors (MKIs) sunitinib and sorafenib have become a standard of care for metastatic renal cell carcinoma (mRCC). This study assessed safety and treatment patterns for these agents in a real-world clinical practice setting in Italy. METHODS: A retrospective medical record review was performed at a tertiary oncology center in Italy. The study included MKI-naive non-trial patients >/=18 years old, with a histological diagnosis of mRCC, and who received sunitinib or sorafenib as first MKI during 9/2005-7/2008. Data were collected on adverse events (AEs), treatment modifications (discontinuations, interruptions, dose changes), and reasons for these modifications. RESULTS: 145 patients were included; 85 received sunitinib and 60 received sorafenib as first-line MKI. Median treatment duration was 6.6 (sunitinib) and 5.8 (sorafenib) months. 97.6% and 70.0% of patients receiving sunitinib and sorafenib, respectively, experienced >/=1 AE; 27.1% and 31.7% had >/=1 grade 3/4 AE. The most common any grade AE for sunitinib was fatigue/asthenia (81.2%), followed by mucositis/stomatitis (58.8%) and decreased taste sensation (42.4%), while for sorafenib this was fatigue/asthenia (43.3%) followed by hand-foot syndrome (38.3%) and diarrhea (31.7%). Treatment discontinuation, interruption, and dose reduction due to AEs occurred in 11.8%, 23.5%, and 30.6%, respectively, of patients receiving sunitinib, and 5.0%, 23.3%, and 36.7%, respectively, of patients receiving sorafenib. CONCLUSIONS: In this retrospective study, most patients experienced >/=1 AE during first-line MKI treatment. AEs were reported frequently and resulted in treatment modifications in 40% of patients receiving sunitinib and 45% of patients receiving sorafenib. These results suggest a need for additional effective and more tolerable treatments for mRCC. FAU - Porta, Camillo AU - Porta C AD - Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Piazzale C, Golgi 19, 27100 Pavia, Italy. c.porta@smatteo.pv.it FAU - Paglino, Chiara AU - Paglino C FAU - Imarisio, Ilaria AU - Imarisio I FAU - Canipari, Cinzia AU - Canipari C FAU - Chen, Kristina AU - Chen K FAU - Neary, Maureen AU - Neary M FAU - Duh, Mei Sheng AU - Duh MS LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20110324 PL - England TA - BMC Cancer JT - BMC cancer JID - 100967800 RN - 0 (Benzenesulfonates) RN - 0 (Indoles) RN - 0 (Phenylurea Compounds) RN - 0 (Protein Kinase Inhibitors) RN - 0 (Pyridines) RN - 0 (Pyrroles) RN - 25X51I8RD4 (Niacinamide) RN - 9ZOQ3TZI87 (Sorafenib) RN - V99T50803M (Sunitinib) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Benzenesulfonates/administration & dosage/adverse effects MH - Carcinoma/*drug therapy/pathology/physiopathology MH - Fatigue/etiology/prevention & control MH - Female MH - Humans MH - Indoles/administration & dosage/adverse effects MH - Italy MH - Kidney Neoplasms/*drug therapy/pathology/physiopathology MH - Male MH - Middle Aged MH - Neoplasm Metastasis MH - Niacinamide/analogs & derivatives MH - Oncology Service, Hospital MH - Phenylurea Compounds MH - Protein Kinase Inhibitors/administration & dosage/adverse effects MH - Pyridines/administration & dosage/adverse effects MH - Pyrroles/administration & dosage/adverse effects MH - Sorafenib MH - Sunitinib MH - Treatment Outcome PMC - PMC3079688 EDAT- 2011/03/26 06:00 MHDA- 2011/08/02 06:00 PMCR- 2011/03/24 CRDT- 2011/03/26 06:00 PHST- 2010/06/07 00:00 [received] PHST- 2011/03/24 00:00 [accepted] PHST- 2011/03/26 06:00 [entrez] PHST- 2011/03/26 06:00 [pubmed] PHST- 2011/08/02 06:00 [medline] PHST- 2011/03/24 00:00 [pmc-release] AID - 1471-2407-11-105 [pii] AID - 10.1186/1471-2407-11-105 [doi] PST - epublish SO - BMC Cancer. 2011 Mar 24;11:105. doi: 10.1186/1471-2407-11-105.