PMID- 25115744
OWN - NLM
STAT- MEDLINE
DCOM- 20150402
LR  - 20211021
IS  - 1559-131X (Electronic)
IS  - 1357-0560 (Linking)
VI  - 31
IP  - 9
DP  - 2014 Sep
TI  - Use of "Real-World" data to describe adverse events during the treatment of 
      metastatic renal cell carcinoma in routine clinical practice.
PG  - 156
LID - 10.1007/s12032-014-0156-8 [doi]
AB  - Insights into the experience of metastatic renal cell carcinoma (mRCC) patients 
      are needed to optimize patient care. A retrospective, multicenter registry of 
      mRCC patients treated at academic (Duke) and community (ACORN) practices was 
      developed to fill this need. Treatment data were collected on 466 patients who 
      received first-line therapy from 2007 to 2011. Clinically significant adverse 
      events (AEs) were abstracted from medical records and compared to clinical 
      trials. Two hundred and seventy patients received first-line therapy with 
      sunitinib, 60 temsirolimus, 53 sorafenib, 25 pazopanib, and 58 "other." A total 
      of 85.8 % of all patients experienced at least one AE: fatigue (56.7 %), vomiting 
      (40.1 %), diarrhea (33.7 %), asthenia (32.8 %), and mucosal inflammation (20.8 
      %). When comparisons were made between patients >65 versus <65 years old, rates 
      of AEs were higher in the younger group. Dosing approaches and timing of AEs 
      during therapy were varied. These data shine light on the patient experience in 
      routine practice versus structured clinical trials. Real-world AE frequency and 
      severity differ from pivotal trials demonstrating the need to monitor patients 
      closely and manage their AEs to optimize outcomes. As the number of treatment 
      options with similar effectiveness grows, it is imperative to understand the 
      real-world patient experience.
FAU - Hirsch, Bradford R
AU  - Hirsch BR
AD  - Division of Medical Oncology, Duke University Medical Center, DUMC Box 17969, 
      Durham, NC, 27715, USA, bradford.hirsch@duke.edu.
FAU - Harrison, Michael R
AU  - Harrison MR
FAU - George, Daniel J
AU  - George DJ
FAU - Walker, Mark S
AU  - Walker MS
FAU - Chen, Connie
AU  - Chen C
FAU - Korytowsky, Beata
AU  - Korytowsky B
FAU - Stepanski, Edward
AU  - Stepanski E
FAU - Abernethy, Amy P
AU  - Abernethy AP
LA  - eng
PT  - Journal Article
DEP - 20140814
PL  - United States
TA  - Med Oncol
JT  - Medical oncology (Northwood, London, England)
JID - 9435512
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*administration & dosage/*adverse effects/*therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/epidemiology
MH  - *Databases, Factual
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/epidemiology
MH  - Male
MH  - Middle Aged
MH  - *Registries
MH  - Retrospective Studies
EDAT- 2014/08/15 06:00
MHDA- 2015/04/04 06:00
CRDT- 2014/08/14 06:00
PHST- 2014/06/05 00:00 [received]
PHST- 2014/07/29 00:00 [accepted]
PHST- 2014/08/14 06:00 [entrez]
PHST- 2014/08/15 06:00 [pubmed]
PHST- 2015/04/04 06:00 [medline]
AID - 10.1007/s12032-014-0156-8 [doi]
PST - ppublish
SO  - Med Oncol. 2014 Sep;31(9):156. doi: 10.1007/s12032-014-0156-8. Epub 2014 Aug 14.