title: Use of "Real-World" data to describe adverse events during the treatment of metastatic renal cell carcinoma in routine clinical practice.
abstract: 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.
authors.affiliation: Division of Medical Oncology, Duke University Medical Center, DUMC Box 17969, Durham, NC, 27715, USA, bradford.hirsch@duke.edu.
authors.forename: Bradford R
authors.initials: BR
authors.lastname: Hirsch
authors.forename: Michael R
authors.initials: MR
authors.lastname: Harrison
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: George
authors.forename: Mark S
authors.initials: MS
authors.lastname: Walker
authors.forename: Connie
authors.initials: C
authors.lastname: Chen
authors.forename: Beata
authors.initials: B
authors.lastname: Korytowsky
authors.forename: Edward
authors.initials: E
authors.lastname: Stepanski
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000453:epidemiology; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies
chemical_list: D000970:Antineoplastic Agents