title: Prevalence of off-label use of oral oncolytics at a community cancer center.
abstract: OBJECTIVE
  Oral oncolytics are becoming increasingly utilized for cancer treatment, but the frequency of off-label oral oncolytic use is not well described. The extent of off-label oral oncolytic use is a concern because the clinical benefits of such use to patients may not outweigh adverse health outcomes or cost concerns.
  
  
  METHODS
  Prescription data for January 2011 through November 2013 from the St. Lukes Mountain States Tumor Institute (MSTI) Oral Chemotherapy program (OCP) was retrospectively analyzed. Use was classified as "on-label" if the cancer site, stage, and line of therapy met the FDA-approved indication. All other uses were classified as "off- label." Off-label use was further evaluated by whether it conformed to and was supported by National Comprehensive Cancer Network (NCCN) guideline recommendations.
  
  
  RESULTS
  Twelve hundred and six first-fill oral chemotherapy prescriptions were reviewed, representing 990 unique patients and 44 individual medications. On-label use amounted to 71% and off-label use amounted to 29%. Eighty-eight percent of off-label uses were supported by NCCN guideline recommendations. A total of 3.3% of all prescriptions analyzed were for off-label uses not supported by NCCN guideline recommendations. The top five oral chemotherapies prescribed for off-label uses were capecitabine, temozolomide, lenalidomide, abiraterone, and everolimus.
  
  
  CONCLUSIONS
  Oral chemotherapies are more often used on label than off label in current practice at our community cancer center. The majority of off-label use of oral oncolytics in this study was supported by NCCN guideline recommendations.
authors.affiliation: St. Lukes Mountain States Tumor Institute, Boise, ID kalis.joseph@gmail.com.
authors.forename: Joseph A
authors.initials: JA
authors.lastname: Kalis
authors.affiliation: St. Lukes Mountain States Tumor Institute, Boise, ID.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Pence
authors.affiliation: St. Lukes Mountain States Tumor Institute, Boise, ID.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mancini
authors.affiliation: St. Lukes Mountain States Tumor Institute, Boise, ID.
authors.forename: Dan S
authors.initials: DS
authors.lastname: Zuckerman
authors.affiliation: St. Lukes Mountain States Tumor Institute, Boise, ID.
authors.forename: Joseph R
authors.initials: JR
authors.lastname: Ineck
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002173:Cancer Care Facilities / Q000706:statistics & numerical data*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D056687:Off-Label Use / Q000706:statistics & numerical data*
chemical_list: D000970:Antineoplastic Agents