Prevalence of off-label use of oral oncolytics at a community cancer center.

Purpose: 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.

Conclusion: 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.