Background: Prescribing drugs outside of the label indication is legal and may reflect standard practice; however, some off-label use may be inappropriate. This study measured the prevalence and safety of off-label use both in accordance with practice guidelines and inconsistent with practice guidelines in older patients with breast cancer. Patients and Methods: The SEER-Medicare data set was used to identify women diagnosed with breast cancer. Intravenous chemotherapy was identified using Medicare claims and classified as either on-label, off-label but included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer ("off-label/supported"). Or Off-label and Not Included in the NCCN Guidelines . Hospitalization/emergency Dept. Admission Rates Were Compared. Results: A Total of 13,347 Women Were Treated with 16,127 Regimens ; 64% of Regimens Were Off-label/supported, 25% Were On-label, and 11% Were Off-label/unsupported, and Hospitalization/ED Admission Occurred in 27%, 25%, and 32% of Regimens, Respectively . Drugs Never Included in the NCCN Guidelines for Breast Cancer Accounted for 19% of Off-label/unsupported Use . Conclusions: Off-label Use Without Sci. Support Was Not Com., whereas 64% of Use Was Off-label/supported, Reflecting the Fact That Widely Accepted Indications Are Often Not Tested in Registration Trials. Off-label/supported Use Will Likely Increase As More Drugs Are Expected to Have Activ. Across Cancer Sites, and Therefore Understanding the Implications of Such Use Is Critical.
|Original language||English (US)|
|Number of pages||9|
|Journal||JNCCN Journal of the National Comprehensive Cancer Network|
|State||Published - Jan 1 2016|
Bibliographical noteFunding Information:
From the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York. Submitted May 29, 2015; accepted for publication November 6, 2015. Ms. Eaton and Dr. Panageas have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors. Dr. Sima has disclosed that she is employed by Genentech, Inc. This work was partially supported by the Goldstein Fund and Core Grant (P30CA008748) awards. This work was previously presented as a poster at the 2012 San Antonio Breast Cancer Symposium. Correspondence: Anne A. Eaton, MS, Memorial Sloan Kettering Cancer Center, Department of Epidemiology and Biostatistics, 485 Lexington Avenue, 2nd Floor, New York, NY 10017. E-mail: firstname.lastname@example.org
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