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 ("off-label/unsupported"). Hospitalization/emergency department (ED) admission rates were compared. RESULTS: A total of 13,347 women were treated with 16,127 regimens (12% of women switched regimen); 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 (P<.0001). Drugs never included in the NCCN Guidelines for Breast Cancer accounted for 19% of off-label/unsupported use (1% of total use). CONCLUSIONS: Off-label use without scientific support was not common, 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 activity across cancer sites, and therefore understanding the implications of such use is critical.
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 ("off-label/unsupported"). Hospitalization/emergency department (ED) admission rates were compared. RESULTS: A total of 13,347 women were treated with 16,127 regimens (12% of women switched regimen); 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 (P<.0001). Drugs never included in the NCCN Guidelines for Breast Cancer accounted for 19% of off-label/unsupported use (1% of total use). CONCLUSIONS: Off-label use without scientific support was not common, 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 activity across cancer sites, and therefore understanding the implications of such use is critical.
Authors: Rena M Conti; Arielle C Bernstein; Victoria M Villaflor; Richard L Schilsky; Meredith B Rosenthal; Peter B Bach Journal: J Clin Oncol Date: 2013-02-19 Impact factor: 44.544
Authors: Jennifer L Lund; Til Stürmer; Linda C Harlan; Hanna K Sanoff; Robert S Sandler; Maurice Alan Brookhart; Joan L Warren Journal: Med Care Date: 2013-05 Impact factor: 2.983
Authors: Kendra L Schwartz; Michael S Simon; Lauren C Bylsma; Julie J Ruterbusch; Jennifer L Beebe-Dimmer; Neil M Schultz; Scott C Flanders; Arie Barlev; Jon P Fryzek; Ruben G W Quek Journal: Cancer Date: 2018-03-05 Impact factor: 6.860
Authors: Donna R Rivera; Clara J K Lam; Lindsey Enewold; Valentina I Petkov; Quyen Tran; Sean Brennan; Lois Dickie; Timothy S McNeel; Annie M Noone; Bradley Ohm; Dolly P White; Joan L Warren; Angela B Mariotto; Lynne Penberthy Journal: J Natl Cancer Inst Monogr Date: 2020-05-01
Authors: Mark K Greenwald; Julie J Ruterbusch; Jennifer L Beebe-Dimmer; Michael S Simon; Terrance L Albrecht; Ann G Schwartz Journal: Cancer Date: 2018-11-02 Impact factor: 6.860