Abstract
PurposeTo determine the level of off-label cancer therapy use in a population of female breast cancer patients and to establish whether this use was evidence-based.MethodsA study was conducted by sampling Cerner’s data warehouse for all women diagnosed with breast cancer between January 2000 and June 2009 who received at least one cancer therapy approved by the US-FDA during the study period. Drug encounters were considered off-label if the circumstances of use did not match the age or medical diagnoses specified on the product label at the time of study. The level of evidence for the use of these drugs in a breast cancer setting was evaluated from randomized phase III trials using a tiered approach.ResultsThe study included 2,663 women with a median age of 59 years. A total of 1,636 off-label encounters were recorded, representing 13.0% of all encounters. Of the 65 cancer therapies investigated, 55.4% were prescribed off-label. The drugs with the highest off-label use were, in a descending order, vinorelbine, carboplatin, bevacizumab, leuprolide, liposomal doxorubicin and cisplatin. Most off-label encounters were evidence-based and more likely to be associated with private insurance coverage, younger age, ethnicities other than Caucasian, smaller treatment centres and drugs with limited labeled indications that have a longer market history.ConclusionsOff-label prescribing is common practice in oncology and is an integral component of breast cancer treatment strategies. While this practice tends to be associated with specific socio-demographic factors and disease characteristics, the majority of off-label encounters appear to be evidence-based.
Highlights
All prescription drugs are labeled in accordance with the circumstances of use and evidence collected from randomized controlled clinical trials
Off-label use in breast cancer has been previously reported (United States General Accounting Office 1991; Delpeuch et al 2011), but only one study has focused on the off-label chemotherapeutic use in women over 65 years old diagnosed with breast cancer between 1991 and 2002 (Dean-Colomb et al 2009)
Number of drugs used beyond the label specifications Among the 107 drugs considered in this study, 43 chemotherapies and 22 other cancer therapies were administered to a population of 2,633 breast cancer patients totaling 14,586 drug encounters
Summary
All prescription drugs are labeled in accordance with the circumstances of use and evidence collected from randomized controlled clinical trials. Once a drug reaches the market, a physician may exert clinical judgement and prescribe drugs for other conditions or circumstances. This type of prescribing is considered 'off-label’ and has become part of mainstream medical practice extending beyond the specifications of the drug label (American Society of Clinical Oncology 2006; Poole & Dooley 2004; United States General Accounting Office 1991). Off-label use of chemotherapy has been reported, breast cancer patients are treated with a wide variety of agents which are not considered typical chemotherapies. Investigating the extent of off-label use, taking into consideration the broader range of therapies available and extending the analysis to the overall breast cancer population, regardless of age, may provide insight into the scope of this practice
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