Background Gene expression profiling (GEP) testing can help predict the risk of cancer recurrence and guide decisions about adjuvant chemotherapy for breast cancer. However, no prior US studies have evaluated the relationship between GEP testing and the use of adjuvant chemotherapy by women treated in general oncology practice. Methods Eligible patients were women under 65 newly diagnosed with their first stage I or II, hormone-receptor positive breast cancer between 2006–2011 (n=9,405). We conducted a retrospective study using a dataset consisting of registry data, health claims data, and GEP testing results. We report the distribution of GEP test results in terms of risk of recurrence predicted, and used logistic regression to assess the association of test results with chemotherapy use adjusting for multiple patient characteristics. Results The proportions of tested women with low, intermediate, and high Recurrence Score results were 51%, 39%, and 10%, respectively. Among these women, 11%, 47%, and 88% received adjuvant chemotherapy, respectively. There was a significant, positive linear relationship of assay scores with chemotherapy use within the low and intermediate sub-groups after adjusting for all other factors (adjusted ORs = 1.17 and 1.20, respectively). Conclusion Adjuvant chemotherapy use following GEP testing is generally consistent with recommended test interpretation for women at high or low predicted risk of recurrence. Chemotherapy use in the intermediate risk group increased with Recurrence Score values, and evidence from ongoing randomized trials may help clarify whether this finding reflects optimal interpretation of GEP test results. These results demonstrate the principle that genomic testing, given research establishing its utility, can be applied appropriately in general practice following guideline recommendations.

Our claims-based cohort study suggests a potentially elevated TE risk with different IG products and shows importance of recipient factors such as older age, previous TE, hypercoagulable state(s), and other health conditions. The results of this study suggest the need for continuous evaluation of procoagulant activity and manufacturing processes for IG products to further assure their safety.

son SA, Menis MD. Clotting factor product administration and same-day occurrence of thrombotic events, as recorded in a large healthcare database during 2008. J Thromb Haemost. 2015 13: 2168-79. Summary: Background: Thrombotic events (TEs) are serious adverse events that can occur following administration of clotting factors (CFs). Objectives: To evaluate occurrence of same-day TEs for different CF products and potential risk factors. Methods: A retrospective cohort study of individuals exposed to CF products during 2008-2013 was conducted using a large commercial insurance database. CF products were identified by procedure codes, and TEs were ascertained via diagnosis codes. Crude same-day TE rates (per 1000 persons exposed) were estimated overall and by congenital factor deficiency (CFD) status, CF products, age and gender. Multivariable logistic regression analyses were used to control for confounding. Laboratory analysis was used to compare the procoagulant activities of FIX products. Results: Of 3801 individuals exposed to CFs, 117 (30.8 per 1000) had same-day TEs recorded. The crude same-day TE rate was higher for CF users without CFD, 70.2 (102 of 1452), as compared with those with CFD, 6.4 (15 of 2349) (RR, 11.0; 95% CI,). For individuals without CFD, a significantly increased same-day TE risk was identified for factor IX complex (OR, 6.92; 95% CI, 3.11-15.40), factor VIIa (OR, 9.42; 95% CI, 4.99-17.78) and other products when compared with fibrin sealant. An increased risk of a TE was found with older age (≥ 45 years), history of TEs and underlying health conditions. The laboratory identified elevated procoagulant activity in Profilnine Ò and Benefix Ò. Conclusions: The study shows an increased same-day TE risk for CF users without CFD and suggests substantial off-label CF use. The study findings also show elevated same-day TE rates for different CF products and suggest the importance of product properties and patient factors.

Background Four practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone-receptor positive, HER2 negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women under age 65. Patients and Methods Data from five state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9444 commercially-insured women under age 65, newly-diagnosed with Stage I or II hormone-receptor positive breast cancer from 2006–2012. Results Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P < .001), included being diagnosed from 2008–2012 vs. 2006–2007 (adjusted odds ratio, 1.67; 95% CI, 1.47 to 1.90), having preexisting comorbidities (adjusted odds ratio, 1.35; 95% CI, 1.14 to 1.59), and higher out-of-pocket pharmacy costs (adjusted odds ratio, 1.66; 95% CI, 1.40 to 1.97). Women under age 50 were more likely to be tested if they had Stage I vs. Stage II disease (P < .0001). Conclusions In an insured population of women under age 65, GEP testing increased following its inclusion in guidelines and mounting evidence. Additional research is needed to better understand oncologists’ decision not to order GEP testing for their patients who are otherwise eligible.

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