Dataset Information

Longitudinal Changes in Volumetric Breast Density with Tamoxifen and Aromatase Inhibitors.

ABSTRACT: Background: Reductions in breast density with tamoxifen and aromatase inhibitors may be an intermediate marker of treatment response. We compare changes in volumetric breast density among breast cancer cases using tamoxifen or aromatase inhibitors (AI) to untreated women without breast cancer.Methods: Breast cancer cases with a digital mammogram prior to diagnosis and after initiation of tamoxifen (n = 366) or AI (n = 403) and a sample of controls (n = 2170) were identified from the Mayo Clinic Mammography Practice and San Francisco Mammography Registry. Volumetric percent density (VPD) and dense breast volume (DV) were measured using Volpara (Matakina Technology) and Quantra (Hologic) software. Linear regression estimated the effect of treatment on annualized changes in density.Results: Premenopausal women using tamoxifen experienced annualized declines in VPD of 1.17% to 1.70% compared with 0.30% to 0.56% for controls and declines in DV of 7.43 to 15.13 cm3 compared with 0.28 to 0.63 cm3 in controls, for Volpara and Quantra, respectively. The greatest reductions were observed among women with ?10% baseline density. Postmenopausal AI users had greater declines in VPD than controls (Volpara P = 0.02; Quantra P = 0.03), and reductions were greatest among women with ?10% baseline density. Declines in VPD among postmenopausal women using tamoxifen were only statistically greater than controls when measured with Quantra.Conclusions: Automated software can detect volumetric breast density changes among women on tamoxifen and AI.Impact: If declines in volumetric density predict breast cancer outcomes, these measures may be used as interim prognostic indicators. Cancer Epidemiol Biomarkers Prev; 26(6); 930-7. ©2017 AACR.

SUBMITTER: Engmann NJ

PROVIDER: S-EPMC5457346 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Longitudinal Changes in Volumetric Breast Density with Tamoxifen and Aromatase Inhibitors.

Engmann Natalie J NJ Scott Christopher G CG Jensen Matthew R MR Ma Lin L Brandt Kathleen R KR Mahmoudzadeh Amir Pasha AP Malkov Serghei S Whaley Dana H DH Hruska Carrie B CB Wu Fang Fang FF Winham Stacey J SJ Miglioretti Diana L DL Norman Aaron D AD Heine John J JJ Shepherd John J Pankratz V Shane VS Vachon Celine M CM Kerlikowske Karla K

Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology 20170201 6

Background: Reductions in breast density with tamoxifen and aromatase inhibitors may be an intermediate marker of treatment response. We compare changes in volumetric breast density among breast cancer cases using tamoxifen or aromatase inhibitors (AI) to untreated women without breast cancer.Methods: Breast cancer cases with a digital mammogram prior to diagnosis and after initiation of tamoxifen (n = 366) or AI (n = 403) and a sample of controls (n = 2170) we ...[more]

PMID: 28148596

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Project description:ImportanceTamoxifen is commonly used as adjuvant therapy in breast cancer and is proposed to interfere with cytochrome P450 enzyme and P-glycoprotein pathways. Concurrent use with direct oral anticoagulants (DOACs) poses the threat of a potentially dangerous drug-drug interaction by leading to an increase in hemorrhage risk.ObjectiveTo assess the risk of hemorrhage in patients with breast cancer coprescribed a DOAC and tamoxifen compared with a DOAC and an aromatase inhibitor (AI).Design, setting, and participantsThis population-based, retrospective cohort study was conducted among adults aged 66 years or older who were prescribed tamoxifen (compared with an AI) concurrently with a DOAC in Ontario, Canada, between June 23, 2009, and November 30, 2020, and followed up until December 31, 2020.InterventionsConcurrent prescription of a DOAC and tamoxifen compared with a DOAC and an AI.Main outcomes and measuresThe primary outcome was major hemorrhage requiring an emergency department visit or hospitalization after prescription. Overlap weighted Cox proportional hazards models, accounting for multiple covariates, were used to assess the association between hemorrhage and tamoxifen or AI use with a DOAC.ResultsAmong a total of 4753 patients (4679 [98.4%] women; mean [SD] age, 77.4 [7.4] years), 1179 (24.8%) were prescribed tamoxifen, and 3574 (75.2%) were prescribed an AI. Rivaroxaban (2530 [53.2%]) and apixaban (1665 [35.0%]) were the most frequently used DOACs. Patients taking AIs were younger than patients taking tamoxifen (mean [SD] age, 77.1 [7.3] vs 78.3 [7.6] years), with higher Charlson Comorbidity Index (mean [SD], 1.8 [2.4] vs 1.5 [2.2]) and more advanced cancer stage (stages III and IV, 569 [15.9%] vs 127 [10.8%]). During a median follow-up of 166 days (IQR, 111-527 days), tamoxifen was not associated with a higher risk of major hemorrhage (29 of 1179 [2.5%]) compared with an AI (119 of 3574 [3.3%]) when combined with a DOAC (absolute risk difference, -0.8%; weighted hazard ratio, 0.68 [95% CI, 0.44-1.06]). These results were similar in additional analyses using a more liberal definition of hemorrhage, accounting for kidney function, limiting follow-up to 90 days, stratifying by incident and prevalent DOAC users, and accounting for cancer duration and the competing risk of death.Conclusions and relevanceIn this cohort study, findings suggest that among DOAC users, the concurrent use of tamoxifen was not associated with a higher risk of hemorrhage compared with the concurrent use of an AI. These findings should directly inform prescribers regarding the apparent safety of concurrent DOAC and tamoxifen use.

Project description:BackgroundA key priority in developing policies for providing affordable cancer care is measuring the value for money of new therapies using cost-effectiveness analyses (CEAs). For CEA to be useful it should focus on relevant outcomes and include thorough investigation of uncertainty. Randomized controlled trials (RCTs) of five years of aromatase inhibitors (AI) versus five years of tamoxifen in the treatment of post-menopausal women with early stage breast cancer, show benefit of AI in terms of disease free survival (DFS) but not overall survival (OS) and indicate higher risk of fracture with AI. Policy-relevant CEA of AI versus tamoxifen should focus on OS and include analysis of uncertainty over key assumptions.MethodsWe conducted a systematic review of published CEAs comparing an AI to tamoxifen. We searched Ovid MEDLINE, EMBASE, PsychINFO, and the Cochrane Database of Systematic Reviews without language restrictions. We selected CEAs with outcomes expressed as cost per life year or cost per quality adjusted life year (QALY). We assessed quality using the Neumann checklist. Using structured forms two abstractors collected descriptive information, sources of data, baseline assumptions on effectiveness and adverse events, and recorded approaches to assessing parameter uncertainty, methodological uncertainty, and structural uncertainty.ResultsWe identified 1,622 citations and 18 studies met inclusion criteria. All CE estimates assumed a survival benefit for aromatase inhibitors. Twelve studies performed sensitivity analysis on the risk of adverse events and 7 assumed no additional mortality risk with any adverse event. Sub-group analysis was limited; 6 studies examined older women, 2 examined women with low recurrence risk, and 1 examined women with multiple comorbidities.ConclusionPublished CEAs comparing AIs to tamoxifen assumed an OS benefit though none has been shown in RCTs, leading to an overestimate of the cost-effectiveness of AIs. Results of these CEA analyses may be suboptimal for guiding policy.

Dataset Information

Longitudinal Changes in Volumetric Breast Density with Tamoxifen and Aromatase Inhibitors.

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Longitudinal Changes in Volumetric Breast Density with Tamoxifen and Aromatase Inhibitors.

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