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AbstractObjective:The 21-gene assay (OncotypeDX Breast Cancer Test (Genomic Health Inc., Redwood City, CA)) is a well validated test that predicts the likelihood of adjuvant chemotherapy benefit and the 10-year risk of distant recurrence in patients with ER, HER2− early-stage breast cancer. The aim of this analysis was to evaluate the cost-effectiveness of using the assay to inform adjuvant chemotherapy decisions in Germany.Methods:A Markov model was developed to make long-term projections of distant recurrence, survival, quality-adjusted life expectancy, and direct costs for patients with ER, HER2−, node-negative, or up to 3 node-positive early-stage breast cancer. Scenarios using conventional diagnostic procedures or the 21-gene assay to inform treatment recommendations for adjuvant chemotherapy were modeled based on a prospective, multi-center trial in 366 patients. Transition probabilities and risk adjustment were based on published landmark trials. Costs (2011 Euros (€)) were estimated from a sick fund perspective based on resource use in patients receiving chemotherapy. Future costs and clinical benefits were discounted at 3 annually.Results:The 21-gene assay was projected to increase mean life expectancy by 0.06 years and quality-adjusted life expectancy by 0.06 quality-adjusted life years (QALYs) compared with current clinical practice over a 30-year time horizon. Clinical benefits were driven by optimized allocation of adjuvant chemotherapy. Costs from a healthcare payer perspective were lower with the 21-gene assay by ∼€561 vs standard of care. Probabilistic sensitivity analysis indicated that there was an 87 probability that the 21-gene assay would be dominant (cost and life saving) to standard of care.Limitations:Country-specific data on the risk of distant recurrence and quality-of-life were not available.Conclusions:Guiding decision-making on adjuvant chemotherapy using the 21-gene assay was projected to improve survival, quality-adjusted life expectancy, and be cost saving vs the current standard of care women with ER, HER2− early-stage breast cancer.

The insulin-like growth factor 1 (IGF1) and its binding protein IGFBP3 (insulin-like growth factor binding protein 3) play a pivotal role during the growth and development of tissues. The purpose of this study was to evaluate the influence of anthracycline- and taxane-containing adjuvant chemotherapy in breast cancer patients on the circulating plasma levels of IGF1 and its main binding protein, IGFBP3. This investigation was part of a prospective randomized phase III study in which breast cancer patients were treated with either conventional or dose-intensified adjuvant chemotherapy. The factors were quantified in the plasma of 151 patients with a commercially available sandwich enzyme immunoassay. Before therapy, both parameters were within the normal range in most patients (n=145 and n=144). After therapy, both factors had increased significantly by 29% (IGF1) and 19% (IGFBP3), with the highest increase being observed in the dose-intensified group. Correlations with patient and tumor characteristics revealed a relatively higher increase in both parameters in premenopausal patients, patients with lower-grade tumors, more positive lymph nodes, larger tumor volume, and positive hormone receptor status. No correlation was found with the HER2 expression of the tumors.

Abstract.: Objective: Color Doppler sonography (CD) was compared with other diagnostic imaging methods [mammography (MG), breast ultrasound (US) and magnetic resonance imaging (MRI)] in the planning of surgery for breast tumors. Materials and methods: 99 patients with breast cancer and 101 with ultimately benign breast lesions were examined preoperatively. The specificity and sensitivity were calculated, as well as the predictive values. Various qualitative and semi-quantitative CD parameters were also analysed for their diagnostic value. Results: The sensitivity/specificity of the various methods (in %) was: MG 85/77; US 95/80; CD 82/75; MRI 90/63. The positive predictive value (ppv)/negative predictive value (npv) (in %) was: MG 79/83; US 81/94; CD 72/84; MRI 79/63. The median maximum systolic flow velocity and the resistance index (RI) were significantly higher in breast cancer vessels than in benign lesions. The number of pulsating color pixels detected by CD was significantly higher for breast cancer. In cases of breast cancer significantly more blood flows were detected in the body of the tumor than at its periphery. Conclusion: Color Doppler sonography was not superior to other diagnostic methods for preoperative assessment of a breast lesion. The combination of all diagnostic procedures gave a correct classification rate of 93.3% and is much better than the correct classification of any single diagnostic imaging procedure.