ABSTRACT
BACKGROUND: We carried out a prospective clinical study to evaluate the impact of the Recurrence Score (RS) on treatment decisions in early breast cancer (EBC). PATIENTS AND METHODS: A total of 379 eligible women with estrogen receptor positive (ER+), HER2-negative EBC and 0-3 positive lymph nodes were enrolled. Treatment recommendations, patients' decisional conflict, physicians' confidence before and after knowledge of the RS and actual treatment data were recorded. RESULTS: Of the 366 assessable patients 244 were node negative (N0) and 122 node positive (N+). Treatment recommendations changed in 33% of all patients (N0 30%, N+ 39%). In 38% of all patients (N0 39%, N+ 37%) with an initial recommendation for chemoendocrine therapy, the post-RS recommendation changed to endocrine therapy, in 25% (N0 22%, N+ 39%) with an initial recommendation for endocrine therapy only to combined chemoendocrine therapy, respectively. A patients' decisional conflict score improved by 6% (P = 0.028) and physicians' confidence increased in 45% (P < 0.001) of all cases. Overall, 33% (N0 29%, N+ 38%) of fewer patients actually received chemotherapy as compared with patients recommended chemotherapy pre-test. Using the test was cost-saving versus current clinical practice. CONCLUSION: RS-guided chemotherapy decision-making resulted in a substantial modification of adjuvant chemotherapy usage in node-negative and node-positive ER+ EBC.
Subject(s)
Antineoplastic Agents, Hormonal/therapeutic use , Breast Neoplasms/drug therapy , Neoplasm Recurrence, Local/prevention & control , Antineoplastic Agents, Hormonal/economics , Breast Neoplasms/genetics , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Chemotherapy, Adjuvant , Cost-Benefit Analysis , Decision Making , Female , Humans , Lymphatic Metastasis , Markov Chains , Middle Aged , Neoplasm Recurrence, Local/genetics , Neoplasm Staging , Patient Care Planning , Prospective Studies , Receptors, Estrogen/metabolism , Surveys and QuestionnairesABSTRACT
AIMS: With the increasing availability of new drugs for the treatment of insulin resistance in patients with Type 2 diabetes, simple methods for their identification is an important challenge. The aim of our study was to compute a new algorithm for estimating insulin resistance in a routine clinical setting. METHODS: Clinical data and blood samples were collected from 4265 Type 2 diabetic patients from 149 clinical sites. A clinical algorithm to estimate insulin resistance was developed by stepwise multiple regression analysis. The new generated score was compared with the HOMAIR-score, calculated from fasting insulin and glucose levels measured in a central laboratory. In a subgroup of 48 patients, the score was verified against a frequently sampled intravenous glucose tolerance test with subsequent modified minimal model analysis according to Bergman. RESULTS: Multiple regression analysis revealed fasting blood glucose, BMI, triglycerides and HDL as the most powerful predictors of insulin resistance which were used for further computation of the IRIS II score. A significant overall correlation was found between the HOMAIR-score and the new clinical IRIS II score (r = 0.42; P < 0.0001). Compared with HOMAIR, the new score revealed a specificity of 0.95, a sensitivity of 0.34 and a positive predictive value of 0.95. This was in good agreement with the subset analysis of the intravenous glucose tolerance test, where a sensitivity of 0.37 and a specificity of 0.85 of the IRIS II score was calculated. Patients with insulin resistance according to the IRIS II score revealed an increased odds ratio for overall vascular complications (1.28; 1.11-1.46; P < 0.001). CONCLUSIONS: The new IRIS II score can identify insulin resistance in Type 2 diabetic patients with high predictive value and high specificity.
Subject(s)
Diabetes Mellitus, Type 2/metabolism , Diabetic Angiopathies/metabolism , Insulin Resistance/physiology , Algorithms , Blood Glucose/metabolism , Body Mass Index , Cholesterol, HDL/metabolism , Diabetes Mellitus, Type 2/etiology , Diabetic Angiopathies/etiology , Female , Glucose Tolerance Test , Humans , Hypertension/etiology , Hypertension/metabolism , Male , Middle Aged , Regression Analysis , Risk Factors , Sensitivity and Specificity , Triglycerides/metabolismABSTRACT
The objective of this retrospective analysis was the evaluation of direct/medical costs of immunosuppressive treatment with tacrolimus (FK 506) and cyclosporin A in liver transplantation. The analysis was based on data from the german centers of a pan-European clinical trial where all given drugs as well as all serious events, graft reactions and the number of transplantations were documented. The costs of the treatment with tacrolimus were DM 158,276 per patient; those for cyclosporin A were DM 176,392. The main reason for the difference was the amount and types of drugs administered. The direct costs per surviving patient were in the tacrolimus group DM 192,314 (20 of 113 patients) and in the cyclosporin A group DM 227,669 (25 of 111 patients). The cost-effectiveness ratio for tacrolimus is about 15.5% better than for cyclosporin A.
