Search

PURPOSE: To compare a full-dose epirubicin-cyclophosphamide (HEC) regimen with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) therapy and with a moderate-dose epirubicin-cyclophosphamide regimen (EC) in the adjuvant therapy of node-positive breast cancer. PATIENTS AND METHODS: Node-positive breast cancer patients who were aged 70 years or younger were randomly allocated to one of the following treatments: CMF for six cycles (oral cyclophosphamide); EC for eight cycles (epirubicin 60 mg/m(2), cyclophosphamide 500 mg/m(2); day 1 every 3 weeks); and HEC for eight cycles (epirubicin 100 mg/m(2), cyclophosphamide 830 mg/m(2); day 1 every 3 weeks). RESULTS: Two hundred fifty-five, 267, and 255 eligible patients were treated with CMF, EC, and HEC, respectively. Patient characteristics were well balanced among the three arms. One and three cases of congestive heart failure were reported in the EC and HEC arms, respectively. Three cases of acute myeloid leukemia were reported in the HEC arm. After 4 years of median follow-up, no statistically significant differences were observed between HEC and CMF (event-free survival [EFS]: hazards ratio [HR] = 0.96, 95% confidence interval [CI], 0.70 to 1.31, P =.80; distant-EFS: HR = 0.97, 95% CI, 0.70 to 1.34, P =.87; overall survival [OS]: HR = 0.97, 95% CI, 0.65 to 1.44, P =.87). HEC is more effective than EC (EFS: HR = 0.73, 95% CI, 0.54 to 0.99, P =.04; distant-EFS: HR = 0.75, 95% CI, 0.55 to 1.02, P =.06; OS HR = 0.69, 95% CI, 0.47 to 1.00, P =.05). CONCLUSION: This three-arm study does not show an advantage in favor of an adequately dosed epirubicin-based regimen over classical CMF in the adjuvant therapy of node-positive pre- and postmenopausal women with breast cancer. Moreover, this study confirms that there is a dose-response curve for epirubicin in breast cancer adjuvant therapy., Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, info:eu-repo/semantics/published

BACKGROUND: The predictive role of HER-2 in node-positive breast cancer patients receiving CMF or an anthracycline-based adjuvant therapy remains unclear. In addition, topo-isomerase II alpha (topo IIalpha), as the cellular target of anthracyclines, might have value as a predictive marker. PATIENTS AND METHODS: Four hundred eighty-one archival primary tumor samples were collected among 777 patients entered into a multicenter phase III trial comparing classical CMF with epirubicin cyclophosphamide (HEC) as adjuvant therapy of node-positive breast cancer. HER-2 was evaluated by immunohistochemistry (IHC) using different antibodies (Abs). Topo IIalpha was evaluated by IHC using the Ab KiS 1. In each subgroup of patients identified by HER-2 and topo IIalpha, adjusted hazard ratios for event-free survival (EFS) and the corresponding 95% confidence intervals have been calculated for the different study comparisons. An interaction test has been performed to investigate the role of HER-2 and topo IIalpha as predictive markers. RESULTS: When HER-2 was evaluated by CB-11 and 4D5 mAbs, the EFS adjusted hazard ratios (HR) for the main study comparison HEC vs. CMF were: HER-2 positive: 0.33 (95% confidence interval (95% CI): 0.09 1.27, P = 0.08), HER-2 negative: 1.16 (95%, CI: 0.71-1.90, P = 0.56); the P-value for the interaction test was 0.10. When HER-2 was evaluated by TAB-250 + pAbl Abs, the adjusted HR for the same comparison were: HER-2 positive: 1.06 (95% CI: 0.45-2.52, P = 0.90), HER-2 negative: 0.99 (95% CI: 0.58-1.68, P = 0.97); the P-value for the interaction test was 0.84. With regard to topo IIalpha, the adjusted HR for the EFS comparison HEC vs. CMF were: topo IIalpha positive: 0.66 (95% CI: 0.32-1.36, P = 0.25), topo IIalpha negative: 1.26 (95% CI: 0.63-2.50, P = 0.51); the P-value for the interaction test was 0.13. CONCLUSIONS: This study suggests that in node-positive breast cancer patients randomly treated with CMF or an epirubicin-based regimen, the predictive, Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

A brief history of casemix systems in Belgium All Belgian citizens are today covered by the social security system (following the Bismarck model), which is mainly financed through employment-related social contributions and general taxation. The health care system is regulated by the state and managed by INAMI (the National Institute against Illness and Disability). In INAMI, mutualities and representatives of medical professionals negotiate medical services, such as procedures and drugs, included in the nomenclature. For each service, a national fee and percentage of reimbursement is determined. Fees cover full costs and are owed to the physician, who is paid by service for ambulatory care, outpatient and inpatient care. The Ministry (Federal Public Service) of Public Health defines the price of a day's stay for each hospital, based upon its infrastructure, accommodation and nursing care (45 percent of hospital financing). This price is based on the advice of several committees, including members of the hospital administration, physicians, and financial partners. Physicians' activities in hospitals are covered by the reimbursement of fees for services (41 percent of hospital financing) and drugs by fees (14 percent). Inside each hospital, physicians negotiate with the medical and financial managers to determine the portion of their fees retained for overhead costs (equipment, materials, infrastructure, worker s, etc.). This open hospital financing system (by day and by service), which operates without a predetermined budget, has generated a rapid increase in the number of days, medical services and procedures performed, resulting in an exponential growth in the overall cost.

The economic burden of hip fractures is thought to be important, but the excess medical costs they induce remain largely unknown. We assessed the direct medical costs induced by hip fractures during and after hospitalization. Hospital costs of 170 consecutive Belgian women with hip fracture were gathered. During the year following discharge, all medical costs were collected for the 159 hip fracture women who survived the acute hospitalization stay. A similar collection of data was performed on a comparison group of 159 age-and residence-matched women without a history of hip fracture. The mean cost of the acute hospital stay was 8,667 Belgian francs and the mean 1-year hip-fracture-related extra costs after hospitalization was 6,636 Belgian francs. During the year following the acute hospital stay, 19% of the hip fracture women and 4% of the comparison women were newly admitted to nursing homes (p<0.001). Although health care costs increased with age, hip-fracture-related extra costs after hospitalization seemed similar in those below or above 81 years old. These extra costs amounted to 7,710 Belgian francs in women not living in nursing homes at the time of fracture, and to 3,479 Belgian francs in women who lived in nursing homes. Health or mental status before hip fracture seemed not to affect extra costs. Taking into account the higher mortality of women with hip fracture, the extra costs during the acute hospital stay and during the 1-year follow-up amounted to a mean 15,151 Belgian francs. In conclusion, both acute hospital stays and subsequent medical care contribute significantly to medical costs induced by hip fractures.

AIMS: As the West of Scotland Coronary Prevention Study (WOSCOPS) was conducted in Scotland, a country well-known for its high cardiovascular risk, the generalizability of its findings on pravastatin's clinical and economic effects has been questioned. This study examines the legitimacy of this concern, using Belgium as a case study. METHODS AND RESULTS: Local information on the prevalence and clustering of risk factors in individual patients was used in a risk equation to estimate the reference risk in Belgium. In contrast to prevailing beliefs, this risk was shown to coincide with the trial population's risk. As the relative risk reduction documented in a trial should apply across populations, the health benefits observed in WOSCOPS can clearly be extrapolated. This information in combination with local costs was then used to assess the economic efficiency of primary prevention with pravastatin in Belgium by means of a previously developed model. In parallel with the original estimates for the United Kingdom, the cost-effectiveness ratios remain well within the range of what is considered strong to moderate evidence for adoption and appropriate utilization, over a wide range of input values. CONCLUSION: This study demonstrates that the clinical and economic findings from WOSCOPS can indeed be generalized to other populations.

The economic burden of hip fractures is thought to be important, but the excess medical costs they induce remain largely unknown. We assessed the direct medical costs induced by hip fractures during and after hospitalization. Hospital costs of 170 consecutive Belgian women with hip fracture were gathered. During the year following discharge, all medical costs were collected for the 159 hip fracture women who survived the acute hospitalization stay. A similar collection of data was performed on a comparison group of 159 age- and residence-matched women without a history of hip fracture. The mean cost of the acute hospital stay was £8667, and the mean 1-year hip-fracture-related extra costs after hospitalization was £6636. During the year following the acute hospital stay, 19% of the hip fracture women and 4% of the comparison women were newly admitted to nursing homes (p < 0.001). Although health care costs increased with age, hip-fracture-related extra costs after hospitalization seemed similar in those below or above 81 years old. These extra costs amounted to £7710 in women not living in nursing homes at the time of fracture, and to £3479 in women who lived in nursing homes. Health or mental status before hip fracture seemed not to affect extra costs. Taking into account the higher mortality of women with hip fracture, the extra costs during the acute hospital stay and during the 1-year follow-up amounted to a mean £15,151. In conclusion, both acute hospital stays and subsequent medical care contribute significantly to medical costs induced by hip fractures., SCOPUS: ar.j, info:eu-repo/semantics/published

Mémoire réalisé dans le cadre de l'obtention du diplôme de 2e cycle :Licence en Sciences Psychologiques et Pédagogiques, info:eu-repo/semantics/nonPublished

Making an effort to control health expenditure's escalation, especially in hospital, the Belgian government is planning and experimenting with prospective budgeting. A research financed by the Ministry of Public Health allows us to point out the structure of the pathologies treated as well as other variables included in the medical MBDS like urgency, number of diseased systems, ... and explains a high percentage of the variance (62%) in drugs expenditures of the surgical cases. These variables have to be used in order to calibrate hospital drugs budgets. The Interdisciplinary Centre in Health Economics has developed tools to compare drugs prescriptions by type of surgical procedures in order to help hospitals to evaluate their performance should such drugs budgets be progressively introduced.

Methodological differences and variations in health care regulations among countries often preclude direct comparisons of cost-effectiveness studies. A projected risk model was applied, designed to determine the economic value in the United States of pravastatin in the secondary prevention of coronary heart disease (CHD), to Belgium using local health care costs. A Markov process was used to model the effectiveness of treatment for 3 years with pravastatin versus placebo in 1000 male CHD patients aged 60 years and clinically similar to those in the pravastatin limitation of atherosclerosis in the coronary arteries (PLAC I) and pravastatin, lipids and atherosclerosis in the carotid arteries (PLAC II) studies. The PLAC I and II trials have shown that pravastatin treatment for 3 years at a weighted mean dose of 36.64 mg daily significantly reduced the incidence of non-fatal myocardial infarction in patients with CHD. Framingham data were used to project the risk of mortality 10 years post-myocardial infarction. The incremental cost per life year gained (LYG), after discounting costs and benefits by 5% annually, in the setting of Belgian health care regulations, was Belgian francs (BEF) 720 794 (US$ 24 359) for CHD patients with one additional risk factor; BEF 526 464 (US$ 17 792) for those with two additional risk factors; and BEF 392 765 (US$ 13 274) for those with three or more additional risk factors. The cost per LYG in Belgium appeared to be more sensitive to drug acquisition cost than to costs of medical interventions. The cost-effectiveness ratios of pravastatin monotherapy for 3 years in secondary prevention of CHD, obtained with the same projected risk model, are from 86 to 92% higher in Belgium than in the United States, due to differences in medical patterns of practice and in intervention costs. (C) 1998 Elsevier Science Ireland Ltd. All rights reserved.