ABSTRACT
Although the metastasic breast cancer is still an incurable disease, recent advances have increased significantly the time to progression and the overall survival. However, too much information has been produced in the last 2 years, so a well-based guideline is a valuable document in treatment decision making. The SEOM guidelines are intended to make evidence-based recommendations on how to manage patients with advanced and recurrent breast cancer to achieve the best patient outcomes based on a rational use of the currently available therapies. To assign a level of certainty and a grade of recommendation the United States Preventive Services Task Force guidelines methodology was selected as reference
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Subject(s)
Humans , Female , Breast Neoplasms/pathology , Neoplasm Recurrence, Local/pathology , Neoplasm Metastasis/pathology , Neoplasm Recurrence, Local/therapy , Breast Neoplasms/therapy , Quality of Life/psychology , Practice Patterns, Physicians'ABSTRACT
The coming into force of Directive 2001/20/EC represented a step forward in harmonising clinical trial regulation in European countries, guaranteeing a uniform protection of subjects participating in clinical research across Europe. However, it led to a disproportionate increase in the bureaucratization, and thus, it became evident that procedures needed to be simplified without detriment to patients safety. Thus, Regulation 536/2014, that repealed Directive 2001/20/EC, with the aim of decreasing the growing bureaucratization and stimulating clinical research in Europe, established simplified procedures, such as regulating a common procedure for authorising trials in Europe, the institution of strict assessment timelines, or the definition of new concepts, such as «low-intervention clinical trial». The legal form of a Regulation allowed the norm to be directly applied to Member States without the need for transposition. By means of the new Royal Decree, the national legislation is adapted to make the application of the regulation feasible and it allows the development of the aspects that the Regulation leaves to national legislation. Both documents seek to stimulate clinical research with medicinal products to foster knowledge, facilitate transparency, and reinforce subjects safety. This will surely be the case, but with this revision, we will look at the novelties and key aspects that are most relevant to investigators and we will analyse the consequences for all parties involved in clinical research (AU)
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Subject(s)
Humans , Male , Female , Clinical Trials as Topic/legislation & jurisprudence , Patient Freedom of Choice Laws/standards , Legal Intervention , Controlled Before-After Studies/legislation & jurisprudence , Compensation and Redress/legislation & jurisprudence , 51725/legislation & jurisprudence , Biomedical Research/legislation & jurisprudence , Clinical Trials Data Monitoring Committees/legislation & jurisprudence , Health Care Coordination and Monitoring , Helsinki Declaration , European Union/organization & administrationABSTRACT
PURPOSE: To estimate the cost per skeletal-related event (SRE) in patients with bone metastases secondary to solid tumours in the Spanish healthcare setting. METHODS: Patients diagnosed with bone metastases secondary to breast, prostate or lung cancer were included in this multicentre, observational study. SREs are defined as pathologic fracture (vertebral and non-vertebral fracture), radiation to bone, spinal cord compression or surgery to bone. Health resource utilisation associated with these events (inpatient stays, outpatient, emergency room and home health visits, nursing home stays and procedures) were collected retrospectively for all SREs that occurred in the 97 days prior to enrolment and prospectively during follow-up. Unit costs were obtained from the 2010 eSalud healthcare costs database. RESULTS: A total of 93 Spanish patients with solid tumours were included (31 had breast cancer, 21 prostate cancer and 41 lung cancer), contributing a total of 143 SREs to this cost analysis. Inpatient stays (between 9.0 and 29.9 days of mean length of stay per inpatient stay by SRE type) and outpatient visits (between 1.7 and 6.4 mean visits per SRE type) were the most frequently reported types of health resources utilised. The mean cost per SRE was between
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Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Bone Neoplasms/economics , Breast Neoplasms/pathology , Costs and Cost Analysis , Lung Neoplasms/pathology , Prostatic Neoplasms/pathology , SpainABSTRACT
INTRODUCTION: The randomised controlled trial BCIRG001 has recently demonstrated that docetaxel in combination with doxorubicin and cyclophosphamide (TAC) has better efficacy than the standard treatment (FAC, i.e., 5-fluorouracil, doxorubicin and cyclophosphamide) in the adjuvant treatment of patients with node-positive breast cancer. The cost-effectiveness of TAC vs. FAC in the Spanish setting is analysed. PATIENTS AND METHODS: Clinical outcomes from trial BCIRG001 were combined with Spanish costs and longterm efficacy of FAC and TAC extrapolated up to 5 years by means of a Markov model. Results are shown as cost per life year gained (C/LYG) and cost per quality-adjusted life year (C/QALY). Costs and effects were discounted at a rate of 3%. RESULTS: Mean survival was 17.8 and 16.5 years for TAC and FAC, with total costs of euro14,611 and euro11,586, respectively. The results of the cost-effectiveness analysis showed that TAC achieves a C/LYG and a C/QALY of only euro2345 and euro2631, respectively. Sensitivity analysis confirmed the robustness of the results. CONCLUSIONS: Combined therapy based on docetaxel (TAC) is not only an effective option, but also presents a favourable cost-effectiveness ratio, clearly below the Spanish efficiency threshold in all the scenarios considered.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/economics , Breast Neoplasms/drug therapy , Breast Neoplasms/economics , Fluorouracil/economics , Taxoids/economics , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/mortality , Cost-Benefit Analysis , Cyclophosphamide/administration & dosage , Cyclophosphamide/adverse effects , Docetaxel , Doxorubicin/administration & dosage , Doxorubicin/adverse effects , Female , Fluorouracil/adverse effects , Fluorouracil/therapeutic use , Humans , Models, Economic , Quality-Adjusted Life Years , Taxoids/administration & dosage , Taxoids/adverse effectsABSTRACT
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Subject(s)
Humans , Neoplasms/complications , Nutrition Disorders/epidemiology , Medical Oncology/trends , Comprehensive Health Care/trendsABSTRACT
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Subject(s)
Humans , Nutrition Disorders/physiopathology , Neoplasms/complications , Malnutrition/physiopathology , Anorexia/epidemiology , Protein-Energy Malnutrition/epidemiology , Cachexia/epidemiology , Weight Loss , Antineoplastic Agents/adverse effects , Radiotherapy/adverse effectsABSTRACT
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Subject(s)
Humans , Neoplasms/complications , Nutrition Disorders/epidemiology , Nutritional Status , Protein-Energy Malnutrition/complications , Quality of Life , Treatment Outcome , Drug Tolerance , Medication Adherence/statistics & numerical data , Indicators of Morbidity and Mortality , Cachexia/physiopathology , Health Care Costs/statistics & numerical dataABSTRACT
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Subject(s)
Humans , Neoplasms/complications , Nutrition Disorders/diagnosis , Nutrition Assessment , Nutritional Status , Malnutrition/diagnosis , Mass Screening/methods , Early Diagnosis , Weight Loss/physiology , Feeding and Eating Disorders/physiopathologyABSTRACT
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Subject(s)
Humans , Neoplasms/complications , Nutrition Disorders/epidemiology , Malnutrition/diet therapy , Nutrition Therapy/methods , Evaluation of Results of Therapeutic Interventions , Nutritional Support/methods , Risk Factors , Anorexia/diet therapy , Nausea/diet therapy , Constipation/diet therapy , Deglutition Disorders/diet therapyABSTRACT
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Subject(s)
Humans , Feeding and Eating Disorders/drug therapy , Appetite Stimulants/therapeutic use , Anorexia/drug therapy , Cachexia/drug therapy , Neoplasms/complications , Nutrition Disorders/epidemiology , Weight Loss , Progestins/therapeutic use , Adrenal Cortex Hormones/therapeutic useABSTRACT
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