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1.
Pharmacol Res Perspect ; 12(1): e1167, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-38193611

RESUMO

Off-label use (OLU) is quite common in oncology due to the complexity of cancer and the time-consuming regulatory process. However, outcomes of OLU in cancer treatment remain unclear. This study aimed to evaluate the overall survival (OS), event-free survival (EFS), duration of treatment (DOT), and reason for treatment discontinuation in patients receiving immune checkpoint inhibitors (ICI) as OLU for solid tumors from 2011 to 2020. The study collected data on 356 episodes (353 patients), with a median age of 64.4 years, 36.2% women, and 14.6% ECOG ≥ 2. Median OS was 15.7 (11.9-18.7) months, and median EFS was 5.4 (3.8-6.6) months. Men, patients with metastatic disease or ECOG-PS higher than 1, had worse survival outcomes. The findings derived from this study provide valuable information regarding the real-world use of ICI-OLU and contributes to enhancing the decision-making process for individuals with cancer. Further research on immunotherapy outcomes of OLU in cancer is needed.


Assuntos
Inibidores de Checkpoint Imunológico , Neoplasias , Masculino , Humanos , Feminino , Pessoa de Meia-Idade , Inibidores de Checkpoint Imunológico/uso terapêutico , Uso Off-Label , Neoplasias/tratamento farmacológico , Oncologia , Resultado do Tratamento
3.
Cancer Med ; 12(16): 17112-17125, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37496404

RESUMO

PURPOSE: Medicines in special situations (MSS) refer to off-label or to unlicensed drugs under investigation (compassionate use). Our objectives were to evaluate characteristics and to estimate overall survival (OS), event-free survival (EFS), and the duration of treatment (DT) of MSS used for cancer treatment at a multicentre comprehensive cancer institution. METHODS: Retrospective cohort study on adult cancer patients for whom an MSS treatment was requested (January 2011-December 2020). A descriptive analysis was performed and median OS and EFS and 95% confidence intervals (CIs) were estimated. Survival curves were stratified by type of tumor, ECOG (Eastern Cooperative Oncology Group) performance status (PS), age, sex, treatment stage and type of drug (mechanism of action and target). RESULTS: Treatment was initiated in 2092 episodes (1930 patients) out of 2377 MSS episodes (2189 patients) requested, 33% for hematological treatment and 87% for advanced stage cancer. Median OS (months) was 21.1 (95% CI 19.4-22.7), median EFS was 5.6 (95% CI 5.1-6.0) months, and median DT was 4.5 [0.0; 115.3] months. OS and EFS statistically significantly favored female patients, ECOG PS ≥2 episodes showed worse OS and EFS outcomes (p < 0.0001). Statistically significant differences in survival were found within solid and hematological cancer, disease stage, drug mechanism of action, and type of cancer (p < 0.001) but not for age. Survival outcomes by tumor subtype and drug are presented both globally and separately based on disease stage. CONCLUSION: MSS uses are practiced across almost all cancer types, mostly for advanced disease. ECOG PS ≥2, along with advanced disease, was related to worse survival. Information about real-world outcomes is valuable and contributes to better decision-making regarding MSS and our experience in this field could be of interest for other colleagues.


Assuntos
Ensaios de Uso Compassivo , Neoplasias , Adulto , Humanos , Feminino , Estudos Retrospectivos , Uso Off-Label , Neoplasias/tratamento farmacológico , Resultado do Tratamento
5.
Clin Transl Oncol ; 25(2): 555-559, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36229738

RESUMO

INTRODUCTION: The Catalan Institute of Oncology (ICO) is a Comprehensive Cancer Center (CCC) responsible for the oncological care of 46% of the Catalan population. OBJECTIVE: Given the increasing and ongoing approval of onco-hematological treatments, the professionals at the ICO decided to have clinical practice guidelines (called ICOPraxis) based on available evidence. In this report, we intend to share how the ICOPraxis has developed and what its impact has been in the 14 years it has been running. RESULTS: In the 14 years, since the project has been running, 17 clinical practice guidelines (some of them with several editions) have been prepared for major onco-hematology clinical conditions. These guidelines will be utilized in the four ICO centers (Girona, Badalona, Tarragona, and Hospitalet) and ICO works in a network with 18 regional hospitals. Between 2018 and 2022, the guidelines have been viewed 38.645 times and downloaded 24.614 times, with an average time spent on each page of 3 min. The ICOPraxis have been consulted in 25 countries in America (3.163 views), 20 countries in Europe (35.365 views), 10 countries in Asia (36 views), and 3 countries in Africa (12 views). The country with the highest number of downloads is Spain with a total of 34.742 downloads (Analytics [Internet]). CONCLUSION: The ICOPraxis have succeeded in establishing an evidence-based system that facilitates prescription decision-making according to the established harmonization process and reduction in variability in treatments, increasing equity in our population.


Assuntos
Doenças Hematológicas , Hematologia , Humanos , Europa (Continente) , Espanha , Oncologia
6.
Value Health ; 25(5): 803-809, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35500950

RESUMO

OBJECTIVES: Publications assessing health and economic outcomes of risk-sharing arrangements (RSAs) are limited. Better knowledge of these outcomes would shed light on the pertinence of such arrangements, informing design improvements for the future. The aim of the study is to describe the different types of RSAs implemented in Catalonia and their health and economic outcomes. METHODS: Retrospective descriptive analysis of RSAs implemented from January 2016 to December 2019 in the Catalan Health Service, CatSalut. Individual RSAs were reviewed and categorized according to standard RSA guidelines. Relevant health and economic outcomes pertaining to the RSAs were analyzed using aggregate data recorded in Catalan central registries. RESULTS: A total of 15 RSAs were implemented over the study period (10 of which are still ongoing). A total of 8 consisted of performance-linked reimbursements (PLRs) and 7 of cost-sharing arrangements (CSAs). The arrangements were implemented in the oncohematology (n = 11), rare disease (n = 3), and neurology (n = 1) areas. A total of 951 patients were included in PLR and 73% achieved the target health outcomes. Total medication costs were €9 295 755 of which 11% were refunded to CatSalut. CSAs involved 2066 patients and resulted in overall refunds of €1 349 564 (2.61%) for CatSalut. CONCLUSIONS: Both PLRs and CSAs were used to manage the different uncertainties related to accessing innovative medicines in Catalonia. The data generated provide relevant information to inform decision-making, allowing an adaptation of the initial recommendation for use and access. Additional efforts are required to increase the RSA assessments and their publication.


Assuntos
Custo Compartilhado de Seguro , Custos de Medicamentos , Humanos , Estudos Retrospectivos , Espanha
7.
BMJ Open ; 12(4): e056637, 2022 04 21.
Artigo em Inglês | MEDLINE | ID: mdl-35450905

RESUMO

OBJECTIVES: Patients with cancer are at higher risk for severe COVID-19 infection. COVID-19 surveillance of workers in oncological centres is crucial to assess infection burden and prevent transmission. We estimate the SARS-CoV-2 seroprevalence among healthcare workers (HCWs) of a comprehensive cancer centre in Catalonia, Spain, and analyse its association with sociodemographic characteristics, exposure factors and behaviours. DESIGN: Cross-sectional study (21 May 2020-26 June 2020). SETTING: A comprehensive cancer centre (Institut Català d'Oncologia) in Catalonia, Spain. PARTICIPANTS: All HCWs (N=1969) were invited to complete an online self-administered epidemiological survey and provide a blood sample for SARS-CoV-2 antibodies detection. PRIMARY OUTCOME MEASURE: Prevalence (%) and 95% CIs of seropositivity together with adjusted prevalence ratios (aPR) and 95% CI were estimated. RESULTS: A total of 1266 HCWs filled the survey (participation rate: 64.0%) and 1238 underwent serological testing (97.8%). The median age was 43.7 years (p25-p75: 34.8-51.0 years), 76.0% were female, 52.0% were nursing or medical staff and 79.0% worked on-site during the pandemic period. SARS-CoV-2 seroprevalence was 8.9% (95% CI 7.44% to 10.63%), with no differences by age and sex. No significant differences in terms of seroprevalence were observed between onsite workers and teleworkers. Seropositivity was associated with living with a person with COVID-19 (aPR 3.86, 95% CI 2.49 to 5.98). Among on-site workers, seropositive participants were twofold more likely to be nursing or medical staff. Nursing and medical staff working in a COVID-19 area showed a higher seroprevalence than other staff (aPR 2.45, 95% CI 1.08 to 5.52). CONCLUSIONS: At the end of the first wave of the pandemic in Spain, SARS-CoV-2 seroprevalence among Institut Català d'Oncologia HCW was lower than the reported in other Spanish hospitals. The main risk factors were sharing household with infected people and contact with COVID-19 patients and colleagues. Strengthening preventive measures and health education among HCW is fundamental.


Assuntos
COVID-19 , Neoplasias , Adulto , Anticorpos Antivirais , COVID-19/epidemiologia , Estudos Transversais , Feminino , Pessoal de Saúde , Humanos , Masculino , Neoplasias/epidemiologia , SARS-CoV-2 , Estudos Soroepidemiológicos , Espanha/epidemiologia
8.
J Med Econ ; 20(1): 1-7, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27441909

RESUMO

BACKGROUND: In 2011 the first payment-by-results (PbR) scheme in Catalonia was signed between the Catalan Institute of Oncology (ICO), the Catalan Health Service, and AstraZeneca (AZ) for the introduction of gefitinib in the treatment of advanced EGFR-mutation positive non-small-cell lung cancer. The PbR scheme includes two evaluation points: at week 8, responses, stabilization and progression were evaluated, and at week 16 stabilization was confirmed. AZ was to reimburse the total treatment cost of patients that failed treatment, defined as progression at weeks 8 or 16. OBJECTIVE: To estimate the financial consequences of this PbR reimbursement model and determine the perception of the stakeholders involved in the agreement. METHODS: Differential drug costs between two scenarios, with and without the PbR, were calculated. A qualitative investigation of the organizational elements was performed by interviewing the parties involved in the agreement. RESULTS: Forty-one patients were included from June 2011 to October 2013 and assessed at two evaluation points. Clinical results were comparable to those observed in the pivotal studies of gefitinib. The difference in the cost of gefitinib using the PbR compared to the traditional purchasing scenario was 6.17% less at 8 weeks, 11.18% at 16 weeks and 4.15% less for the overall treatment. The PbR resulted in total savings of around €36,000 (€880 per patient). From an operational and organizational perspective, the availability of adequate data systems to measure outcomes and monitor accountability and the involvement of healthcare professionals were acknowledged as crucial. CONCLUSIONS: Tangible and intangible benefits were identified with respect to the interests of the parties involved. This has led to the incorporation of innovation for patients under acceptable conditions.


Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Mutação , Quinazolinas/economia , Quinazolinas/uso terapêutico , Reembolso de Incentivo/economia , Idoso , Idoso de 80 Anos ou mais , Carcinoma Pulmonar de Células não Pequenas/genética , Análise Custo-Benefício , Custos de Medicamentos , Receptores ErbB/genética , Receptores ErbB/uso terapêutico , Feminino , Gefitinibe , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Espanha
9.
Sci Rep ; 6: 19532, 2016 Jan 20.
Artigo em Inglês | MEDLINE | ID: mdl-26787510

RESUMO

Effective quality assurance is essential in any screening programme. This article provides a unique insight into key quality indicators of five rounds of the first population-based colorectal cancer screening programme implemented in Spain (2000-2012), providing the results according to the type of screening (prevalent or first screen and incident or subsequent screen) and test (guaiac or immunochemical). The total crude participation rate increased from 17.2% (11,011) in the first round to 35.9% (22,988) in the last one. Rescreening rate was very high (88.6% in the fifth round). Positivity rate was superior with the faecal immunochemical test (6.2%) than with the guaiac-based test (0.7%) (p < 0.0001) and detection rates were also better with the immunochemical test. The most significant rise in detection rate was observed for high risk adenoma in men (45.5 per 1,000 screened). Most cancers were diagnosed at an early stage (61.4%) and there was a statistically significant difference between those detected in first or subsequent screening (52.6% and 70.0% respectively; p = 0.024). The availability of these results substantially improves data comparisons and the exchange of experience between screening programmes.


Assuntos
Neoplasias Colorretais/epidemiologia , Adulto , Idoso , Neoplasias Colorretais/diagnóstico , Detecção Precoce de Câncer/métodos , Humanos , Programas de Rastreamento , Pessoa de Meia-Idade , Vigilância da População , Indicadores de Qualidade em Assistência à Saúde , Reprodutibilidade dos Testes , Espanha/epidemiologia
10.
J Med Econ ; 16(6): 736-43, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23541251

RESUMO

PURPOSE: To evaluate the cost-effectiveness of posaconazole vs itraconazole in the prevention of invasive fungal infections (IFIs) in recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). METHODS: Total hospital-based costs from initial admission for allo-HSCT until day 100 after transplantation were evaluated for 49 patients in whom the clinical efficacy of antifungal prophylaxis with posaconazole vs itraconazole had been previously analyzed and reported. Clinical and economic data were used to determine the incremental costs per IFI avoided and per life-year gained for posaconazole compared with itraconazole. Confidence intervals for the incremental cost-effectiveness ratio (ICER) and a cost-effectiveness acceptability curve were estimated through bootstrapping with the bias-corrected percentile method. RESULTS: According to our analysis, the total cost of allo-HSCT per patient during the 100-day fixed-treatment period was €46,562 in the posaconazole group (n = 33) and €45,080 in the itraconazole group (n = 16). However, the reduction in the incidence of IFI and the improved outcome with posaconazole resulted in a favorable ICER of €11,856 per IFI avoided and €5218 per life-year gained. With the outcomes of the bootstrap procedure, the cost-effectiveness acceptability curve was constructed. Assuming a threshold of €30,000 per life-year gained, the ICER based on life-years gained is acceptable with 75% certainty. LIMITATIONS: This evaluation is based on data from a single-center, non-randomized study. Preference weights or utilities were not available to calculate quality-adjusted life-years. Extra-mural costs were only partially evaluated from a hospital perspective. Indirect costs and economic consequences are not included. CONCLUSIONS: This economic evaluation compared direct medical costs associated with posaconazole or itraconazole treatment; the data suggest that posaconazole may be cost-effective as antifungal prophylaxis during the early high-risk neutropenic period and up to 100 days after allo-HSCT.


Assuntos
Antifúngicos/economia , Fluconazol/economia , Transplante de Células-Tronco Hematopoéticas/economia , Itraconazol/economia , Triazóis/economia , Antifúngicos/uso terapêutico , Institutos de Câncer , Intervalos de Confiança , Análise Custo-Benefício/estatística & dados numéricos , Fluconazol/uso terapêutico , Recursos em Saúde/estatística & dados numéricos , Humanos , Itraconazol/uso terapêutico , Estudos Observacionais como Assunto , Espanha , Triazóis/uso terapêutico
11.
J Liposome Res ; 19(4): 261-6, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19863161

RESUMO

As a dose-finding phase I study of a new liposomal formulation of doxorubicin (LipD), patients (n = 39; median age: 60 years; range, 41-75; median ECOG performance status, 1; range, 0-2) with refractory cancer had a starting dose of LipD administered at 30 mg/m(2) as a 1-hour intravenous infusion. Cycle duration was 21 days. At the recommended dose (RD), patients received a first cycle of nonliposomal doxorubicin (non-LipD) to evaluate intrapatient pharmacokinetic differences between non-LipD and LipD. The most frequent diagnosis was head and neck tumor (7 patients). Tolerance and safety of dose levels of 30, 40, 50, 60, 70, 80, and 90 mg/m(2) were evaluated. A total of 131 cycles were administered (median per patient, 3; range, 1-6). Of the 39 patients, 8 completed the planned six cycles. Febrile neutropenia was dose limiting and defined the toxic dose of LipD as 70 mg/m(2). Other significant toxicities included asthenia (G2: 31%; G3: 8%), neutropenia (G3: 35%; G4: 29%), thrombopenia (G3: 15%; G4: 2%), anemia (G1-G2: 67%; G3-G4: 5%), mucositis (G1-G2: 32%, G3: 4%), and acute allergic reactions (G1-G2: 36%). Comparison of pharmacokinetic profiles of non-LipD and LipD showed that higher exposure was achieved with LipD. Stable disease was observed in 14 patients. We conclude that the LipD regimen, given as a 1-hour infusion every 3 weeks, is well tolerated and has a favorable pharmacokinetic profile. The recommended dose is 70 mg/m(2) with prophylactic antihistamines and corticoids to preempt allergic reaction.


Assuntos
Antineoplásicos/farmacocinética , Doxorrubicina/farmacocinética , Neoplasias/tratamento farmacológico , Adulto , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Feminino , Febre/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Neutropenia/induzido quimicamente
12.
Farm. hosp ; 33(5): 237-239, sept.-oct. 2009.
Artigo em Espanhol | IBECS | ID: ibc-105311

RESUMO

Introducción: Fludarabina ha demostrado su eficacia, seguridad y eficiencia en el tratamiento de la leucemia linfocítica crónica de células B (LLC-B) en diversos estudios internacionales. El objetivo del presente estudio fue realizar un análisis de minimización de costes de 2 formas alternativas de fludarabina (oral e intravenosa) para el tratamiento de la LLC-B en España. Métodos: La existencia de evidencias clínicas sobre la equivalencia terapéutica de las 2 opciones comparadas (fludarabina oral frente a fludarabina intravenosa) llevó a la realización de un análisis de minimización de costes. Se construyó un modelo farmacoeconómico que combinó datos de la bibliografía y la opinión de expertos para determinar el uso de recursos sanitarios asociados al tratamiento, y los costes unitarios se obtuvieron de bases de datos españolas. El análisis consideró 2 perspectivas: a) la del Sistema Nacional de Salud, que incluía sólo los costes directos sanitarios, y b) la perspectiva social, que además de éstos, incluía los costes indirectos derivados de la pérdida de productividad. Resultados: Aunque la forma oral de fludarabina tiene un coste de adquisición mayor que la especialidad farmacéutica genérica de fludarabina intravenosa, los mayores costes de administración de esta última, de uso hospitalario, se tradujeron en unos ahorros totales asociados a fludarabina oral de 1.908 y 1.292 € en monoterapia y tratamiento combinado con ciclofosfamida, respectivamente. La inclusión de los costes indirectos aumentó los ahorros asociados a la forma oral. Conclusiones: El tratamiento de los pacientes con LLC-B con fludarabina oral presenta unos costes menores respecto a fludarabina intravenosa, tanto en monoterapia, como en tratamiento combinado. Diversos análisis de sensibilidad confirmaron estos resultados, en los que se constata que la forma oral de fludarabina debería ser la opción de elección en el tratamiento de la LLC-B en España, salvo que se contraindique (AU)


Introduction: Various international studies have shown that fludarabine is effective, safe, and effi cient for treating B-cell chronic lymphocytic leukemia (B-CLL). The purpose of the present study was to carry out a cost-minimization analysis for two alternative forms of fludarabine (oral and intravenous) used to treat B-CLL in Spain. Methods: The presence of clinical evidence about the treatment equivalence of the two options being compared (oral fludarabine vs. intravenous fludarabine) led us to carry out a cost-minimization analysis. A pharmacoeconomic model was constructed to compile data from the literature and experts’ opinions in order to determine the use of health resources associated with the treatment; unit costs were obtained from Spanish databases. The analysis contemplated two perspectives: that of the national health service, which includes only direct health costs, and the social perspective, which also includes the indirect costs that result from loss of productivity. Results: Although fludarabine in its oral form has a higher purchase price than generic intravenous fludarabine does, increased administration costs for the latter, which is used in hospitals, mean that oral fludarabine use produces total savings of €1,908 and €1,292 for single-drug therapy and combined therapy with cyclophosphamide, respectively. Including indirect costs increased the savings associated with the oral form of the drug. Conclusions: In B-CLL patients, treatment with oral fludarabine has a lower cost than treatment with intravenous fludarabine, in both single-drug therapy and combined therapy. Various sensitivity analyses confirmed these results and showed that oral fludarabine should be the treatment of choice for B-CLL in Spain, unless contrain (AU)


Assuntos
Humanos , Serviço de Farmácia Hospitalar/legislação & jurisprudência , Uso de Medicamentos/legislação & jurisprudência , Farmacêuticos/estatística & dados numéricos , Legislação Farmacêutica/tendências
14.
Cancer Manag Res ; 1: 137-50, 2009 Oct 30.
Artigo em Inglês | MEDLINE | ID: mdl-21188132

RESUMO

Chemotherapy is assuming an increasingly important role in the treatment of malignant gliomas, of which temozolomide (TMZ) is a key part. TMZ belongs to a class of second-generation imidazotetrazinone prodrugs that exhibit linear pharmacokinetics and do not require hepatic metabolism for activation to the active metabolite. New intravenous (iv) TMZ formulations have recently been approved based on studies of bioequivalence between iv and oral TMZ. The efficacy of TMZ was initially evaluated in patients with recurrent disease but phase II and III trials in newly diagnosed gliomas are available. The results of a large phase III trial that compared RT alone vs RT concomitant with oral TMZ created a new standard of adjuvant treatment. Efficacy data for iv TMZ on which its approval was based are those extrapolated from clinical trials with oral TMZ. No comparative data are available on the differences in tolerability and patient satisfaction between oral and iv formulations of TMZ, or for quality of life. New oral formulations could encourage the adherence of patients to treatment. Although patients presumably would prefer oral treatment, iv formulations may be an alternative in noncompliant patients or patients for whom good adherence could not be expected.

15.
Med Clin (Barc) ; 129(4): 134-6, 2007 Jun 23.
Artigo em Espanhol | MEDLINE | ID: mdl-17663967

RESUMO

BACKGROUND AND OBJECTIVE: To assess the impact on the medicines budget of the introduction of new treatments in colorectal cancer, as monoclonal antibodies cetuximab and bevacizumab and oxaliplatin in the adjuvant setting, for the Catalan health public system in 2006. METHOD: In advanced stages of the disease, the medicines budget impact of the introduction of cetuximab and bevacizumab in relation to the standard treatment (FOLFIRI and FOLFOX regimes) was evaluated. In adjuvant treatment stage II-III, the medicines budget impact of the utilization of FOLFOX regime compared to the combination of fluorouracil and folinic acid was evaluated. RESULTS: The medicines budget impact of the new therapies is evaluated at 27.9 million euros and 18.3 million euros in advanced stages of the disease and the adjuvant setting, respectively. In the adjuvant setting, the impact assessed depends on the number of new cases estimated. CONCLUSIONS: The impact on the health budget in Catalonia will be of great magnitude, and it could be higher considering these drugs are just only an example. Health policy should take this impact into account when future costs of health care are assessed in the public sector.


Assuntos
Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Orçamentos , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/economia , Humanos
16.
Med. clín (Ed. impr.) ; 129(4): 134-136, jun. 2007. tab
Artigo em Es | IBECS | ID: ibc-057895

RESUMO

Fundamento y objetivo: Evaluar el impacto presupuestario de los nuevos fármacos para el tratamiento del cáncer colorrectal, como son los anticuerpos monoclonales cetuximab y bevacizumab y el oxaliplatino en adyuvancia, para el sistema público catalán en el año 2006. Método: En estadios avanzados se evaluó el impacto en el presupuesto para fármacos de la incorporación de cetuximab y bevacizumab con respecto al tratamiento considerado estándar (FOLFIRI ­irinotecán, fluorouracilo y ácido folínico­ y FOLFOX ­oxaliplatino, fluorouracilo y ácido folínico­). En el tratamiento adyuvante por estadios II-III se evaluó el impacto presupuestario de la utilización del esquema FOLFOX con respecto a la combinación de fluorouracilo con ácido folínico. Resultados: En estadios avanzados la introducción de los nuevos tratamientos supone un coste incremental de 27,9 millones de euros. En adyuvancia, la introducción del FOLFOX supone un coste incremental de 18,3 millones de euros, que dependerá notablemente del número de pacientes diagnosticados. Conclusiones: El impacto sobre el presupuesto sanitario público en Cataluña será de gran magnitud, más aún si se tiene en cuenta que los fármacos considerados son sólo un ejemplo


Background and objective: To assess the impact on the medicines budget of the introduction of new treatments in colorectal cancer, as monoclonal antibodies cetuximab and bevacizumab and oxaliplatin in the adjuvant setting, for the Catalan health public system in 2006. Method: In advanced stages of the disease, the medicines budget impact of the introduction of cetuximab and bevacizumab in relation to the standard treatment (FOLFIRI and FOLFOX regimes) was evaluated. In adjuvant treatment stage II-III, the medicines budget impact of the utilization of FOLFOX regime compared to the combination of fluorouracil and folinic acid was evaluated. Results: The medicines budget impact of the new therapies is evaluated at 27.9 million euros and 18.3 million euros in advanced stages of the disease and the adjuvant setting, respectively. In the adjuvant setting, the impact assessed depends on the number of new cases estimated. Conclusions: The impact on the health budget in Catalonia will be of great magnitude, and it could be higher considering these drugs are just only an example. Health policy should take this impact into account when future costs of health care are assessed in the public sector


Assuntos
Humanos , Custos de Medicamentos/estatística & dados numéricos , Antineoplásicos/economia , Neoplasias Colorretais/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Economia Hospitalar/tendências
17.
Biol Blood Marrow Transplant ; 11(6): 437-47, 2005 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-15931632

RESUMO

We prospectively compared outcomes after a fludarabine (Flu) plus oral busulfan (Bu)-containing reduced-intensity conditioning regimen (150 mg/m2 Flu and 10 mg/kg oral Bu), with (n = 32; Flu- T Bu group) or without (n = 30; Flu-Bu group) therapeutic dose monitoring and dose adjustment of Bu. All patients received peripheral blood stem cells from a genoidentical sibling, and study cohorts had similar patient characteristics. Dose adjustments of Bu were required in 20 (63%) patients in the Flu- T Bu group (median final dose, 8.89 mg/kg; range, 6.3-13.34 mg/kg). Donor T-cell and granulocyte engraftments were similar, and early conditioning-related toxicities were mild and similar in both study groups. With a median follow-up of 45 months (51 months in the 37 survivors), posttransplantation outcomes did not differ between cohorts. The strongest predictor of 2-year overall survival and leukemia-free survival was the presence of chronic graft-versus-host disease (77% versus 34% for overall survival and 74% versus 34% for leukemia-free survival; P < .001 for both outcomes). In conclusion, therapeutic dose monitoring of oral Bu in a reduced-intensity conditioning setting does not seem to affect outcome, although further studies may identify very-high-risk patients who benefit from this strategy.


Assuntos
Bussulfano/administração & dosagem , Transplante de Células-Tronco Hematopoéticas , Imunossupressores/administração & dosagem , Leucemia Mieloide/terapia , Condicionamento Pré-Transplante , Vidarabina/análogos & derivados , Administração Oral , Adulto , Idoso , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Leucemia Mieloide/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Condicionamento Pré-Transplante/métodos , Transplante Homólogo , Vidarabina/administração & dosagem
18.
Med. clín (Ed. impr.) ; 116(15): 580-582, abr. 2001.
Artigo em Es | IBECS | ID: ibc-3036

RESUMO

FUNDAMENTO: Los trasplantes con regímenes de acondicionamiento no mieloablativos son procedimientos que se asocian a una menor morbilidad y mortalidad. En consecuencia, se puede considerar una opción válida en el tratamiento ambulatorio de los pacientes, incluso en aquellos de edad avanzada. OBSERVACIÓN CLÍNICA Y RESULTADOS: Este procedimiento fue considerado en una enferma de 62 años con leucemia mieloide crónica en fase crónica. El régimen de acondicionamiento consistió en fludarabina y 200 cGy de irradiación corporal total. Como inmunodepresión se utilizó ciclosporina A y micofenolato mofetil. El acondicionamiento, la infusión de progenitores y el seguimiento posterior se realizaron en régimen ambulatorio. La enferma requirió dos ingresos breves. A los 8 meses del trasplante, la paciente está en remisión hematológica, tiene un quimerismo completo del donante, un índice de Karnofsky del 100 por ciento y sigue los controles de manera ambulatoria. CONCLUSIONES: Los trasplantes alogénicos de progenitores hematopoyéticos mediante acondicionamiento atenuado se pueden realizar con carácter ambulatorio, incluso en pacientes de edad avanzada (AU)


Assuntos
Pessoa de Meia-Idade , Feminino , Humanos , Transplante de Células-Tronco Hematopoéticas , Condicionamento Pré-Transplante , Assistência Ambulatorial , Espanha , Transplante Homólogo , Leucemia Mieloide de Fase Crônica , Irradiação Corporal Total , Antineoplásicos , Imunossupressores
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