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1.
BMC Cancer ; 15: 787, 2015 Oct 24.
Artigo em Inglês | MEDLINE | ID: mdl-26498283

RESUMO

BACKGROUND: Healthcare resource utilization in breast cancer varies by disease characteristics and treatment choices. However, lack of clarity in guidelines can result in varied interpretation and heterogeneous treatment management and costs. In Europe, the extent of this variability is unclear. Therefore, evaluation of chemotherapy use and costs versus hormone therapy across Europe is needed. METHODS: This retrospective chart review (N = 355) examined primarily direct costs for chemotherapy versus hormone therapy in postmenopausal women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer across 5 European countries (France, Germany, The Netherlands, Belgium, and Sweden). RESULTS: Total direct costs across the first 3 treatment lines were approximately €10,000 to €14,000 lower for an additional line of hormone therapy-based treatment versus switching to chemotherapy-based treatment. Direct cost difference between chemotherapy-based and hormone therapy-based regimens was approximately €1900 to €2500 per month. Chemotherapy-based regimens were associated with increased resource utilization (managing side effects; concomitant targeted therapy use; and increased frequencies of hospitalizations, provider visits, and monitoring tests). The proportion of patients taking sick leave doubled after switching from hormone therapy to chemotherapy. CONCLUSIONS: These results suggest chemotherapy is associated with increased direct costs and potentially with increased indirect costs (lower productivity of working patients) versus hormone therapy in HR+, HER2- advanced breast cancer.


Assuntos
Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Pós-Menopausa , Neoplasias de Mama Triplo Negativas/economia , Neoplasias de Mama Triplo Negativas/epidemiologia , Antineoplásicos/administração & dosagem , Antineoplásicos/economia , Bélgica/epidemiologia , Estudos de Coortes , Método Duplo-Cego , Terapia de Reposição de Estrogênios/economia , Terapia de Reposição de Estrogênios/estatística & dados numéricos , Europa (Continente)/epidemiologia , Feminino , França/epidemiologia , Alemanha/epidemiologia , Humanos , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Pós-Menopausa/efeitos dos fármacos , Estudos Retrospectivos , Inquéritos e Questionários , Suécia/epidemiologia , Neoplasias de Mama Triplo Negativas/terapia
2.
BMC Med ; 12: 93, 2014 Jun 05.
Artigo em Inglês | MEDLINE | ID: mdl-24898705

RESUMO

BACKGROUND: The aim of this study is to outline a general process for assessing the feasibility of performing a valid network meta-analysis (NMA) of randomized controlled trials (RCTs) to synthesize direct and indirect evidence for alternative treatments for a specific disease population. METHODS: Several steps to assess the feasibility of an NMA are proposed based on existing recommendations. Next, a case study is used to illustrate this NMA feasibility assessment process in order to compare everolimus in combination with hormonal therapy to alternative chemotherapies in terms of progression-free survival for women with advanced breast cancer. RESULTS: A general process for assessing the feasibility of an NMA is outlined that incorporates explicit steps to visualize the heterogeneity in terms of treatment and outcome characteristics (Part A) as well as the study and patient characteristics (Part B). Additionally, steps are performed to illustrate differences within and across different types of direct comparisons in terms of baseline risk (Part C) and observed treatment effects (Part D) since there is a risk that the treatment effect modifiers identified may not explain the observed heterogeneity or inconsistency in the results due to unexpected, unreported or unmeasured differences. Depending on the data available, alternative approaches are suggested: list assumptions, perform a meta-regression analysis, subgroup analysis, sensitivity analyses, or summarize why an NMA is not feasible. CONCLUSIONS: The process outlined to assess the feasibility of an NMA provides a stepwise framework that will help to ensure that the underlying assumptions are systematically explored and that the risks (and benefits) of pooling and indirectly comparing treatment effects from RCTs for a particular research question are transparent.


Assuntos
Antineoplásicos Hormonais/uso terapêutico , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/tratamento farmacológico , Metanálise como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Sirolimo/análogos & derivados , Teorema de Bayes , Neoplasias da Mama/patologia , Intervalo Livre de Doença , Everolimo , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Sirolimo/uso terapêutico , Resultado do Tratamento
3.
Curr Med Res Opin ; 30(6): 1007-16, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24490834

RESUMO

BACKGROUND: International guidelines for hormone-receptor-positive (HR(+)), human epidermal growth factor receptor-2 negative (HER2(-)) advanced breast cancer (BC) recommend sequential lines of hormonal therapy (HT), and only recommend chemotherapy for patients with extensive visceral involvement or rapidly progressive disease. This study evaluated actual physician-reported treatments for advanced BC in Europe. METHODS: We conducted a retrospective chart review of 355 postmenopausal women with HR(+), HER2(-) advanced BC who progressed on ≥1 line of HT (adjuvant or advanced) and completed ≥1 line of chemotherapy (advanced). Treatment choice was evaluated for each line of therapy. RESULTS: Of 355 patients, 111 (31%) received first-line chemotherapy, whereas 218 (61%) and 26 (7%) switched from HT to chemotherapy in second and third line, respectively. More patients receiving first-line HT had bone metastases (73% vs 27% chemotherapy). Patients treated with first-line chemotherapy had more brain (12% vs 3% HT) or extensive liver (13% vs 6% HT) metastases. Subgroup analysis of 188 patients who received first-line HT and had de novo advanced BC or relapsed/recurrent disease more than 1 year after adjuvant therapy found that the majority (89%; n = 167) of these patients switched to chemotherapy in second line. However, among these 167 patients, 27% had no significant changes in metastases between first and second line. Among the 73% of patients who had significant changes in metastases, 20% had no brain metastases or extensive visceral disease. CONCLUSIONS: Our study suggests that the guideline-recommended use of multiple HT lines is open to interpretation and that optimal treatment for European postmenopausal women with HR(+), HER2(-) advanced BC who responded to HT may not be achieved.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/metabolismo , Pós-Menopausa/metabolismo , Receptor ErbB-2/deficiência , Receptores de Estrogênio/metabolismo , Receptores de Progesterona/metabolismo , Antineoplásicos Hormonais/administração & dosagem , Quimioterapia Adjuvante , Europa (Continente) , Feminino , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos
4.
Ann N Y Acad Sci ; 1291: 14-32, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23659703

RESUMO

Everolimus is a potent, oral inhibitor of the mammalian target of rapamycin (mTOR) that has been investigated in multiple clinical development programs since 1996. A unique collaboration between academic and pharmaceutical experts fostered research that progressed rapidly, with simultaneous indication findings across numerous tumor types. Initially developed for the prophylaxis of organ transplant rejection, everolimus has demonstrated efficacy and safety for the treatment of patients with various types of cancer (renal cell carcinoma, neuroendocrine tumors of pancreatic origin, and breast cancer) and for adult and pediatric patients with tuberous sclerosis complex. The FDA approval of everolimus for these diseases has addressed several unmet medical needs and is widely accepted by the medical community where treatment options may be limited. An extensive clinical development program is ongoing to establish the role of everolimus as monotherapy, or in combination with other agents, in the treatment of a broad spectrum of malignancies.


Assuntos
Antineoplásicos/administração & dosagem , Imunossupressores/administração & dosagem , Neoplasias/tratamento farmacológico , Sirolimo/análogos & derivados , Serina-Treonina Quinases TOR/antagonistas & inibidores , Administração Oral , Animais , Antineoplásicos/imunologia , Ensaios Clínicos como Assunto/métodos , Everolimo , Humanos , Imunossupressores/química , Neoplasias/imunologia , Sirolimo/administração & dosagem , Sirolimo/imunologia , Serina-Treonina Quinases TOR/imunologia , Esclerose Tuberosa/tratamento farmacológico , Esclerose Tuberosa/imunologia
5.
Oncologist ; 18(1): 46-53, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23263288

RESUMO

INTRODUCTION: The incidence of colorectal neuroendocrine tumors (NETs) is increasing, and patients with this disease have particularly poor prognoses. Treatment options are limited, and survival times have not improved in the past decade. METHODS: A post hoc analysis of the efficacy and tolerability of everolimus plus octreotide long-acting repeatable (LAR) was conducted in patients with colorectal NETs enrolled in the phase III RAD001 in Advanced Neuroendocrine Tumors, Second Trial (RADIANT-2) study. The primary endpoint (progression-free survival [PFS]), secondary endpoints (including objective response rate), and safety were assessed. RESULTS: Patients with colorectal NETs receiving everolimus plus octreotide LAR had a significantly longer median PFS (29.9 months; n = 19) than did those receiving placebo plus octreotide LAR (6.6 months; n = 20). Everolimus plus octreotide LAR treatment also significantly reduced the risk for disease progression (hazard ratio: 0.34; 95% confidence interval: 0.13-0.89; p = .011). Although no objective responses were observed, tumor shrinkage was more frequently noted in the everolimus plus octreotide LAR arm than in the placebo plus octreotide LAR arm (67% vs. 37%, respectively). The combination of everolimus plus octreotide LAR was generally well tolerated by patients with colorectal NETs; rash and stomatitis were the most commonly reported adverse events. CONCLUSIONS: Everolimus plus octreotide LAR treatment had significant benefits and improved outcomes for patients with advanced colorectal NETs compared with placebo plus octreotide LAR treatment. Results of this exploratory analysis are consistent with those reported from the RADIANT-2 primary analysis. These findings support additional investigations of everolimus plus octreotide LAR in patients with colorectal NETs.


Assuntos
Neoplasias Colorretais/tratamento farmacológico , Tumores Neuroendócrinos/tratamento farmacológico , Octreotida/administração & dosagem , Sirolimo/análogos & derivados , Adulto , Antineoplásicos Hormonais/administração & dosagem , Antineoplásicos Hormonais/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Neoplasias Colorretais/epidemiologia , Neoplasias Colorretais/patologia , Intervalo Livre de Doença , Everolimo , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estadiamento de Neoplasias , Tumores Neuroendócrinos/epidemiologia , Tumores Neuroendócrinos/patologia , Octreotida/efeitos adversos , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos
6.
Chest ; 143(4): 955-962, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23187897

RESUMO

BACKGROUND: The incidence of neuroendocrine tumors (NETs) has increased approximately fivefold since the 1980s. A similar increase in the incidence of lung NETs has been reported, but therapy has not been optimized. METHODS: This exploratory subanalysis evaluated the efficacy and safety of everolimus plus octreotide long-acting repeatable (LAR) in a cohort of patients with low- to intermediate-grade advanced lung NET from the phase 3, randomized, placebo-controlled RADIANT-2 (RAD001 in Advanced Neuroendocrine Tumors) study. The primary end point was progression-free survival (PFS). Secondary end points included objective response rate, overall survival, change from baseline in biomarker levels, and safety outcomes. RESULTS: Patients were randomly assigned to everolimus plus octreotide LAR (n 5 33) or placebo plus octreotide LAR (n 5 11). Median PFS was 13.63 months in the everolimus plus octreotide LAR arm compared with 5.59 months in the placebo plus octreotide LAR arm (relative risk for progression: HR, 0.72; 95% CI, 0.31­1.68; P 5 .228). More patients receiving everolimus plus octreotide LAR (67%) experienced minor tumor shrinkage (not partial response as per RECIST [Response Evaluation Criteria in Solid Tumors]) than those receiving placebo plus octreotide LAR (27%). Most frequently reported adverse events (AEs) included stomatitis, rash, diarrhea, and asthenia. This was consistent with the overall RADIANT-2 trial and the safety profile of everolimus. CONCLUSIONS: This exploratory subgroup analysis of the RADIANT-2 trial indicates that in patients with advanced lung NET, the addition of everolimus to octreotide LAR improves median PFS by 2.4-fold compared with placebo plus octreotide LAR. These clinically significant observations support the continued evaluation of everolimus treatment regimens in this patient population. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00412061


Assuntos
Antineoplásicos/uso terapêutico , Imunossupressores/uso terapêutico , Neoplasias Pulmonares/tratamento farmacológico , Tumores Neuroendócrinos/tratamento farmacológico , Octreotida/uso terapêutico , Sirolimo/análogos & derivados , Idoso , Antineoplásicos/efeitos adversos , Intervalo Livre de Doença , Relação Dose-Resposta a Droga , Método Duplo-Cego , Quimioterapia Combinada , Everolimo , Feminino , Humanos , Imunossupressores/efeitos adversos , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Gradação de Tumores , Tumores Neuroendócrinos/mortalidade , Tumores Neuroendócrinos/patologia , Octreotida/efeitos adversos , Sirolimo/efeitos adversos , Sirolimo/uso terapêutico , Taxa de Sobrevida , Resultado do Tratamento
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