RESUMO
PURPOSE: Glioblastoma (GB) is the most common primary malignant brain tumor with the highest incidence occurring in older adults with a median age at diagnosis of 64 years old. While treatment often improves survival it brings toxicities and adverse events (AE). Here we identify sex differences in treatment patterns and AE in individuals ≥ 66 years at diagnosis with GB. METHODS: Using the SEER-Medicare dataset sex differences in adverse events were assessed using multivariable logistic regression performed to calculate the male/female odds ratio (M/F OR) and 95% confidence intervals [95% CI] of experiencing an AE adjusted for demographic variables and Elixhauser comorbidity score. RESULTS: Males with GB were more likely to receive standard of care (SOC; Surgery with concurrent radio-chemotherapy) [20%] compared to females [17%], whereas females were more likely to receive no treatment [26%] compared to males [21%]. Females with GB receiving SOC were more likely to develop gastrointestinal disorders (M/F OR = 0.76; 95% CI,0.64-0.91, p = 0.002) or blood and lymphatic system disorders (M/F OR = 0.79; 95% CI,0.66-0.95, p = 0.012). Males with GB receiving SOC were more likely to develop cardiac disorders (M/F OR = 1.21; 95% CI,1.02-1.44, p = 0.029) and renal disorders (M/F OR = 1.65; 95% CI,1.37-2.01, p < 0.001). CONCLUSIONS: Sex differences for individuals, 66 years and older, diagnosed with GB exist in treatment received and adverse events developed across different treatment modalities.
Assuntos
Neoplasias Encefálicas , Glioblastoma , Medicare , Humanos , Masculino , Feminino , Idoso , Estados Unidos/epidemiologia , Glioblastoma/terapia , Glioblastoma/epidemiologia , Neoplasias Encefálicas/terapia , Neoplasias Encefálicas/epidemiologia , Idoso de 80 Anos ou mais , Caracteres Sexuais , Fatores Sexuais , Programa de SEER , Terapia Combinada/efeitos adversosRESUMO
Aims: To characterize elderly large B-cell lymphoma patients who progress to second-line treatment to identify potential unmet treatment needs. Patients & methods: Retrospective USA cohort study, patients receiving second-line autologous stem cell transplant (SCT) preparative regimen ('ASCT-intended') versus those who did not; stratified further into those who received a stem cell transplant and those who did not. Primary outcomes were: healthcare resource utilization, costs and adverse events. Results: 1045 patients (22.0%) were included in the ASCT-intended group, 23.3% of whom received SCT (5.1% of entire second-line population). Non-SCT patients were older and had more comorbidities and generally higher rates of healthcare resource utilization and costs. Conclusion: Elderly second-line large B-cell lymphoma patients incurred substantial costs and a minority received potentially curative SCT, suggesting significant unmet need.
Lay abstract Large B-cell lymphoma (LBCL) is an aggressive form of cancer. Although chemotherapy is often initially successful, LBCL recurs in about 50% of patients. For many years, the standard of care for recurrent LBCL has been a course of strong chemotherapy followed by stem cell transplant (SCT). However, many older patients cannot tolerate or do not respond well to chemotherapy and therefore cannot proceed to SCT. In this real-world study of Medicare patients, we found that only 5.1% of patients with recurrent LBCL ever received potentially curative SCT. They also had higher healthcare costs than similar patients who did receive SCT. This shows a significant unmet need in elderly LBCL patients that may potentially be addressed with recent treatment innovations.
Assuntos
Efeitos Psicossociais da Doença , Linfoma Difuso de Grandes Células B/epidemiologia , Linfoma Difuso de Grandes Células B/terapia , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisão Clínica , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Gerenciamento Clínico , Feminino , Humanos , Benefícios do Seguro , Linfoma Difuso de Grandes Células B/complicações , Linfoma Difuso de Grandes Células B/mortalidade , Masculino , Medicare , Pessoa de Meia-Idade , Prognóstico , Vigilância em Saúde Pública , Retratamento , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos/epidemiologiaAssuntos
Neoplasias/terapia , Microambiente Tumoral , Antineoplásicos/administração & dosagem , Antineoplásicos/efeitos adversos , Técnicas de Reprogramação Celular , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Apoio Financeiro , Humanos , Metáfora , Ciência Militar , Terapia de Alvo Molecular/métodos , Neoplasias/patologia , Neoplasias/fisiopatologiaRESUMO
OPINION STATEMENT: Recently introduced systemic therapies for locally advanced and metastatic non-melanoma skin cancers (NMSCs) are paving the way for neoadjuvant approach. Although none of the therapeutic options has currently gained indication in this setting, neoadjuvant approach for NMSCs is an open field and we are likely to see huge developments in the near future. Targeted therapy with sonic hedgehog pathway inhibitors is very effective in locally advanced or multiple basal cell carcinomas while immunotherapy with immune checkpoint inhibitors appears to be promising for advanced cutaneous squamous cell carcinoma and Merkel cell carcinoma. To date, targeted therapy and immunotherapy represent the frontiers in NMSC therapeutic management and, according to recent studies, good results can be achieved.
Assuntos
Neoplasias Cutâneas/diagnóstico , Neoplasias Cutâneas/terapia , Biomarcadores Tumorais , Tomada de Decisão Clínica , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Análise Custo-Benefício , Diagnóstico Diferencial , Gerenciamento Clínico , Suscetibilidade a Doenças , Custos de Cuidados de Saúde , Humanos , Prognóstico , Neoplasias Cutâneas/etiologia , Resultado do TratamentoRESUMO
INTRODUCTION: Total knee replacement (TKR) is a surgical procedure that is being increasingly performed as a result of population aging and the increased average human life expectancy in South Korea. Consistent with the growing number of TKR procedures, the number of patients seeking acupuncture for relief from adverse effects, effective pain management, and the enhancement of rehabilitative therapy effects and bodily function after TKR has also been increasing. Thus, an objective examination of the evidence regarding the safety and efficacy of acupuncture treatments is essential. The aim of this study is to verify the hypothesis that the concurrent use of acupuncture treatment and usual care after TKR is more effective, safe, and cost-effective for the relief of TKR symptoms than usual care therapy alone. METHODS/DESIGN: This is an open-label, parallel, assessor-blinded randomized controlled trial that includes 50 patients with TKR. After screening the patients and receiving informed consent, the patients are divided into two groups (usual care + acupuncture group and usual care group); the patients will then undergo TKR surgery and will be hospitalized for 2 weeks. The patients will receive a total of 8 acupuncture treatments over 2 weeks after surgery and will be followed up at 3, 4, and 12âweeks after the end of the intervention. The primary outcome is assessed using the Korean version of the Western Ontario and McMaster Universities Arthritis Index (K-WOMAC), and the secondary outcome is measured using the Numerical Rating Scale (NRS), Risk of Fall, and Range of Motion (ROM). Moreover, the cost per quality-adjusted life years (QALYs) is adopted as a primary economic outcome for economic evaluation, and the cost per NRS is adopted as a secondary economic outcome. ETHICS AND DISSEMINATION: This trial has received complete ethical approval from the Ethics Committee of Catholic Kwandong University International St. Mary's Hospital (IS17ENSS0063). We intend to submit the results to a peer-reviewed journal and/or conferences. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03633097.
Assuntos
Terapia por Acupuntura/efeitos adversos , Artroplastia do Joelho/reabilitação , Osteoartrite do Joelho/cirurgia , Manejo da Dor/métodos , Dor Pós-Operatória/diagnóstico , Terapia por Acupuntura/economia , Idoso , Idoso de 80 Anos ou mais , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/economia , Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Terapia Combinada/métodos , Análise Custo-Benefício , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/economia , Manejo da Dor/efeitos adversos , Manejo da Dor/economia , Medição da Dor/estatística & dados numéricos , Dor Pós-Operatória/economia , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/reabilitação , Projetos Piloto , Anos de Vida Ajustados por Qualidade de Vida , República da Coreia , Resultado do TratamentoRESUMO
OPINION STATEMENT: Chimeric receptor antigen (CAR) T cells are an innovative cellular immunotherapeutic approach that involves genetic modification of T cells to express CAR targeting tumor antigen. Prior to the development of CAR-T, the only potential cure for patients with relapsed or refractory (RR) acute lymphoblastic leukemia (ALL) was allogeneic hematopoietic stem cell transplantation (HSCT). Several CAR-T cell products have been studied in prospective clinical trials which ultimately have resulted in the approval of one anti-CD19 CAR-T cell product in pediatric RR ALL: tisagenlecleucel (CD3ζ and 41BB). While some patients achieve durable responses with CAR-T, lack of response and relapse remains clinical challenges. Reasons for sub-optimal response include lack of CAR-T cell persistence and target antigen down-regulation. Future CARs are under development to improve long-term persistence and to be able to overcome resistance mechanisms associated with the disease and the hostile tumor microenvironment. With evolving understanding about CARs and new constructs under investigation, there is optimism that future products will improve the safety and efficacy from the current standard of care.
Assuntos
Imunoterapia Adotiva , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Antígenos CD19/imunologia , Antígenos de Neoplasias/genética , Antígenos de Neoplasias/imunologia , Ensaios Clínicos como Assunto , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Análise Custo-Benefício , Gerenciamento Clínico , Engenharia Genética , Transplante de Células-Tronco Hematopoéticas , Humanos , Imunoterapia Adotiva/efeitos adversos , Imunoterapia Adotiva/economia , Imunoterapia Adotiva/métodos , Depleção Linfocítica , Leucemia-Linfoma Linfoblástico de Células Precursoras/diagnóstico , Leucemia-Linfoma Linfoblástico de Células Precursoras/etiologia , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Prognóstico , Receptores de Antígenos de Linfócitos T/genética , Receptores de Antígenos de Linfócitos T/imunologia , Receptores de Antígenos Quiméricos/genética , Receptores de Antígenos Quiméricos/imunologia , Linfócitos T/imunologia , Linfócitos T/metabolismo , Resultado do TratamentoRESUMO
Cancer treatment by magnetic hyperthermia offers numerous advantages, but for practical applications many variables still need to be adjusted before developing a controlled and reproducible cancer treatment that is bio-compatible (non-damaging) to healthy cells. In this work, Fe3O4 and CoFe2O4 were synthesized and systematically studied for the development of efficient therapeutic agents for applications in hyperthermia. The biocompatibility of the materials was further evaluated using HepG2 cells as biological model. Colorimetric and microscopic techniques were used to evaluate the interaction of magnetic nano-materials (MNMs) and HepG2 cells. Finally, the behavior of MNMs was evaluated under the influence of an alternating magnetic field (AMF), observing a more efficient temperature increment for CoFe2O4, a desirable behavior for biomedical applications since lower doses and shorter expositions to alternating magnetic field might be required.
Assuntos
Hipertermia Induzida/métodos , Nanopartículas de Magnetita/administração & dosagem , Nanomedicina/métodos , Neoplasias/terapia , Animais , Materiais Biocompatíveis/administração & dosagem , Materiais Biocompatíveis/química , Materiais Biocompatíveis/toxicidade , Cobalto/administração & dosagem , Cobalto/química , Cobalto/toxicidade , Colorimetria , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Compostos Férricos/administração & dosagem , Compostos Férricos/química , Compostos Férricos/toxicidade , Óxido Ferroso-Férrico/administração & dosagem , Óxido Ferroso-Férrico/química , Óxido Ferroso-Férrico/toxicidade , Células Hep G2 , Humanos , Hipertermia Induzida/efeitos adversos , Fígado/efeitos da radiação , Magnetoterapia/efeitos adversos , Magnetoterapia/métodos , Nanopartículas de Magnetita/química , Nanopartículas de Magnetita/toxicidade , Masculino , Teste de Materiais/métodos , Ratos , Fatores de Tempo , Testes de Toxicidade/métodosRESUMO
There are several different modalities, e.g. surgery, chemotherapy and radiotherapy, that are currently used to treat cancer. It is common practice to use a combination of these modalities to maximize clinical outcomes, which are often measured by a balance between maximizing tumor damage and minimizing normal tissue side effects due to treatment. However, multi-modality treatment policies are mostly empirical in current practice and are therefore subject to individual clinicians' experiences and intuition. We present a novel formulation of optimal multi-modality cancer management using a finite-horizon Markov decision process approach. Specifically, at each decision epoch, the clinician chooses an optimal treatment modality based on the patient's observed state, which we define as a combination of tumor progression and normal tissue side effect. Treatment modalities are categorized as (1) type 1, which has a high risk and high reward, but is restricted in the frequency of administration during a treatment course; (2) type 2, which has a lower risk and lower reward than type 1, but may be repeated without restriction; and (3) type 3, no treatment (surveillance), which has the possibility of reducing normal tissue side effect at the risk of worsening tumor progression. Numerical simulations using various intuitive, concave reward functions show the structural insights of optimal policies and demonstrate the potential applications of using a rigorous approach to optimizing multi-modality cancer management.
Assuntos
Terapia Combinada/métodos , Sistemas de Apoio a Decisões Clínicas , Cadeias de Markov , Neoplasias/terapia , Algoritmos , Terapia Combinada/efeitos adversos , Terapia Combinada/estatística & dados numéricos , Simulação por Computador , Progressão da Doença , Humanos , Conceitos Matemáticos , Medicina de Precisão/métodos , Medicina de Precisão/estatística & dados numéricos , Probabilidade , Processos EstocásticosRESUMO
PURPOSE: Endovascular embolization nowadays is a well-established treatment option for direct carotid cavernous fistulas (dCCF, Barrow Type A). There are many publications on the complication and success rates of this method. However, little is known on the patients´ opinion on the treatment result after several years. We report on this issue also including the "pioneer patients" treated almost two decades ago. METHODS: We retrospectively reviewed the records of all patient (n = 25) with a more than 24 months follow-up interval after endovascular treatment of a dCCF at our institution from 01/1999 to 08/2018. We determined primary therapy success, complication rate, state of the fistula in the last imaging follow-up and quoted the patient's subjective perception of the long-term treatment success using a standardized interview form. RESULTS: Occlusion rate in the last imaging follow up was 96% (24/25) with a complication rate of 8% (2/25). The response rate on our interview request was 96% (24/25) with a rate of considered feedback of 84% (21/25 patients). Duration of our observation interval for the patient reported outcome was 143 months / 11 years (median, range: 35-226 m / 2-18 y). Most of them (21/25, 84%) felt they benefited from the treatment. CONCLUSIONS: Endovascular supply of dCCF is a highly effective treatment method leading to a sustainable therapy success with long-lasting stable subjective benefit even to our "pioneer patients" treated almost two decades ago.
Assuntos
Fístula Carótido-Cavernosa/terapia , Embolização Terapêutica , Procedimentos Endovasculares , Adulto , Idoso , Fístula Carótido-Cavernosa/diagnóstico , Fístula Carótido-Cavernosa/etiologia , Angiografia Cerebral/métodos , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Embolização Terapêutica/efeitos adversos , Embolização Terapêutica/métodos , Procedimentos Endovasculares/efeitos adversos , Procedimentos Endovasculares/métodos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Complicações Pós-Operatórias , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND/OBJECTIVES: Survivors of high-risk neuroblastoma (NB) are exposed to multimodality therapies early in life and confront late therapy-related toxicities. This study assessed respiratory symptoms, exercise capacity, and longitudinal changes in pulmonary function tests (PFTs) among survivors. DESIGN/METHODS: Survivors of high-risk NB followed in the long-term follow-up clinic at Memorial Sloan Kettering Cancer Center were enrolled. Symptom and physical activity questionnaires were completed. Medical records were reviewed for treatments and comorbidities. Participants completed spirometry, plethysmography, diffusion capacity of the lung for carbon monoxide, 6-minute walk tests (6MWTs), and cardiopulmonary exercise testing. Questionnaires and PFTs were repeated at least one year after enrollment. RESULTS: Sixty-two survivors participated (median age at study: 10.92 years; median age at diagnosis: 2.75 years; median time since completion of therapy: 5.29 years). Thirty-two percent had chronic respiratory symptoms. Seventy-seven percent had PFT abnormalities, mostly mild to moderate severity. Thirty-three completed 6MWTs (median, 634.3 meters); eight completed cardiopulmonary exercise tests (mean VO2 max: 63% predicted); 23 completed a second PFT revealing declines over a median 2.97 years (mean percent predicted forced vital capacity: 79.9 to 70.0; mean forced expiratory volume in 1 second: 81.6 to 69.9). Risks for abnormalities included thoracic surgery, chest radiation therapy (RT), thoracic surgery plus chest RT, and hematopoietic stem cell transplant. CONCLUSIONS: In this cohort of survivors of high-risk NB, PFT abnormalities were common but mostly mild or moderate. Maximal exercise capacity may be affected by respiratory limitations and declines in lung function may occur over time. Continued pulmonary surveillance of this at-risk population is warranted.
Assuntos
Sobreviventes de Câncer , Tolerância ao Exercício , Pulmão/fisiopatologia , Neuroblastoma/terapia , Adolescente , Sobreviventes de Câncer/estatística & dados numéricos , Criança , Terapia Combinada/efeitos adversos , Progressão da Doença , Feminino , Seguimentos , Humanos , Masculino , Transtornos Respiratórios/diagnóstico , Transtornos Respiratórios/epidemiologia , Transtornos Respiratórios/etiologia , Testes de Função Respiratória , Risco , Fumar/efeitos adversos , Inquéritos e Questionários , Resultado do Tratamento , Adulto JovemRESUMO
PURPOSE: Oncologists, clinical trialists, and guideline developers need tools that enable them to efficiently review the settings and results of previous studies testing metastatic breast cancer (MBC) drug therapies. METHODS: We searched the literature to identify clinical trials testing MBC drug therapies. Key eligibility criteria included at least 90% of patients enrolled in the trial having MBC, therapeutic clinical trials, and Phase II-III studies. Studies were stratified based on patients' tumor receptor statuses and prior exposure to therapy. Survival and toxicity of each drug therapy were estimated from randomized controlled trials using network meta-analysis and from all studies using meta-analysis. These results, along with estimated drug costs, are presented in a web-based visualization tool. RESULTS: We included 1865 studies containing 2676 treatment arms and 184,563 patients in the tool ( http://www.cancertrials.info ). Meta-analysis-based efficacy and toxicity estimates are available for 85 HER-2-directed therapies, 84 hormonal therapies, and 442 undirected therapies. Network meta-analysis-based estimates are available for 16 HER-2-directed therapies, 26 hormonal therapies, and 131 undirected therapies. CONCLUSIONS: In this era of increasing choices of MBC therapeutic agents and no superior approach to choosing a treatment regimen, the ability to compare multiple therapies based on survival, toxicity and cost would enable treating physicians to optimize therapeutic choices for patients. For investigators, it can point them in research directions that were previously non-obvious and for guideline designers, enable them to efficiently review the MBC clinical trial literature and visualize how regimens compare in the key dimensions of clinical benefit, toxicity, and cost.
Assuntos
Neoplasias da Mama/patologia , Neoplasias da Mama/terapia , Terapia Combinada , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/mortalidade , Ensaios Clínicos como Assunto , Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Terapia Combinada/métodos , Gerenciamento Clínico , Feminino , Custos de Cuidados de Saúde , Humanos , Metástase Neoplásica , Estadiamento de Neoplasias , Avaliação de Resultados em Cuidados de SaúdeRESUMO
BACKGROUND: We compared the efficacy, safety, and costs of hypofractionated radiotherapy (HFRT) and conventional fractionated radiotherapy (CFRT) for the neoadjuvant treatment of esophageal cancer. MATERIALS AND METHODS: Overall, 110 patients with esophageal cancer treated with neoadjuvant chemoradiotherapy from October 2002 to July 2017 were retrospectively included and divided into a HFRT group (42 patients received 30 Gray [Gy]/10 fractions for 2 weeks) and a CFRT group [68 patients received 40 Gy/20 fractions for 4 weeks]. Concurrent chemotherapy comprised cisplatin combined with either 5-FU or taxane. Surgery was performed 3-8 weeks after radiotherapy. We compared the outcomes, adverse events, and costs between the two groups. RESULTS: Pathological downstaging was achieved in 78.6% of the HFRT group and 83.8% of the CFRT group (P = 0.612). Compared with the CFRT group, the HFRT group had similar pathological complete response (pCR) (33.3% vs 35.3%; P = 0.834), median overall survival (OS) (40.8 months vs 44.9 months; P = 0.772) and progression free survival (32.7 months vs 35.4 months; P = 0.785). The perioperative complication rates were also similar between the groups, but the treatment time and costs were significantly reduced in the HFRT group (P < 0.05). Finally, multivariate analysis identified cN0 stage, pathological downstaging and pCR as independent predictors of better OS. CONCLUSION: Preoperative HFRT is effective and safe for esophageal cancer. Moreover, it is similar to CFRT in terms of overall survival and toxicity and is cost effective and less time consuming.
Assuntos
Fracionamento da Dose de Radiação , Neoplasias Esofágicas/radioterapia , Custos de Cuidados de Saúde , Radioterapia Adjuvante , Adulto , Idoso , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Análise Custo-Benefício , Neoplasias Esofágicas/epidemiologia , Neoplasias Esofágicas/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Gradação de Tumores , Estadiamento de Neoplasias , Hipofracionamento da Dose de Radiação , Radioterapia Adjuvante/efeitos adversos , Radioterapia Adjuvante/economia , Radioterapia Adjuvante/métodos , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Laparoscopic hyperthermic intraperitoneal chemotherapy (HIPEC) has been used to treat various peritoneal malignancies. Cisplatin and mitomycin C (MMC) are agents commonly used in these procedures and, individually, each has been associated with acute kidney injury (AKI). There is limited literature on the complications associated with the use of both agents in HIPEC. Therefore, we sought to determine the incidence of nephrotoxicity and electrolyte abnormalities in patients undergoing laparoscopic HIPEC using this chemotherapeutic combination. METHODS: We retrospectively evaluated patients undergoing laparoscopic HIPEC for gastric or gastroesophageal adenocarcinoma using both cisplatin and MMC. Sodium thiosulfate was given for renal protection and kidney function was evaluated daily up to postoperative day #2. Details regarding patient characteristics, selection criteria, chemotherapeutic regimen, perioperative lab values and anesthetic management were collected. RESULTS: Twenty-three patients underwent 31 laparoscopic HIPEC procedures. Fifteen (65%) were male and the median age was 57 (range 21-75). Thirteen procedures were associated with an elevation in creatinine (Cr) with the median difference between POD#2 and baseline being 0.09 mg/dL (range 0-0.43). The glomerular filtration rate median difference between POD#2 and baseline was -17 mL/min/1.37 sq. m (range -42 to 11). No cases demonstrated AKI, defined as a 50% increase in Cr levels above baseline. An 84% incidence of postoperative hypophosphatemia (26/31) and 94% incidence of postoperative hypocalcemia (29/31) was observed. CONCLUSION: The laparoscopic approach to HIPEC using both cisplatin and MMC in our cohort was not associated with an increased incidence of AKI. The incidence of hypophosphatemia and hypocalcemia needs further evaluation to determine the exact etiology. Precis' statement: We retrospectively studied the association of AKI with the combined use of cisplatin and MMC in laparoscopic HIPEC.
Assuntos
Injúria Renal Aguda/induzido quimicamente , Cisplatino/efeitos adversos , Terapia Combinada/efeitos adversos , Hipertermia Induzida/métodos , Laparoscopia/métodos , Mitomicina/efeitos adversos , Adulto , Idoso , Cisplatino/farmacologia , Terapia Combinada/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mitomicina/farmacologia , Estudos Retrospectivos , Adulto JovemRESUMO
Adverse event (AE)-related costs represent an important component of economic models for cancer care. However, since previous studies mostly focused on specific AEs, treatments, or cancer types, limited information is currently available. Therefore, this study assessed the incremental healthcare costs associated with a large number of AEs among patients diagnosed with some of the most prevalent types of cancer. Data were obtained from a large US claims database. Adult patients were included if diagnosed with and treated for one of the following cancer types: breast, digestive organs and peritoneum, genitourinary organs (including bladder and ovary and other uterine adnexa), lung, lymphatic and hematopoietic tissue, and skin. Treatment episodes were defined as the period from initiation of the first antineoplastic pharmacologic therapy to discontinuation (i.e., gap of ≥ 45 days), or change in treatment regimen, or end of data availability. A total of 36 AEs were selected from the product inserts of 104 treatments recommended by practice guidelines. A retrospective matched cohort design was used, matching a treatment episode with a certain AE with a treatment episode without that AE. A total of 412,005 patients were selected, for a total of 794,243 treatment episodes, resulting in 1,617,368 matched treatment episodes across all 36 AEs. Incremental healthcare costs associated with AEs of any severity ranged from $546 for cough/upper respiratory infections to $24,633 for gastrointestinal perforation. The three most costly AEs when considering any severity were gastrointestinal perforation ($24,633), central nervous system hemorrhage ($24,322), and sepsis/septicemia ($23,510). Incremental healthcare costs associated with severe AEs ranged from $15,709 for dermatitis and rash to $48,538 for gastrointestinal fistula. The three most costly severe AEs were gastrointestinal fistula ($48,538), gastrointestinal perforation ($41,281), and central nervous system hemorrhage ($38,428). In conclusion, AEs during treatment episodes for cancer were frequent and associated with a substantial economic burden.
Assuntos
Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Custos de Cuidados de Saúde , Neoplasias/epidemiologia , Vigilância em Saúde Pública , Idoso , Comorbidade , Bases de Dados Factuais , Feminino , Custos de Cuidados de Saúde/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/diagnóstico , Neoplasias/terapia , Avaliação de Resultados em Cuidados de Saúde , Prevalência , Estudos RetrospectivosRESUMO
BACKGROUND: Patient characteristics and survival outcomes in randomized trials may be different from those in real-life clinical practice. The objective of this study was to describe treatment pathways, safety, drug costs and survival in patients with metastatic Renal Cell Carcinoma (mRCC) in a real world setting. METHODS: A retrospective analysis was performed using IQVIA real world oncology cross-sectional survey data, a retrospective treatment database collecting anonymized patient-level data in Europe. Data on treatment naïve patients with mRCC who received a first-line targeted therapy in France were extracted for the period 2005-2015. Descriptive analyses were performed on treatment patterns, patient characteristics and safety profiles. Progression Free Survival (PFS) was determined using Kaplan-Meier survival analysis. RESULTS: One thousand three hundred thirty-one patients with mRCC who received a first-line targeted therapy were included. The male/female sex ratio was 2.5 and 66% of patients were aged > 60 years. 83% of patients had clear cell adenocarcinoma. 83% of patients underwent a surgical procedure, 10% had radiotherapy. In patients who received a first-line targeted therapy, 73% received sunitinib. The mean time from diagnosis to first-line treatment by targeted therapies in patients initially diagnosed with metastatic disease was 3.3 months [95% CI:2.5-4.1]. In patients who received second-line targeted therapy n = 257 (19%), the most frequently observed treatment sequences were sunitinib-everolimus (33%) and sunitinib-sorafenib (27%). Adverse events data were available for 501 patients and adverse events were documented in 70% of patients, most frequently diarrhoea. The overall median PFS was 13 months [95% CI:11.5-16]. CONCLUSION: Patient characteristics were consistent with the literature. Treatment patterns appeared to follow current practice guidelines. Despite some variations, PFS in our study seems to be consistent with findings from other real world studies. Nevertheless, PFS results were higher than those observed in clinical trials. Due to the use of cross-sectional data, PFS in our study should be interpreted with caution.
Assuntos
Carcinoma de Células Renais/epidemiologia , Neoplasias Renais/epidemiologia , Padrões de Prática Médica , Carcinoma de Células Renais/diagnóstico , Carcinoma de Células Renais/mortalidade , Carcinoma de Células Renais/terapia , Terapia Combinada/efeitos adversos , Terapia Combinada/métodos , Estudos Transversais , Gerenciamento Clínico , Intervalo Livre de Doença , Feminino , Custos de Cuidados de Saúde , Humanos , Estimativa de Kaplan-Meier , Neoplasias Renais/diagnóstico , Neoplasias Renais/mortalidade , Neoplasias Renais/terapia , Masculino , Avaliação de Resultados em Cuidados de Saúde , Vigilância em Saúde Pública , Estudos RetrospectivosRESUMO
OBJECTIVES: The aim of this study was to evaluate the pharmacoeconomic profile in Italy of preoperative treatment with ulipristal acetate at the dose of 5â¯mg/day for 13 weeks in comparison with placebo prior to surgical management of symptomatic uterine fibroids. STUDY DESIGN: The pharmacoeconomic analysis was based on the calculation of incremental cost-effectiveness ratio (ICER). Effectiveness data were derived from the randomized-controlled trial PEARL-1, whilst costs data were retrieved from the published literature. A Markov model was employed to simulate the pattern of costs and two univariate sensitivity analyses tested the robustness of the results. RESULTS: In comparison with placebo, ulipristal acetate 5â¯mg for presurgical therapy was estimated to be associated with an incremental cost of 351 per patient. Costs per patient were 3836 for ulipristal acetate vs 3485 for placebo. The incremental effectiveness was 0.01931 QALYs per patient (around 7 quality-adjusted days per patient). Hence, the cost effectiveness ratio was calculated to be 18,177 per QALY gained. CONCLUSIONS: Preoperative use of ulipristal acetate 5â¯mg in patients with uterine fibroids has a favourable pharmacoeconomic profile.
Assuntos
Anticoncepcionais Orais Hormonais/uso terapêutico , Leiomioma/tratamento farmacológico , Leiomiomatose/tratamento farmacológico , Modelos Econômicos , Norpregnadienos/uso terapêutico , Cuidados Pré-Operatórios , Neoplasias Uterinas/tratamento farmacológico , Adulto , Estudos de Coortes , Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Anticoncepcionais Orais Hormonais/efeitos adversos , Anticoncepcionais Orais Hormonais/economia , Análise Custo-Benefício , Feminino , Custos de Cuidados de Saúde , Humanos , Histerectomia/efeitos adversos , Histerectomia/economia , Itália , Leiomioma/economia , Leiomioma/fisiopatologia , Leiomioma/cirurgia , Leiomiomatose/economia , Leiomiomatose/fisiopatologia , Leiomiomatose/cirurgia , Norpregnadienos/efeitos adversos , Norpregnadienos/economia , Cuidados Pré-Operatórios/efeitos adversos , Cuidados Pré-Operatórios/economia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Carga Tumoral/efeitos dos fármacos , Embolização da Artéria Uterina/efeitos adversos , Embolização da Artéria Uterina/economia , Hemorragia Uterina/economia , Hemorragia Uterina/etiologia , Hemorragia Uterina/prevenção & controle , Hemorragia Uterina/terapia , Miomectomia Uterina/efeitos adversos , Miomectomia Uterina/economia , Neoplasias Uterinas/economia , Neoplasias Uterinas/fisiopatologia , Neoplasias Uterinas/cirurgiaRESUMO
AIMS: To evaluate the clinical and patient-reported outcomes and healthcare utilization and costs associated with patient-reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. MATERIALS AND METHODS: This was an observational, cross-sectional, survey-based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid-acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non-severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health-related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. RESULTS: Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non-severe or no hypoglycaemia. Patients with non-severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. CONCLUSIONS: Patients with T2D using basal insulin ± OADs or rapid-acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non-severe or no hypoglycaemia. The study also demonstrated the impact that non-severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs.
Assuntos
Efeitos Psicossociais da Doença , Diabetes Mellitus Tipo 2/tratamento farmacológico , Custos de Cuidados de Saúde , Hipoglicemia/induzido quimicamente , Hipoglicemiantes/efeitos adversos , Insulina/efeitos adversos , Qualidade de Vida , Administração Oral , Adulto , Idoso , Estudos de Coortes , Terapia Combinada/efeitos adversos , Terapia Combinada/economia , Custos e Análise de Custo , Estudos Transversais , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/economia , Quimioterapia Combinada/efeitos adversos , Quimioterapia Combinada/economia , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Hipoglicemia/economia , Hipoglicemia/fisiopatologia , Hipoglicemia/terapia , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/economia , Hipoglicemiantes/uso terapêutico , Insulina/economia , Insulina/uso terapêutico , Internet , Masculino , Pessoa de Meia-Idade , Autorrelato , Índice de Gravidade de Doença , Estados UnidosRESUMO
BACKGROUND AND OBJECTIVE: Rheumatoid arthritis (RA) is a predominant inflammatory autoimmune disorder. The incidence and prevalence of RA is increasing with considerable morbidity and mortality worldwide. The pathophysiology of RA has become clearer due to many significant research outputs during the last two decades. Many inflammatory cytokines involved in RA pathophysiology and the presence of autoantibodies are being used as potential biomarkers via the use of effective diagnostic techniques for the early diagnosis of RA. Currently, several disease-modifying anti-rheumatic drugs are being prescribed targeting RA pathophysiology, which have shown significant contributions in improving the disease outcomes. DISCUSSION: Even though innovations in treatment strategies and monitoring are helping the patients to achieve early and sustained clinical and radiographic remission, the high cost of drugs and limited health care budgets are restricting the easy access of RA treatment. Both direct and indirect high cost of treatment are creating economic burden for the patients and affecting their quality of life. CONCLUSION: The aim of this review is to describe the updated concept of RA pathophysiology and highlight current diagnostic tools used for the early detection as well as prognosis - targeting several biomarkers of RA. Additionally, we explored the updated treatment options with side effects besides discussing the global economic burden.