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1.
Cancers (Basel) ; 13(13)2021 Jun 30.
Artigo em Inglês | MEDLINE | ID: mdl-34209210

RESUMO

In uveal melanoma (UM), gene expression profiling (GEP) is commonly used to classify metastatic risk into three groups (Class 1A, 1B, and 2). Class 1A patients have a lower metastatic risk of 2% at 5 years compared to other groups. We aimed to describe clinical features associated with the development of metastasis in this low-risk group. This single-center IRB-approved retrospective case series review included all UM patients between February 2006 and March 2019 with an archived or fresh specimen classified as Class 1A. Cox regression and receiver operating characteristics analyses were used to identify factors associated with metastasis development and OS. Among 73 UM patients with Class 1A, the 5-year cumulative incidence of local recurrence and distant metastasis was 4.2% and 17.0%, respectively. Stage III disease (HR 20.7; 95% confidence interval (95% CI) 1.4-300.6; p = 0.0264) was found to be independently associated with metastatic recurrence, while primary therapy was associated with OS (enucleation vs. brachytherapy, HR 13.5; 95% CI 1.3-147.6; p = 0.0348). Combined clinical decision-making utilizing factors such as GEP class, American Joint Committee on Cancer (AJCC) stage, and COMS size could have a significant clinical impact by improving risk stratification and adapting follow-up intervals in UM Class 1A patients.

2.
Haematologica ; 2021 May 06.
Artigo em Inglês | MEDLINE | ID: mdl-33951890

RESUMO

High-dose chemotherapy and autologous stem-cell transplant (HDC/ASCT) is standard treatment of chemosensitive relapsed classical Hodgkin lymphoma (cHL), although outcomes of high-risk relapse (HRR) patients remain suboptimal. We retrospectively analyzed all HRR cHL patients treated with HDC/ASCT at our institution between 01/01/2005-12/31/2019. HRR criteria included primary refractory disease/relapse within 1 year, extranodal extension, B symptoms, requiring > 1 salvage line, or PET+ disease at ASCT. All patients met the same ASCT eligibility criteria. We treated 501 patients with BEAM (N=146), BuMel (N=38), GemBuMel (N=189) and vorinostat/GemBuMel (N=128). The GemBuMel and vorinostat/GemBuMel cohorts had more HRR criteria and more patients with PET+ disease at ASCT. Pre-ASCT BV, anti-PD1, PET-negative disease at ASCT, and maintenance BV increased over time. BEAM and BuMel predominated in earlier years (2005-2007), GemBuMel and BEAM in middle years (2008-2015), and vorinostat/GemBuMel and BEAM in later years (2016-2019). Median follow-up is 50 months (6-186). Outcomes improved over time, with 2-year PFS/OS rates of 58%/82% (2005-2007), 59%/83% (2008-2011), 71%/94% (2012-2015) and 86%/99% (2016-2019) (P.

3.
Breast Cancer Res Treat ; 187(1): 95-104, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33813685

RESUMO

PURPOSE: HER2 overexpression and gene amplification are routinely tested by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH), respectively. In addition, HER2 mRNA expression is also tested by the Oncotype DX assay. Discordance between laboratories among the different assays remains a problem. To improve the routine HER2 reporting, the American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) updated their guidelines in 2018. Our study will compare concordance of HER2 status by IHC and FISH using ASCO/CAP 2013 and 2018 guidelines with Oncotype DX. METHODS: We retrospectively reviewed 657 estrogen receptor positive primary breast cancer cases with available Oncotype DX tests between 2011 and 2018. Medical records were reviewed for HER2 results by IHC, FISH, and Oncotype DX. The HER2 results by different assays and between 2013 and 2018 guidelines were compared. RESULTS: Of the 657 cases, 280 were tested by IHC, FISH, and Oncotype DX. HER2-equivocal cases by IHC 2013 guidelines were all negative (67/67, 100%) by FISH 2018 guidelines and by Oncotype DX. HER2-equivocal cases by FISH 2013 guidelines were all negative (16/16, 100%) by FISH 2018 guidelines, while 15/16 (93.8%) negative and 1/16 (6.2%) equivocal by Oncotype DX. The HER2-equivocal and HER2-negative groups were similar in age, gender, histology, grade, and Ki67 score. CONCLUSIONS: HER2 concordance was highest between Oncotype DX (99.6%) and FISH per 2018 guidelines. This suggests that the ASCO/CAP 2018 guidelines improved the accurate stratification of HER2-equivocal cases.


Assuntos
Neoplasias da Mama , Biomarcadores Tumorais/genética , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/genética , Feminino , Humanos , Imuno-Histoquímica , Hibridização in Situ Fluorescente , Receptor ErbB-2/genética , Estudos Retrospectivos
4.
J Immunother Cancer ; 9(2)2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33637601

RESUMO

BACKGROUND: Immune checkpoint inhibitors (ICIs) are being used after allogeneic hematopoietic stem cell transplantation (alloHCT) to reverse immune dysfunction. However, a major concern for the use of ICIs after alloHCT is the increased risk of graft-versus-host disease (GVHD). We analyzed the association between GVHD prophylaxis and frequency of GVHD in patients who had received ICI therapy after alloHCT. METHODS: A retrospective study was performed in 21 patients with acute myeloid leukemia (n=16) or myelodysplastic syndromes (n=5) who were treated with antiprogrammed cell death protein 1 (16 patients) or anticytotoxic T lymphocyte-associated antigen 4 (5 patients) therapy for disease relapse after alloHCT. Associations between the type of GVHD prophylaxis and incidence of GVHD were analyzed. RESULTS: Four patients (19%) developed acute GVHD. The incidence of acute GVHD was associated only with the type of post-transplantation GVHD prophylaxis; none of the other variables included (stem cell source, donor type, age at alloHCT, conditioning regimen and prior history of GVHD) were associated with the frequency of acute GVHD. Twelve patients received post-transplantation cyclophosphamide (PTCy) for GVHD prophylaxis. Patients who received PTCy had a significantly shorter median time to initiation of ICI therapy after alloHCT compared with patients who did not receive PTCy (median 5.1 months compared with 26.6 months). Despite early ICI therapy initiation, patients who received PTCy had a lower observed cumulative incidence of grades 2-4 acute GVHD compared with patients who did not receive PTCy (16% compared with 22%; p=0.7). After controlling for comorbidities and time from alloHCT to ICI therapy initiation, the analysis showed that PTCy was associated with a 90% reduced risk of acute GVHD (HR 0.1, 95% CI 0.02 to 0.6, p=0.01). CONCLUSIONS: ICI therapy for relapsed acute myeloid leukemia/myelodysplastic syndromes after alloHCT may be a safe and feasible option. PTCy appears to decrease the incidence of acute GVHD in this cohort of patients.

5.
J Clin Oncol ; 39(6): 599-607, 2021 02 20.
Artigo em Inglês | MEDLINE | ID: mdl-33125309

RESUMO

PURPOSE: Metastatic uveal melanoma has poor overall survival (OS) and no approved systemic therapy options. Studies of single-agent immunotherapy regimens have shown minimal benefit. There is the potential for improved responses with the use of combination immunotherapy. PATIENTS AND METHODS: We conducted a phase II study of nivolumab with ipilimumab in patients with metastatic uveal melanoma. Any number of prior treatments was permitted. Patients received nivolumab 1 mg/kg and ipilimumab 3 mg/kg for four cycles, followed by nivolumab maintenance therapy for up to 2 years. The primary outcome of the study was overall response rate (ORR) as determined by RECIST 1.1 criteria. Progression-free survival (PFS), OS, and adverse events were also assessed. RESULTS: Thirty-five patients were enrolled, and 33 patients were evaluable for efficacy. The ORR was 18%, including one confirmed complete response and five confirmed partial responses. The median PFS was 5.5 months (95% CI, 3.4 to 9.5 months), and the median OS was 19.1 months (95% CI, 9.6 months to NR). Forty percent of patients experienced a grade 3-4 treatment-related adverse event. CONCLUSION: The combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal melanoma, with deep and sustained confirmed responses.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Ipilimumab/uso terapêutico , Melanoma/tratamento farmacológico , Nivolumabe/uso terapêutico , Neoplasias Uveais/tratamento farmacológico , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Feminino , Humanos , Ipilimumab/farmacologia , Masculino , Pessoa de Meia-Idade , Nivolumabe/farmacologia
6.
Invest Ophthalmol Vis Sci ; 60(6): 2388-2398, 2019 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-31141610

RESUMO

Purpose: Conjunctival squamous cell carcinoma (SCC), a type of ocular surface neoplasia, is primarily treated by surgical resection and topical immuno- or chemotherapy. Metastatic disease may be treated with systemic chemo- or immunotherapy, albeit with variable response. The purpose of this study was to determine whether immune checkpoint blockade might be considered in the management of conjunctival SCC. Methods: In this retrospective study, we evaluated tumor programmed death-ligand 1 (PD-L1) expression, high-risk human papillomavirus (HPV) status, and immunohistochemical expression of cluster of differentiation 3 (CD3), cluster of differentiation 8 (CD8), and programmed death 1 (PD1) in tumor-associated immune infiltrate in a series of 31 conjunctival SCCs. Results: PD-L1 expression in ≥1% of tumor cells was noted in 14 conjunctival SCCs (47%) and was more prevalent in invasive than in situ SCC and among tumors with higher American Joint Committee on Cancer (AJCC) T category (≥T3 versus ≤T2). The density of CD3-positive T cells was higher in primary than recurrent tumors and higher in invasive than in situ tumors. Density of CD3-positive and CD8-positive T cells was higher in higher AJCC stage tumors. Density of CD8-positive T cells was higher in HPV-positive than HPV-negative tumors. PD-L1 expression correlated with a higher density of CD3-, CD8-, and PD1-positive cells in the tumor-associated immune infiltrate but not with HPV status. Conclusions: Our findings demonstrate that PD-L1 is expressed in almost half of conjunctival SCCs. The density of tumor-associated immune cells correlated with invasive SCC, stage, and HPV status in conjunctival SCC. Our findings support further studies to establish the potential application of immune checkpoint blockade in the management of conjunctival SCC.


Assuntos
Antígeno B7-H1/metabolismo , Carcinoma de Células Escamosas/metabolismo , Neoplasias da Túnica Conjuntiva/metabolismo , Infecções por Papillomavirus/complicações , Receptor de Morte Celular Programada 1/metabolismo , Antígenos CD/metabolismo , Biomarcadores Tumorais/metabolismo , Linfócitos T CD8-Positivos/citologia , Humanos , Estudos Retrospectivos
7.
BMJ Open Respir Res ; 6(1): e000471, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31921429

RESUMO

Background: Pneumonia is a major cause of mortality and morbidity, but the development of new antimicrobials is lacking. Radiological assessment of pneumonia severity may serve as an effective intermediate endpoint to reduce barriers to successful completion of antimicrobial trials. We sought to determine whether the Radiologic Severity Index (RSI) correlated with mortality and healthcare resource utilisation in patients with acute leukaemia undergoing induction chemotherapy. Methods: We measured RSI (range 0-72) on all chest radiographs performed within 33 days of induction chemotherapy in 165 haematological malignancy patients with pneumonia. Peak RSI was defined as the highest RSI score within 33 days of induction. We used extended Cox proportional hazards models to measure the association of time-varying RSI with all-cause mortality within the first 33 days after induction chemotherapy, and logistic regression or generalised models to measure the association of RSI with total daily cost and healthcare resource utilisation. Results: After adjustment for clinical variables, each one-point increase in RSI was associated with a 7% increase in all-cause 33-day mortality (HR 1.07, 95% CI 1.05 to 1.09, p<0.0001). Peak RSI values of 37.5 or higher were associated with 86% higher daily direct costs (p<0.0001), more days in intensive care unit (9.9 vs 4.8 days, p=0.001) and higher odds for mechanical ventilation (OR 12.1, p<0.0001). Conclusions: Greater radiological severity as measured by RSI was associated with increased mortality and morbidity in acute leukaemia patients with pneumonia. RSI is a promising intermediate marker of pneumonia severity and is well suited for use in antimicrobial trials.


Assuntos
Leucemia Mieloide Aguda/mortalidade , Pulmão/diagnóstico por imagem , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Pneumonia/diagnóstico , Índice de Gravidade de Doença , Adulto , Idoso , Anti-Infecciosos/uso terapêutico , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Progressão da Doença , Feminino , Humanos , Unidades de Terapia Intensiva/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Leucemia Mieloide Aguda/complicações , Leucemia Mieloide Aguda/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Pneumonia/etiologia , Pneumonia/mortalidade , Pneumonia/terapia , Radiologia , Indução de Remissão , Respiração Artificial , Medição de Risco
8.
Aerosp Med Hum Perform ; 88(8): 784-788, 2017 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-28720190

RESUMO

INTRODUCTION: Antarctica is a useful analog for spaceflight, as both environments are remote, isolated, and with limited resources. While previous studies have demonstrated increased asymptomatic viral shedding in both the Antarctic and spaceflight environments, clinical manifestations of reactivated viral disease have been less frequently identified. We sought to identify the incidence of clinical herpes zoster from viral reactivation in the Antarctic winter-over population. METHODS: Medical records from the 2014 winter season were reviewed for the incidence of zoster in U.S. Antarctic personnel and then compared to the age-matched U.S. RESULTS: Five cases of clinical herpes zoster occurred in the Antarctic Station population of 204 persons, for an incidence of 33.3 per 1000 person-years vs. 3.2 per 1000 person-years in the general population. Four cases were in persons under age 40, yielding an incidence of 106.7 per 1000 person-years in persons ages 30-39 compared to an incidence of 2.0 per 1000 person-years in the same U.S. age group. DISCUSSION: Immune suppression due to the stressful Antarctic environment may have contributed to the increased incidence of herpes zoster in U.S. Antarctic personnel during the winter of 2014. Working and living in isolated, confined, and extreme environments can cause immune suppression, reactivating latent viruses and increasing viral shedding and symptomatic disease. Such changes have been observed in other austere environments, including spaceflight, suggesting that clinical manifestations of viral reactivation may be seen in future spaceflight.Reyes DP, Brinley AA, Blue RS, Gruschkus SK, Allen AT, Parazynski SE. Clinical herpes zoster in Antarctica as a model for spaceflight. Aerosp Med Hum Perform. 2017; 88(8):784-788.


Assuntos
Herpes Zoster/epidemiologia , Simulação de Ambiente Espacial , Adulto , Idoso , Regiões Antárticas/epidemiologia , Feminino , Herpes Zoster/imunologia , Humanos , Hospedeiro Imunocomprometido/imunologia , Incidência , Masculino , Pessoa de Meia-Idade , Estações do Ano , Voo Espacial , Estresse Fisiológico/imunologia , Estresse Psicológico/imunologia , Estados Unidos/epidemiologia , Eliminação de Partículas Virais , Adulto Jovem
10.
Am J Health Syst Pharm ; 71(18): 1556-65, 2014 Sep 15.
Artigo em Inglês | MEDLINE | ID: mdl-25174016

RESUMO

PURPOSE: Results of a study of postsurgical opioid-related adverse drug events (ORADEs) within a large health system are reported. METHODS: In a retrospective cohort study, data from the information database of an 11-hospital Texas health system were analyzed to (1) describe postsurgical opioid use among adult patients undergoing elective or emergency surgery over a one-year period, (2) identify ORADE risk factors and associated costs, and (3) compare clinical and economic outcomes in patients who experienced ORADEs and those who did not. Multivariate logistic regression was used to identify ORADE risk factors. Propensity score-matched comparisons of outcomes in patients with and without ORADEs were conducted. RESULTS: Among 6,285 patients in the study population, 6,274 (99.8%) received postsurgical opioids; 11.5% of those patients experienced an ORADE. ORADE risk factors included age (≥65 years), male sex, prior opioid use, chronic obstructive pulmonary disease, cardiac dysrhythmias, regional enteritis, diverticulitis, and ulcerative colitis. Patients with multiple risk factors had higher mean hospitalization costs ($21,073) relative to patients with one risk factor ($14,110) or no risk factor ($11,433) and accounted for a disproportionately large share of overall costs; patients who experienced ORADEs were more likely to be cost and length of stay (LOS) outliers. CONCLUSION: Analysis of information from a large database demonstrated that opioid-treated postsurgical inpatients who had multiple risk factors for ORADEs were more likely to have higher mean costs, greater readmission rates, and longer LOS than patients with fewer risk factors.


Assuntos
Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/economia , Serviços de Saúde Comunitária/economia , Custos Hospitalares , Dor Pós-Operatória/tratamento farmacológico , Adolescente , Adulto , Bases de Dados de Produtos Farmacêuticos , Feminino , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/economia , Readmissão do Paciente/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Texas , Resultado do Tratamento , Adulto Jovem
11.
J Manag Care Spec Pharm ; 20(9): 948-58, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25166294

RESUMO

BACKGROUND: Opioid-related adverse drug events (ORADEs) are common causes of hospitalization and increased health care costs. OBJECTIVES: To (a) estimate rates of specific adverse drug events (ADEs) among gastrointestinal (GI) surgery patients receiving postoperative opioids; (b) examine the utility of a risk-scoring model in categorizing patients at high risk of experiencing ORADEs; and (c) quantify potential clinical/economic benefits of targeting high-risk GI surgical patients for opioid-sparing regimens in terms of hospitalization cost, length of stay (LOS), and 30-day readmission rates. METHODS: Using a retrospective design based on an administrative database, patients with an inpatient surgical procedure between January 1, 2010, and December 31, 2010, were included. GI surgical patients aged greater than 18 years followed from admission through 30 days postdischarge were characterized as high or low risk using clinical/demographic characteristics and were evaluated for several outcomes. Using multivariate logistic regression, the ORADE incidence, total hospitalization cost, LOS, and 30-day readmissions were compared for high-risk and low-risk patients. RESULTS: In 87.8% (n = 3,235) of the surgical population, there was a strong concordance between risk assignment and ORADE incidence. Among the remaining 12.2% (n = 449) of patients, 5.5% (n = 202) were low risk with an ORADE, and 6.7% (n = 247) were high risk without an ORADE. Overall, 20.6% (n = 344) of high-risk patients experienced ≥1 ORADE (mean cost: $31,988; LOS: 12.1 days) compared with only 5.3% (n = 107) of low-risk patients (mean cost: $25,216; LOS: 8.0 days). High-risk patients had higher hospitalization costs and longer LOS than low-risk patients, respectively (mean cost: $19,234 vs. $13,036; mean LOS: 6.8 days vs. 3.3 days). These differences correspond to 47.0% higher costs for high-risk patients and an LOS approximately twice as long compared with low-risk patients. CONCLUSIONS: Patient clinical/demographic characteristics influence the risk of developing ORADEs. Risk assessment tools can effectively identify high-risk patients, thereby enabling interventions that can reduce ORADEs, decrease hospital costs, and improve postsurgical experiences for patients.


Assuntos
Analgésicos Opioides/efeitos adversos , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Dor Pós-Operatória/tratamento farmacológico , Avaliação de Resultados da Assistência ao Paciente , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/economia , Analgésicos Opioides/uso terapêutico , Estudos de Coortes , Custos e Análise de Custo , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Feminino , Custos Hospitalares , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Sistemas Multi-Institucionais , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/economia , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Dor Pós-Operatória/economia , Dor Pós-Operatória/etiologia , Readmissão do Paciente/economia , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Texas/epidemiologia , Adulto Jovem
12.
Lung Cancer ; 82(1): 121-7, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23973203

RESUMO

This retrospective observational study evaluated cost effectiveness of first-line treatment of advanced nonsquamous non-small cell lung cancer (NSCLC) with pemetrexed/platinum (Pem/Plat) relative to paclitaxel/carboplatin (Pac/Carbo) and paclitaxel/carboplatin/bevacizumab (Pac/Carbo/Bev). Patients initiating first-line treatment from 2006 to 2009 were identified in electronic medical records of 20 US oncology practices. Pem/Plat patients were matched 1:1 on important characteristics with Pac/Carbo and Pac/Carbo/Bev patients and followed for 1 year to assess progression, survival, and costs. Bootstrapping was used to calculate the probability of falling within quadrants of the incremental cost-effectiveness plane. Kaplan-Meier analysis and Cox proportional hazards regression modeling were also performed. Three hundred Pem/Plat patients (mean age, 67.6 years; male, 56.0%; PS 0/1, 71.0%) were matched with 300 patients in the other cohorts. Median PFS was 134 days (Pem/Plat) versus 106 days (Pac/Carbo) (hazard ratio [HR]: 0.67, P < 0.001) and 126 days (Pac/Carbo/Bev) (HR: 0.68, P < 0.001). Median OS was 298 days (Pem/Plat) versus 218 days (Pac/Carbo) (HR: 0.88, P = 0.08) and 271 days (Pac/Carbo/Bev) (HR: 0.93, P = 0.31). Pem/Plat therapy costs were higher versus Pac/Carbo ($21,841 higher PFS; $19,137 higher OS; P ≤ 0.05) and lower versus Pac/Carbo/Bev ($15,160 lower PFS; $19,946 lower OS; P ≤ 0.05). Pem/Plat had a greater probability of higher costs/higher effectiveness versus Pac/Carbo (PFS, 90.1%; OS, 96.3%) and lower costs/higher effectiveness versus Pac/Carbo/Bev (PFS, 69.5%; OS, 85.0%). Pem/Plat had higher cost and effectiveness than Pac/Carbo; depending on a payer's or society's willingness to pay, Pem/Plat may be considered cost effective compared with Pac/Carbo. Pem/Plat yielded greater effectiveness with lower costs than Pac/Carbo/Bev.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/economia , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Neoplasias Pulmonares/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carboplatina/administração & dosagem , Carcinoma Pulmonar de Células não Pequenas/economia , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Análise Custo-Benefício , Intervalo Livre de Doença , Feminino , Glutamatos/administração & dosagem , Guanina/administração & dosagem , Guanina/análogos & derivados , Humanos , Quimioterapia de Indução , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/economia , Neoplasias Pulmonares/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Observacionais como Assunto , Pemetrexede , Platina/administração & dosagem , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos
13.
Pharmacotherapy ; 33(4): 383-91, 2013 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-23553809

RESUMO

STUDY OBJECTIVE: To determine the prevalence of postsurgical opioid use in the inpatient setting, to ascertain the frequency of and risk factors for opioid-related adverse drug events (ORADEs) among patients who received opioids, and to evaluate the impact of ORADEs on clinical and economic outcomes. DESIGN: Retrospective cohort study using administrative data. SETTING: Hospital system encompassing 26 hospitals in the southeastern United States. PATIENTS: A total of 37,031 patients aged 18 years or older who underwent a common surgical procedure between January 1, 2009, and December 31, 2010. MEASUREMENTS AND MAIN RESULTS: Patients were evaluated for receipt of postsurgical opioids. Outcomes among opioid users included ORADE rates, hospital length of stay, total hospitalization costs, 30-day readmission rates, outlier status, and inpatient mortality. Factors associated with ORADEs were evaluated; length of stay, costs, readmissions, and mortality were compared between patients experiencing and not experiencing ORADEs by using propensity score matching on age, race-ethnicity, sex, presurgery opioid use, and comorbidities. Length of stay and cost rate ratios were generated by using negative binomial regression and generalized linear models. Odds ratios for 30-day readmissions and inpatient mortality were generated by using logistic regression. Among all surgical patients, 36,529 (98.6%) of patients received opioids, of whom 4955 (13.6%) experienced an ORADE. Increased risk of ORADEs was associated with age 65 years or older, male sex, obesity, presurgery opioid use, and higher score on Charlson Comorbidity Index. Patients with an ORADE had a 55% longer length of stay, 47% higher costs of care, 36% increased risk of 30-day readmission, and 3.4 times higher risk of inpatient mortality than did patients who did not experience an ORADE. CONCLUSION: Opioid use was ubiquitous among hospitalized patients who underwent common surgical procedures. The observed negative outcomes of ORADEs and their impact on patients and the health care system should be considered when evaluating the balance between effectively managing postsurgical pain while minimizing the risk of ORADEs.


Assuntos
Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/economia , Uso de Medicamentos/economia , Custos Hospitalares , Dor Pós-Operatória/tratamento farmacológico , Complicações Pós-Operatórias/mortalidade , Adolescente , Adulto , Idoso , Analgésicos Opioides/uso terapêutico , Feminino , Humanos , Tempo de Internação/economia , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/economia , Estudos Retrospectivos , Fatores de Risco
14.
P T ; 37(8): 464-70, 2012 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-23091339

RESUMO

OBJECTIVE: Our goal was to quantify relationships between adherence to 5-alpha reductase inhibitors (5-ARIs), the risk of acute urinary retention (AUR) and prostate surgery, and medical costs related to patients with benign prostatic hyperplasia (BPH). METHODS: Claims recorded over a period of 6.5 years in a nationwide managed care database were analyzed. We conducted time-to-event multivariate analysis to evaluate relationships between adherence (medication possession ratio [MPR] thresholds of 70% or higher, 75% or higher, and 80% or higher), persistence (length of therapy), and the risk of AUR and surgery. We compared mean monthly BPH-related medical costs in patients with MPRs at or above thresholds and those with MPRs below thresholds and determined changes in BPH-related costs associated with 30-day increments of therapy. RESULTS: In AUR analyses (N = 17,293), meeting or exceeding MPR thresholds was associated with a reduced likelihood of AUR for 70% (hazard ratio [HR], 0.380), 75% (HR, 0.613), and 80% (HR, 0.519) (P < 0.05 for all). In prostate surgery analyses (N = 17,739), the likelihood of surgery was reduced with MPR thresholds of 70% or above (HR, 0.294), 75% or above (HR, 0.542), and 80% or above (HR, 0.436) (P < 0.05 for all). A longer duration of therapy was associated with a reduced likelihood of AUR (HR, 0.860) and surgery (HR, 0.884) (P < 0.05 for both). In both populations, adherence and persistence were also associated with significantly decreased BPH-related medical costs. CONCLUSION: In patients with BPH who received 5-ARI therapy, greater adherence and persistence were associated with significantly reduced risks of AUR and prostate surgery and with significantly lower medical costs. Maximizing adherence may enable patients to realize the potential long-term benefits of 5ARIs.

15.
J Cancer Epidemiol ; 2011: 983271, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21765829

RESUMO

Background. Traditional methods for identifying comorbidity data in EMRs have relied primarily on costly and time-consuming manual chart review. The purpose of this study was to validate a strategy of electronically searching EMR data to identify comorbidities among cancer patients. Methods. Advanced stage NSCLC patients (N = 2,513) who received chemotherapy from 7/1/2006 to 6/30/2008 were identified using iKnowMed, US Oncology's proprietary oncology-specific EMR system. EMR data were searched for documentation of comorbidities common to advanced stage cancer patients. The search was conducted by a series of programmatic queries on standardized information including concomitant illnesses, patient history, review of systems, and diagnoses other than cancer. The validity of the comorbidity information that we derived from the EMR search was compared to the chart review gold standard in a random sample of 450 patients for whom the EMR search yielded no indication of comorbidities. Negative predictive values were calculated. Results. The overall prevalence of comorbidities of 22%. Overall negative predictive value was 0.92 in the 450 patients randomly sampled patients (36 of 450 were found to have evidence of comorbidities on chart review). Conclusion. Results of this study suggest that efficient queries/text searches of EMR data may provide reliable data on comorbid conditions among cancer patients.

16.
Oncologist ; 16(4): 486-96, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21441299

RESUMO

Bevacizumab significantly extends progression-free survival (PFS) and overall survival (OS) times when combined with initial chemotherapy and continued as monotherapy until disease progression or unacceptable toxicity in patients with nonsquamous non-small cell lung cancer (NSCLC). In clinical practice, bevacizumab is sometimes discontinued after completion of chemotherapy. This retrospective analysis of the US Oncology network's electronic medical records evaluated the association between PFS and OS times and bevacizumab monotherapy to progression (BTP) among patients with advanced NSCLC. Patients treated from July 2006 through June 2008 were analyzed as two cohorts based on whether or not they received BTP after completion of first-line chemotherapy plus bevacizumab. Hazard ratios for PFS and OS were estimated using Cox proportional hazards, adjusting for relevant treatment and patient characteristics. To account for survivorship bias, landmark analyses were conducted at 18, 21, and 26 weeks from initial therapy to examine residual PFS and OS times, defined as the time from the landmark to disease progression or death. From the total 498 nonsquamous NSCLC patients, 403 received first-line chemotherapy plus bevacizumab: 154 received BTP, 249 did not. Longer PFS and OS times were observed in patients who received BTP than in those who received no BTP (median OS, 20.9 months versus 10.2 months; median PFS, 10.3 months versus 6.5 months). BTP was associated with a longer residual OS time at all specified landmarks and longer residual PFS time at week 18 than with no BTP. In conclusion, this retrospective analysis provides supportive evidence that continued vascular endothelial growth factor suppression in advanced nonsquamous NSCLC patients is associated with favorable clinical outcomes.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas , Carcinoma de Células Escamosas , Neoplasias Pulmonares , Adulto , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados , Bevacizumab , Carcinoma Pulmonar de Células não Pequenas/tratamento farmacológico , Carcinoma Pulmonar de Células não Pequenas/mortalidade , Carcinoma Pulmonar de Células não Pequenas/patologia , Carcinoma de Células Escamosas/tratamento farmacológico , Carcinoma de Células Escamosas/mortalidade , Carcinoma de Células Escamosas/patologia , Quimioterapia Adjuvante , Serviços de Saúde Comunitária , Intervalo Livre de Doença , Feminino , Humanos , Estimativa de Kaplan-Meier , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/mortalidade , Neoplasias Pulmonares/patologia , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores
17.
Value Health ; 14(2): 253-62, 2011.
Artigo em Inglês | MEDLINE | ID: mdl-21402294

RESUMO

OBJECTIVE: To determine the cost-effectiveness (as measured as cost per life-year saved) of white blood cell growth factor or colony-stimulating factor (CSF) use among a large cohort of elderly non-Hodgkin's lymphoma (NHL) patients in a real-world setting. METHODS: We identified 13,203 NHL patients from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database who received the diagnosis from 1992 to 2002 and who received chemotherapy within 12 months of diagnosis. Benefit (effectiveness) of CSF use (primary and secondary prophylaxis) was measured as observed improvement in overall survival. Costs for each patient were calculated by adding the cumulative reimbursement amounts from Medicare claims. Cost-effectiveness was estimated by modeling the joint influence of CSF use on both costs and effectiveness using a propensity-score net monetary benefit approach. RESULTS: Primary prophylactic CSF use was cost-effective at lower willingness-to-pay thresholds, whereas at higher thresholds, not providing prophylactic CSF became the cost-effective strategy. For secondary prophylactic CSF use among patients experiencing neutropenia, fever, and/or infection, the opposite trend was observed. For low willingness-to-pay thresholds (<$20,000 per life-year gained), not administering CSF was the cost-effective strategy, whereas CSF use became cost-effective as willingness to pay increased (from $100,000+ per life-year gained). CONCLUSION: To our knowledge, this is the first large population-based study to empirically measure the cost-effectiveness of CSF among NHL patients treated with chemotherapy. CSF use as primary or secondary prophylaxis may be a cost-effective strategy depending on society's (or payers') willingness to pay for improvements in outcomes.


Assuntos
Antineoplásicos/efeitos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Fator Estimulador de Colônias de Granulócitos/economia , Linfoma não Hodgkin/sangue , Linfoma não Hodgkin/tratamento farmacológico , Neutropenia/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/economia , Antineoplásicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Estudos de Coortes , Análise Custo-Benefício , Feminino , Fator Estimulador de Colônias de Granulócitos/uso terapêutico , Humanos , Revisão da Utilização de Seguros , Linfoma não Hodgkin/economia , Masculino , Medicare/economia , Neutropenia/induzido quimicamente , Neutropenia/economia , Programa de SEER , Análise de Sobrevida , Estados Unidos
18.
J Am Geriatr Soc ; 58(10): 1885-95, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20840455

RESUMO

OBJECTIVES: To determine the effect of colony-stimulating factor (CSF) on incidence of febrile neutropenia, infection, and survival in older people with non-Hodgkin's lymphoma (NHL) treated with chemotherapy. DESIGN: Retrospective cohort study. SETTING: The Surveillance, Epidemiology, and End Results-Medicare database. PARTICIPANTS: Thirteen thousand two hundred twenty-three people diagnosed with NHL at age 65 and older (mean age 74.9, range 65-102) in 1992 to 2002 who received chemotherapy within 12 months of diagnosis. MEASUREMENTS: Primary prophylaxis was defined as CSF administered at the start of chemotherapy before febrile neutropenia or infection; secondary prophylaxis was defined as CSF use after febrile neutropenia or infection. RESULTS: Participants with five to nine administrations of primary prophylactic CSF had a 42% lower risk of febrile neutropenia (odds ratio (OR)=0.58, 95% confidence interval (CI)=0.41-0.83), and participants with 10 or more administrations had a 48% lower risk (OR=0.52, 95% CI=0.36-0.76) after adjusting for age, stage, histology, and comorbidity. Results did not differ significantly after adjusting for propensity score of receiving CSF. There was no significant association between primary prophylactic CSF and overall survival, but secondary prophylactic CSF was significantly associated with better survival. Four to 10 administrations of secondary prophylactic CSF was associated with 9% lower mortality risk (hazard ratio (HR)=0.91, 95% CI=0.84-0.99), 11 to 23 administrations was associated with 23% lower mortality risk (HR=0.77, 95% CI=0.71-0.84) and 24 or more administrations was associated with 13% lower mortality risk (HR=0.87, 95% CI+0.79-0.95) than in participants not receiving CSF after neutropenia or infection. CONCLUSION: Primary prophylactic CSF was observed to be effective in reducing the incidence of neutropenia and infection. These findings substantiate the clinical guidelines for recommending prophylactic CSF in older people with NHL receiving chemotherapy.


Assuntos
Antineoplásicos/uso terapêutico , Fatores Estimuladores de Colônias/uso terapêutico , Infecções/epidemiologia , Linfoma não Hodgkin/tratamento farmacológico , Neutropenia/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Incidência , Infecções/etiologia , Linfoma não Hodgkin/complicações , Linfoma não Hodgkin/mortalidade , Masculino , Neutropenia/etiologia , Neutropenia/prevenção & controle , Prognóstico , Estudos Retrospectivos , Programa de SEER , Taxa de Sobrevida/tendências , Estados Unidos/epidemiologia
19.
Cancer ; 116(22): 5279-89, 2010 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-20665502

RESUMO

BACKGROUND: The current study was conducted to evaluate the association between colony-stimulating factor (CSF) use and the risk of developing therapy-related myelodysplastic syndromes or acute myeloid leukemia (t-MDS/AML) among a large cohort of elderly patients with non-Hodgkin lymphoma (NHL) who were treated with chemotherapy. METHODS: A total of 13,203 NHL patients were identified from the Surveillance, Epidemiology, and End Results-Medicare database who were diagnosed from 1992 through 2002. Patients were followed from their initial chemotherapy date until the date they were diagnosed with t-MDS/AML, death, or last follow-up (October 31, 2006), whichever occurred first. RESULTS: Overall, 40% (n = 5266) of patients received CSF. During the follow-up period (median follow-up, 2.9 years [range, 1-14.7 years]), 272 (5.2%) patients who were treated with CSF developed t-MDS/AML, compared with 230 (2.9%) patients who did not (P < .0001, log-rank test). The 5-year incidence of t-MDS/AML for patients receiving CSF was 14.1 per 1000 person-years compared with 8.3 per 1000 person-years for patients not receiving CSF. In a multivariable Cox regression analysis adjusted for gender, histology, stage, comorbidities, radiotherapy, and chemotherapy agent, CSF use was found to be independently associated with a 53% increased risk of t-MDS/AML (hazard ratio [HR], 1.53; 95% confidence interval [95% CI], 1.26-1.84). The observed association between CSF use and t-MDS/AML persisted across histologic subgroups (ie, diffuse large B-cell lymphoma, follicular lymphoma, and others). Patients who received both CSF and antimetabolite chemotherapy were found to have a 2.5-fold increased risk of t-MDS/AML (HR, 2.49; 95% CI, 1.91-3.26) compared with patients who received neither agent. CONCLUSIONS: The current study, which to our knowledge is the first large population-based study published to date, demonstrated that the administration of CSF among elderly NHL patients receiving chemotherapy was associated with an increased risk of t-MDS/AML, although the absolute risk was low.


Assuntos
Fatores Estimuladores de Colônias/efeitos adversos , Leucemia Mieloide Aguda/epidemiologia , Linfoma não Hodgkin/tratamento farmacológico , Síndromes Mielodisplásicas/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Antineoplásicos/uso terapêutico , Interações Medicamentosas , Feminino , Humanos , Incidência , Leucemia Mieloide Aguda/induzido quimicamente , Linfoma não Hodgkin/complicações , Masculino , Síndromes Mielodisplásicas/induzido quimicamente , Risco , Programa de SEER
20.
J Oncol Pract ; 6(1): 12-8, 2010 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-20539725

RESUMO

PURPOSE: The goal of this study was to evaluate the cost-effectiveness of Level I Pathways, a program designed to ensure the delivery of evidence-based care, among patients with non-small-cell lung cancer (NSCLC) treated in the outpatient community setting. PATIENTS AND METHODS: We included patients with NSCLC initiating a chemotherapy regimen between July 1, 2006, and December 31, 2007, at eight practices in the US Oncology network. Patients were characterized with respect to age, sex, stage, performance status, and line of therapy and were classified by whether they were treated according to Level I Pathways guidelines. Twelve-month cost of care and overall survival were compared between patients treated on Pathway and off Pathway. A net monetary benefit approach and corresponding cost-effectiveness acceptability curves were used to evaluate the cost-effectiveness of Level I Pathways. RESULTS: Overall, outpatient costs were 35% lower for on-Pathway versus off-Pathway patients (average 12-month cost, $18,042 v $27,737, respectively). Costs remained significantly less for patients treated on Pathway versus off Pathway in the adjuvant and first-line settings, whereas no difference in overall cost was observed in patients in the second-line setting. No difference in overall survival was observed overall or by line of therapy. In the net monetary benefit analysis, after adjusting for potential confounders, we found that treating patients on Pathway was cost effective across a plausible range of willingness-to-pay thresholds. CONCLUSIONS: Results of this study suggest that treating patients according to evidence-based guidelines is a cost-effective strategy for delivering care to those with NSCLC.

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