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1.
Res Pract Thromb Haemost ; 6(5): e12753, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35859579

RESUMO

Background and Objectives: Current clinical guidelines recommend thromboprophylaxis for adults hospitalized with coronavirus disease 2019 (COVID-19), yet it is unknown whether higher doses of thromboprophylaxis offer benefits beyond standard doses. Methods: We studied electronic health records from 50 091 adults hospitalized with COVID-19 in the United States between February 2020 and February 2021. We compared standard (enoxaparin 30 or 40 mg/day, fondaparinux 2.5 mg, or heparin 5000 units twice or thrice per day) versus intermediate (enoxaparin 30 or 40 mg twice daily, or up to 1.2 mg/kg of body weight daily, heparin 7500 units thrice per day or heparin 10 000 units twice or thrice per day) thromboprophylaxis. We separately examined risk of escalation to therapeutic anticoagulation, severe disease (first occurrence of high-flow nasal cannula, noninvasive positive pressure ventilation or invasive mechanical ventilation), and death. To summarize risk, we present hazard ratios (HRs) with 95% confidence intervals (CIs) using adjusted time-dependent Cox proportional hazards regression models. Results: People whose first dose was high intensity were younger, more often obese, and had greater oxygen support requirements. Intermediate dose thromboprophylaxis was associated with increased risk of therapeutic anticoagulation (HR, 3.39; 95% CI, 3.22-3.57), severe disease (HR, 1.22; 95% CI, 1.17-1.28), and death (HR, 1.37; 95% CI, 1.21-1.55). Increased risks associated with intermediate-dose thromboprophylaxis persisted in subgroup and sensitivity analyses varying populations and definitions of exposures, outcomes, and covariates. Conclusions: Our findings do not support routine use of intermediate-dose thromboprophylaxis to prevent clinical worsening, severe disease, or death among adults hospitalized with COVID-19.

2.
J Clin Invest ; 131(20)2021 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-34464352

RESUMO

BACKGROUNDEvidence supporting convalescent plasma (CP), one of the first investigational treatments for coronavirus disease 2019 (COVID-19), has been inconclusive, leading to conflicting recommendations. The primary objective was to perform a comparative effectiveness study of CP for all-cause, in-hospital mortality in patients with COVID-19.METHODSThe multicenter, electronic health records-based, retrospective study included 44,770 patients hospitalized with COVID-19 in one of 176 HCA Healthcare-affiliated community hospitals. Coarsened exact matching (1:k) was employed, resulting in a sample of 3774 CP and 10,687 comparison patients.RESULTSExamination of mortality using a shared frailty model, controlling for concomitant medications, date of admission, and days from admission to transfusion, demonstrated a significant association of CP with lower mortality risk relative to the comparison group (adjusted hazard ratio [aHR] = 0.71; 95% CI, 0.59-0.86; P < 0.001). Examination of patient risk trajectories, represented by 400 clinico-demographic features from our real-time risk model (RTRM), indicated that patients who received CP recovered more quickly. The stratification of days to transfusion revealed that CP within 3 days after admission, but not within 4 to 7 days, was associated with a significantly lower mortality risk (aHR = 0.53; 95% CI, 0.47-0.60; P < 0.001). CP serology level was inversely associated with mortality when controlling for its interaction with days to transfusion (HR = 0.998; 95% CI, 0.997-0.999; P = 0.013), yet it did not reach univariable significance.CONCLUSIONSThis large, diverse, multicenter cohort study demonstrated that CP, compared with matched controls, is significantly associated with reduced risk of in-hospital mortality. These observations highlight the utility of real-world evidence and suggest the need for further evaluation prior to abandoning CP as a viable therapy for COVID-19.FUNDINGThis research was supported in whole by HCA Healthcare and/or an HCA Healthcare-affiliated entity, including Sarah Cannon and Genospace.


Assuntos
COVID-19/terapia , SARS-CoV-2 , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , COVID-19/mortalidade , Estudos de Casos e Controles , Estudos de Coortes , Medicina Baseada em Evidências , Feminino , Mortalidade Hospitalar , Humanos , Imunização Passiva , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Análise Multivariada , Pandemias , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologia , Adulto Jovem , Soroterapia para COVID-19
3.
Biol Blood Marrow Transplant ; 26(7): 1247-1256, 2020 07.
Artigo em Inglês | MEDLINE | ID: mdl-32165328

RESUMO

The American Society for Transplantation and Cellular Therapy (ASTCT) published its first white paper on indications for autologous and allogeneic hematopoietic cell transplantation (HCT) in 2015. It was identified at the time that periodic updates of indications would be required to stay abreast with state of the art and emerging indications and therapy. In recent years the field has not only seen an improvement in transplantation technology, thus widening the therapeutic scope of HCT, but additionally a whole new treatment strategy using modified immune effector cells, including chimeric antigen receptor T cells and engineered T-cell receptors, has emerged. The guidelines review committee of the ASTCT deemed it optimal to update the ASTCT recommendations for indications for HCT to include new data and to incorporate indications for immune effector cell therapy (IECT) where appropriate. The guidelines committee established a multiple stakeholder task force consisting of transplant experts, payer representatives, and a patient advocate to provide guidance on indications for HCT and IECT. This article presents the updated recommendations from the ASTCT on indications for HCT and IECT. Indications for HCT/IECT were categorized as (1) Standard of care, where indication is well defined and supported by evidence; (2) Standard of care, clinical evidence available, where large clinical trials and observational studies are not available but have been shown to be effective therapy; (3) Standard of care, rare indication, for rare diseases where demonstrated effectiveness exists but large clinical trials and observational studies are not feasible; (4) Developmental, for diseases where preclinical and/or early-phase clinical studies show HCT/IECT to be a promising treatment option; and (5) Not generally recommended, where available evidence does not support the routine use of HCT/IECT. The ASTCT will continue to periodically review these guidelines and update them as new evidence becomes available.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Linfócitos , Humanos , Receptores de Antígenos de Linfócitos T , Transplante Autólogo , Transplante Homólogo , Estados Unidos
4.
Bone Marrow Transplant ; 55(5): 906-917, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31740767

RESUMO

Allogeneic hematopoietic cell transplantation (alloHCT) is a highly specialized procedure. We surveyed adult transplant centers in the United States (US) and then used data reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) (2008-2010) to evaluate associations of center volume, infrastructure, and care delivery models with survival post alloHCT. Based on their 2010 alloHCT volume, centers were categorized as low-volume (≤40 alloHCTs; N = 42 centers, 1900 recipients) or high-volume (>40 alloHCTs; N = 41 centers, 9637 recipients). 100-day survival was 86% (95% CI, 85-87%) in high-volume compared with 83% (95% CI, 81-85%) in low-volume centers (difference 3%; P < 0.001). One-year survival was 62% (95% CI, 61-63%) and 56% (95% CI, 54-58%), respectively (difference 6%; P < 0.001). Logistic regression analyses adjusted for patient and center characteristics; alloHCT at high-volume centers (odds ratio [OR] 1.32; P < 0.001) and presence of a survivorship program dedicated to HCT recipients (OR 1.23; P = 0.009) were associated with favorable 1-year survival compared to low-volume centers. Similar findings were observed in a CIBMTR validation cohort (2012-2014); high-volume centers had better 1-year survival (OR 1.24, P < 0.001). Among US adult transplant centers, alloHCT at high-volume centers and at centers with survivorship programs is associated with higher 1-year survival.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Transplantes , Adulto , Estudos de Coortes , Humanos , Condicionamento Pré-Transplante , Transplante Homólogo , Estados Unidos
5.
Biol Blood Marrow Transplant ; 25(11): 2243-2250, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31284070

RESUMO

The rapid evolution of blood and marrow transplantation (BMT), coupled with diverse outcomes associated with heterogeneous groups of patients, led to the formation of 2 important organizations early in the development of the field: the Center for International Blood and Marrow Transplant Research (CIBMTR) and the Foundation for the Accreditation of Cellular Therapy (FACT). These organizations have addressed 2 of the 9 elements identified by the National Quality Strategy (NQS) for achieving better health care, more affordable care, and healthy people and communities: a registry that promotes improvement of care and accreditation based on quality standards. More recently, a federally mandated database in the United States addresses the third element of the NQS: public reporting of treatment results. Here we describe the current process by which FACT incorporates patient outcomes reported by the CIBMTR into standards for accreditation, the requirements for accredited programs with performance below expected outcomes to maintain accreditation, and preliminary findings of an assessment of corrective action plans intended to improve outcomes.


Assuntos
Acreditação , Transplante de Medula Óssea , Humanos , Estados Unidos
6.
Biol Blood Marrow Transplant ; 24(1): 4-12, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-28963077

RESUMO

Patient-centered medical home models are fundamental to the advanced alternative payment models defined in the Medicare Access and Children's Health Insurance Plan Reauthorization Act (MACRA). The patient-centered medical home is a model of healthcare delivery supported by alternative payment mechanisms and designed to promote coordinated medical care that is simultaneously patient-centric and population-oriented. This transformative care model requires shifting reimbursement to include a per-patient payment intended to cover services not previously reimbursed such as disease management over time. Payment is linked to quality measures, including proportion of care delivered according to predefined pathways and demonstrated impact on outcomes. Some medical homes also include opportunities for shared savings by reducing overall costs of care. Recent proposals have suggested expanding the medical home model to specialized populations with complex needs because primary care teams may not have the facilities or the requisite expertise for their unique needs. An example of a successful care model that may provide valuable lessons for those creating specialty medical home models already exists in many hematopoietic cell transplantation (HCT) centers that deliver multidisciplinary, coordinated, and highly specialized care. The integration of care delivery in HCT centers has been driven by the specialty care their patients require and by the payment methodology preferred by the commercial payers, which has included bundling of both inpatient and outpatient care in the peritransplant interval. Commercial payers identify qualified HCT centers based on accreditation status and comparative performance, enabled in part by center-level comparative performance data available within a national outcomes database mandated by the Stem Cell Therapeutic and Research Act of 2005. Standardization across centers has been facilitated via voluntary accreditation implemented by Foundation for the Accreditation of Cell Therapy. Payers have built on these community-established programs and use public outcomes and program accreditation as standards necessary for inclusion in specialty care networks and contracts. Although HCT centers have not been described as medical homes, most HCT providers have already developed the structures that address critical requirements of MACRA for medical homes.


Assuntos
Transplante de Células-Tronco Hematopoéticas/economia , Administração dos Cuidados ao Paciente/tendências , Atenção à Saúde/economia , Atenção à Saúde/métodos , Humanos , Administração dos Cuidados ao Paciente/economia , Equipe de Assistência ao Paciente/tendências , Qualidade da Assistência à Saúde/normas , Reembolso de Incentivo/economia
7.
Biol Blood Marrow Transplant ; 21(11): 1863-1869, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26256941

RESUMO

Approximately 20,000 hematopoietic cell transplantation (HCT) procedures are performed in the United States annually. With advances in transplantation technology and supportive care practices, HCT has become safer, and patient survival continues to improve over time. Indications for HCT continue to evolve as research refines the role for HCT in established indications and identifies emerging indications where HCT may be beneficial. The American Society for Blood and Marrow Transplantation (ASBMT) established a multiple-stakeholder task force consisting of transplant experts, payer representatives, and a patient advocate to provide guidance on "routine" indications for HCT. This white paper presents the recommendations from the task force. Indications for HCT were categorized as follows: (1) Standard of care, where indication for HCT is well defined and supported by evidence; (2) Standard of care, clinical evidence available, where large clinical trials and observational studies are not available but HCT has been shown to be effective therapy; (3) Standard of care, rare indication, for rare diseases where HCT has demonstrated effectiveness but large clinical trials and observational studies are not feasible; (4) Developmental, for diseases where preclinical and/or early phase clinical studies show HCT to be a promising treatment option; and (5) Not generally recommended, where available evidence does not support the routine use of HCT. The ASBMT will periodically review these guidelines and will update them as new evidence becomes available.


Assuntos
Transplante de Medula Óssea , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas , Doenças Raras/terapia , Adulto , Fatores Etários , Criança , Ensaios Clínicos como Assunto , Neoplasias Hematológicas/patologia , Humanos , Doenças Raras/patologia , Sociedades Médicas , Padrão de Cuidado , Transplante Autólogo , Transplante Homólogo , Estados Unidos
8.
Biol Blood Marrow Transplant ; 21(10): 1815-22, 2015 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-26071866

RESUMO

Controversy surrounds the question of whether clinical trial participants have better outcomes than comparable patients who are not treated on a trial. We explored this question using a recent large, randomized, multicenter study comparing peripheral blood (PB) with bone marrow transplantation from unrelated donors, conducted by the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). We compared characteristics and outcomes of study participants (n = 494) and nonparticipants (n = 1384) who appeared eligible and received similar treatment without enrolling on the BMT CTN trial at participating centers during the study time period. Data were obtained from the Center for International Blood and Marrow Transplant Research. Outcomes were compared between the 2 groups using Cox proportional hazards regression models. No significant differences in age, sex, disease distribution, race/ethnicity, HLA matching, comorbidities, and interval from diagnosis to hematopoietic cell transplantation were seen between the participants and nonparticipants. Nonparticipants were more likely to have lower performance status, lower risk disease, and older donors, and to receive myeloablative conditioning and antithymocyte globulin. Nonparticipants were also more likely to receive PB grafts, the intervention tested in the trial (66% versus 50%, P < .001). Overall survival, transplantation-related mortality, and incidences of acute or chronic graft-versus-host disease were comparable between the 2 groups though relapse was higher (hazard ratio, 1.22; 95% confidence interval, 1.02 to 1.46; P = .028) in nonparticipants. Despite differences in certain baseline characteristics, survival was comparable between study participants and nonparticipants. The results of the BMT CTN trial appear generalizable to the population of trial-eligible patients.


Assuntos
Transplante de Medula Óssea/estatística & dados numéricos , Transplante de Células-Tronco de Sangue Periférico/estatística & dados numéricos , Ensaios Clínicos Controlados Aleatórios como Assunto/estatística & dados numéricos , Adolescente , Adulto , Idoso , Soro Antilinfocitário/uso terapêutico , Transplante de Medula Óssea/mortalidade , Criança , Pré-Escolar , Intervalo Livre de Doença , Feminino , Doença Enxerto-Hospedeiro/epidemiologia , Doença Enxerto-Hospedeiro/etiologia , Humanos , Imunossupressores/uso terapêutico , Lactente , Recém-Nascido , Pacientes Internados/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Agonistas Mieloablativos/uso terapêutico , Seleção de Pacientes , Transplante de Células-Tronco de Sangue Periférico/mortalidade , Modelos de Riscos Proporcionais , Recidiva , Sistema de Registros , Indução de Remissão , Sujeitos da Pesquisa/estatística & dados numéricos , Análise de Sobrevida , Linfócitos T/imunologia , Condicionamento Pré-Transplante/métodos , Resultado do Tratamento , Doadores não Relacionados , Adulto Jovem
9.
Biol Blood Marrow Transplant ; 21(7): 1308-14, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25840337

RESUMO

Hematopoietic cell transplantation (HCT) is a complex procedure that requires availability of adequate infrastructure, personnel, and resources at transplantation centers. We conducted a national survey of transplantation centers in the United States to obtain data on their personnel, infrastructure, and care delivery models. A 42-item web-based survey was administered to medical directors of transplantation centers in the United States that reported any allogeneic HCT to the Center for International Blood and Marrow Transplant Research in 2011. The response rate for the survey was 79% for adult programs (85 of 108 centers) and 82% for pediatric programs (54 of 66 centers). For describing results, we categorized centers into groups with similar volumes based on 2010 total HCT activity (adult centers, 9 categories; pediatric centers, 6 categories). We observed considerable variation in available resources, infrastructure, personnel, and care delivery models among adult and pediatric transplantation centers. Characteristics varied substantially among centers with comparable transplantation volumes. Transplantation centers may find these data helpful in assessing their present capacity and use them to evaluate potential resource needs for personnel, infrastructure, and care delivery and in planning for growth.


Assuntos
Centros Médicos Acadêmicos , Atenção à Saúde/métodos , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Unidades Hospitalares , Centros Médicos Acadêmicos/economia , Adulto , Criança , Pesquisas sobre Atenção à Saúde , Unidades Hospitalares/economia , Humanos , Recursos Humanos
10.
Biol Blood Marrow Transplant ; 21(4): 583-8, 2015 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-25639771

RESUMO

The Patient Protection and Affordable Care Act requires that health care insurers cover routine patient costs associated with participating in clinical trials for cancer and other life-threatening diseases. There is a need to better define routine costs within the context of hematopoietic stem cell transplantation (HSCT) clinical trials. This white paper presents guidance on behalf of the American Society for Blood and Marrow Transplantation for defining a standard HSCT episode and delineates components that may be considered as routine patient costs versus research costs. The guidelines will assist investigators, trial sponsors, and transplantation centers in planning for clinical trials that are conducted as a part of the HSCT episode and will inform payers who provide coverage for transplantation.


Assuntos
Transplante de Células-Tronco Hematopoéticas/economia , Transplante de Células-Tronco Hematopoéticas/métodos , Transplante de Células-Tronco Hematopoéticas/normas , Ensaios Clínicos como Assunto , Custos e Análise de Custo , Guias como Assunto , Humanos
11.
Biol Blood Marrow Transplant ; 20(11): 1819-27, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25064747

RESUMO

Several studies have shown comparable survival outcomes with different graft sources, but the relative resource needs of hematopoietic cell transplantation (HCT) by graft source have not been well studied. We compared total hospital length of stay in the first 100 days after HCT in 1577 patients with acute leukemia in remission who underwent HCT with an umbilical cord blood (UCB), matched unrelated donor (MUD), or mismatched unrelated donor (MMUD) graft between 2008 and 2011. To ensure a relatively homogenous study population, the analysis was limited to patients with acute myelogenous leukemia and acute lymphoblastic leukemia in first or second complete remission who underwent HCT in the United States. To account for early deaths, we compared the number of days alive and out of the hospital in the first 100 days post-transplantation. For children who received myeloablative conditioning, the median time alive and out of the hospital in the first 100 days was 50 days for single UCB recipients, 54 days for double UCB recipients, and 60 days for MUD bone marrow (BM) recipients. In multivariate analysis, use of UCB was significantly associated with fewer days alive and out of the hospital compared with MUD BM. For adults who received myeloablative conditioning, the median time alive and out of the hospital in first 100 days was 52 days for single UCB recipients, 55 days for double UCB recipients, 69 days for MUD BM recipients, 75 days for MUD peripheral blood stem cell (PBSC) recipients, 63 days for MMUD BM recipients, and 67 days for MMUD PBSC recipients. In multivariate analysis, UCB and MMUD BM recipients had fewer days alive and out of the hospital compared with recipients of other graft sources. For adults who received a reduced-intensity preparative regimen, the median time alive and out of the hospital during the first 100 days was 65 days for single UCB recipients, 63 days for double UCB recipients, 79 days for MUD PBSC recipients, and 79 days for MMUD PBSC recipients. Similar to the other 2 groups, receipt of UCB was associated with a fewer days alive and out of the hospital. In conclusion, length of stay in the first 100 days post-transplantation varies by graft source and is longer for UCB HCT recipients. These data provide insight into the resource needs of patients who undergo HCT with these various graft sources.


Assuntos
Transplante de Células-Tronco de Sangue do Cordão Umbilical/métodos , Transplante de Células-Tronco Hematopoéticas/métodos , Leucemia Mieloide Aguda/terapia , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Adulto , Estudos de Coortes , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Análise de Sobrevida , Doadores de Tecidos , Condicionamento Pré-Transplante/métodos , Resultado do Tratamento , Doadores não Relacionados , Adulto Jovem
12.
Biol Blood Marrow Transplant ; 20(6): 829-36, 2014 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-24607554

RESUMO

Adolescents and young adults (AYAs, ages 15 to 40 years) with cancer have not experienced survival improvements to the same extent as younger and older patients. We compared changes in survival after myeloablative allogeneic hematopoietic cell transplantation (HCT) for acute lymphoblastic leukemia (ALL) among children (n = 981), AYAs (n = 1218), and older adults (n = 469) who underwent transplantation over 3 time periods: 1990 to 1995, 1996 to 2001, and 2002 to 2007. Five-year survival varied inversely with age group. Survival improved over time in AYAs and paralleled that seen in children; however, overall survival did not change over time for older adults. Survival improvements were primarily related to lower rates of early treatment-related mortality in the most recent era. For all cohorts, relapse rates did not change over time. A subset of 222 AYAs between the ages of 15 and 25 at 46 pediatric or 49 adult centers were also analyzed to describe differences by center type. In this subgroup, there were differences in transplantation practices among pediatric and adult centers, although HCT outcomes did not differ by center type. Survival for AYAs undergoing myeloablative allogeneic HCT for ALL improved at a similar rate as survival for children.


Assuntos
Transplante de Células-Tronco Hematopoéticas/métodos , Leucemia-Linfoma Linfoblástico de Células Precursoras/terapia , Adolescente , Adulto , Fatores Etários , Criança , Pré-Escolar , Intervalo Livre de Doença , Feminino , Humanos , Lactente , Masculino , Análise de Sobrevida , Condicionamento Pré-Transplante/métodos , Transplante Homólogo , Resultado do Tratamento , Adulto Jovem
13.
Biol Blood Marrow Transplant ; 19(7): 1116-23, 2013 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-23660172

RESUMO

Autologous hematopoietic cell transplantation (auto-HCT) is performed to treat relapsed and recurrent malignant disorders and as part of initial therapy for selected malignancies. This study evaluated changes in use, techniques, and survival in a population-based cohort of 68,404 patients who underwent first auto-HCT in a US or Canadian center between 1994 and 2005 and were reported to the Center for International Blood and Marrow Transplant Research (CIBMTR). The mean annual number of auto-HCTs performed was highest during 1996-1999 (6948), and decreased subsequently 2000-2003 (4783), owing mainly to fewer auto-HCTs done to treat breast cancer. However, the mean annual number of auto-HCTs increased from 5278 annually in 1994-1995 to 5459 annually in 2004-2005, reflecting increased use for multiple myeloma, non-Hodgkin lymphoma, and Hodgkin lymphoma. Despite an increase in the median recipient age from 44 to 53 years, there has been a significant improvement in overall survival (OS) from 1994 to 2005 in patients with chemotherapy-sensitive relapsed non-Hodgkin lymphoma (day +100 OS, from 85% to 96%; 1-year OS, from 68% to 80%; P < .001) and chemotherapy-sensitive multiple myeloma (day +100 OS, from 96% to 98%; 1-year OS, from 83% to 92%; P < .001). This improvement in OS was most pronounced in middle-aged (>40 years) and older (>60 years) individuals.


Assuntos
Transplante de Células-Tronco Hematopoéticas/mortalidade , Transplante de Células-Tronco Hematopoéticas/tendências , Doença de Hodgkin/terapia , Linfoma não Hodgkin/terapia , Mieloma Múltiplo/terapia , Adolescente , Adulto , Fatores Etários , Idoso , Criança , Pré-Escolar , Feminino , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Doença de Hodgkin/mortalidade , Doença de Hodgkin/patologia , Humanos , Lactente , Linfoma não Hodgkin/mortalidade , Linfoma não Hodgkin/patologia , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/mortalidade , Mieloma Múltiplo/patologia , América do Norte , Prognóstico , Estudos Retrospectivos , Análise de Sobrevida , Transplante Autólogo
14.
J Clin Oncol ; 31(19): 2437-49, 2013 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-23715573

RESUMO

PURPOSE: Over the past four decades, allogeneic hematopoietic cell transplantation (alloHCT) has evolved as a curative modality for patients with hematologic diseases. This study describes changes in use, technique, and survival in a population-based cohort. PATIENTS AND METHODS: The study included 38,060 patients with hematologic malignancies or disorders who underwent first alloHCT in a US or Canadian center from 1994 to 2005 and were reported to the Center for International Blood and Marrow Transplant Research. RESULTS: AlloHCT as treatment for acute lymphoblastic (ALL) and myeloid leukemias (AML), myelodysplastic syndrome (MDS), and Hodgkin and non-Hodgkin lymphomas increased by 45%, from 2,520 to 3,668 patients annually. From 1994 to 2005, use of both peripheral (7% to 63%) [corrected] and cord blood increased (2% to 10%), whereas use of marrow decreased (90% to 27%). Despite a median age increase from 33 to 40 years and 165% [corrected] increase in unrelated donors for alloHCT, overall survival (OS) at day 100 significantly improved for patients with AML in first complete remission after myeloablative sibling alloHCT (85% to 94%; P < .001) and unrelated alloHCT (63% to 86%; P < .001); 1-year OS improved among those undergoing unrelated alloHCT (48% to 63%; P = .003) but not among those undergoing sibling alloHCT. Similar results were seen for ALL and MDS. Day-100 OS after cord blood alloHCT improved significantly from 60% to 78% (P < .001) for AML, ALL, MDS, and chronic myeloid leukemia. Use of reduced-intensity regimens increased, yielding OS rates similar to those of myeloablative regimens. CONCLUSION: Survival for those undergoing alloHCT has significantly improved over time. However, new approaches are needed to further improve 1-year OS.


Assuntos
Neoplasias Hematológicas/mortalidade , Neoplasias Hematológicas/cirurgia , Transplante de Células-Tronco Hematopoéticas/estatística & dados numéricos , Síndromes Mielodisplásicas/mortalidade , Síndromes Mielodisplásicas/cirurgia , Doadores não Relacionados , Adolescente , Adulto , Fatores Etários , Idoso , Canadá/epidemiologia , Criança , Pré-Escolar , Estudos de Coortes , Feminino , Doença de Hodgkin/mortalidade , Doença de Hodgkin/cirurgia , Humanos , Lactente , Leucemia Mieloide Aguda/mortalidade , Leucemia Mieloide Aguda/cirurgia , Linfoma não Hodgkin/mortalidade , Linfoma não Hodgkin/cirurgia , Masculino , Pessoa de Meia-Idade , Leucemia-Linfoma Linfoblástico de Células Precursoras/mortalidade , Leucemia-Linfoma Linfoblástico de Células Precursoras/cirurgia , Estudos Retrospectivos , Programa de SEER , Análise de Sobrevida , Taxa de Sobrevida , Transplante Homólogo , Estados Unidos/epidemiologia
15.
Biol Blood Marrow Transplant ; 18(7): 1055-60, 2012 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-22178402

RESUMO

Seizures as a complication of the infusion of autologous peripheral blood stem cells (PBSC) are rare. Seizures during infusion of autologous PBSC in 3 of our patients prompted us to review our cell therapy and cytapheresis protocols and procedures. We retrospectively analyzed 159 adult patients collected between January 2006 and July 2009. Patients were collected on either the COBE Spectra (Caridian BCT, Lakewood, CO) cell separator (n = 85) or Fresenius AS (Fresenius Kabi AG, Bad Homburg, Germany) 104 cell separator (n = 74) and mobilized with granulocyte-colony stimulating factor (G-CSF) alone (n = 47), G-CSF and Plerixafor (n = 36), or G-CSF and chemotherapy (n = 76). Patient characteristics (including age, weight, number of collections, volume processed, disease type, and mobilization strategy) did not differ significantly between the COBE and Fresenius cohorts, and adverse effects from infusion were similar except for 3 of 159 patients who experienced seizures upon infusion of PBSC; all 3 were collected on the COBE and had PBSC product white blood cell (WBC) counts of 590 × 10(3)/µL or above. We prospectively correlated WBC counts midcollection, with final WBC counts to identify products with high WBC concentration during cytapheresis. Fifty-one patients had 66 cytapheresis procedures using the COBE, with WBC counts midway and at the end of collection of 287 × 10(3) ± 150/µL and 273 × 10(3) ± 144/µL, respectively. Mid-WBC therefore correlated with WBC at the end of the collection. Finally, we prospectively collected mid-WBC from 65 patients who underwent 80 PBSC collections between June 2009 and January 2010 to identify products with midcollection WBC concentration >450 × 10(3)/µL. In those cases, additional autologous plasma was collected at the time of collection to dilute the final product before cryopreservation. Patients who received diluted products experienced no delays in engraftment and no additional seizure episodes occurred.


Assuntos
Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Convulsões/prevenção & controle , Manejo de Espécimes/métodos , Adulto , Idoso , Benzilaminas , Criopreservação , Ciclamos , Feminino , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Mobilização de Células-Tronco Hematopoéticas/métodos , Compostos Heterocíclicos/administração & dosagem , Humanos , Leucaférese , Contagem de Leucócitos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Convulsões/etiologia , Transplante Autólogo
16.
Biol Blood Marrow Transplant ; 18(6): 903-12, 2012 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-22062801

RESUMO

The relationship of race/ethnicity with outcomes of umbilical cord blood transplantation (UCBT) is not well known. We analyzed the association between race/ethnicity and outcomes of unrelated single UCBT for leukemia and myelodysplastic syndromes. Our retrospective cohort study consisted of 885 adults and children (612 whites, 145 blacks, and 128 Hispanics) who received unrelated single UCBT for leukemia and myelodysplastic syndromes between 1995 and 2006 and were reported to the Center for International Blood and Marrow Transplant Research. A 5-6/6 HLA-matched unit with a total nucleated cell count infused of ≥2.5 × 10(7)/kg was given to 40% white and 42% Hispanic, but only 21% black patients. Overall survival at 2 years was 44% for whites, 34% for blacks, and 46% for Hispanics (P = .008). In multivariate analysis adjusting for patient, disease, and treatment factors (including HLA match and cell dose), blacks had inferior overall survival (relative risk of death, 1.31; P = .02), whereas overall survival of Hispanics was similar (relative risk, 1.03; P = .81) to that of whites. For all patients, younger age, early-stage disease, use of units with higher cell dose, and performance status ≥80 were independent predictors of improved survival. Black patients and white patients infused with well-matched cords had comparable survival; similarly, black and white patients receiving units with adequate cell dose had similar survival. These results suggest that blacks have inferior survival to whites after single UCBT, but outcomes are improved when units with a higher cell dose are used.


Assuntos
População Negra , Sangue Fetal/transplante , Hispânico ou Latino , Leucemia/etnologia , Síndromes Mielodisplásicas/etnologia , População Branca , Adolescente , Adulto , Fatores Etários , Idoso , Contagem de Células , Criança , Pré-Escolar , Transplante de Células-Tronco de Sangue do Cordão Umbilical/métodos , Intervalo Livre de Doença , Feminino , Sangue Fetal/imunologia , Antígenos HLA/imunologia , Teste de Histocompatibilidade , Humanos , Lactente , Leucemia/imunologia , Leucemia/mortalidade , Leucemia/terapia , Masculino , Pessoa de Meia-Idade , Síndromes Mielodisplásicas/imunologia , Síndromes Mielodisplásicas/mortalidade , Síndromes Mielodisplásicas/terapia , Estudos Retrospectivos , Resultado do Tratamento , Estados Unidos
17.
Health Serv Res ; 46(6pt1): 1762-77, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-21790588

RESUMO

OBJECTIVE: In 1999, three randomized controlled trials concluded that high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (HDC/HCT) is no better than conventional chemotherapy for women with breast cancer. This study documents the impact of the trials on use of HDC/HCT and describes how hospitals reacted to the trials. DATA SOURCE: We used patient-level data on 15,847 HDC/HCTs reported to the Center for International Blood and Marrow Transplant Research between 1994 and 2005. STUDY DESIGN: We report trends in total HDC/HCT procedure volume, compare the time to hospitals' exit from the HDC/HCT market between research and nonresearch hospitals, and document trends in hospital-specific volumes in the 2 years before exit. PRINCIPAL FINDINGS: HDC/HCT volume declined from 3,108 in 1998 to 1,363 the year after trial results were released. In 2002, only 76 procedures were performed. Teaching hospitals and the hospitals that participated in the trials were no slower to discontinue the procedure compared with nonteaching, nonparticipating hospitals. At the hospital level, volume declined steadily in the months before abandonment. CONCLUSION: The results suggest that comparative effectiveness research studies that report negative results can reduce spending, but specialists may be reluctant to relinquish cutting-edge technologies.


Assuntos
Antineoplásicos/uso terapêutico , Neoplasias da Mama/terapia , Transplante de Células-Tronco Hematopoéticas , Disseminação de Informação , Padrões de Prática Médica , Terapia Combinada , Pesquisa Comparativa da Efetividade , Feminino , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Biol Blood Marrow Transplant ; 16(3): 395-402, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19922808

RESUMO

Blacks are twice as likely to develop and die from multiple myeloma (MM), and are less likely to receive an autologous hematopoietic-cell transplant (AHCT) for MM compared to Whites. The influence of race on outcomes of AHCT for MM is not well described. We compared the probability of overall survival (OS), progression-free survival (PFS), disease progression, and nonrelapse mortality (NRM) among Black (N=303) and White (N=1892) recipients of AHCT for MM, who were reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) from 1995 to 2005. The Black cohort was more likely to be female, and had better Karnofsky performance scores, but lower hemoglobin and albumin levels at diagnosis. Black recipients were younger and more likely to be transplanted later in their disease course. Disease stage and treatment characteristics prior to AHCT were similar between the 2 groups. Black and White recipients had similar probabilities of 5-year OS (52% versus 47%, P=.19) and PFS (19% versus 21%, P=.64) as well as cumulative incidences of disease progression (72% versus 72%, P=.97) and NRM (9% versus 8%, P=.52). In multivariate analyses, race was not associated with any of these endpoints. Black recipients of AHCT for MM have similar outcomes compared to Whites, suggesting that the reasons underlying lower rates of AHCT in Blacks need to be studied further to ensure equal access to effective therapy.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Mieloma Múltiplo/terapia , Grupos Raciais/estatística & dados numéricos , Adulto , Negro ou Afro-Americano/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Progressão da Doença , Intervalo Livre de Doença , Tratamento Farmacológico/estatística & dados numéricos , Feminino , Humanos , Estimativa de Kaplan-Meier , Avaliação de Estado de Karnofsky/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Mieloma Múltiplo/diagnóstico , Mieloma Múltiplo/mortalidade , Recidiva , Transplante Autólogo , Resultado do Tratamento , População Branca/estatística & dados numéricos
19.
Biol Blood Marrow Transplant ; 16(3): 368-75, 2010 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-19879951

RESUMO

Studies suggest that patients who live in rural areas may have worse clinical outcomes compared with patients living in urban areas. We studied whether place of residence (rural versus urban) is associated with clinical outcomes of patients with leukemia or myelodysplastic syndrome (MDS) who received an unrelated donor hematopoietic cell transplantation (HCT). Patients' residential ZIP code at the time of transplant was used to determine rural or urban designation based on the Rural Urban Commuting Codes. The study included 6140 patients reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) from 121 U.S. HCT centers: 1179 (19%) came from rural areas, whereas 4961 (81%) came from urban areas. Rural and urban patients were similar in patient-, disease-, and transplant-related characteristics aside from household income and distance traveled to the HCT center. After adjusting for income and other significant patient, disease, and transplant-related variables, the risk of overall mortality between patients residing in rural and urban areas were not statistically significant (relative risk 1.01, 95% confidence intervals 0.93-1.10, P = .74). Similar outcomes were noted for treatment-related mortality (TRM), disease-free survival (DFS), and relapse. Patient's income, derived from the U.S. Census and based on their residential ZIP code, was independently associated with outcomes. In summary, our study showed no differences in the clinical outcomes of patients from rural or urban areas after unrelated donor HCT.


Assuntos
Neoplasias Hematológicas/mortalidade , Neoplasias Hematológicas/terapia , Transplante de Células-Tronco Hematopoéticas/mortalidade , Saúde da População Rural/estatística & dados numéricos , Saúde da População Urbana/estatística & dados numéricos , Adolescente , Adulto , Criança , Pré-Escolar , Intervalo Livre de Doença , Feminino , Rejeição de Enxerto/mortalidade , Doença Enxerto-Hospedeiro/mortalidade , Humanos , Renda/estatística & dados numéricos , Lactente , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/mortalidade , Grupos Raciais/estatística & dados numéricos , Recidiva , Estudos Retrospectivos , Fatores de Risco , Transplante Homólogo , Resultado do Tratamento , Estados Unidos , Adulto Jovem
20.
Biol Blood Marrow Transplant ; 14(12): 1323-33, 2008 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-19041053

RESUMO

To compare the clinical outcomes of older (age > or =55 years) non-Hodgkin lymphoma (NHL) patients with younger NHL patients (<55 years) receiving autologous hematopoietic cell transplantation (HCT) while adjusting for patient-, disease-, and treatment-related variables, we compared autologous HCT outcomes in 805 NHL patients aged > or =55 years to 1949 NHL patients <55 years during the years 1990-2000 using data reported to the Center for International Blood and Marrow Transplant Research (CIBMTR). In multivariate analysis, older patients with aggressive histologies were 1.86 times (95% confidence interval [CI] 1.43-2.43, P < .001) more likely than younger patients to experience treatment-related mortality (TRM). Relative death risks were 1.33 times (CI 1.04-1.71, P = .024) and 1.50 times (CI 1.33-16.9, P < .001) higher in older compared to younger patients with follicular grade I/II and aggressive histologies, respectively. Autologous HCT in older NHL patients is feasible, but most disease-related outcomes are statistically inferior to younger patients. Studies addressing supportive care particular to older patients, who are most likely to benefit from this approach, are recommended.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Linfoma não Hodgkin/mortalidade , Linfoma não Hodgkin/patologia , Linfoma não Hodgkin/terapia , Adulto , Fatores Etários , Idoso , Intervalo Livre de Doença , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Taxa de Sobrevida , Transplante Autólogo
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