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Article ; Online: Building a Fit for Purpose Clinical Trials Infrastructure to Accelerate the Assessment of Novel Hematopoietic Cell Transplantation Strategies and Cellular Immunotherapies.

Devine, Steven M / Horowitz, Mary M

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2021 Volume 39, Issue 5, Page(s) 534–544

MeSH term(s)	Clinical Trials as Topic/methods ; Clinical Trials, Phase III as Topic ; Hematologic Neoplasms/immunology ; Hematologic Neoplasms/therapy ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunotherapy, Adoptive/methods ; Neoplasms/immunology ; Neoplasms/therapy ; Randomized Controlled Trials as Topic/methods
Language	English
Publishing date	2021-01-12
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.20.01623
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Article ; Online: Should an HLA-matched donor still be considered the perfect donor?

Jones, Richard J / Horowitz, Mary M

The Lancet. Haematology

2018 Volume 5, Issue 9, Page(s) e388–e390

MeSH term(s)	Graft vs Host Disease/etiology ; Graft vs Host Disease/immunology ; HLA Antigens/immunology ; Hematopoietic Stem Cell Transplantation/adverse effects ; Humans ; Tissue Donors
Chemical Substances	HLA Antigens
Language	English
Publishing date	2018-11-07
Publishing country	England
Document type	Journal Article
ISSN	2352-3026
ISSN (online)	2352-3026
DOI	10.1016/S2352-3026(18)30119-4
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Article ; Online: HLA-matching with PTCy: a reanalysis of a CIBMTR dataset with propensity score matching and donor age.

Ambinder, Alexander / Jain, Tania / Tsai, Hua-Ling / Horowitz, Mary M / Jones, Richard J / Varadhan, Ravi

Blood advances

2022 Volume 6, Issue 14, Page(s) 4335–4346

Abstract: Blood or marrow transplantation (BMT) outcomes using haploidentical donors (Haplo) and posttransplant cyclophosphamide (PTCy)-based graft-versus-host disease (GVHD) prophylaxis compare favorably to HLA-matched donors using calcineurin inhibitor-based ... ...

Abstract	Blood or marrow transplantation (BMT) outcomes using haploidentical donors (Haplo) and posttransplant cyclophosphamide (PTCy)-based graft-versus-host disease (GVHD) prophylaxis compare favorably to HLA-matched donors using calcineurin inhibitor-based prophylaxis. A recent Center for International Blood and Marrow Transplant Research analysis of patients receiving homogenous PTCy-based prophylaxis found that, with reduced intensity conditioning, Haplo BMTs had worse outcomes than matched unrelated donor (MUD) BMTs. Due to significant differences between groups, we reanalyzed the dataset using propensity score matching and, additionally, added a donor age variable. After matching MUD BMTs to Haplo BMTs in a 1:5 ratio, no significant differences were found between groups across all measured baseline characteristics. Outcomes analyses demonstrated no significant differences in overall survival (hazard ratio [HR] of mortality with MUD vs Haplo [95% confidence interval], 0.95 [0.65-1.16], P = .75), disease-free survival (HR of relapse or death, 0.98 [0.73-1.18], P = .89), relapse rate (HR, 1.06 [0.77-1.38], P = .69), or nonrelapse mortality (NRM) (HR, 0.85 [0.42-1.13], P = .49) between groups. After stratification by conditioning intensity, MUD BMTs in the reduced-intensity cohort had lower risk of NRM (HR, 0.56 [0.14-0.99], P = .05), with no significant difference in other clinical outcomes. These results suggest the effect of HLA matching on BMT outcomes with PTCy is less meaningful than previously reported. Timely identification of a young, at least half-matched (related or unrelated) donor may be more important than finding a fully matched donor if the latter leads to a delay in BMT or use of an older donor.
MeSH term(s)	Cyclophosphamide/therapeutic use ; Graft vs Host Disease/drug therapy ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Propensity Score ; Recurrence ; Unrelated Donors
Chemical Substances	Cyclophosphamide (8N3DW7272P)
Language	English
Publishing date	2022-05-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2022007741
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Article ; Online: Allogeneic Transplantation for Follicular Lymphoma: Does One Size Fit All?

Hamadani, Mehdi / Horowitz, Mary M

Journal of oncology practice

2017 Volume 13, Issue 12, Page(s) 798–806

Abstract: Follicular lymphoma (FL) exhibits striking biologic and clinical heterogeneity. Patients with newly diagnosed asymptomatic or low-bulk disease may be observed or managed with immunotherapies alone. Chemoimmunotherapy is considered a standard treatment ... ...

Abstract	Follicular lymphoma (FL) exhibits striking biologic and clinical heterogeneity. Patients with newly diagnosed asymptomatic or low-bulk disease may be observed or managed with immunotherapies alone. Chemoimmunotherapy is considered a standard treatment for patients with advanced, symptomatic disease. In patients with FL who achieve at least a partial remission after first-line chemoimmunotherapy, autologous (auto-) hematopoietic cell transplantation (HCT) consolidation is not recommended; however, most patients with FL experience disease relapse after frontline therapies, with the experience of therapy failure within 2 years of first-line treatments predicting poor survival. Despite remarkable efficacy, even in patients who experience failure with other therapies, auto-HCT and allogeneic (allo-) HCT remain underutilized in relapsed/refractory FL, even among healthy and younger patients. Early use of auto-HCT consolidation should be considered a standard therapy option for high-risk patients who experience early failure of chemoimmunotherapy (< 2 years). For patients with FL who experience failure of frontline therapies late (> 2 years), deferring auto-HCT until later in the disease course is reasonable. Allo-HCT is best reserved for medically fit individuals with heavily pretreated disease, persistent marrow involvement, refractory, but low-bulk, disease, and in those who experience a failure to mobilize stem cells for auto-HCT. Allo-HCT is also a reasonable option for patients with FL who experience failure with a prior autograft; lower-intensity conditioning regimens and HLA-matched related donors are preferred in that setting. Future research should focus on the eradication of minimal residual disease before HCT and the prevention of disease relapse after HCT by integrating novel targeted agents into pre-HCT and post-HCT regimens.
MeSH term(s)	Hematopoietic Stem Cell Transplantation/methods ; Humans ; Immunotherapy/methods ; Lymphoma, Follicular/drug therapy ; Lymphoma, Follicular/surgery ; Lymphoma, Follicular/therapy ; Neoplasm Recurrence, Local/drug therapy ; Transplantation Conditioning/methods ; Transplantation, Autologous/methods ; Transplantation, Homologous/methods ; Treatment Outcome
Language	English
Publishing date	2017-12-11
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2236338-5
ISSN	1935-469X ; 1554-7477
ISSN (online)	1935-469X
ISSN	1554-7477
DOI	10.1200/JOP.2017.026336
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Article ; Online: Application of the CIBMTR One Year Survival Outcomes Calculator as a tool for retrospective analysis.

Cho, Christina / Devlin, Sean / Maloy, Molly / Horowitz, Mary M / Logan, Brent / Rizzo, J Douglas / Giralt, Sergio A / Perales, Miguel-Angel

Bone marrow transplantation

2023 Volume 58, Issue 10, Page(s) 1089–1095

Abstract: The Web-based One Year Survival Outcomes Calculator developed by the Center for International Blood and Marrow Transplant Research (CIBMTR) applies large-scale registry data to generate individualized estimates of overall survival (OS) probability 1 year ...

Abstract	The Web-based One Year Survival Outcomes Calculator developed by the Center for International Blood and Marrow Transplant Research (CIBMTR) applies large-scale registry data to generate individualized estimates of overall survival (OS) probability 1 year after first allogeneic hematopoietic cell transplant (HCT) and can therefore provide a data-driven foundation for personalized patient counseling. We assessed the calibration of the CIBMTR One Year Survival Outcomes Calculator when applied to retrospective data among adult recipients of first allogeneic HCT for acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic syndrome (MDS) with peripheral blood stem cell transplant (PBSCT) from a 7/8- or 8/8-matched donor from 2000 through 2015 at a single center. Predicted 1 year OS was estimated for each patient using the CIBMTR Calculator. Corresponding observed 1 year OS was estimated for each group by the Kaplan-Meier method. A weighted Kaplan-Meier estimator was used to visually display the average of observed 1 year survival estimates over the continuous range of predicted OS. In the first analysis of its kind, we demonstrated that the CIBMTR One Year Survival Outcomes Calculator could be applied to larger patient cohorts and predicted 1 year prognosis with general agreement between predicted and observed survival.
Language	English
Publishing date	2023-07-08
Publishing country	England
Document type	Journal Article
ZDB-ID	632854-4
ISSN	1476-5365 ; 0268-3369 ; 0951-3078
ISSN (online)	1476-5365
ISSN	0268-3369 ; 0951-3078
DOI	10.1038/s41409-023-02031-2
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Zs.A 2168: Show issues

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Article ; Online: Does matched unrelated donor transplantation have the same outcome as matched sibling transplantation in unselected patients?

Horowitz, Mary M

Best practice & research. Clinical haematology

2012 Volume 25, Issue 4, Page(s) 483–486

Abstract: Outcome differences by donor type for allogeneic hematopoietic stem cell transplantation vary based on disease and recipient age. The following paper summarizes analyses of transplant outcome among adults with acute myeloid leukemia (AML) and ... ...

Abstract	Outcome differences by donor type for allogeneic hematopoietic stem cell transplantation vary based on disease and recipient age. The following paper summarizes analyses of transplant outcome among adults with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who received transplants from HLA-identical siblings, fully (8/8) matched unrelated donors (MUD), or mismatched (7/8) unrelated donors. The paper also reviews transplantation outcomes for children with leukemia who had genotypically matched sibling donors, mismatched (7/8) or phenotypically matched related donors or matched (8/8) unrelated donors. Morbidity is higher after unrelated donor vs HLA-matched sibling transplants due to higher rates of acute graft-vs-host disease (GVHD). However, survival is similar or within 10%-15% with all studies donor type, with disease-specific differences probably reflecting differences in underlying population risk for treatment-related mortality.
MeSH term(s)	Acute Disease ; Adult ; Child ; Child, Preschool ; Disease-Free Survival ; Donor Selection ; Female ; Graft vs Host Disease/mortality ; Graft vs Host Disease/therapy ; Hematopoietic Stem Cell Transplantation ; Histocompatibility Testing ; Humans ; Infant ; Leukemia, Myeloid, Acute/mortality ; Leukemia, Myeloid, Acute/therapy ; Male ; Myelodysplastic Syndromes/mortality ; Myelodysplastic Syndromes/therapy ; Risk Factors ; Siblings ; Survival Rate ; Transplantation, Homologous
Language	English
Publishing date	2012-11-20
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2048027-1
ISSN	1532-1924 ; 1521-6926
ISSN (online)	1532-1924
ISSN	1521-6926
DOI	10.1016/j.beha.2012.10.012
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Article ; Online: Incorporating patient-reported outcome data into a predictive calculator for allogeneic hematopoietic cell transplantation recipients.

Shaw, Bronwen E / Flynn, Kathryn E / He, Naya / Cusatis, Rachel / D'Souza, Anita / Hamilton, Betty K / Horowitz, Mary M / Mattila, Deborah / Phelan, Rachel / Lee, Stephanie J / Brazauskas, Ruta

Cancer

2024 Volume 130, Issue 10, Page(s) 1826–1835

Abstract: Background: The Center for International Blood and Marrow Transplant Research (CIBMTR) provides a 1-year overall survival calculator to estimate outcomes for individual patients before they undergo allogeneic hematopoietic cell transplantation (HCT) to ... ...

Abstract	Background: The Center for International Blood and Marrow Transplant Research (CIBMTR) provides a 1-year overall survival calculator to estimate outcomes for individual patients before they undergo allogeneic hematopoietic cell transplantation (HCT) to inform risk. The calculator considers pre-HCT clinical and demographic characteristics, but not patient-reported outcomes (PROs). Because pre-HCT PRO scores have been associated with post-HCT outcomes, the authors hypothesized that adding PRO scores to the calculator would enhance its predictive power. Methods: Clinical data were obtained from the CIBMTR and the Blood and Marrow Transplant Clinical Trials Network. The PRO measures used were the 36-Item Short Form Survey (SF-36) and the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation. One thousand thirty-three adult patients were included. Results: When adjusted for clinical characteristics, the SF-36 physical component score was significantly predictive of 1-year survival (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.81-0.95; p = .0015), whereas the mental component score was not (HR, 1.02; 95% CI, 0.95-1.10; p = 0.6396). The baseline single general health question on the SF-36 was also significantly associated with mortality (HR, 1.91 for those reporting fair/poor health vs. good, very good, or excellent health; 95% CI, 1.33-2.76; p = .0005). The addition of PRO scores to the calculator did not result in a significant change in the model's predictive ability. Self-reported pre-HCT scores were strongly predictive of self-reported health status (odds ratio, 3.35; 95% CI, 1.66-6.75; p = .0007) and quality of life (odds ratio, 3.24; 95% CI, 1.93-5.41; p < .0001) after HCT. Conclusions: The authors confirmed the significant, independent association of pre-HCT PRO scores with overall survival, although adding PRO scores to the survival calculator did not improve its performance. They also demonstrated that a single general health question was as accurate as the full measure for predicting survival, an important finding that may reduce respondent burden and promote its inclusion in routine clinical practice. Validation of these findings should be performed.
MeSH term(s)	Humans ; Hematopoietic Stem Cell Transplantation ; Patient Reported Outcome Measures ; Male ; Female ; Middle Aged ; Adult ; Transplantation, Homologous ; Aged ; Quality of Life ; Young Adult
Language	English
Publishing date	2024-01-10
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1429-1
ISSN	1097-0142 ; 0008-543X ; 1934-662X
ISSN (online)	1097-0142
ISSN	0008-543X ; 1934-662X
DOI	10.1002/cncr.35189
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Article ; Online: The Changing Landscape of Treatment in Acute Myeloid Leukemia.

Koenig, Kristin / Mims, Alice / Levis, Mark J / Horowitz, Mary M

American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

2020 Volume 40, Page(s) 1–12

Abstract: The treatment of acute myeloid leukemia is evolving, with increased understanding of molecular pathogenesis allowing better risk stratification and development of new therapies. Tests to identify and drugs to target specific molecular abnormalities are ... ...

Abstract	The treatment of acute myeloid leukemia is evolving, with increased understanding of molecular pathogenesis allowing better risk stratification and development of new therapies. Tests to identify and drugs to target specific molecular abnormalities are improving remission rates and prolonging survival in patients with high-risk disease. Allogeneic hematopoietic stem cell transplantation remains an important curative therapy, with advances in donor availability and approaches to reduce transplant-related mortality making it applicable in many more patients. Considerations in identifying appropriate patients for targeted therapy and transplantation are presented.
MeSH term(s)	Clinical Decision-Making ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Leukemia, Myeloid, Acute/genetics ; Leukemia, Myeloid, Acute/therapy ; Molecular Targeted Therapy/methods ; Precision Medicine ; Remission Induction ; Survival Analysis ; Tissue Donors ; Transplantation, Homologous ; Treatment Outcome
Language	English
Publishing date	2020-04-02
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2431126-1
ISSN	1548-8756 ; 1548-8748
ISSN (online)	1548-8756
ISSN	1548-8748
DOI	10.1200/EDBK_279129
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Article ; Online: Transplantation for myelodysplastic syndromes: who, when, and which conditioning regimens.

Saber, Wael / Horowitz, Mary M

Hematology. American Society of Hematology. Education Program

2016 Volume 2016, Issue 1, Page(s) 478–484

Abstract: Allogeneic hematopoietic stem cell transplantation (HCT) is the only curative therapy for myelodysplastic syndrome (MDS). Broad application is hindered by high risks of transplant-related morbidity and mortality, especially in the older age range ... ...

Abstract	Allogeneic hematopoietic stem cell transplantation (HCT) is the only curative therapy for myelodysplastic syndrome (MDS). Broad application is hindered by high risks of transplant-related morbidity and mortality, especially in the older age range represented by the MDS population. However, recent advances in strategies to minimize regimen-related toxicity make HCT a viable option for many more patients. Appropriate selection of patients involves consideration of patient factors, including use of geriatric assessment tools and comorbidity scales, that predict risks of regimen-related toxicity as well as disease factors, including genetic markers, which predict survival with both non-HCT and HCT therapy. Optimal timing of HCT for fit patients must consider MDS risk scores and life-years to be gained, with earlier transplantation indicated for patients with intermediate-2 and high-risk disease but judicious delay for lower risk patients. Selection of suitable conditioning regimens must balance risks of toxicity with opportunity for maximum disease control.
MeSH term(s)	Allografts ; Hematopoietic Stem Cell Transplantation/methods ; Humans ; Myelodysplastic Syndromes/mortality ; Myelodysplastic Syndromes/therapy ; Risk Factors ; Transplantation Conditioning/methods
Language	English
Publishing date	2016-11-24
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2084287-9
ISSN	1520-4383 ; 1520-4391
ISSN (online)	1520-4383
ISSN	1520-4391
DOI	10.1182/asheducation-2016.1.478
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Article ; Online: High-resolution typing for unrelated donor transplantation: how far do we go?

Horowitz, Mary M

Best practice & research. Clinical haematology

2009 Volume 22, Issue 4, Page(s) 537–541

Abstract: For best results with unrelated donor transplantation of acute myeloid leukaemia (AML) patients, high-resolution typing should be completed for human leucocyte antigens (HLAs) A, B, C and DR. In the absence of an HLA-identical sibling, an unrelated adult ...

Abstract	For best results with unrelated donor transplantation of acute myeloid leukaemia (AML) patients, high-resolution typing should be completed for human leucocyte antigens (HLAs) A, B, C and DR. In the absence of an HLA-identical sibling, an unrelated adult donor, fully matched or with a single mismatch at these loci, should be used. If such a donor is not available in a timely manner, cord blood mismatched at one or two loci may be used. Data also suggest that peripheral blood transplantation may be more permissive of HLA mismatching than bone marrow transplants. Transplant decisions should be based on several factors, including availability of matched donors, as well as patient age, performance status and disease stage.
MeSH term(s)	Histocompatibility Testing ; Humans ; Leukemia, Myeloid, Acute/therapy ; Stem Cell Transplantation ; Tissue Donors
Language	English
Publishing date	2009-12-05
Publishing country	Netherlands
Document type	Journal Article ; Review
ZDB-ID	2048027-1
ISSN	1532-1924 ; 1521-6926
ISSN (online)	1532-1924
ISSN	1521-6926
DOI	10.1016/j.beha.2009.09.006
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