Defining the Intensity of Conditioning Regimens: Working Definitions

Bacigalupo, Andrea; Ballen, Karen K.; Rizzo, Douglas; Giralt, Sergio; Lazarus, Hillard M.; Ho, Vincent T.; Apperley, Jane F.; Slavin, Shimon; Pasquini, Marcelo C.; Sandmaier, Brenda M.; Barrett, John; Blaise, Didier; Lowski, Robert; Horowitz, Mary M.

doi:10.1016/j.bbmt.2009.07.004

Cited by 1,536 publications

(1,095 citation statements)

References 43 publications

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“…We therefore grouped the intensity of conditioning in our study according to expected toxicities and length of aplasia in RIC and NMA. 16,17 In the most published studies the intensity of conditioning was comparable to our regimens. 10,20 In elderly patients MRD are mostly of similar advanced age as the recipient.…”

Section: Discussionsupporting

confidence: 58%

Influence of age on outcome after allogeneic hematopoietic cell transplantation: a single center study in patients aged ⩾60

Federmann

Faul

Meisner

et al. 2015

Bone Marrow Transplant

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Reduced intensity conditioning regimens lead to an increasing use of allogeneic hematopoietic cell transplantation (HCT) in elderly patients. We retrospectively analyzed 151 patients aged ⩾ 60 receiving allogeneic HCT 2000-2012 at our center. Median age was 66 years. Kaplan-Meier estimated 3-year OS was 42% with a median follow-up of 38 months. Cumulative incidences of progression and non-relapse mortality after 3 years were 38 and 24%. OS was better in the group of patients 465 years with a Kaplan-Meier estimated OS of 50% vs 34%, P = 0.060. We observed a significant influence of donor age (o 50 years: 53% vs 450 years: 30%, P = 0.017) and gender match (matched: 57% vs mismatched: 32%, P = 0.007) on outcome. The use of a matched related donor was inferior compared with a matched or mismatched unrelated donor (19% vs 47%, P = 0.015). On multivariate analysis there was an increased hazard ratio for a non-gender-matched HLA-matched-related donor (hazard ratio 3.23, 95% confidence interval 1.55-6.74, P = 0.002). Age had no significant impact on OS (P = 0.414). In conclusion, the data suggest that older age alone has no negative impact on the outcome of allogeneic HCT. Transplant decision should be tailored to disease risk and patient performance status rather than age.

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Section: Discussionsupporting

confidence: 58%

Influence of age on outcome after allogeneic hematopoietic cell transplantation: a single center study in patients aged ⩾60

Federmann

Faul

Meisner

et al. 2015

Bone Marrow Transplant

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“…The group difference was statistically significant in survival analysis (p 5 0.030), and was essentially confirmed by a Cox regression analysis controlling for the predefined variables (p 5 0.034). The reduced event rate was further related (p 5 0.046) to one of the predefined control variables, that is, to reduced conditioning regimes (classified according to Bacigalupo et al 33 ).…”

Section: Resultsmentioning

confidence: 97%

“…To account for potential confounders, analyses of crude log-rank tests were corroborated with Cox regression models accounting for the Cancer Therapy following predefined, potentially confounding variables: (i) EBMT risk score, 5 (ii) Karnofsky Performance Score, 6 (iii) intensity of condition regimes according to Bacigalupo et al, 33 (iv) gender 34 and (v) fitness at baseline. 8 For analyses of competing risks, that is, simultaneous analyses of both NRM and deaths related to a relapse-estimation of cumulative incidence functions was based on the approach described by Fine and Gray.…”

Section: Resultsmentioning

confidence: 99%

Effects of physical exercise on survival after allogeneic stem cell transplantation

Wiskemann

Kleindienst

Kuehl

et al. 2015

Intl Journal of Cancer

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Observational studies have suggested that physical activity may be associated with improved survival after cancer treatment. However, data from controlled clinical trials are required. We analyzed survival data of 103 patients from a previously published randomized controlled trial in allogeneic stem cell transplant patients who were randomized to either an exercise intervention (EX) or to a social contact control group. EX patients trained prior to hospital admission, during inpatient treatment, and for 6-8 weeks after discharge. Survival analyses were used to compare both total mortality (TM) and non-relapse mortality (NRM) after discharge and transplantation during an observation period of 2 years after transplantation. Analyses were corroborated with Cox and Fine & Gray regression models adjusting for potential confounders. After discharge, EX patients had a significantly lower TM rate than controls (12.0 vs. 28.3%, p 5 0.030) and a numerically lower NRM rate (4.0 vs. 13.5%, p 5 0.086). When the inpatient period was included, absolute risk reductions were similar but not significantly different (TM: 34.0 vs. 50.9%, p 5 0.112; NRM: 26.0 vs. 36.5%, p 5 0.293). The number needed to treat (NNT) to prevent one death with EX was about 6. Furthermore, regression analyses revealed that baseline fitness was protective against mortality. The data suggest that exercise might improve survival in patients undergoing allo-HCT. However, the results should be interpreted with caution as the study was not designed to detect differences in survival rates, and as no stratification on relevant prognostic factors was carried out.Allogeneic hematopoietic stem cell transplantation (allo-HCT) is an effective treatment option for patients with highrisk hematological malignancies such as acute leukemia. However, recipients of allo-HCT may suffer from numerous treatment-related side effects and complications, such as infections and graft-versus-host disease (GvHD), and the transplant-related mortality rate is considerable. 1 Due to the high mortality rates in myeloablative regimens (30-40% 2 ) and even in reduced intensity conditioning (RIC) regimens (20-30% 3 ), clinicians and researchers have attempted to determine variables that can be used to characterize subtypes of patients who are candidates for transplantation. 4 Several prognostic risk scores have been established to predict survival after allo-HCT. The EBMT risk score 5 is a well-known tool that predicts the risk of death after allo-HCT using a score based on age, disease stage, time interval from diagnosis to transplant, donor type and donor-recipient gender combination. Prognostic validity has also been demonstrated by the clinician-assessed Karnofsky Performance Score and by the co-morbidity score by Sorror et al. 6,7 A recently published pilot study by Wood et al. suggests that cardiopulmonary fitness, as defined by either peak oxygen uptake or the 6-minute walk distance Test (6-MWD), is a predictor of symptom severity, quality of life, and mortality in patients undergoi...

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“…Myeloablative conditioning (MAC) regimen included either 8 Gy fractionated Total Body Irradiation or non-fractionated equivalent, or high-dose busulfan (>8 mg/kg orally or intravenous equivalent). Regimen not meeting these criteria was considered to be reduced intensity conditioning (RIC) [21].…”

Section: Introductionmentioning

confidence: 99%

Impact of the source of hematopoietic stem cell in unrelated transplants: Comparison between 10/10, 9/10‐HLAmatched donors and cord blood

et al. 2015

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In absence of available matched-related or unrelated donor (MUD), mismatched unrelated donors (MMUD) and unrelated cord blood (UCB) are both considered to be suitable donors, with similar post-transplant overall survival. In most of these retrospective comparisons, HLA typing of adult donors was performed at eight loci. The aim of this study was to compare the outcome of patients transplanted from UCB (N 5 64) with those transplanted from 9/10-HLA MMUD (N 5 84) or 10/10-HLA MUD (N 5 196). In multivariate analysis, UCB was associated with less Grade II-IV acute GVHD in comparison with MUD (aHR 1.97, 95% CI 1.19-3.27, P 5 0.009) and MMUD transplants (aHR 1.79, 95% CI 1.02-3.15, P 5 0.042), while the cumulative incidence of chronic GVHD was not significantly different between the three groups. Overall survival (OS), non-relapse mortality, and relapse were not different between MMUD and UCB transplantation, whereas OS was impaired after UCB in comparison with MUD (aHR 0.65, 95% CI 0.43-0.99, P 5 0.043). Factors also impacting OS were the donor/recipient CMV serostatus (Donor2/Recipient1 aHR 1.76, 95% CI 1.23-2.52, P 5 0.002 compared with D2/R2), the donor/recipient gender combination (Female/Male versus other combinations aHR 1.57, 95% CI 1.11-2.22, P 5 0.012) and disease risk (aHR 1.58, 95% CI 1.05-2.38, P 5 0.027 for high vs. low risk disease). Our data confirm that UCB and 9/10-HLA MMUD are both relevant alternative options when no 10/10-HLA donor is available. Donor/recipient gender combination and CMV serostatus had a significant impact on survival and may be taken into account, along with donor type, in the setting of MMUD and UCB transplants.

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Defining the Intensity of Conditioning Regimens: Working Definitions

Cited by 1,536 publications

References 43 publications

Influence of age on outcome after allogeneic hematopoietic cell transplantation: a single center study in patients aged ⩾60

Influence of age on outcome after allogeneic hematopoietic cell transplantation: a single center study in patients aged ⩾60

Effects of physical exercise on survival after allogeneic stem cell transplantation

Impact of the source of hematopoietic stem cell in unrelated transplants: Comparison between 10/10, 9/10‐HLAmatched donors and cord blood

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