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A randomized phase 2 trial of oral vitamin A for graft-versus-host disease in children and young adults
Khandelwal, P., Langenberg, L., Luebbering, N., Lake, K., Butcher, A., Werling, K., Ramos, K. N., Taggart, C., Choe, H. K., Vasu, S., et al
Blood. 2024
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Editor's Choice
Abstract
Vitamin A plays a key role in the maintenance of gastrointestinal homeostasis and promotes a tolerogenic phenotype in tissue resident macrophages. We conducted a prospective randomized double-blinded placebo-controlled clinical trial in which 80 hematopoietic stem cell transplant recipients were randomized 1:1 to receive pre-transplant high-dose vitamin A or placebo. A single oral dose of vitamin A of 4000 I.U/kg, maximum 250,000 I.U was given prior to conditioning. Primary endpoint was incidence of acute GVHD at day+100. In an intent-to-treat analysis, incidence of acute GVHD was 12.5% in vitamin A arm and 20% in placebo (p=0.5). Incidence of acute GI GVHD was 2.5% in the vitamin A arm (p=0.09) and 12.5% in placebo at day+180. Incidence of chronic GVHD was 5% in the vitamin A arm and 15% in placebo (p=0.02) at 1 year. In an "as treated" analysis, cumulative incidence of acute GI GVHD at day+180 was 0% in vitamin A recipients and 12.5% in placebo (p=0.02) and chronic GVHD incidence 2.7% in the vitamin A recipients and 15% in placebo (p=0.01). The only possibly attributable toxicity was asymptomatic grade 3 hyperbilirubinemia in one vitamin A recipient at day+30, which self-resolved. Absolute CCR9+ CD8+effector memory T-cells, reflecting gut T-cell trafficking, were lower in the vitamin A arm at day+30 after HSCT (p=0.01). Levels of serum amyloid A-1, a vitamin A transport protein with pro-inflammatory effects, were lower in the vitamin A arm. The vitamin A arm had lower IL-6, IL-8, ST2 levels and likely more favorable gut microbiome and short chain fatty acids. Pre-HSCT oral vitamin A is inexpensive, has low toxicity and reduces GVHD (clinicaltrials.gov NCT03202849).
PICO Summary
Population
Children aged 12 months and over with pre transplant vitamin A levels below 75th centile of normal range for age, from a single centre in USA (n=80)
Intervention
A single oral dose of vitamin A of 4000 I.U/kg, maximum 250,000 I.U prior to conditioning pre-transplant (n=40)
Comparison
Placebo (n=40)
Outcome
In an intent-to-treat analysis, incidence of acute GVHD was 12.5% in vitamin A arm and 20% in placebo. Incidence of acute GI GVHD was 2.5% in the vitamin A arm and 12.5% in placebo at day+180. Incidence of chronic GVHD was 5% in the vitamin A arm and 15% in placebo at 1 year. In an "as treated" analysis, cumulative incidence of acute GI GVHD at day+180 was 0% in vitamin A recipients and 12.5% in placebo and chronic GVHD incidence 2.7% in the vitamin A recipients and 15% in placebo. The only possibly attributable toxicity was asymptomatic grade 3 hyperbilirubinemia in one vitamin A recipient at day+30, which self-resolved. Absolute CCR9+ CD8+effector memory T-cells, reflecting gut T-cell trafficking, were lower in the vitamin A arm at day+30 after HSCT. Levels of serum amyloid A-1, a vitamin A transport protein with pro-inflammatory effects, were lower in the vitamin A arm. The vitamin A arm had lower IL-6, IL-8, ST2 levels and likely more favorable gut microbiome and short chain fatty acids.
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The outcome and complications of total parenteral nutrition in pediatric hematopoietic stem cell transplantation
Alsalamah, S., Alramyan, R., Alakel, R., Altheyeb, F., Alrashed, R., Masuadi, E., Alyousif, G., Bin Sunaid, F. F., Alsultan, A., Essa, M. F.
Pediatric transplantation. 2021;:e14198
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Editor's Choice
Abstract
BACKGROUND Nutritional support posthematopoietic stem cell transplantation (HSCT) with total parenteral nutrition (TPN) or nasogastric tube feeding (NGT) in pediatric patients is associated with benefits and risks. METHODS We retrospectively reviewed the indication of TPN use in our pediatric HSCT patients and its impact on survival and possible related complications. RESULTS A total of 228 HSCTs were performed during the study period. TPN was used in 144 patients (63.2%) for a median of 14 days, while 8.8% had NGT feeding and 28% were able to tolerate oral feeding. Severe mucositis was seen in 104 TPN patients (72.2%) in comparison with 22 patients (26.2%) who were on Enteral Nutrition (EN) (p = <.001). Sinusoidal obstruction syndrome (SOS) was seen in 19 (13.2%) patients who had TPN compared to none in the patients who received EN (p = .001). The majority of patients who had SOS received myeloablative conditioning (MAC) therapy for hemoglobinopathy. Acute graft-versus-host disease (aGVHD) was seen in 24.8% of TPN patients and 9.1% of non-TPN patients (p = .01). However, there were no statistically significant differences in chronic GVHD, bacteremia, and patients' survival between both groups. CONCLUSIONS TPN is commonly used after pediatric HSCT in cases of severe mucositis. NGT feeding was found to be the least used nutritional support method. SOS and aGVHD were associated more frequently in TPN patients compared to EN patients. This suggests the possible disadvantages of TPN and importance of SOS preventative measures in high-risk patients.
PICO Summary
Population
Children under the age of 14 years who underwent HSCT at a single centre in Saudi Arabia (n=228)
Intervention
Total parenteral nutrition (TPN, n=144)
Comparison
Enteral nutrition (EN, n=84): either nasogastric tube feeding (n=20) or oral feeding (n=64)
Outcome
Severe mucositis was seen in 104 TPN patients (72.2%) in comparison with 22 patients (26.2%) who were on Enteral Nutrition (EN). Sinusoidal obstruction syndrome (SOS) was seen in 19 (13.2%) patients who had TPN compared to none in the patients who received EN. The majority of patients who had SOS received myeloablative conditioning therapy for hemoglobinopathy. Acute graft-versus-host disease (aGVHD) was seen in 24.8% of TPN patients and 9.1% of non-TPN patients. However, there were no statistically significant differences in chronic GVHD, bacteremia, and patients' survival between both groups.
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Geriatric nutritional risk index as a useful prognostic factor in second allogeneic hematopoietic stem cell transplantation
Kaito, S., Wada, A., Adachi, H., Konuma, R., Kishida, Y., Nagata, A., Konishi, T., Yamada, Y., Kumagai, T., Yoshifuji, K., et al
Annals of hematology. 2020
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Full text
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Editor's Choice
Abstract
Second allogeneic hematopoietic stem cell transplantation (allo-HSCT) has a low survival outcome and a high non-relapse mortality (NRM) rate which is a major obstacle to this treatment. We hypothesized that the status of malnourishment after first allo-HSCT as represented by the geriatric nutritional risk index (GNRI) could be used as a prognostic factor to determine the outcomes of second allo-HSCT. A total of 108 patients with a median age of 42 (range, 17-69) years, who received second allo-HSCT for disease recurrence after first allo-HSCT from our institution, were included in this study. Low GNRI had a significant impact on NRM at 2 years after second allo-HSCT: 56.9% in patients with GNRI ≤ 92 compared with 27.5% in patients with GNRI > 92 (P = 0.002). In multivariate analysis, GNRI of ≤ 92 was the only significant factor for NRM (hazard ratio [HR] 2.29, 95% confidence interval [CI] 1.15-4.56, P = 0.018). High-risk disease status at second allo-HSCT (HR 2.74, 95% CI 1.46-5.14, P = 0.002) and GNRI of ≤ 92 (HR 1.70, 95% CI 1.02-2.82, P = 0.042) were identified as significant factors for overall survival (OS). A score of 1 was assigned to each factor, and the OS rate at 2 years after second allo-HSCT decreased according to the score: 53.0% in patients with score 0, 32.3% with score 1, and 2.5% with score 2 (P < 0.001). In conclusion, GNRI could be a useful predictor for the outcomes of second allo-HSCT. A prospective study in other cohorts is warranted to validate the findings of our study.
PICO Summary
Population
Patients receiving a second allo-HSCT for disease recurrence after first allo-HSCT (n=108)
Intervention
Patients with low score on the geriatric nutritional risk index (GNRI </= 92) (n=60)
Comparison
Patients with a high score on the geriatric nutritional risk index (GNRI >92) (n=48)
Outcome
Low GNRI had a significant impact on NRM at 2 years after second allo-HSCT: 56.9% in patients with GNRI </= 92 compared with 27.5% in patients with GNRI > 92. In multivariate analysis, GNRI of </= 92 was the only significant factor for NRM (hazard ratio [HR] 2.29). High-risk disease status at second allo-HSCT (HR 2.74) and GNRI of </= 92 (HR 1.70) were identified as significant factors for overall survival (OS). A score of 1 was assigned to each factor, and the OS rate at 2 years after second allo-HSCT decreased according to the score: 53.0% in patients with score 0, 32.3% with score 1, and 2.5% with score 2.
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Impact of a Replacement Algorithm for Vitamin D Deficiency in Adult Hematopoietic Stem Cell Transplant Patients
Kenny, S. A., Collum, K., Featherstone, C. A., Farooki, A., Jakubowski, A.
Journal of the advanced practitioner in oncology. 2019;10(2):109-118
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Free full text
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Editor's Choice
Abstract
Adults undergoing hematopoietic stem cell transplant (HSCT) are at risk for vitamin D deficiency. After HSCT, exposure to sunlight is restricted, and patients may experience poor nutrition and malabsorption from HSCT-related side effects. Vitamin D affects bone health and immunologic processes. The aim of this project is to establish a process for monitoring and treating vitamin D deficiency and to evaluate if therapeutic vitamin D levels are attainable posttransplant using an HSCT vitamin D replacement algorithm. A multidisciplinary group led by advanced practice providers established a workflow for monitoring and supplementing vitamin D and created an HSCT vitamin D replacement guideline. The medical records of 144 adult HSCT patients were reviewed, and the records of another 72 patients were reviewed a year later. Historical baseline data before the intervention found that 81% of patients were vitamin D deficient and 30% received supplementation. Postintervention and at 1-year follow-up, 76% and 65% of patients were vitamin D deficient before transplant and 97.1% and 100%, respectively, received supplementation for vitamin D deficiency. Post-HSCT compliance with monitoring demonstrated that approximately 91% of patients had a vitamin D level checked within 6 months of transplant. After implementation of the algorithm, there was a statistically significant difference (p < .001) between deficient vitamin D levels pretransplant (72.9%) and posttransplant (26.4%). Results demonstrate sustained compliance over a 2-year period with monitoring and supplementation of vitamin D pre- and peritransplant. Aggressive vitamin D repletion posttransplant decreased the incidence of vitamin D deficiency in HSCT patients. Further study is needed to investigate the long-term effects of vitamin D repletion on posttransplant complications.
PICO Summary
Population
Adults undergoing haematopoietic stem cell transplant (n=346)
Intervention
Vitamin D replacement guideline (n=162)
Comparison
Historical cohort prior to guideline implementation (n=184)
Outcome
Postintervention and at 1-year follow-up, 76% and 65% of patients were vitamin D deficient before transplant and 97.1% and 100%, respectively, received supplementation for vitamin D deficiency. Post-HSCT compliance with monitoring demonstrated that approximately 91% of patients had a vitamin D level checked within 6 months of transplant. After implementation of the algorithm, there was a statistically significant difference between deficient vitamin D levels pretransplant (72.9%) and posttransplant (26.4%). Results demonstrate sustained compliance over a 2-year period with monitoring and supplementation of vitamin D pre- and peritransplant. Aggressive vitamin D repletion posttransplant decreased the incidence of vitamin D deficiency in HSCT patients.