Search

High treatment-related mortality (TRM) and high graft failure rate are serious concerns in HLA-mismatched umbilical cord blood (UCB) transplantation with myeloablative conditioning. We conducted a prospective trial of dual UCB transplantation using modified myeloablation consisting of total-body irradiation (TBI; 1350 cGy) and fludarabine (Flu) (160 mg/m2). Twenty-seven patients (median age, 33 years; range: 20-58 years) with hematologic malignancies were enrolled. The median combined cryopreserved total nucleated cell (TNC) dose was 4.3 × 107/kg (range: 3.2-7.7 × 107/kg). The cumulative incidences of neutrophil (≥500/μL) and platelet (≥50,000/μL) engraftment were 80% (95% confidence interval [CI], 58%-91%) and 68% (95% CI, 46%-83%), respectively. Among engrafted patients, a single cord blood unit was predominant by 100 days posttransplantation. A higher cryopreserved and infused TNC dose and infused CD3+ cell dose were significant factors associated with the predominant UCB unit (P = .032, .020, and .042, respectively). TRM and relapse rates at 2 years were 28% (95% CI, 12%-47%) and 20% (95% CI, 7%-37%), respectively. Cumulative incidences of grades II–IV and grades III–IV acute graft-versus-host disease (aGVHD) were 37% (95% CI, 20%-55%) and 11% (95% CI, 3%-26%), respectively, and that of chronic GVHD was 31% (95% CI, 15%-49%). With a median follow-up of 23 months, overall survival and disease-free survival rates at 2 years were 58% (95% CI, 34%-75%) and 52% (95% CI, 29%-70%), respectively. This study supports the use of TBI 1350 cGy/Flu as an alternative to conventional myeloablative conditioning for dual UCB transplantation. [ABSTRACT FROM AUTHOR]

Currently, no agents are approved by the United States Food and Drug Administration (FDA) for either prevention or treatment of acute graft-versus-host disease (aGVHD). Formal precedents establishing a comparative basis for assessing the efficacy and safety of new investigational agents are still lacking. As a step toward addressing this problem, a panel of experts met on 2 occasions to reach consensus on recommendations for terminology describing a clinically meaningful primary endpoint in studies assessing treatment for aGVHD. The panel recommended terminology for “very good partial response” (VGPR) that includes both diagnostic and functional criteria. The central hypothesis leading to this proposal is that the potential harm of giving more treatment than needed to produce or maintain complete response exceeds the harm of slight undertreatment that may be associated with less than complete response. VGPR clearly cannot be used as the sole outcome measure in GVHD treatment trials, and must be considered in the context of survival and safety. The proposed use of VGPR as the primary endpoint in GVHD treatment trials will remain provisional until its use has been validated through experience. [Copyright &y& Elsevier]

Background Several professional societies have established nutrition guidelines for patients undergoing HSCT. We surveyed HSCT programs to understand how these compare with clinical practice. Methods Qualitative surveys were emailed to HSCT dietitians. Surveys addressed malnutrition screening; dietary recommendations including nutrition support, graft-versus-host disease (GVHD), immune enhancing nutrients, and prebiotics/probiotics; and nutrition-related preventive care screening. Results Twenty adult programs (19 United States (US), 1 Australia) and 3 pediatric programs (3 US) responded. Annual volume across the 22 US programs was 5405 patients, representing 25% of all transplants in the US. Nineteen programs (83%) follow guidelines for nutrition screening and fourteen for nutrition therapy in the inpatient setting (Table 1); six (26%) follow guidelines for screening and therapy in the outpatient setting. All programs adhere to food safety recommendations and 5 (22%) have additional institutional precautions. However, only 2 programs (9%) report frequent adherence to guidelines for use of enteral nutrition. While there are no guidelines for GVHD diet and uncertainty over alternative nutrition practices, 8 programs (35%) follow a stepwise GVHD diet; 4 (17%) allow immunonutrition supplements; 2 (9%) allow prebiotics, and 7 (30%) allow probiotics after the resolution of neutropenia. With regard to adherence to preventive screening recommendations, only 4 programs (17%) screen for diabetes, 6 (26%) screen for hyperlipidemia, and none screen for abdominal obesity. There are no guidelines for vitamin D deficiency screening, but 10 programs (43%) screen for this. Discussion Wide variations in nutrition practices exist across HSCT programs. Similarly, with the exception of food safety recommendations, there are also wide variations in adherence to established nutrition guidelines. The use of enteral nutrition and preventive screening is particularly varied. Efforts are needed to understand barriers to guideline implementation and their correlation to patient outcomes. Further research is needed regarding new interventions such as immunonutrition, prebiotics, and probiotics. [ABSTRACT FROM AUTHOR]