Sole Upfront Therapy with Beclomethasone and Budesonide for Upper Gastrointestinal Acute Graft-versus-Host Disease.

Systemic glucocorticoids remain the standard treatment for gastrointestinal (GI) acute graft-versus-host disease (aGVHD) despite their toxicity and incomplete efficacy. Controlled trials have tested poorly absorbable steroids as adjuncts with systemic glucocorticoids, but only small case series have reported treatment with poorly absorbed beclomethasone dipropionate (BDP) and budesonide (BUD) alone. Our team has adopted the practice of administering BDP or BDP+BUD without systemic glucocorticoids as first-line therapy for isolated upper GI (UGI) aGVHD. We report results in 76 patients treated with BDP alone and in 81 patients treated with BDP+BUD, with allocation by physician choice. Almost all patients received peripheral blood stem cells (92%) from a fully HLA-matched related or unrelated donor (80%) after myeloablative conditioning (76%) for acute leukemia (49%), myelodysplastic syndrome (17%), non-Hodgkin lymphoma (14%), or another hematopoietic disorders (20%). After 28 days of treatment with BDP, 46% of the patients had a complete response (CR) and 10% had a partial response (PR); after 200 days, 61 (80%) patients were alive, 34% maintained a CR, and 3% maintained a PR, whereas 53% required additional immunosuppression (IS). After 28 days of treatment with BDP+BUD, 67% had a CR and 10% a PR; after 200 days, 74 (91%) patients were alive, 46% maintained a CR, and 2% maintained a PR, whereas 43% required additional IS. Among the entire cohort of 157 patients, 66 (42%) were treated successfully without systemic glucocorticoids. This study reports the efficacy of poorly absorbable steroids alone for patients with isolated UGI aGVHD. Prospective trials should test for the potential advantages of BDP and BUD use over systemic glucocorticoids.

Pharmacoeconomics of hematopoietic stem cell mobilization: an overview of current evidence and gaps in the literature.

Adequate hematopoietic stem cell (HSC) mobilization and collection is required prior to proceeding with high dose chemotherapy and autologous hematopoietic stem cell transplant. Cytokines such as G-CSF, GM-CSF, and peg-filgrastim, alone or in combination with plerixafor, and after chemotherapy have been used to mobilize HSCs. Studies have shown that the efficiency of HSC mobilization and collection may vary when different methods of mobilization are used. No studies have shown that survival is significantly affected by the method of mobilization, but some studies have suggested that cost and resource utilization may be different between different mobilization techniques. After the FDA approval of plerixafor with G-CSF to mobilize HSCs many transplant centers became concerned about the cost of HSC mobilization. A panel of experts was convened ant this paper reviews the current literature on the pharmacoeconomics of HSC mobilization.

Utilization of collaborative practice agreements between physicians and pharmacists as a mechanism to increase capacity to care for hematopoietic stem cell transplant recipients.

Survival after hematopoietic stem cell transplantation (HSCT) has improved and the number of allogeneic HSCTs performed annually in the United States is expected to reach 10,000 by 2015. The National Marrow Donor Program created the System Capacity Initiative to formulate mechanisms to care for the growing number of HSCT recipients. One proposed method to increase capacity is utilization of pharmacists to manage drug therapy via collaborative practice agreements (CPAs). Pharmacists have managed drug therapy in oncology patients with CPAs for decades; however, there are limited HSCT centers that employ this practice. Engaging in collaborative practice and billing agreements with credentialed pharmacists to manage therapeutic drug monitoring, chronic medical conditions, and supportive care in HSCT recipients may be cost-effective and enable physicians to spend more time on new or more complex patients. The goal of this paper is to provide a framework for implementation of a CPA and address how it may improve HSCT program capacity.

Burning bright or burning out: a qualitative investigation of leader vitality.

Introduction: Leaders of organizations have incessant demands placed on them, including cultivating teams, building culture, and increasing the bottom line, in addition to caring for followers' well-being and thriving. Numerous resources are required to meet these continuous demands, and vitality is one of the most valuable. Methods: Through interviewing 20 of the most influential and pressured leaders of Fortune 1,000 companies, this qualitative study answers three important questions: what drains vitality, what fosters it, and how do leaders most effectively utilize vitality for followers? Results: The results shed light on psychological mechanisms that drain leaders' vitality, including emotional labor, self-control, loss of job control, the unproductive mindsets of others, and isolation created from the role. In terms of fostering vitality, several of the pathways of the PERMA+4 model of well-being were highlighted, including fostering relationships, physical health, accomplishment, mindset, meaning, environment, and engagement. Two additional themes that foster vitality included job autonomy and time away from work. Themes emerged that underscore how leaders utilize their vitality for followers, and the potentially detrimental impacts to leadership when leaders are drained. Discussion: Overall, results highlight the importance of vitality and self-care as critical for leaders' ability to maximize their leadership performance.

Retrospective comparison of filgrastim plus plerixafor to other regimens for remobilization after primary mobilization failure: clinical and economic outcomes.

We performed a retrospective analysis to evaluate clinical and economic outcomes in patients receiving remobilization therapy after primary mobilization failure. Our primary endpoint was to compare filgrastim plus plerixafor to other regimens in their ability to collect a target cell dose of at least 2 million CD34+ cells/kg (cumulative). Of 96 consecutive patients who failed their primary mobilization therapy and in whom a second mobilization was attempted, remobilization consisted of filgrastim plus plerixafor (n = 38), filgrastim with or without sargramostim (n = 43), or chemotherapy plus filgrastim (n = 15), 84% of filgrastim/plerixafor patients were able to collect at least 2 million CD34+ cells/kg from both mobilizations, compared to 60% of patients mobilized with chemotherapy/filgrastim and 79% of the filgrastim ± sargramostim patients (P = 0.17). However, when combined with cells collected from the first mobilization, 53% of filgrastim/plerixafor patients reached the target of 2 million CD34+ cells in one apheresis, compared to 20% of those receiving chemotherapy/filgrastim and 28% of those receiving filgrastim ± sargramostim (P = 0.02). Resource utilization, mobilization drug costs, clinical care costs, and total costs were significantly different. We conclude that while filgrastim/plerixafor is the most efficient remobilization strategy, those clinical benefits may not translate into lower cost, especially when multiple days of plerixafor administration are required.

Kate F. Hays (1943-2021).

Memorializes Kate F. Hays (1943-2021), a pioneer in the field of Sport, Exercise, and Performance Psychology (SEPP). Kate was a practitioner in the field of SEPP since 1971 and maintained an independent practice, The Performing Edge, in Toronto, Canada. As a psychologist with 50 years of innovative and influential contributions to SEPP, Kate was not only a master practitioner, but also an educator and scholar in the field. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

The Leader Vitality Scale: Development, Psychometric Assessment, and Validation.

One of the most important units of analysis for positive organizational psychology research is leaders and future leaders in the workplace. Leaders often have a large responsibility for and influence on the well-being and performance of their followers. They also face the unique challenge of serving their followers and the organization while needing to maintain their own vitality and well-being. Vitality can provide a foundation of energy resources to a leader to serve at their full capacity. This study develops and empirically examines a new three factor scale to measure leader vitality which includes physical, psychological, and emotional components. In study 1, a total of 175 participants (including n = 128 leaders) completed the Leader Vitality Scale (LVS) and other positive psychology related measures. Exploratory factor analysis and then confirmatory factor analysis showed that the LVS is hierarchical with three distinct factors, with overall vitality as the higher-order factor. Correlational tests with two established vitality scales for general use showed that the LVS is positively related to existing scales, demonstrating convergent validity. In study 2, data was gathered from 92 top level leaders in the C-Suite (n = 25), vice presidents (n = 23), directors (n = 21), and managers (n = 23) of organizations across the United States. Results showed that LVS scores significantly correlated with life satisfaction, positive emotions, positive functioning at work, and psychological capital. Overall, these findings suggest that the LVS is a valid measure for assessing leader vitality, and can used in future studies of well-being and positive functioning at work.

ATG prevents severe acute graft-versus-host disease in mismatched unrelated donor hematopoietic cell transplantation.

Severe acute graft-versus-host disease (aGVHD) remains a major source of morbidity and mortality following mismatched unrelated donor hematopoietic cell transplantation (HCT). Through a retrospective analysis, we investigated the efficacy of GVHD prophylaxis with rabbit anti-thymocyte globulin (ATG) 7.5 mg/kg (1 mg/kg given on day -3, then 3.25 mg/kg/day on days -2 and -1 before stem cell infusion) followed by standard tacrolimus plus methotrexate in a consecutive series of 45 HLA partially matched unrelated donor HCT recipients. The cumulative incidence of grade III-IV aGVHD was 11% by 100 days (95% confidence interval [CI] 5%-25%). Moderate to severe chronic GVHD (per NIH consensus criteria) was 19% (95% CI 10%-36%) at 1 year, and 28% (95% CI 16%-48%) at 2 years. With a median follow-up time for surviving patients of 12 months (range: 5-39 months), overall survival was 55% (95% CI 39%-71%) at 1 year, and 45% (95% CI 27%-63%) at 2 years. Nonrelapse mortality was 11% (95% CI 5%-25%) by 100 days post-HCT, 26% (95% CI 16%-44%) by 1 year, and 30% (95% CI 18%-50%) by 2 years. The cumulative incidence of primary disease relapse was 23% (95% CI 13%-41%) at 1 year, and 33% (95% CI 20%-56%) by 2 years after HCT. Cytomegalovirus (CMV) infection or reactivation varied according to recipient and donor CMV serostatus. Epstein-Barr Virus (EBV) reactivation occurred in 54% (95% CI 40%-71%) of patients. Preemptive rituximab therapy was administered for EBV reactivation, however, posttransplant lymphoproliferative disorder was diagnosed in 5 (11%) cases, and was fatal in 1. A regimen of ATG 7.5 mg/kg total ending on day -1 effectively decreased the occurrence of grade III-IV aGVHD and severe chronic GVHD.

Severe hypoalbuminemia at day 90 predicts worse nonrelapse mortality and overall survival after allogeneic hematopoietic stem cell transplantation for acute myelogenous leukemia and myelodysplastic syndrome.

Because patients who undergo allogeneic hematopoietic cell transplantation (allo-HCT) remain in the vicinity of the transplant center for approximately 90 days posttransplantation, identifying prognostic factors to determine those at immediate higher risk of mortality is essential. A normal serum albumin level generally denotes healthiness. We evaluated the prognostic significance of day 90 hypoalbuminemia (and other clinical, pharmacologic, and laboratory variables) in 163 patients, median age 48 years (range, 19-69 years), who underwent allo-HCT for acute myelogenous leukemia (n = 124) or myelodysplastic syndrome (n = 39). Day 90 hypoalbuminemia (serum albumin <3.0 g/dL) was associated with worse nonrelapse mortality (NRM) and poor overall survival (OS). The estimated 1- and 2-year cumulative incidence rates of NRM were 48% and 52%, respectively, and the corresponding OS rates were 7% and 3%. Serum albumin level <3.0 g/dL and Karnofsky score <80 at day 90 were strong independent predictors of worse NRM and OS in multivariate analysis. These results support day 90 hypoalbuminemia as an adverse prognostic marker for NRM and OS after allo-HCT for acute myelogenous leukemia and myelodysplastic syndrome.

Understanding Black Matriarchal Role Models in the U.S. Attitudes and Beliefs About Breastfeeding.

Introduction: Despite the tremendous health benefits for both mother and infant, black women (including African Americans and those who self-identify as black) have lower rates of breastfeeding than all other racial groups. Historically, matriarchal role models have been essential within the black family structure. The purpose of this study was to explore matriarchal role models' attitudes and beliefs about breastfeeding. Methods: Thirty-eight black women between the ages of 46-82 years were surveyed regarding their perceptions of breastfeeding. Results: Our results revealed that 44.1% of the participants believed that breastfeeding is a better infant feeding method. However, 52.6% of the participants did not demonstrate confidence in their ability to breastfeed overall. Conclusions: These findings suggest that while black matriarchal role models have positive attitudes about breastfeeding behaviors, they may need to be educated along with postpartum and/or prenatal women about breastfeeding benefits and techniques to better support and improve black women's initiation and continuation of breastfeeding.

Pentostatin as rescue therapy for glucocorticoid-refractory acute and chronic graft-versus-host disease.

BACKGROUND: Despite scientific advances in hematopoietic cell allografting, glucocorticoid-refractory acute (aGVHD) and chronic graft-versus-host disease (cGVHD) represent major sources of transplant-related morbidity and mortality. We aimed to characterize the activity of pentostatin as rescue therapy for refractory GVHD. MATERIAL/METHODS: In a retrospective analysis, we examined the activity of pentostatin as rescue therapy of glucocorticoid-refractory acute and chronic GVHD. RESULTS: In 12 patients with advanced (overall aGVHD grade III/IV in 8/12) refractory aGVHD, overall response (ORR) was achieved in 6/12, and complete remission (CR) of aGVHD in 4/12 allowing additional rescue immunosuppressive agents. Median overall survival (OS) was 1.4 months (95% CI: 0.26-2.4). Causes of death included refractory aGVHD and infection. In 18 patients with refractory cGVHD (12/18 with severe cGVHD), pentostatin induced CR in 1/18, and partial response (PR) in 9/18. Activity was observed in all affected organs. The median decrease in glucocorticoid therapy over 24 months after pentostatin initiation for refractory cGVHD was 38% (range=0-100%). Median OS was 5 months (95% CI: 1.6 - NR). CONCLUSIONS: Allowing for the utilization of additional immune suppressive agents, this series suggests the activity of pentostatin as rescue therapy of refractory GVHD.

Modern systemic chemotherapy in surgically unresectable neoplasms of appendiceal origin: a single-institution experience.

BACKGROUND: Appendiceal neoplasms include tumors ranging from benign-appearing cells with widespread mucin deposits to aggressive poorly differentiated signet ring cell adenocarcinomas. Traditionally, these tumors are treated with cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy. For some patients, cytoreductive surgery is not an option, and minimal published data exist in the management and outcome of these patients. A retrospective analysis was conducted to determine the benefit of modern systemic chemotherapy in patients with disseminated appendiceal neoplasm who were not considered optimal candidates for cytoreductive surgery. METHODS: A retrospective review was conducted using The University of Texas M. D. Anderson Cancer Center tumor registry between January 2000 and July 2005. Response was determined by radiographic response and/or overall clinical benefit. RESULTS: Of 186 patients diagnosed with appendiceal neoplasm, 54 (29%) patients considered to be suboptimal surgical candidates received > or =2 cycles of systemic chemotherapy. Thirty (55.6%) patients had a disease control rate noted as a complete response, partial response, or stable disease. After a median follow-up of 24 months, the median progression-free survival (PFS) and overall survival were determined to be 7.6 months (95% confidence interval [CI], 4-11) and 56 months (95% CI, 36-not applicable), respectively. CONCLUSIONS: Systemic chemotherapy has a role in appendiceal neoplasm patients who are suboptimal candidates for cytoreductive surgery. The intermediate PFS indicates the challenges that exist for appendiceal neoplasm patients in this setting. Prospective randomized trials including systemic chemotherapy are needed to provide further insight into this malignancy, for which no standard exists.

Prevalence of osteoporosis in community-dwelling individuals with intellectual and/or developmental disabilities.

OBJECTIVE: Measure central bone mineral density (BMD) in community-dwelling individuals with intellectual and/or developmental disabilities. DESIGN: A cross-sectional study. SETTING: A regional center providing outpatient medical, residential, and day activity services for individuals with intellectual and/or developmental disabilities. PARTICIPANTS: Documented BMD results were obtained for 298 community-dwelling individuals with intellectual and/or developmental disabilities. MEASUREMENTS: BMD by central dual-energy x-ray absorptiometry (DXA) on the participant's spine, converted into T-scores categories using CDC guidelines (T < or = -2.5 [osteoporotic]; -2.5 > T < -1.0 [osteopenic]; > or = -1.0 [normal]). Comparisons were made using multiple regression to determine significant independent risk factors for low BMD. RESULTS: Significant predictors were noted in the rates of osteoporosis attributable to subject age, race, and level of ambulation. No gender differences were noted for the rate of osteoporosis in this community sample of individuals with intellectual and/or developmental disabilities, nor were any differences noted for varying levels of mental retardation. Diagnostic differences were significant only for those individuals with a diagnosis of metabolic error, who had a significantly lower rate of osteoporosis than the rest of the study population. CONCLUSION: This study's findings regarding age, race, and level of ambulation are consistent with those of previous studies using an intellectually and/or developmentally disabled population as well as the general population at large. Our finding that the rate of osteoporosis among disabled males is higher than for males in the general population suggests a possible case-finding deficit for asymptomatic males in the general population. It is also interesting that the only diagnostic category observed to be statistically different from the group in general was metabolic error, a finding that warrants further investigation.