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1.
[Effects of Pre-Transplant CONUT and Post-Transplant MRD on Prognosis of Patients with Multiple Myeloma after Auto-HSCT]
Xiong, Y. Y., Zhou, Q., Chen, L., Yu, W., Zhang, H. B., Chen, J. B.
Zhongguo shi yan xue ye xue za zhi. 2024;32(1):146-154
Abstract
OBJECTIVE To explore the effects of pre-transplant controlling nutritional status (CONUT) and post-transplant minimal residual disease (MRD) on prognosis of patients with multiple myeloma (MM) after autologous hematopoietic stem cell transplantation (auto-HSCT). METHODS The clinical data of 79 patients who received auto-HSCT from 2011 to 2020 in The First Affiliated Hospital of Chongqing Medical University were retrospectively analyzed. The patients were divided into Low-CONUT group (n=62) and High-CONUT group (n=17) according to whether the CONUT score was less than 5. The differences in clinical features, hematopoietic reconstruction, adverse reactions, efficacy and survival between the two groups were compared. In addition, the prognostic risk factors were analyzed and verified by time-dependent ROC curve. RESULTS The proportions of male patients and bone marrow plasma cells>30% at initial diagnosis in High-CONUT group were both higher than those in Low-CONUT group (both P <0.05). While, there were no significant differences in hematopoietic reconstruction and adverse reactions (>grade 2) between the two groups. The complete response (CR) rate and CR+very good partial response (VGPR) rate before transplantation in Low-CONUT group were both significantly higher than those in High-CONUT group (both P <0.05). After 3 months of transplantation, the CR+VGPR rate still remained an advantage in Low-CONUT group compared with High-CONUT group (P <0.01), but CR rate did not(P >0.05). The overall survival (OS) and progression-free survival (PFS) in Low-CONUT group were both superior to those in High-CONUT group (both P <0.05). Low CONUT score (0-4) before transplantation and negative MRD at 6 months after transplantation were favorable factors affecting OS and PFS (both P <0.05), while the International Myeloma Working Group (IMWG) high-risk at initial diagnosis and lactate dehydrogenase (LDH) level>250 U/L before transplantation were only risk factors for PFS (both P <0.05). Time-dependent ROC curve analysis showed that pre-transplant CONUT score and MRD status at 6 months after transplantation could independently or jointly predict 1- and 2-year OS and PFS, and the combined prediction was more effective. CONCLUSION The combination of pre-transplant CONUT and post-transplant MRD can better predict the prognosis of MM patients.
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2.
Effects of Korean red ginseng on T-cell repopulation after autologous hematopoietic stem cell transplantation in childhood cancer patients
Hong, K. T., Kang, Y. J., Choi, J. Y., Yun, Y. J., Chang, I. M., Shin, H. Y., Kang, H. J., Lee, W. W.
Journal of ginseng research. 2024;48(1):68-76
Abstract
BACKGROUND Although the survival outcomes of childhood cancer patients have improved, childhood cancer survivors suffer from various degrees of immune dysfunction or delayed immune reconstitution. This study aimed to investigate the effect of Korean Red Ginseng (KRG) on T cell recovery in childhood cancer patients who underwent autologous hematopoietic stem cell transplantation (ASCT) from the perspective of inflammatory and senescent phenotypes. METHODS This was a single-arm exploratory trial. The KRG group (n = 15) received KRG powder from month 1 to month 12 post-ASCT. We compared the results of the KRG group with those of the control group (n = 23). The proportions of T cell populations, senescent phenotypes, and cytokine production profiles were analyzed at 1, 3, 6, and 12 months post-ASCT using peripheral blood samples. RESULTS All patients in the KRG group completed the treatment without any safety issues and showed a comparable T cell repopulation pattern to that in the control group. In particular, KRG administration influenced the repopulation of CD4(+) T cells via T cell expansion and differentiation into effector memory cell re-expressing CD45RA (EMRA) cells. Although the KRG group showed an increase in the number of CD4(+) EMRA cells, the expression of senescent and exhausted markers in these cells decreased, and the capacity for senescence-related cytokine production in the senescent CD28(-) subset was ameliorated. CONCLUSIONS These findings suggest that KRG promotes the repopulation of CD4(+) EMRA T cells and regulates phenotypical and functional senescent changes after ASCT in pediatric patients with cancer.
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3.
Efficacy and safety of biosimilar Peg-filgrastim after autologous stem cell transplant in myeloma and lymphoma patients: a comparative study with biosimilar Filgrastim, Lenograstim, and originator Peg-filgrastim
Marchesi, F., Terrenato, I., Papa, E., Tomassi, M., Falcucci, P., Gumenyuk, S., Palombi, F., Pisani, F., Renzi, D., Romano, A., et al
Annals of hematology. 2024
Abstract
Data about biosimilar Peg-filgrastim (bioPEG) in autologous stem cell transplant (ASCT) are still scarce. The aim of this study has been to assess efficacy and safety of bioPEG among lymphoma and myeloma patients undergoing ASCT, comparing these data with historical controls receiving other G-CSFs. Furthermore, an economic evaluation has been included to estimate the savings by using bioPEG. This is a prospective cohort study comparing lymphoma and myeloma patients undergoing ASCT and receiving bioPEG (n = 73) with three historical consecutive cohorts collected retrospectively who received other G-CSFs (Lenograstim - Leno - n = 101, biosimilar Filgrastim - bioFIL n = 392, and originator Peg-filgrastim - oriPEG n = 60). We observed a significantly shorter time to neutrophils and platelet engraftment (p < 0.001) in patients treated with bioPEG and oriPEG. Moreover, patients who received bioPEG showed a shorter hospitalization time (p < 0.001) and a lower transfusion need (p < 0.001). We did not observe any significant difference in terms of transplant-related mortality, mucositis, and diarrhea among the four groups. No serious adverse events were associated with bioPEG. Similar data were obtained after running a stratified analysis for lymphomas and myeloma separately conducted by using a propensity score matching. The average total cost per patient of bioPEG was € 18218.9 compared to € 23707.8, € 20677.3 and € 19754.9 of Leno, oriPEG, and bioFIL, respectively. In conclusion, bioPEG seems to be as effective as the originator and more effective than short-acting G-CSFs in terms of post-transplant engraftment in myeloma and lymphoma patients undergoing ASCT. Moreover, bioPEG was cost-effective when compared with the other G-CSFs.
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4.
Revisiting the utility of G-CSF post-autologous hematopoietic stem cell transplantation for outpatient-based transplants
Portuguese, A. J., Holmberg, L., Hill, G. R., Lee, S. J., Green, D. J., Mielcarek, M., Gooley, T., Yeh, A. C.
Transplantation and cellular therapy. 2023
Abstract
BACKGROUND The use of granulocyte colony-stimulating factor (G-CSF) after autologous stem cell transplant (ASCT) has been shown to reduce time to neutrophil engraftment as well as duration of hospitalization post-transplant. However, prior studies have focused on inpatient-based transplants, where patients are routinely admitted for conditioning and frequently remain hospitalized until signs of neutrophil recovery. Given improvements in post-transplant care, an increasing number of patients, particularly those receiving ASCT for multiple myeloma, are now being transplanted in an outpatient setting. OBJECTIVE We hypothesize that the routine use of G-CSF for outpatient-based ASCT may not result in the same benefit with respect to reduction of duration of hospitalization and therefore should be reconsidered in this setting. STUDY DESIGN We performed a retrospective cohort study of 633 patients with multiple myeloma (MM; n=484) and non-Hodgkin lymphoma (NHL; n=149) who were transplanted consecutively between 9/2018 and 2/2023. Outpatient ASCT comprised 258 (53%) of MM and no NHL cases. Starting September 2021, post-transplant G-CSF was incorporated into the supportive care regimen for all ASCTs. There were 410 (309 MM, 101 NHL) and 223 patients (175 MM, 48 NHL) transplanted in the pre- and post-G-CSF policy periods, respectively. The primary outcome focused on the duration of hospitalization within the first 30 days following graft infusion. RESULTS As expected, after implementation of the G-CSF policy, the time to neutrophil engraftment was reduced among patients with MM (mean -2.8 days, p<.0001) and NHL (mean -2.9 days, p<.0001). However, among patients with MM, roughly half of whom underwent outpatient-based ASCT, the inpatient duration during the first 30 days was not reduced after G-CSF implementation (p=.40). Comparatively, the inpatient duration (mean -1.8 days, p=.030) was reduced among patients with NHL, all of whom were electively admitted for ASCT. CONCLUSIONS For patients with MM at an outpatient-based transplant center, incorporation of G-CSF post-ASCT resulted in reduced time to neutrophil engraftment but did not significantly reduce the time spent in the inpatient setting through day +30.
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5.
Prehabilitation to improve outcomes afteR Autologous sTem cEll transplantation (PIRATE): A pilot randomised controlled trial protocol
Dennett, A. M., Porter, J., Ting, S. B., Taylor, N. F.
PloS one. 2023;18(4):e0277760
Abstract
BACKGROUND Autologous stem cell transplant is a common procedure for people with haematological malignancies. While effective at improving survival, autologous stem cell transplant recipients may have a lengthy hospital admission and experience debilitating side-effects such as fatigue, pain and deconditioning that may prolong recovery. Prehabilitation comprising exercise and nutrition intervention before stem cell transplant aims to optimise physical capacity before the procedure to enhance functional recovery after transplant. However, few studies have evaluated prehabilitation in this setting. We aim to explore preliminary efficacy of improving physical capacity of prehabilitation for people undergoing autologous stem cell transplant. METHODS The PIRATE study is a single-blinded, parallel two-armed pilot randomised trial of multidisciplinary prehabilitation delivered prior to autologous stem cell transplantation. Twenty-two patients with haematological malignancy waitlisted for transplant will be recruited from a tertiary haematology unit. The intervention will include up to 8 weeks of twice-weekly, supervised tailored exercise and fortnightly nutrition education delivered via phone, in the lead up to autologous stem cell transplant. Blinded assessments will be completed at week 13, approximately 4 weeks after transplant and health service measures collected at week 25 approximately 12 weeks after transplant. The primary outcome is to assess changes in physical capacity using the 6-minute walk test. Secondary measures are time to engraftment, C-reactive protein, physical activity (accelerometer), grip strength, health-related quality of life (EORTC QLQ-C30 and HDC29 supplement), self-efficacy and recording of adverse events. Health service data including hospital length of stay, hospital readmissions, emergency department presentations and urgent symptom clinic presentation at will also be recorded. DISCUSSION This trial will inform design of a future definitive randomised controlled trial and implementation of prehabilitation for people receiving autologous stem cell transplant by providing data on efficacy and safety. TRIAL REGISTRATION The PIRATE Trial has been approved by the Eastern Health Human Research Ethics Committee (E20/003/61055) and is funded by the Eastern Health Foundation. This trial is registered with the Australian New Zealand Clinical Trials Registry ACTRN12620000496910. Registered April 20, 2020.
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6.
Exercise prehabilitation for people with myeloma undergoing autologous stem cell transplantation: results from PERCEPT pilot randomised controlled trial
McCourt, O., Fisher, A., Ramdharry, G., Land, J., Roberts, A. L., Rabin, N., Yong, K.
Acta oncologica (Stockholm, Sweden). 2023;:1-10
Abstract
BACKGROUND Autologous stem cell transplant (ASCT) is first line treatment for newly diagnosed patients with myeloma but often results in functional deficits and reduced quality of life (QOL). Physically active myeloma patients have better QOL, less fatigue and reduced morbidity. This trial aimed to investigate the feasibility of a physiotherapist-led exercise intervention delivered across the continuum of the myeloma ASCT pathway at a UK centre. Initially designed and delivered as a face-to-face trial, the study protocol was adapted to virtual delivery in response to the COVID-19 pandemic. MATERIAL AND METHODS A pilot randomised controlled trial of a partly supervised exercise intervention with incorporated behaviour change techniques delivered before, during and for 3 months following ASCT compared to usual care. Face-to-face delivery of the pre-ASCT supervised intervention was adapted to virtually-supervised group classes via video conferencing. Primary outcomes related to feasibility; recruitment rate, attrition and adherence. Secondary outcomes included patient reported measures of QOL (EORTC C30, FACT-BMT, EQ5D), and fatigue (FACIT-F), measures of functional capacity (six-minute walk test (6MWT), timed sit-to-stand (TSTS), hand grip strength, self-reported and objective physical activity (PA). RESULTS Over 11 months 50 participants were enrolled and randomised. Overall, uptake to the study was 46%. The attrition rate was 34%, mainly related to failure to undergo ASCT. Loss of follow-up for other reasons was low. Secondary outcomes demonstrate potential for the benefit of exercise prior to, during and after ASCT with improvements in QOL, fatigue, functional capacity and PA evident on admission for ASCT and 3 months post-ASCT. DISCUSSION Results indicate acceptability and feasibility of delivering exercise prehabilitation, in person and virtually within the ASCT pathway in myeloma. The effects of prehabilitation and rehabilitation provision as a component of the ASCT pathway warrants further investigation.
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7.
Efficacy and Safety of Synbiotics in Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Randomized, Double-blinded, Placebo-controlled Pilot Study
Mizutani, Y., Kawamoto, S., Takahashi, M., Doi, H., Wakida, K., Tabuchi, S., Tanda, M., Soga, A., Chijiki, R., Takakura, H., et al
Internal medicine (Tokyo, Japan). 2023
Abstract
Objective High-dose chemotherapy with autologous hematopoietic stem cell transplantation (auto-HSCT) is an effective treatment option for relapsed and refractory aggressive malignant lymphoma. However, patients frequently experience treatment-induced gastrointestinal symptoms. Synbiotics, including live microorganisms and nondigestible food ingredients, reportedly ameliorate chemotherapy-induced mucosal damage. In this study, we assessed the efficacy and safety of synbiotics in patients undergoing auto-HSCT. Methods This randomized, double-blinded study included patients with malignant lymphoma eligible for auto-HSCT. The patients were randomly assigned to either a synbiotic group receiving Bifidobacterium longum (BB536) and guar gum or a placebo group receiving a placebo containing dextrin. The supplements were administered twice daily from the start of conditioning chemotherapy up to 28 days after auto-HSCT. The primary endpoint was the duration of total parenteral nutrition (TPN). Results In total, 12 patients were included and randomized. The median duration of TPN was 15 (range, 12-33) days in the synbiotic group and 17.5 (range, 0-32) days in the placebo group. The median duration of grade ≥3 diarrhea was shorter in the synbiotic group than in then placebo group (2.5 vs. 6.5 days), as was the duration of hospital stay (31.5 vs. 43 days). The oral intake and quality of life regarding diarrhea and anorexia improved in the synbiotic group after engraftment. Synbiotic infections, including bacteremia, were not observed. Conclusion Synbiotics may reduce gastrointestinal toxicity, thereby reducing nutritional problems and improving the quality of life of patients undergoing auto-HSCT, without severe adverse events.
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8.
Feasibility of a Hospital-at-Home Program for Autologous Hematopoietic Stem Cell Transplantation
González-Barrera, S., Martín-Sánchez, G., Parra-Jordán, J. J., Fernández-Luis, S., Calvo, J. A., Lobeira, R., Yañez, L., Manzano, A., Carrera, C., Baro, J., et al
Transplantation and cellular therapy. 2023;29(2):111.e1-111.e7
Abstract
The Hospital at Home (HaH) model has been positioned as an appropriate therapeutic strategy for selected patients undergoing autologous hematopoietic stem cell transplantation (ASCT). This care model provides hospital-equivalent care, in terms of both quality and quantity, with medical and nursing staff that go to the patient's home. Here we describe our experience with a full HaH model for patients undergoing ASCT during the phase of aplasia. The patients met the eligibility criteria between January 1997 and December 2019 and were discharged from the hospital and admitted into the HaH-ASCT program on the same day they in which hematopoietic stem cells were infused. A total of 84 patients were included. The median patient age was 54 years (range, 16 to 74 years), and the median duration of participation in the HaH program was 17 days (range, 3 to 86 days). Only 10 of these patients (12%) required hospital readmission to the hematology department, 9 of them due to sepsis and 1 because of family care support claudication. Seventy-two patients (86%) experienced an episode of neutropenic fever during the HAH admission, with a median duration of 2 days (interquartile range [IQR], 1 to 11 days); all were treated with empiric i.v. antimicrobial therapy. Most patients (88%) presented with mucositis (44% with grade 3-4). Parenteral nutrition was administered in 26% of patients for a median of 6 days (IQR, 1 to 12 days). Most patients (94%) required at least 1 blood product transfusion at home. There was no transplantation-related mortality during the HaH-ASCT program or in the patients who were readmitted. With careful selection of patients and a comprehensive and well- experienced multidisciplinary team (doctors, nurses, and auxiliary nurses) in the HaH department and in close collaboration with the hematology department, complete at-home management of ASCT recipients immediately after transplantation is possible. This allows patients undergoing an aggressive procedure such as ASCT to remain in their own familiar environment, providing a better quality of life with a program that has demonstrated to be effective and safe, with a low incidence of complications and no associated mortality.
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9.
A phase II trial of netupitant/palonosetron for prevention of chemotherapy-induced nausea/vomiting in patients receiving BEAM prior to hematopoietic cell transplantation
Bubalo, J. S., Radke, J. L., Bensch, K. G., Chen, A. I., Misra, S., Maziarz, R. T.
Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners. 2023;:10781552231173863
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Full text
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Editor's Choice
Abstract
Objective: The purpose of this study was to investigate the efficacy and safety of netupitant/palonosetron (NEPA) for the prevention of chemotherapy-induced nausea and vomiting (CINV) for hematopoietic cell transplantation (HCT) patients receiving BEAM therapy. Study Design: This phase II, prospective, intention-to-treat, single-center, single-arm study involved 43 adult patients who received NEPA and dexamethasone for the prevention of CINV due to BEAM conditioning chemotherapy. An interim analysis, performed after 13 patients, determined utility versus futility, and supported continuation to full enrollment. Descriptive statistics were used to report complete response (CR), complete protection, incidence of emesis, and administration of rescue agents. A Kaplan-Meier curve depicted time to first emesis and first rescue medication. Patients self-reported levels of daily nausea descriptively via a CINV Questionnaire. Results: By study end, 13 of 43 patients achieved a CR with an average of 10.6 emesis-free days (SD 0.95) over the 11-day observation period, with no emetic events in any patient during the acute/chemotherapy phase. Nausea was well-controlled throughout the acute therapy phase (Day 1-6) and increased during the delayed phase (Day 7-11) with a peak mean level of 2.79/10 at Day 10. Aside from lower grade (≤2), headaches, constipation, and diarrhea were the most widely reported adverse effects. Conclusion: The combination of NEPA and dexamethasone is safe and effective for the prevention of CINV in patients receiving BEAM conditioning therapy prior to HCT. The regimen demonstrated greater effectiveness in the acute phase versus the delayed phase, with low levels of nausea throughout the study period and complete emesis prevention during chemotherapy.
PICO Summary
Population
Adults from a single centre in USA undergoing BEAM conditioning chemotherapy before transplant (n=43)
Intervention
Netupitant/palonosetron (NEPA) and dexamethasone for the prevention of chemotherapy induced nausea and vomiting (CINV)
Comparison
None
Outcome
By study end, 13 of 43 patients achieved a CR with an average of 10.6 emesis-free days (SD 0.95) over the 11-day observation period, with no emetic events in any patient during the acute/chemotherapy phase. Nausea was well-controlled throughout the acute therapy phase (Day 1-6) and increased during the delayed phase (Day 7-11) with a peak mean level of 2.79/10 at Day 10. Aside from lower grade (≤2), headaches, constipation, and diarrhea were the most widely reported adverse effects.
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10.
The impact of anticipatory care on the therapeutic effectiveness and quality of life of lymphoma patients undergoing autologous hematopoietic stem cell transplantation
Ma, Y., Wei, F., Wang, A.
Minerva pediatrics. 2023