Autologous hematopoietic progenitor cell transplantation for multiple myeloma through an outpatient program

Martino, Massimo; Montanari, Mauro; Bruno, Benedetto; Console, Giuseppe; Irrera, Giuseppe; Messina, Giuseppe; Offidani, Massimo; Scortechini, Ilaria; Moscato, Tiziana; Fedele, Roberta; Milone, Giuseppe; Castagna, Luca; Olivieri, Attilio

doi:10.1517/14712598.2012.707185

Cited by 20 publications

(20 citation statements)

References 96 publications

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“…Patients undergoing ASCT are usually admitted to bone marrow transplantation units on a "whole inpatient program," where central venous catheter (CVC) insertion, HDC administration, hematopoietic progenitor cell (HPC) infusion, and supportive care during neutropenia are carried out in positive-pressure reverse isolation rooms, with a hospital stay of approximately 3 to 4 weeks [15][16][17]. The growing demand for ASCT significantly increases waiting lists and generates concerns about the appropriate use of health care resources.…”

Section: Introductionmentioning

confidence: 99%

“…The growing demand for ASCT significantly increases waiting lists and generates concerns about the appropriate use of health care resources. Over the past years, a number of studies have investigated safety, efficacy, and potential cost advantages of outpatient programs to reduce hospital stays after ASCT in both hematological and nonhematological diseases [17]. The early-discharge outpatient model (EDOM) is 1 of the most common approaches.…”

Section: Introductionmentioning

confidence: 99%

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Very Low Rate of Readmission after an Early Discharge Outpatient Model for Autografting in Multiple Myeloma Patients: An Italian Multicenter Retrospective Study

Martino¹,

Montanari

Ferrara

et al. 2014

Biology of Blood and Marrow Transplantation

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We analyzed the main modalities and clinical outcomes of the early discharge outpatient model in autologous stem cell transplantation (EDOM-ASCT) for multiple myeloma in Italy. EDOM-ASCT was employed in 382 patients, for a total of 522 procedures, between 1998 and 2012. Our study showed high homogeneity among centers in terms of inclusion criteria, supportive care, and in hospital readmission criteria. Overall, readmissions during the aplastic phase occurred in 98 of 522 transplantations (18.8%). The major extrahematological complication was neutropenic fever in 161 cases (30.8%), which required readmission in 76 cases. The incidence of severe World Health Organization grade 3 to 4 mucositis was 9.6%. By univariate analysis, fever, mucositis, altered renal function at diagnosis, second transplantation, and transplantation performed late in the course of the disease were significantly correlated with readmission, whereas fever, mucositis, altered renal function, and timing of transplantation remained the only independent predictors by multivariate analysis. Overall, transplantation-related mortality was 1.0%. No center effect was observed in this study (P = .36). The safety and low rate of readmission of the EDOM-ASCT in myeloma trial suggest that this strategy could be extended to other transplantation centers if a stringent patient selection and appropriate management are applied.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Very Low Rate of Readmission after an Early Discharge Outpatient Model for Autografting in Multiple Myeloma Patients: An Italian Multicenter Retrospective Study

Martino¹,

Montanari

Ferrara

et al. 2014

Biology of Blood and Marrow Transplantation

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“…5,6 Elderly patients may not be good candidates for outpatient ASCT due to their reduced medical fitness and presence of comorbidities. 10 Is the ASCT outpatient model safe as the conventional inpatient ASCT model in MM patients? Reported early morbidity and early mortality rates (TRM at day +100) after conventional inpatient ASCT in younger patients were evaluated.…”

Section: Background Questionsmentioning

confidence: 99%

“…Two outpatient ASCT models are employed in the GITMO network: the EDOM and delayed admission model (DAM). 53 In the EDOM model, 10,23,26 the most commonly used in Italy, patients and caregivers should carefully trained on home behavior and a detailed information sheet on the management of mild/moderate mucositis, fever or mucosal bleeding should be provided for the general practitioner. In the delayed admission model, discharge is scheduled on day 1 and re-admission on day 5 post-HSC infusion.…”

Section: Hdc Administration Hpc Infusionmentioning

confidence: 99%

“…7-9 The significant increase in the waiting lists generated concerns about the appropriate use of health care resources and, over the past years, some studies have investigated the safety, efficacy and potential cost advantages of reducing hospital stay for patients undergoing ASCT. [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] The ease of administering HDM, the relatively low extra-hematological toxicity and the short period of neutropenia 5,6 make MM patients ideal candidates for outpatient ASCT programs. Standardization of criteria for the outpatient ASCT policy is a relevant goal of the Italian hematology and transplant community and may facilitate comparison of retrospective and prospective data.…”

Section: Introductionmentioning

confidence: 99%

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Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Martino¹,

Lemoli

Girmenia

et al. 2016

Bone Marrow Transplant

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Multiple myeloma (MM) is the leading indication for autologous stem cell transplantation (ASCT) worldwide. The safety and efficacy of reducing hospital stay for MM patients undergoing ASCT have been widely explored, and different outpatient models have been proposed. However, there is no agreement on the criteria for selecting patients eligible for this strategy as well as the standards for their clinical management. On the basis of this rationale, the Italian Group for Stem Cell Transplantation (GITMO) endorsed a project to develop guidelines for the management of outpatient ASCT in MM, using evidence-based knowledge and consensus-formation techniques. An expert panel convened to discuss the currently available data on the practice of outpatient ASCT management and formulated recommendations according to the supporting evidence. Evidence gaps were filled with consensus-based statements. Three main topics were addressed: (1) the identification of criteria for selecting MM patients eligible for outpatient ASCT management; (2) the definition of standard procedures for performing outpatient ASCT (model, supportive care and monitoring during the aplastic phase); (3) the definition of the standard criteria and procedures for re-hospitalization during the aplastic phase at home. Herein, we report the summary and the results of the discussion and the consensus. INTRODUCTIONMultiple myeloma (MM) remains the leading indication for highdose chemotherapy and autologous stem cell transplantation (ASCT) worldwide 1,2 and the International Guidelines recommend that ASCT should be offered at some point during the treatment program for a medically fit patient. 3,4 High-dose melphalan (HDM) at 200 mg/m 2 is the standard conditioning for ASCT 5,6 and, today, the treatment should be considered a safe procedure with a very low transplant-related mortality (TRM). 7-9 The significant increase in the waiting lists generated concerns about the appropriate use of health care resources and, over the past years, some studies have investigated the safety, efficacy and potential cost advantages of reducing hospital stay for patients undergoing ASCT. [10][11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] The ease of administering HDM, the relatively low extra-hematological toxicity and the short period of neutropenia 5,6 make MM patients ideal candidates for outpatient ASCT programs. Standardization of criteria for the outpatient ASCT policy is a relevant goal of the Italian hematology and transplant community and may facilitate comparison of retrospective and prospective data. The Italian Group for Stem Cell Transplantation (GITMO) endorsed a panel of 10 experts in the transplant field (MMa, RML, CG, LC, BB, MO, IL, MMo, GM and AO) to propose a consensus for the selection criteria and management of MM patients for ASCT procedure in the outpatient setting. METHODSA working group of 10 experts from 7 GITMO centers, with specific expertise in the field of ASCT, convened four times to: (a) identify common criteria for selecti...

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Resource Utilization and Safety of Outpatient Management Following Intensive Induction or Salvage Chemotherapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

et al. 2015

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Importance Adults with acute myeloid leukemia (AML) typically remain hospitalized after induction or salvage chemotherapy until blood count recovery, with resulting prolonged inpatient stays being a primary driver of healthcare cost. Pilot studies suggest that outpatient management following chemotherapy might be safe and could reduce cost for these patients. Objective To compare safety, resource utilization, infections and cost between adults discharged early following AML induction or salvage chemotherapy and inpatient controls. Design Non-randomized phase 2 study. Setting Single center study conducted at the University of Washington Medical Center in Seattle, WA. Participants Over a 43-month period (January 1, 2011 – July 31, 2014), 178 adults receiving intensive AML chemotherapy were enrolled. After completion of chemotherapy, 107 met pre-designated medical and logistical criteria for early discharge (ED), while 29 met medical criteria only and served as inpatient controls. Interventions for Clinical Trials ED patients were discharged from the hospital at the completion of chemotherapy, and supportive care was provided in the outpatient setting until count recovery (median 21 days, range 2–45 days). Controls received inpatient supportive care (median 16 days, range 3–42 days). Main Outcome Measures 1) differences in early mortality 2) differences in resource utilization (ICU days, transfusions/study-day and IV antibiotics/study-day) 3) numbers of infections and 3) total and inpatient charges/study-day between early discharge patients and controls. Results Four patients discharged early (4%) but no controls died within 30 days of enrollment (p=0.58). Nine patients discharged early (8%) but no controls required intensive care unit-level care (p=0.20). No differences were noted in the average daily number of red blood cell (p=0.55) or platelet (p=0.31) transfusions. Patients discharged early did have more positive blood cultures (p=0.04) but required fewer days of IV antibiotics (p=0.007). Overall, daily charges among discharged patients were significantly lower (median $3,840 vs. $5,852; p<0.001) despite increased charges per inpatient day when readmitted (median $7,405 vs. $6,267; p<0.001). Conclusions and Relevance Early dischargefollowing intensive AML chemotherapy can reduce cost and use of IV antibiotics, but attention should be paid to complications that may occur in the outpatient setting. This study was registered at www.ClinicalTrials.gov (NCT01235572).

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Autologous hematopoietic progenitor cell transplantation for multiple myeloma through an outpatient program

Cited by 20 publications

References 96 publications

Very Low Rate of Readmission after an Early Discharge Outpatient Model for Autografting in Multiple Myeloma Patients: An Italian Multicenter Retrospective Study

Very Low Rate of Readmission after an Early Discharge Outpatient Model for Autografting in Multiple Myeloma Patients: An Italian Multicenter Retrospective Study

Italian consensus conference for the outpatient autologous stem cell transplantation management in multiple myeloma

Resource Utilization and Safety of Outpatient Management Following Intensive Induction or Salvage Chemotherapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

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