Outpatient Autologous Stem Cell Transplantation Research Articles

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

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.

Safety and Cost-Effectiveness of Outpatient Autologous Stem Cell Transplantation in Patients with Multiple Myeloma

High-dose chemotherapy with autologous stem cell transplantation (ASCT) remains the standard of care for patients with multiple myeloma. Outpatient ASCT can be an attractive option given wait times and costs associated with inpatient procedures. We initiated an outpatient transplantation protocol in 2006. Patients were treated at a university hospital outpatient clinic that was open 5 days a week. The present study investigated safety and cost-effectiveness of the outpatient program. Ninety-one patients underwent ASCT between 2006 and 2010. The majority of patients (77%) had Durie-Salmon stage III disease; 38% had 1 or more comorbidities. Seventy-six patients (84%) were hospitalized during the first 100 days, mainly for febrile neutropenia (n = 71). Overall survival at day 100 was 100%. No patient was admitted to an intensive care unit. Risk factors for prolonged hospitalization (longer than 7 days) were disease stage IIB or higher and age >60 years. The cost savings was $19,522 (Canadian dollars) per patient compared with inpatient ASCT, for an annual savings of approximately $740,000. In summary, outpatient ASCT performed in a weekday clinic for patients with multiple myeloma appears to be safe and cost-effective, but is associated with a relatively high hospitalization rate.

Outpatient versus inpatient autologous stem cell transplantation for malignant hematologic disorders

7042 Background: High-dose chemotherapy with autologous stem cell support is utilized for the treatment of a variety of malignancies including Hodgkin/non-Hodgkins lymphoma and acute leukemias. The aim of this study was to compare the time of engraftment and mortality rate and cost of neutropenic treatment in outpatient versus inpatient autologous stem cell transplantation (SCT). Methods: 9 outpatients (5 HL, 2 NHL, and 2 AML) were compared with 32 inpatients (15 HL, 8 NHL, and 9 AML; for whom the outpatient facilities were not ready) from May 2008 to December 2008. All patients were below 45 yrs; median age for outpatients and inpatients were 26 and 30 years respectively. Also all the patients were in complete remission and without significant organ failure. They received conditioning regimen (CEAM for NHL and HL, busulfan and etoposide for AML) and stem cell infusion in hospital. The day after SCT, outpatient group were discharged and followed by outpatient SCT team, and to be re-hospitalized in case of febrile neutropenia, after sepsis workup and performing chest x-ray, they were received the first dose of antibiotic in hospital and treatment continued in home. Results: For outpatients and inpatients, median time to WBC engraftment was 11 and 12 days (p = 0.03), time to PLT engraftment was 15 and 25 days (p = 0.20), number of transfused single donor PLT was 3 and 4.5 units (p = 0.21), duration of neutropenic fever was 6 and 9 days (p = 0.001), duration of hospitalization (after SCT) 0 and 16 (p < 0.001), respectively. All outpatients are alive and 3 patients from other group died between days +35 and +100 after SCT due to transplantation complications. For inpatient group the cost of drugs, just for neutropenic fever antibiotic therapy was six times than outpatient group. Conclusions: Results show that out-patient autologous SCT in malignant hematologic disorders is feasible and comparable with inpatient protocol. We are waiting for more patients and longer follow-up for future conclusions. No significant financial relationships to disclose.

Outpatient Busulfan (BU)/Cytoxan (CY)/VP-16 and Autologous Stem Cell Transplant (ASCT) for Non-Hodgkin's Lymphoma (NHL) and Hodgkin's Disease (HD): Comprehensive Supportive Care Program Associated with Low Treatment Related Mortality and Hospital Utilization.

Busulfan based ASCT protocols are effective therapy for patients (pt.s) with poor risk NHL and HD. This therapy historically required pt.s to be hospitalized to manage treatment related toxicities until neutrophil engraftment with a median stay in most institutions of 21 days. We have developed a comprehensive outpatient approach for the management of pt.s undergoing ASCT. While potential benefits include decreased hospital utilization and increased patient satisfaction, there is paucity of data regarding its feasibility and safety. We report on treatment related mortality (TRM) and outcome results using a comprehensive outpatient care approach in 169 consecutive patients with NHL and HD transplanted at a single institution between February 1998 and December 2006. Excluding the planned admission for stem cell infusion on Day 0, all other aspects of their management (chemotherapy, supportive care) were to be performed in the outpatient facility. Exceptions to this model occurred for pt.s with circumstances that might compromise the safety of the outpatient management, otherwise this was standard practice. Pt.s were seen daily in the clinic during the first 30 days, unless they were hospitalized. The most common reasons for admission included the development of neutropenic fever or mucositis. One hundred sixty-nine consecutive pt.s with a median age of 54 yr.s (22–73) underwent ASCT for NHL (57 diffuse B-cell large cell (DLC), 53 HD, 17 Mantle Cell (MC), 24 Follicular NHL (FL), 6 ALCL, 3 Burkitts, and 9 other subtypes). The conditioning regimen consisted of dose targeted oral BU (1 mg/kg every 6 hours) on days -8 thru -5, CY 60 mg/kg on days -3 and -2 and VP-16 10 mg/kg days -4, -3 and -2. Autologous peripheral blood stem cells were used for 151 pt.s, bone marrow for 8 pt.s and 10 pt.s received both cell sources. The median CD34+ cell dose was 4.9 × 106/kg. Median time to neutrophil and platelet engraftment was 11 (range 9–34) and 17 (range 0–85) days, respectively. There were no (0%) treatment related deaths in the 169 pt.s during either the first 100 days or 1 year post-transplant. Eight high risk patients (3 DLC, 2 ALCL, 1 Burkitts NHL, 1 HD and 1 FL) died of progressive disease by day 100 (days 52 - 85). Stratifying for disease risk per the CIBMTR criteria, the 3-year Kaplan-Meier overall survival (OS) and progressive-free survival (PFS) for pt.s with DLC NHL in all pt.s (n=57), intermediate risk pt.s (n=24) and low risk pt.s (CR1, n= 9) is 67%, 86% and 100%; and 46%; 60% and 100%, respectively. The 3-year OS and PFS for pt.s with HD with low/intermediate risk (n=24) and high risk (n=29) is 78% and 72%; and 51% and 45%, respectively. The 3-year OS and PFS for patients with MC NHL (low risk n=9, intermediate risk n=6) is 68% and 65%, respectively. The 3-year OS for pt.s with FL is 75%. In summary, outpatient ASCT with expectant inpatient management for treatment related toxicities can be conducted safely in the setting of a comprehensive outpatient treatment program with treatment related mortality outcomes that is at least as comparable, if not superior, to those reported in the literature for conventional inpatient ASCT for similar patient cohorts.

Outpatient autologous hematopoietic stem cell transplantation for patients with relapsed follicular lymphoma

Autologous stem cell transplantation (ASCT) has emerged as a viable option for the treatment of relapsed follicular non-Hodgkin's lymphoma. We report on the outpatient experience of 60 patients who underwent ASCT for this condition. The median age was 51 years (30-65). Pre-transplantation conditioning regimens consisted of either etoposide/melphalan/TBI, CBV or BEAM. Patients participated in this transplant program for a median of 20.5 days (14-78), and 58.4% of the total program days were spent in the outpatient setting. Six patients were well enough to be treated solely as outpatients. Ninety percent of patients required at least one inpatient admission (median 7 days), and 70% of first inpatient transfers occurred within the first week following transplant and always before day +12. There were no predictors for prolonged inpatient stays. Febrile neutropenia and gastrointestinal toxicity were the main reasons for inpatient transfers. No outpatient required an urgent admission to the ICU or died in the outpatient setting. The treatment-related mortality at days 30 and 100 was 0 and 1.7%, respectively. The overall and progression-free survivals at 5 years were 65.7 and 56.1%, respectively. Outpatient ASCT with total body irradiation is feasible, safe, and effective for patients with relapsed follicular lymphoma.

Quality of Life, Quality of Care, and Patient Satisfaction: Perceptions of Patients Undergoing Outpatient Autologous Stem Cell Transplantation

To further expand the limited body of knowledge of the perceptions of quality of life (QOL), quality of care, and patient satisfaction among patients who receive high-dose chemotherapy with an autologous stem cell transplant (ASCT) on an outpatient basis. Descriptive longitudinal. Nine clinical sites associated with a national oncology practice management network in locations across the United States. 36 patients scheduled to receive high-dose chemotherapy with ASCT selected by nonprobability consecutive sampling. Subjects completed the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT) before high-dose chemotherapy, four to six weeks postchemotherapy, and six months postchemotherapy. An independent nurse researcher conducted telephone interviews about the treatment experience, perceptions of quality of care, and satisfaction with care. FACT-BMT data were analyzed using descriptive statistics and multivariate analysis of variance, and qualitative data about perceptions of care were analyzed using Giorgis methodologic reduction. Bivariate associations were made between overall degree of satisfaction with care and QOL as measured by the FACT-BMT. Clinical outcome, QOL, patient satisfaction, and patient perceptions of care quality. Mean FACT-BMT scores were lower one month post-treatment than at baseline and highest six months post-treatment. Subjects with progressive disease reported lower QOL at one and six months post-treatment, noted more complaints, and ranked their satisfaction with care lower than subjects with no evidence of disease. Subjects offered ASCT program improvement recommendations in the areas of communication, information, nursing care, ancillary needs assistance, ancillary agencies, and survivor support. In this study, the QOL of patients undergoing outpatient high-dose chemotherapy with ASCT decreased post-treatment but increased to levels higher than those found at pretreatment by six months. A good clinical outcome following high-dose chemotherapy and ASCT was associated with higher QOL and greater satisfaction with care. Knowledge of the outpatient ASCT experience and its effect on QOL can be used to further refine the content and timing of educational and supportive interventions for patients undergoing ASCT. Information about patients satisfaction with treatment and perceptions of quality of care provides insight about their expectations and perceived needs and can be used to redesign outpatient ASCT programs.