Graff, T.M., et al. Safety of outpatient autologous hematopoietic cell transplantation for multiple myeloma and lymphoma. Bone Marrow Transplant, 2015. 50(7):947-53. Abstract.
Background to paper:
High-dose therapy and autologous stem cell transplantation (HDT-SCT) is the standard of care for eligible newly-diagnosed myeloma patients [1, 2]. In general, HDT-SCT means a three to four week hospital stay to manage treatment toxicities and infection risk.
Outpatient autologous transplantation (OPT) may offer practical and psychological benefits to patients and their families but current evidence from studies on the safety and outcomes of OPT is limited by: small sample sizes; variable transplant protocols; a wide range of clinical indications; no inpatient autologous transplantation (IPT) comparison group; and limited data on toxicity. Furthermore, in most studies the outpatient setting was hospital accommodation rather than home [3, 4].
What the paper looked at:
The paper considered the practicality, outcomes and safety of OPT. Data on quality of life and on cost was captured for some patients.
This was a retrospective, single-centre study of 230 patients treated for myeloma (65%) or lymphoma (35%) at a centre in Wisconsin, United States.
All myeloma patients received melphalan-based conditioning. The principal differences between the IPT and OPT cohorts were pre-planned antibiotic prophylaxis and growth factor use (see Table 1.). Antibiotic prophylaxis, given when ANC was < 500/mL, differed due to concern that, in outpatients, a higher rate of sepsis might cause interruption in treatment.
|IPT cohort||OPT cohort|
|Oral ciprofloxacin bd||i.v. ertapenem od|
|Growth factor||Pegfilgrastim od on day one||Filgrastim od until the ANC >500/mL on two consecutive days|
od = once a day, bd = twice a day
The analysis included 95 patients who received HDT-SCT as outpatients and 135 as inpatients. Selection for OPT was based on expected compliance, proximity to the cancer centre, 24 hour caregiver support, and favourable performance status and comorbidity profile.
There were no significant differences in the rate of any specific toxicity between the IPT and OPT groups. Febrile neutropenia and infection were significant toxicities in both groups but there was no significant difference in the rate or type of infections. In particular, there was no significant difference in the incidence of antibiotic sensitive or resistant infections, or in the outcome of such infections.
The rate of unplanned admissions was higher in the OPT group but this was accounted for by admissions in the pre-engraftment period, when all IPT patients were planned inpatients anyway. The number of unplanned OPT admissions decreased significantly over the latter part of the study. Haemopoietic recovery occurred sooner in the OPT patients (ANC 10 vs 11 days, plts 19 vs 20 days). There were no significant differences in non-relapse mortality, progression free survival (PFS) or overall survival (OS) between the two cohorts.
The authors concluded that OPT is safe and can result in favourable outcomes for myeloma patients but this is dependent upon careful patient selection and optimal supportive care. Data from this study suggested that costs are significantly reduced in OPT procedures but cost data was only available for a limited set of patients.
Study weaknesses include the fact that the study was retrospective, non-randomised, and provided limited data on quality of life and costs. Patients included in the OPT group were a selected population which may bias outcomes – specifically, they were younger and fitter than the majority of the IPT group.
Strengths include: sample size; the limited number of clinical indications and regimens; data on toxicities; and the true home or hotel setting for the OPT group.
The planned difference in prophylactic antibiotic use was based on concerns about potential delays in switching to treatment with broad-spectrum antibiotics when required in patients in the OPT group. The incidence, types and outcome of infection in the cohorts were similar. It therefore remains uncertain whether the more aggressive anti-microbial prophylaxis in the OPT group was necessary.
The faster rate of haemopoietic recovery in the OPT group may be due to earlier use of growth factor, type of growth factor , or a combination of these factors. It may also have been influenced by the fact that these patients had better performance status and comorbidity scores and thus were a fitter population.
Myeloma UK Nursing Best Practice Guides: Myelosuppression
- Jackson, G.H., Transplantation in Myeloma, in BSBMT News. 2014, British Society of Blood and Marrow Transplantation: London. p. 5-7.
- Engelhardt, M., et al., European Myeloma Network recommendations on the evaluation and treatment of newly diagnosed patients with multiple myeloma. Haematologica, 2014. 99(2): p. 232-42.
- Ferrara, F., et al., Outpatient-based peripheral blood stem cell transplantation for patients with multiple myeloma. Hematol J, 2004. 5(3): p. 222-6.
- Meisenberg, B.R., et al., Outpatient high-dose chemotherapy with autologous stem-cell rescue for hematologic and nonhematologic malignancies. J Clin Oncol, 1997. 15(1): p. 11-7.
- Ferrara, F., et al., Comparison of fixed dose pegfilgrastim and daily filgrastim after autologous stem cell transplantation in patients with multiple myeloma autografted on a outpatient basis. Hematol Oncol, 2011. 29(3): p. 139-43.