Home stem cell transplantation could lower infections, costs
ATLANTA — Patients who received autologous and allogeneic hematopoietic stem cell transplantation in their homes maintained their quality of life and had low rates of infectious complications, according to a small, phase 1 study presented at the ASH Annual Meeting and Exposition.
“Home transplant is a new care model that has the potential to decrease complications, improve quality of life and reduce costs,” Anthony D. Sung, MD, assistant professor of medicine at Duke University School of Medicine, told HemOnc Today. “It is a safe, feasible approach that may improve microbiome and may improve transplant outcomes.”
Patients receiving autologous and allogeneic HSCT typically have inpatient hospitalizations, daily hospital visits or both, posing a variety of challenges such as nosocomial infections, hospital-induced delirium and lifestyle adjustments.
Researchers reasoned that performing HSCTs at home could lower complications and improve quality of life, while reducing hospital costs and resource use.
Patients included in the study lived within 25 miles or a 30-minute drive of a transplant center and underwent a home inspection to assess suitability and safety, defined by the absence of black mold. Eligible patients received pretransplant conditioning at the hospital or day hospital and were discharged home after receiving stem cell infusion.
Keeping trial participants at home for the duration of transplant served as the goal of the study.
“We basically tried to keep patients at home as much as possible,” Sung said. “We allowed a variety of home environments, from double-wide trailers to standard single-family homes. Patients would still receive their chemotherapy and total body radiation in the hospital and [we would] discharge patients home as soon as possible.”
Each morning, nurse practitioners or physician assistants made house calls to conduct assessments, examine patients and draw blood for laboratory studies. These studies were run at the hospital, and each afternoon a nurse returned to the patient’s home to provide home blood transfusions, home IV fluids, electrolytes, antibiotics or other interventions.
If an acute event occurred that could not be safely managed at home — such as first evaluation of febrile neutropenia — patients returned to the hospital or day hospital for further workup and care. Likewise, patients returned to the hospital or day hospital for routine procedures, such as IV methotrexate to prevent graft-versus-host disease, or first blood transfusion to ensure there were no reactions.
The medical team monitored transplant outcomes throughout the patient’s care, and a clinical research nurse or specialist confirmed the outcomes by chart review.
Researchers also collected stool samples to assess changes in the gut microbiome at baseline and weekly for the first 4 weeks, at day 60, day 100 and day 180. Samples underwent 16s rRNA sequencing to identify taxonomic groups of bacteria present in the gut.
Researchers evaluated 22 patients, including 16 who received autologous HSCT (median age, 60 years; range 46-74; 75% men; 88% white) and six who received allogeneic HSCT (median age, 52; range, 34-63; 67% women; 83% white). In both groups, two-thirds or more of patients had a baseline Karnofsky performance status of 70 or 80.
Patients in the allogeneic HSCT group spent 72% of their days entirely at home, and patients in the autologous HSCT group spent 52% of their days at home.
Febrile neutropenia represented the main reason for returning to the hospital (autologous, n = 9; allogeneic, n = 4). Aside from cytomegalovirus reactivation (allogeneic, n = 3), two patients in each group developed bloodstream infections.
The three patients in the allogenic HSCT group who developed GVHD also spent the most time in the hospital prior to day 30 (median, 23 days vs. 11 days).
One treatment-related death of GVHD occurred.
“Our main hypothesis is that by keeping patients at home, we’ll be able to maintain their gut microbiome and decrease these complications,” Sung said.
Overall, patients and their caregivers endorsed the program, noting their quality of life was well-preserved.
“Despite including mostly older adults with suboptimal performance status, patients did quite well at home,” Sung said. “They were able to maintain their quality of life and had low rates of infectious complications. Although patients did have to return to the hospital at various times during transplant, keeping patients out of the hospital for even half the duration of transplant could have tremendous cost savings that would offset the increased staffing and travel required for house calls.”
Researchers noted that studies testing the impact of home HSCT on the gut microbiome are pending. In addition, a randomized phase 2 study of home vs. standard transplant for allogeneic HSCT is in progress, with nine out of a desired 90 patients enrolled.
“Logistics are certainly a challenge, which is why this started out as a phase 1 study of safety and feasibility,” Sung said. “Now that we have shown this to be safe and feasible, we are looking at efficacy with respect to the endpoints. Additionally, we will be studying potential mediators including the effect of the care environment on the microbiome, nutrition, activity, exercise, self-efficacy and caregivers.”– by Chuck Gormley
Sung AD, et al. Abstract 745. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta.
Disclosures: Sung reports research funding from Cellective, Merck and Novartis. Please see the study for all other authors’ relevant financial disclosures.