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High-Dose Chemotherapy With Autologous Stem Cell Rescue in the Outpatient Setting

High-Dose Chemotherapy With Autologous Stem Cell Rescue in the Outpatient Setting

ABSTRACT: Intensive outpatient care is rapidly becoming the primary mode of care for selected patients undergoing high-dose chemotherapy with autologous peripheral blood stem cell (PBSC) transplantation. Although the traditional inpatient model of care may still be necessary for high-risk patients, published data suggest that outpatient care is safe and feasible during or after administration of high-dose chemotherapy and autologous PBSC transplant. Blood and marrow transplant (BMT) centers have developed programs to provide more outpatient care under three basic models: an early discharge model, a delayed admission model, and a comprehensive, or total, outpatient model. This review will describe these models of care and address the elements necessary for the development of an outpatient BMT program, including patient selection, staff development, and patient and caregiver education. Available supportive care strategies to facilitate outpatient care will also be highlighted. Clinical outcome data and pharmacoeconomic analyses evaluating various outpatient BMT programs, as well as limited quality-of-life evaluations, will be reviewed. [ONCOLOGY 14(2):171-185, 2000]

Introduction

Advances in the field of blood and marrow
transplantation (BMT) leading to decreased morbidity and mortality
have facilitated a shift in care of the transplant patient from the
hospital to the outpatient clinic. One major factor that has
facilitated this shift is the increased use of peripheral
blood–derived stem cells (PBSCs) instead of bone
marrow–derived stem cells as autologous rescue following
administration of high-dose chemotherapy.[1]

The use of PBSCs is associated with shorter periods of neutropenia
and thrombocytopenia, as well as potentially less severe
regimen-related toxicities.[2-4] In addition, improvements in
supportive care strategies, including antibiotic algorithms for
prophylaxis and treatment, antiemetic regimens, and transfusion
protocols, have allowed patients to be cared for safely in the
outpatient setting.

The potential advantages of outpatient care for BMT patients include
improved patient satisfaction and quality of life by allowing them to
remain in their home environment or in a nearby hotel. In addition,
the elimination of a prolonged hospital stay may potentially decrease
the convalescent period by keeping the patient more active and
responsible during the transplant process.[5] Published data in
cancer patients support these potential advantages of outpatient care
during BMT.[6,7]

Despite the potential impact of outpatient care on quality of life,
thus far, the primary end points evaluated have been safety,
feasibility, and pharmacoeconomics.[8,9] Numerous studies have
documented the safety and feasibility of outpatient care during or
after administration of high-dose chemotherapy with autologous PBSC
rescue.[10-14] In terms of pharmacoeconomics, autologous BMT has
traditionally been an expensive procedure, with historical costs
exceeding $100,000 per patient. Attempts to decrease this cost have
been fueled by the general pressure to decrease health care costs and
the increasing use of global-fee contracts for BMT, in which the
provider assumes the financial risk for all BMT services.[15,16]

Establishment of an outpatient component of care early in the BMT
process requires prudent patient selection, intensive planning and
education, trained staff, and appropriately equipped facilities. This
review will address the logistic requirements and published outcomes
for various outpatient BMT care models.

Models of Outpatient Care

Three models of outpatient care have been described in the literature
and are represented schematically in
Figure 1
.

Early Discharge Model

The first outpatient care model described, the early discharge model,
was implemented by Peters et al at Duke University.[10] In this
program, high-dose chemotherapy is administered on the hospital BMT
unit. After the completion of high-dose chemotherapy and
stabilization of gastrointestinal toxicities, patients are discharged
to the outpatient BMT clinic and followed on a daily basis.

During this period of intensive outpatient visits, patients are
readmitted to the inpatient BMT unit only if they develop such
complications as neutropenic fever, refractory gastrointestinal
toxicities, or other clinical scenarios that cannot be managed in the
outpatient setting.[10] By implementing this approach, Peters et al
reported a reduction in BMT-associated hospital stays from 24.5 to 7 days.

Delayed Admission Model

Another model described less extensively in the literature, but used
in numerous autologous transplant centers, is the delayed admission
model of Weaver et al.[11] In this model, high-dose chemotherapy is
administered in the outpatient setting, and patients are then
admitted to the hospital for supportive care management.

Although the delayed admission approach can decrease the duration of
hospitalization as compared to the traditional inpatient model,
patients generally require 2 weeks of hospitalization during the
supportive care period.[11] For example, although the delayed
admission model is referred to as an outpatient BMT program, Weaver
et al reported that 96% of 80 patients with lymphoma undergoing
autologous transplantation required hospitalization for a median of
14 days.[11]

Total Outpatient Model

Recently, a more extensive approach to outpatient care has been
described, which can be defined as a total, or comprehensive,
outpatient model.[12-14] In this model, both high-dose chemotherapy
administration and supportive care management are conducted in the
outpatient setting, with patients hospitalized for complications that
cannot be managed in the clinic or at home.

Of the three outpatient models, the total outpatient approach is
associated with the shortest duration of hospitalization, but it is
the most labor intensive for the outpatient BMT clinic. The
comprehensive outpatient care model requires extensive coordination
and implementation of resources, often including the establishment of
specialty designated outpatient clinics and home health care programs.

Resources Needed for Outpatient Care

Providing care to the BMT patient in the outpatient setting requires
the availability and establishment of numerous facility and staff
resources. The extent to which certain resources are needed depends
on the established outpatient care model. Essential resources for
every model include a designated outpatient and inpatient care facility.

Most outpatient programs have an equipped outpatient facility that
operates during regular business or extended hours. The mechanisms
used to provide after-hours or weekend care vary among centers,
however. Options implemented include extended clinic hours or direct
admission to the hospital for any complications occurring after
hours.[10] Another option that may minimize hospitalization is the
establishment of a hospital-based outpatient treatment room for
weekend and emergency visits.[14] Provision of after-hours care may
also depend on the level of home health care nursing and infusion
services available.

Specialized Staff

The availability of dedicated, specialized staff is crucial to the
success of an outpatient BMT program. Essential staff members include
inpatient and outpatient BMT-trained nurses, pharmacy services
specializing in high-dose therapy, laboratory and blood-banking
support, medical and surgical consultants, and hematopoietic cell
therapy support services.

In addition to these essential staff members, which are common to all
outpatient models, other personnel have been added or adapted within
various centers based on need and available resources. For example,
the level of home health care involvement among outpatient BMT
programs ranges from minimal to extensive. The model of Peters et al
provides only minimal home health care support and, at one point,
used home health care professionals primarily for ambulatory pump needs.[10]

In contrast, the model of Geller et al integrates BMT-designated home
health care nursing staff into the daily care of the patient.[14] In
this model, the BMT home health care staff consists of inpatient BMT
nurses who rotate weekly. During the home health care week, their
only responsibility is to answer telephone calls, make home visits
for initial assessments and follow-up care, and provide primary
nursing care to patients seen in the weekend outpatient BMT clinic.

Complete integration of home health care into the outpatient BMT
program can expand the comprehensiveness of the program and help
eliminate the need for short hospital stays to initiate intravenous
antibiotics for a first neutropenic febrile episode.[14] However, in
other models with less home health care involvement or prolonged
clinic hours, patients may be admitted to the hospital for evaluation
and initiation of intravenous antibiotics.[10,11]

Outpatient BMT Candidate Selection and Preparation

Before determining the appropriateness of outpatient care, the BMT
candidate first undergoes the routine pre-BMT evaluation to determine
eligibility. This evaluation includes an assessment of clinical
eligibility based on disease restaging, organ function, and
performance status, as well as a psychosocial assessment and
investigation of insurance coverage.

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