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Determining eligibility for autologous hematopoietic cell transplantation

Determining eligibility for autologous hematopoietic cell transplantation
Literature review current through: Jan 2024.
This topic last updated: Mar 07, 2022.

INTRODUCTION — Autologous hematopoietic cell transplantation (HCT) refers to the use of a patient's own hematopoietic cells to reconstitute the bone marrow following treatment for cancer with intensive chemotherapy and/or radiation therapy. Autologous HCT contrasts with allogeneic HCT, in which hematopoiesis is restored using hematopoietic cells from another individual (eg, a sibling, volunteer donor, other relative, or umbilical cord blood).

For suitable patients, the decision to proceed with autologous HCT must be individualized according to the potential benefits versus adverse effects and should consider comorbid conditions, status of the underlying disease, alternative therapeutic approaches, and individual needs and wishes.

This topic will discuss eligibility for autologous HCT.

Indications for autologous HCT, risks, benefits, and outcomes vary according to the underlying disease and include:

Multiple myeloma – (See "Multiple myeloma: Use of hematopoietic cell transplantation".)

Hodgkin lymphoma – (See "Hematopoietic cell transplantation in classic Hodgkin lymphoma".)

Diffuse large B cell lymphoma – (See "Diffuse large B cell lymphoma (DLBCL): Suspected first relapse or refractory disease in patients who are medically fit".)

Follicular lymphoma – (See "Autologous hematopoietic cell transplantation in follicular lymphoma".)

Peripheral T cell lymphoma – (See "Treatment of extranodal NK/T cell lymphoma, nasal type", section on 'Hematopoietic cell transplantation' and "Initial treatment of peripheral T cell lymphoma", section on 'Autologous HCT'.)

Mantle cell lymphoma – (See "Mantle cell lymphoma: Initial management", section on 'Autologous transplantation'.)

Acute myeloid leukemia – (See "Acute myeloid leukemia in adults: Overview", section on 'Hematopoietic cell transplantation'.)

Amyloidosis – (See "Treatment and prognosis of immunoglobulin light chain (AL) amyloidosis".)

Waldenström macroglobulinemia – (See "Treatment and prognosis of Waldenström macroglobulinemia", section on 'Hematopoietic cell transplantation'.)

Testicular germ cell cancer – (See "Diagnosis and treatment of relapsed and refractory testicular germ cell tumors".)  

Management of the patient following transplantation and eligibility for allogeneic HCT are discussed separately. (See "Early complications of hematopoietic cell transplantation" and "Long-term care of the adult hematopoietic cell transplantation survivor" and "Determining eligibility for allogeneic hematopoietic cell transplantation".)

PRETRANSPLANT EVALUATION — Evaluation prior to autologous HCT should assess comorbid conditions that may affect adverse effects and outcomes and the status of the underlying cancer. Our approach to pretransplant evaluation (table 1) follows:

Clinical evaluation

History should evaluate comorbid illnesses, current and prior infections, medications (to identify drugs that might interact with the conditioning regimen), drug allergies, alcohol and drug use disorder, psychological history, and the status of the underlying disease, including prior treatments.

Physical examination should assess findings related to comorbid conditions and the underlying malignancy. The oral cavity should be examined for abscesses or tooth decay that could be a focus for infection, and neurologic examination should seek evidence of involvement of the central nervous system (CNS) by the underlying cancer.

Body mass index (BMI) (calculator 1) should be calculated. Obesity is not a contraindication to transplantation, but it may affect dosing for the conditioning regimen and other medications. (See 'Weight, nutrition, alcohol use' below.)

Laboratory studies

Complete blood count (CBC) with differential.

Prothrombin time (PT)/internationalized normalized ratio (INR), partial thromboplastin time (PTT).

Serum electrolytes, glucose, and liver and renal function studies.

Urine analysis, including microscopic evaluation; 24-hour urine collection for the measurement of creatinine clearance should be performed, if clinically indicated.

Pregnancy test, if appropriate.

Other testing

Infectious diseases – Screening for infectious diseases (table 2) is important for defining infection control policies and post-transplantation antimicrobial prophylaxis and treatments, as discussed separately. (See "Evaluation for infection before hematopoietic cell transplantation".)

Cardiac

Electrocardiogram (EKG), including assessment of QTc interval.

Echocardiogram or radionuclide ventriculogram (RVG or MUGA) to assess cardiac ejection fraction. (See "Tests to evaluate left ventricular systolic function".)

Pulmonary

Chest radiograph.

Pulmonary function testing, including spirometry, total lung capacity, and diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for level of hemoglobin). (See "Overview of pulmonary function testing in adults".)

Liver disease – Imaging and/or biopsy, as clinically indicated by clinical and laboratory findings.

Bone marrow – Bone marrow aspiration and biopsy to assess involvement by the underlying disease and for findings of myelodysplastic syndrome (MDS).

Central nervous system – Patients with findings on neurological examination or at high risk for CNS involvement should be evaluated for meningeal involvement with imaging and lumbar puncture.

Restaging studies — Restaging with laboratory testing and imaging for the underlying cancer is performed prior to transplantation, as guided by the underlying malignancy.

Other evaluation/counseling

Psychosocial evaluation – Psychosocial evaluation should include the patient's usual responsibilities and dependents, financial resources, assessment of high-risk behaviors, and medication adherence.

Counseling – Smokers should be advised to quit smoking and attempt to mitigate other cardiac risk factors (eg, obesity, hyperlipidemia, hypertension, hyperglycemia) prior to the procedure.  

Nutrition – Patients with obesity or those who are malnourished should be referred for nutritional counseling prior to transplantation.

Fertility – Counseling and/or fertility preservation, as appropriate. (See "Fertility and reproductive hormone preservation: Overview of care prior to gonadotoxic therapy or surgery".)

Advance care planning (ACP), including living will, power of attorney for health care, and life-support instructions (eg, resuscitation or mechanical ventilation) should be discussed and completed prior to transplantation to ensure that care is consistent with the patient's values and preferences. (See "Advance care planning and advance directives".)

FUNCTIONAL STATUS AND COMORBID ILLNESSES — Performance status (PS) should be assessed using either the Eastern Cooperative Oncology Group (ECOG) scale or Karnofsky Performance Status (table 3). PS criteria for transplant-eligibility are presented below. (See 'Performance status' below.)

Comorbid illnesses are usually assessed using the HCT comorbidity index (HCT-CI) (table 4), but the preferred instrument may vary between institutions. It is unclear if any comorbidity index is more effective or predictive of outcomes than PS in the setting of autologous HCT [1-3].

ELIGIBILITY CRITERIA — Eligibility for autologous HCT should incorporate functional status, organ function, comorbid conditions, psychosocial issues, and disease status (table 5), but eligibility criteria vary between institutions.

A decision to proceed with transplantation for eligible patients must be individualized and should weigh risks, benefits, and alternative therapeutic approaches.

Age — Eligibility for autologous transplantation is determined by functional capacity ("physiologic age"); it is not determined by chronological age, per se.

Age limits for autologous HCT vary between institutions, but age should not be a barrier to autologous HCT, as transplantation can both prolong survival and improve the quality of life (QoL) for suitable older adults. However, insurers or national policy may set upper age limits for transplantation.

Autologous HCT can be safe and efficacious in older adults with chemotherapy-sensitive non-Hodgkin lymphoma (NHL) [4-11]. As an example, nonrelapse mortality (NRM) was 1 percent at one year, median progression-free survival (PFS) was 56 months, and median overall survival (OS) was not reached among 90 patients (median age, 63 years) with median follow-up >4 years [5]. In a retrospective, single institution study of 59 older patients with NHL (median age, 64 years), autologous HCT was also associated with improved QoL, including physical, social, and emotional well-being [4]. (See "Diffuse large B cell lymphoma (DLBCL): Suspected first relapse or refractory disease in patients who are medically fit", section on 'Autologous hematopoietic cell transplantation'.)

A registry study reported that, compared with younger patients, more than 2000 patients ≥70 years had similar outcomes after autologous HCT for multiple myeloma (MM) [12]. Although more than half of the older patients received reduced-dose conditioning therapy (melphalan 140 mg/m2, rather than 200 mg/m2), multivariate analysis reported no difference between the age cohorts in OS, two-year PFS, or day 100 NRM. (See "Multiple myeloma: Use of hematopoietic cell transplantation", section on 'Older adults'.)

For details on toxicity outcome in other diseases with autologous HCT, see their disease-specific topics.

Performance status — Most institutions require the following levels of performance status (table 3) for transplant eligibility:

Eastern Cooperative Oncology Group (ECOG) performance status: ≤2

Karnofsky Performance Status: ≥60

Some centers also use the HCT comorbidity index (HCT-CI) (table 4) or another instrument for assessing comorbid conditions, but eligibility criteria vary between institutions. It is unclear if any comorbidity index is more effective or predictive of outcomes than performance status in the setting of autologous HCT [1,2,13].

Organ function

Heart — Eligibility for autologous HCT generally includes New York Heart Association (NYHA) class I or class II (table 6), left ventricular ejection fraction (LVEF) ≥40 percent, and no uncontrolled coronary artery disease or uncontrolled arrhythmias; however, the acceptable degree of cardiac dysfunction may vary with the underlying disease and conditioning regimen.

For all patients, we attempt to mitigate cardiac risk factors (eg, smoking, obesity, hyperlipidemia, hypertension, hyperglycemia) prior to the procedure.

Conditioning regimen – For patients who will receive BEAM (BCNU, etoposide, cytarabine, melphalan) conditioning, LVEF ≥40 percent is acceptable. However, for regimens with known cardiac toxicity (eg, cyclophosphamide-based) or total body irradiation (TBI)-based conditioning, we generally restrict autologous HCT to patients with LVEF ≥50 percent.

Underlying disease – We generally do not offer autologous HCT to patients with amyloidosis who have uncompensated heart failure or an LVEF <40 percent because transplantation is associated with reduced survival compared with those without cardiac involvement [14]. Eligibility for transplantation in patients with amyloidosis is discussed separately. (See "Treatment and prognosis of immunoglobulin light chain (AL) amyloidosis", section on 'Determining transplant eligibility'.)

Lungs — Eligibility for autologous HCT is ≥50 percent DLCO (corrected diffusing capacity of the lungs for carbon monoxide), but the acceptable degree of pulmonary dysfunction may vary with the underlying disease. Smokers should be advised to quit smoking during pretransplant counseling sessions.

The optimal threshold for pulmonary function is not well-defined, but the level of ≥50 percent DLCO is based on eligibility criteria for trials and cohort studies that reported inferior survival and higher risk for respiratory failure among patients with previous abnormal pulmonary function [15,16]. However, the threshold may vary with the chosen conditioning regimen and underlying disease. For lymphomas, DLCO ≥50 percent is required if using BEAM or a TBI-based regimen because of potential associated pulmonary toxicity. (See "Preparative regimens for hematopoietic cell transplantation".)

Approximately 3 percent of patients who undergo autologous HCT will have severe pulmonary complications requiring mechanical ventilation; patients with pre-existent pulmonary dysfunction appear to have more pulmonary complications [17].

Kidneys — For most malignancies, eligibility for autologous HCT generally requires serum creatinine <2 mg/dL (177 micromol/L) or creatinine clearance (CrCL) >50 mL/min; MM and amyloidosis are notable exceptions to these criteria.

Severe renal dysfunction, including dialysis-dependence, is not necessarily a contraindication to autologous HCT for MM or amyloidosis, as discussed separately. (See "Multiple myeloma: Use of hematopoietic cell transplantation", section on 'Patients with kidney impairment' and "Clinical presentation, laboratory manifestations, and diagnosis of immunoglobulin light chain (AL) amyloidosis".)

Liver — Many patients with hematological malignances have liver function test (LFT) abnormalities in association with hepatitis, alcohol overuse, hepatic steatosis, transfusion-associated iron overload, and other causes. Patients with abnormal LFTs should be evaluated for the etiology, ideally in consultation with a hepatologist.

Cirrhosis is a contraindication to autologous HCT because of excess morbidity and mortality associated with hepatic sinusoidal obstruction syndrome (also called veno-occlusive disease). (See "Hepatic sinusoidal obstruction syndrome (veno-occlusive disease) in adults".)

Infections — There should be no uncontrolled active infections. The patient should be tested for infection with SARS-CoV-2, HIV, and viral hepatitis. (See "COVID-19: Considerations in patients with cancer".)

Seropositivity for HIV, hepatitis B, or hepatitis C should not exclude patients from undergoing autologous HCT (unless they have cirrhosis due to viral hepatitis), but this does affect transplant care [18,19]. Patients who are seropositive for hepatitis B or hepatitis C are at increased risk of viral reactivation after transplant, even if the infection appears to be resolved; they should undergo further evaluation regarding the status of the infection, ideally in consultation with an infectious disease expert. (See "HIV-related lymphomas: Treatment of systemic lymphoma", section on 'Autologous HCT' and "Hepatitis B virus reactivation associated with immunosuppressive therapy".)

Central nervous system — Secondary involvement of the central nervous system (CNS) is not a contraindication to autologous HCT in a patient with an underlying disease that is otherwise chemotherapy-sensitive. Patients with meningeal involvement usually require CNS-directed treatment (eg, chemotherapy and/or cranial radiation) prior to transplantation; the preferred approach to CNS involvement is discussed with the specific underlying disease.

Hematology/blood product support — There should be no evidence of myelodysplasia on bone marrow examination.

Virtually all patients who undergo autologous HCT require blood product support (eg, red blood cell and platelet transfusions) until the transplanted cells engraft sufficiently to support hematopoiesis (eg, 10 to 14 days).

Some clinicians are hesitant to offer transplant to individuals who decline transfusions (eg, Jehovah's Witnesses), but autologous HCT has been successfully performed without transfusion support. For patients who decline transfusions, hematologic status should be optimized prior to transplantation and bleeding minimized during and after the procedure. Useful techniques for avoidance of blood product support may include:

Prior to HCT:

Priming with intravenous iron and erythropoietin to increase pretransplant hemoglobin

Preference for hematopoietic growth factor mobilization over chemotherapy-based mobilization to minimize cytopenia

Delay of transplant after apheresis until hemoglobin ≥11 g/dL and platelets ≥100 x 103/microL, if possible

Menses cessation in menstruating women (see "Hormonal contraception for menstrual suppression", section on 'Common indications')

During/after HCT:

Minimize unnecessary phlebotomy; use pediatric tubes, when possible

Minimize gastrointestinal blood loss (eg, proton pump inhibitors, stool softeners)

Mechanical thromboembolism prophylaxis, rather than heparin-based prophylaxis

Use of hematopoietic growth factors, erythropoiesis-stimulating agents, aminocaproic acid, vitamin K

Additional aspects of management of the patient who declines transfusion are discussed separately. (See "Approach to the patient who declines blood transfusion".)

In a single-center report of autologous HCT in 125 Jehovah's Witnesses, 100-day mortality was 8 percent [20]. There were 2 major and 15 minor bleeds, all in patients with platelets <5000/microL; 32 percent had cardiac complications (eg, arrhythmias, congestive heart failure), which were more common in those with pre-existing cardiac risk factors.

Psychosocial and economic issues — Autologous HCT eligibility requires that psychiatric illnesses be well-controlled, there is no active use of illicit drugs, and there will be a safe post-transplantation environment.

Prior to transplantation, the individual's usual activities, housing, professional and personal responsibilities, and dependents should be evaluated in the context of psychosocial and financial resources and supports. (See 'Other evaluation/counseling' above.)

Some transplant centers require that the patient have or hire a full-time caregiver during the peri-transplant period, and this may be cost prohibitive. People who are experiencing homelessness may have greater infectious risk because they may be less able to limit contact with others while immunocompromised or they may be less able to receive uninterrupted post-transplantation care. Individuals who live a great distance from the transplant center may have transportation or financial barriers to follow-up care.

There is no association between transplantation outcomes and socioeconomic status or race/ethnicity, but there are disparities in the use of autologous HCT among various racial or ethnic groups [21-26]. As an example, registry data from patients with MM demonstrated that five years after transplantation, compared with White patients, Black patients had similar rates of OS, PFS, and NRM [21]. In another study, there was no association between outcomes after autologous HCT and socioeconomic status in patients with MM [27]. However, rates of transplantation are lower among Black patients and Hispanic patients in the United States, when compared with White patients; health insurance coverage, educational status, and health literacy may contribute to these disparities [26,28].

Weight, nutrition, alcohol use — There are no eligibility criteria for patient weight or body mass index (BMI); obesity should not exclude patients from undergoing autologous HCT. In most centers, patients are dosed according to actual weight, but doses may be adjusted for patients with a very high BMI. To optimize nutritional status, patients with obesity, anorexia, cachexia, or malnutrition should be evaluated by a nutritionist or dietician before undergoing HCT. (See 'Other evaluation/counseling' above.)

In a registry study of >1900 patients who underwent autologous HCT for lymphoma or MM, more than three-quarters of patients received dose-adjusted therapy, but this did not affect the mortality rate [29]. In another registry study of 1087 patients who underwent autologous HCT with high-dose melphalan for MM, outcomes (ie, OS, PFS, disease progression, NRM) did not correlate with classification as having normal BMI, overweight, obese, or severely obese, even though obese patients received a reduced dose of melphalan conditioning [30]. In a study of 80 patients who underwent autologous HCT with BEAM conditioning for relapsed or refractory diffuse large B cell lymphoma, those who received >3.6 mg/kg of melphalan had similar rates of survival and relapse, but they were more likely to have grade ≥3 mucositis (45 versus 10 percent) and prolonged hospitalization (median 13 versus 7 days) [31].

Alcohol use disorder may affect transplantation outcomes. A history of alcohol use disorder was considered along with age >50 years and HCT comorbidity index (HCT-CI) ≥3 as risk factors in 754 patients with lymphoma who were transplanted between 2000 to 2010 [3]. Patients with zero risk factors (21 percent of patients), one risk factor (48 percent), two risk factors (27 percent), and three risk factors (4 percent) had 68, 56, 43, and 42 percent, respectively, rates of five-year OS; rates of NRM at 100 days (a surrogate for treatment-related mortality) were 1, 3, 6, and 27 percent, respectively; and five-year NRM 6, 11, 20, and 30 percent respectively.

SUMMARY

Autologous hematopoietic cell transplantation (HCT) refers to the use of a patient's own hematopoietic cells to reconstitute the bone marrow following treatment for cancer with intensive chemotherapy and/or radiation therapy.

For patients who are eligible for transplantation, the decision to proceed with HCT must be individualized according to the potential benefits versus adverse effects and should consider comorbid conditions, performance status, the extent of the underlying disease, alternative therapeutic approaches, and individual needs and wishes. Some transplant centers require that the patient have or hire a full-time caregiver for the peri-transplant period.

Pretransplant evaluation – Pretransplant evaluation should assess performance status, comorbid conditions, and the status of the underlying cancer.

Our pretransplant evaluation (table 1) includes:

Clinical – The history and physical examination should evaluate performance status, comorbid illnesses, current and prior infections, drug allergies, alcohol and drug use disorder, psychological history, and the status of the underlying disease, including prior treatments. The oral cavity should be examined to identify abscesses or tooth decay (as a potential source for infection) and neurologic examination should seek evidence of involvement of the central nervous system (CNS). (See 'Clinical evaluation' above.)

Body mass index (BMI) (calculator 1) should be calculated.

Laboratory studies – (see 'Laboratory studies' above):

-Complete blood count (CBC) with differential

-Prothrombin time (PT)/internationalized normalized ratio (INR), partial thromboplastin time (PTT)

-Serum electrolytes, glucose, and liver and renal function studies

-Urine analysis (micro and macro). 24-hour urine collection for the measurement of creatinine clearance as clinically indicated

-Pregnancy test, if appropriate

Other testing (see 'Other testing' above):

-Infectious diseases screening (table 2) is important to define infection control policies and post-transplantation antimicrobial prophylaxis and treatments. (See "Evaluation for infection before hematopoietic cell transplantation".)

-Cardiac testing should include an electrocardiogram (EKG) and assessment of cardiac ejection fraction by echocardiogram or radionuclide ventriculogram (RVG or MUGA).

-Pulmonary screening should include a chest radiograph and pulmonary function testing, including corrected diffusing capacity of the lungs for carbon monoxide (DLCO).

-Liver imaging and/or biopsy, if indicated by clinical and laboratory findings.

-Bone marrow aspiration and biopsy to assess for the underlying disease and for changes consistent with myelodysplastic syndrome.

-CNS – Patients with findings on neurologic examination or at high risk for CNS involvement should be evaluated for meningeal involvement with imaging and lumbar puncture.

Restaging laboratory studies and imaging are guided by the underlying malignancy.

Other evaluation and counseling (see 'Other evaluation/counseling' above):

-Psychosocial evaluation – Psychosocial evaluation should include the patient's usual responsibilities and dependents, financial resources, assessment of high-risk behaviors, and medication adherence.

-Counseling – Smokers should be advised to quit smoking, and we attempt to mitigate other cardiac risk factors (eg, obesity, hyperlipidemia, hypertension, hyperglycemia) prior to transplantation [32].

-Nutrition – Patients with obesity or those who are malnourished should be referred for nutritional counseling prior to transplantation.

-Fertility – Fertility counseling and/or preservation, as appropriate. (See "Fertility and reproductive hormone preservation: Overview of care prior to gonadotoxic therapy or surgery".)

-Advance care planning (ACP) – ACP including living will, power of attorney for health care, and life-support instructions should be discussed and completed prior to transplantation to ensure that care is consistent with the patient's values and preferences. (See "Advance care planning and advance directives".)

Functional status – Candidates for autologous transplantation should be assessed for performance status (table 3) and in some cases comorbidity score (table 4).

Eligibility criteria – Eligibility criteria for autologous HCT vary between institutions, but should incorporate functional status, comorbid conditions, and psychosocial supports (table 5) and extent of underlying disease. Our eligibility criteria include:

Age – Eligibility for autologous transplantation is determined by functional capacity (“physiological age”); it is not determined by chronological age, per se. (See 'Age' above.)

Performance status: Eastern Cooperative Oncology Group (ECOG) performance status ≤2 or Karnofsky Performance Status ≥60

Cardiac function – New York Heart Association (NYHA) class I or class II (table 6), left ventricular ejection fraction (LVEF) ≥40 percent, and no uncontrolled coronary artery disease or uncontrolled arrhythmias; the acceptable degree of cardiac dysfunction may vary with the underlying disease and conditioning regimen. (See 'Heart' above.)

For all patients, we attempt to mitigate cardiac risk factors (eg, smoking, obesity, hyperlipidemia, hypertension, hyperglycemia) prior to the procedure.

Pulmonary function – ≥50 percent DLCO (corrected), but the acceptable degree of pulmonary dysfunction may vary with the underlying disease. (See 'Lungs' above.)

Smokers should be advised to quit smoking during pretransplant counseling sessions.

Kidney function – Serum creatinine <2 mg/dL (177 micromol/L) or creatinine clearance (CrCL) >50 mL/min is generally required for malignancies, other than multiple myeloma (MM) and amyloidosis. Severe renal dysfunction, including dialysis-dependence, is not necessarily a contraindication to autologous HCT for MM. (See 'Kidneys' above.)

Liver function – Cirrhosis is a contraindication to autologous HCT because of excess morbidity and mortality associated with hepatic sinusoidal obstruction syndrome (also called veno-occlusive disease). (See "Hepatic sinusoidal obstruction syndrome (veno-occlusive disease) in adults".)  

Other

-Infectious diseases – No unresolved active infections; seropositivity for HIV, hepatitis B, or hepatitis C should not exclude patients from undergoing autologous HCT (unless they have cirrhosis due to viral hepatitis), but this may affect transplant care. (See 'Infections' above.)  

-Hematology – No evidence of myelodysplasia on bone marrow examination. (See 'Hematology/blood product support' above.)

-Psychosocial – Psychiatric illnesses should be well-controlled, there is no active use of illicit drugs, and there will be a safe post-transplantation environment. (See 'Psychosocial and economic issues' above.)

-Weight, nutrition, and alcohol use – Patient weight or body mass index (BMI) are not eligibility criteria for transplantation. Obesity should not exclude patients from undergoing autologous HCT, but it may affect drug dosage and delivery. Alcohol use disorder may contribute to worse outcomes. (See 'Weight, nutrition, alcohol use' above.)

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References

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