Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Sections 92-106: hematop

Complete Summary

GUIDELINE TITLE

Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Sections 92-106: hematopoetic cell transplant.

BIBLIOGRAPHIC SOURCE(S)

Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Sections 92-106: hematopoetic cell transplant. Bethesda (MD): Children's Oncology Group; 2006 Mar. 17 p. [84 references]

GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Version 1.2. 2004 Mar.

REGULATORY ALERT

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

July 31, 2008, Erythropoiesis Stimulating Agents (ESAs): Amgen and the U.S. Food and Drug Administration (FDA) informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated.
November 8, 2007 and January 3, 2008 Update, Erythropoiesis Stimulating Agents (ESAs): The U.S. Food and Drug Administration (FDA) notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs) stating serious adverse events, such as tumor growth and shortened survival in patients with advanced cancer and chronic kidney failure.
September 11, 2007, Rocephin (ceftriaxone sodium): Roche informed healthcare professionals about revisions made to the prescribing information for Rocephin to clarify the potential risk associated with concomitant use of Rocephin with calcium or calcium-containing solutions or products.

COMPLETE SUMMARY CONTENT

** REGULATORY ALERT **
SCOPE
METHODOLOGY - including Rating Scheme and Cost Analysis
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS
QUALIFYING STATEMENTS
IMPLEMENTATION OF THE GUIDELINE
INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER

SCOPE

DISEASE/CONDITION(S)

Late effects resulting from hematopoietic cell transplantation, with or without graft versus host disease, to treat pediatric malignancies

Effects include dental, dermatologic, gastrointestinal, immunologic, musculoskeletal, ophthalmologic, and reproductive sequelae and secondary malignancies.

Note: These guidelines are intended for use beginning two or more years following the completion of cancer therapy, and provide a framework for ongoing late effects monitoring in childhood cancer survivors; however, these guidelines are not intended to provide guidance for follow-up of the pediatric cancer survivor's primary disease.

GUIDELINE CATEGORY

Evaluation
Management
Prevention
Screening

CLINICAL SPECIALTY

Allergy and Immunology
Dentistry
Dermatology
Endocrinology
Family Practice
Gastroenterology
Infectious Diseases
Internal Medicine
Obstetrics and Gynecology
Oncology
Ophthalmology
Pediatrics
Pulmonary Medicine
Radiation Oncology

INTENDED USERS

Advanced Practice Nurses
Dentists
Nurses
Physician Assistants
Physicians

GUIDELINE OBJECTIVE(S)

To provide recommendations for screening and management of late effects in survivors of pediatric malignancies
To increase quality of life and decrease complication-related healthcare costs for pediatric cancer survivors by providing standardized and enhanced follow-up care throughout the life-span that (a) promotes healthy lifestyles, (b) provides for ongoing monitoring of health status, (c) facilitates early identification of late effects, and (d) provides timely intervention for late effects

TARGET POPULATION

Asymptomatic survivors of childhood, adolescent, or young adult cancers who were treated with hematopoietic cell transplantation and who present for routine exposure-related medical follow-up

INTERVENTIONS AND PRACTICES CONSIDERED

Thorough history and physical examination, and screening evaluations

MAJOR OUTCOMES CONSIDERED

Not stated

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METHODOLOGY

METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Pertinent information from the published medical literature over the past 20 years (updated as of October 2005) was retrieved and reviewed during the development and updating of these guidelines. For each therapeutic exposure, a complete search was performed via MEDLINE (National Library of Medicine, Bethesda, MD). Keywords included "childhood cancer therapy," "complications," and "late effects," combined with keywords for each therapeutic exposure. References from the bibliographies of selected articles were used to broaden the search.

NUMBER OF SOURCE DOCUMENTS

Not stated

METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

"High-level evidence" (recommendation category 1) was defined as evidence derived from high quality case control or cohort studies.

"Lower-level evidence" (recommendation categories 2A and 2B) was defined as evidence derived from non-analytic studies, case reports, case series, and clinical experience.

METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The guidelines were scored by the multidisciplinary panel of experts using a modified version of the National Criteria: Comprehensive Cancer Network "Categories of Consensus" system. Each score reflects the expert panel's assessment of the strength of data from the literature linking a specific late effect with a therapeutic exposure, coupled with an assessment of the appropriateness of the screening recommendation based on the expert panel's collective clinical experience. "High-level evidence" (category 1) was defined as evidence derived from high quality case control or cohort studies. "Lower-level evidence" (categories 2A and 2B) was defined as evidence derived from non-analytic studies, case reports, case series and clinical experience. Rather than submitting recommendations representing major disagreements, items scored as "Category 3" were either deleted or revised by the panel of experts to provide at least a "Category 2B" score for all recommendations included in the guidelines.

METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

In 2002, the leadership of the Children's Oncology Group Late Effects Committee and Nursing Discipline appointed a 7-member task force, with representation from the Late Effects Committee, Nursing Discipline, and Patient Advocacy Committee. The task force was convened to review and summarize the medical literature and develop a draft of clinical practice guidelines to direct long-term follow-up care for pediatric cancer survivors. The task force followed a modified version of the guideline development process established by the National Comprehensive Cancer Network (NCCN), integrating available literature with expert opinion using reiterative feedback loops.

The original draft went through several iterations within the task force prior to initial review. Multidisciplinary experts in the field, including nurses, physicians (pediatric oncologists and other subspecialists), patient advocates, behavioral specialists, and other healthcare professionals, were then recruited by the task force to provide an extensive, targeted review of the draft, including focused review of selected guideline sections. Revisions were made based on these recommendations. The revised draft was then sent out to additional multidisciplinary experts for further review. A total of 62 individuals participated in the review process. The guidelines subsequently underwent comprehensive review and scoring by a panel of experts in the late effects of pediatric malignancies, comprised of multidisciplinary representatives from the COG Late Effects Committee.

Revisions

In order to keep the guidelines current and clinically meaningful, the COG Late Effects Committee organized 18 multi-disciplinary task forces in March 2004. These task forces were charged with the responsibility for monitoring the medical literature in regard to specific system-related clinical topics relevant to the guidelines (e.g., cardiovascular, neurocognitive, fertility/reproductive), providing periodic reports to the Late Effects Committee, and recommending revisions to the guidelines and their associated health education materials and references (including the addition of therapeutic exposures) as new information became available. Task force members were assigned according to their respective areas of expertise and clinical interest. A list of these task forces and their membership is included in the "Contributors" section of the original guideline document. The revisions incorporated into the current release of these guidelines (Version 2.0 – March 2006) reflect the contributions and recommendations of these task forces.

All revisions proposed by the task forces were evaluated by a panel of experts, and if accepted, assigned a score (see "Rating Scheme for the Strength of the Evidence"). Proposed revisions that were rejected by the expert panel were returned with explanation to the relevant task force chair. If desired, task force chairs were given an opportunity to respond by providing additional justification and resubmitting the rejected task force recommendation(s) for further consideration by the expert panel. A total of 34 sections and 9 Health Links were added to Version 2.0 of these guidelines.

RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Each score relates to the strength of the association of the identified late effect with the specific therapeutic exposure based on current literature, and is coupled with a recommendation for periodic health screening based on the collective clinical experience of the panel of experts. This is due to the fact that there are no randomized clinical trials (and none forthcoming in the foreseeable future) on which to base recommendations for periodic screening evaluations in this population; therefore, the guidelines should not be misconstrued as representing conventional "evidence-based clinical practice guidelines" or "standards of care".

Each item was scored based on the level of evidence currently available to support it. Scores were assigned according to a modified version of the National Comprehensive Cancer Network "Categories of Consensus," as follows:

1 There is uniform consensus of the panel that (1) there is high-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

2A There is uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

2B There is non-uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

3 There is major disagreement that the recommendation is appropriate.

COST ANALYSIS

A formal cost analysis was not performed and published cost analyses were not reviewed.

METHOD OF GUIDELINE VALIDATION

External Peer Review
Internal Peer Review

DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The initial version of the guidelines (Version 1.0 – Children's Oncology Group Late Effects Screening Guidelines) was released to the Children's Oncology Group (COG) membership in March 2003 for a six-month trial period. This allowed for initial feedback from the COG membership, resulting in additional review and revision of the guidelines by the Late Effects Committee prior to public release.

Revisions

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RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Grades of recommendations (1, 2A, 2B, 3) are defined at the end of the "Major Recommendations" field.

Note from the Children's Oncology Group and the National Guideline Clearinghouse (NGC): The Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers (COG LTFU) are organized according to therapeutic exposures; this guideline has been divided into individual summaries. In addition to the current summary, the following are available:

In order to accurately derive individualized screening recommendations for a specific childhood cancer survivor using this guideline, see "Using the COG LTFU Guidelines to Develop Individualized Screening Recommendations" in the original guideline document. (Note: For ease of use, a Patient-Specific Guideline Identification Tool has been developed to streamline the process and is included in Appendix I of the original guideline document.)

Guideline Organization

The Children's Oncology Group Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers are organized according to therapeutic exposures, arranged by column as follows:

System	Body system (e.g., auditory, musculoskeletal) most relevant to each guideline section.
Score	Score assigned by expert panel representing the strength of data from the literature linking a specific late effect with a therapeutic exposure coupled with an assessment of the appropriateness of the screening recommendation based on collective clinical experience.
Section Number	Unique identifier for each guideline section corresponding with listing in Index.
Therapeutic Agent	Therapeutic intervention for malignancy, including chemotherapy, radiation, surgery, blood/serum products, hematopoietic cell transplant, and other therapeutic modalities.
Risk Factors	Host factors (e.g., age, sex, race, genetic predisposition), treatment factors (e.g., cumulative dose of therapeutic agent, mode of administration, combinations of agents), medical conditions (e.g., pre-morbid or co-morbid conditions), and health behaviors (e.g., diet, smoking, alcohol use) that may increase risk of developing the complication.
Highest Risk Factors	Conditions (host factors, treatment factors, medical conditions and/or health behaviors) associated with the highest risk for developing the complication.
Periodic Evaluations	Recommended screening evaluations, including health history, physical examination, laboratory evaluation, imaging, and psychosocial assessment. Recommendation for minimum frequency of periodic evaluations is based on risk factors and magnitude of risk, as supported by the medical literature and/or the combined clinical experience of the reviewers and panel of experts.
Health Counseling/ Further Considerations	*Health Links: Health education materials developed specifically to accompany these guidelines. Title(s) of Health Link(s) relevant to each guideline section are referenced in this column. Health Link documents are included in Appendix II of the original guideline document. Counseling: Suggested patient counseling regarding measures to prevent/reduce risk or promote early detection of the potential treatment complication. Resources: See the original guideline document for lists of books and web sites that may provide the clinician with additional relevant information. Considerations for Further Testing and Intervention*: Recommendations for further diagnostic evaluations beyond minimum screening for individuals with positive screening tests, recommendations for consultation and/or referral, and recommendations for management of exacerbating or predisposing conditions.
References	References are listed immediately following each guideline section in the original guideline document. Included are medical citations that provide evidence for the association of the therapeutic intervention with the specific treatment complication and/or evaluation of predisposing risk factors. In addition, some general review articles have been included in the Reference section of the original guideline document for clinician convenience.

Note: See the end of the "Major Recommendations" field for explanations of abbreviations included in the summary.

System = SMN
Score = 1

Sec #	Therapeutic Agent(s)	Potential Late Effects	Risk Factors	Highest Risk Factors	Periodic Evaluation	Health Counseling Further Considerations
92	HCT Info Link: Complications after HCT have multifactorial etiology: prior therapy for primary malignancy; intensity of transplant conditioning; stem cell product (e.g., marrow, cord blood, peripheral stem cells); donor (e.g., autologous, allogeneic, unrelated); quality of donor to recipient match; complication of transplant process (immunosuppression and GVHD); complications in the post-transplant period; underlying disease; host genetic factors; lifestyle behaviors. This section includes late treatment complications that may be observed in HCT recipients not covered elsewhere in these guidelines. Refer to the guidelines listed at the beginning of the "Major Recommendations" section for specific details related to late complications of radiation and of specific chemotherapeutic agents.	Acute myeloid leukemia Myelodysplasia	Treatment Factors Radiation therapy Stem cell mobilization with etoposide Alkylating agent chemotherapy Epipodophyllotoxins Anthracyclines Autologous transplant	Host Factors Older age Treatment Factors Autologous transplant for non-Hodgkin's and Hodgkin's lymphoma	History Fatigue Bleeding Easy bruising (Yearly up to 10 years after transplant) Physical Dermatologic exam (pallor, petechiae, purpura) (Yearly up to 10 years after transplant) Screening CBC/differential (Yearly up to 10 years after transplant)	Health Links See "Patient Resources" field Reducing the Risk of Second Cancers Counseling Counsel to promptly report fatigue, pallor, petechiae, or bone pain. Considerations for Further Testing and Intervention Bone marrow exam as clinically indicated.