Transcript Slide 1

SENTINEL LYMPH NODE BIOPSY
FOR MELANOMA
AMERICAN SOCIETY OF CLINICAL ONCOLOGY AND
SOCIETY OF SURGICAL ONCOLOGY
JOINT CLINICAL PRACTICE GUIDELINE
Introduction
• Population: patients with newly diagnosed melanoma
• Metastases to regional lymph nodes most important
prognostic factor in early-stage melanoma
– Occur in 20% of patients with intermediate-thickness tumors (1-4
mm Breslow thickness)
• Sentinel lymph node (SLN) biopsy is accurate in staging
regional nodes and has low morbidity
• Previous studies – Multicenter Selective Lymphadenectomy
Trial I (MLST I) and Sunbelt Melanoma Trial
– SLN biopsy vs. nodal observation – no difference in melanomaspecific survival (MLST I)
– Positive SLN followed by complete lymph node dissection (CLND) –
benefit in melanoma-specific survival, prolonged disease-free
survival, decreased risk of recurrence
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Abbreviations
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SLN: sentinel lymph node
CLND: complete lymph node dissection
PSM: proportion of patients successfully mapped
PVP: predictive value positive
PVN: predictive value negative
PTPN: post-test probability negative (1-PVN)
FNR: false-negative rate (false negative/[true positive +
false negative])
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Guideline Methodology:
Systematic Review
• ASCO and Society of Surgical Oncology (SSO)
convened an Expert Panel to review relevant medical
literature
• Systematic review
– Date parameters: January 1990-August 2011
– Databases searched:
• MEDLINE
• EMBASE
– ASCO and SSO Annual Meeting proceedings 2006-2011
searched
• Meta-analysis completed (Valsecchi et al, JCO, 2011)
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Limitations of the literature
• Only one randomized clinical trial that addresses
whether patients with melanoma managed using SLN
biopsy have better clinical outcomes than those
managed any other way
– Multicenter Lymphadenectomy Trial I (MLST I)
• Systematic review, by necessity, included observational
studies
– Cohort studies (SLN biopsy with or without CLND)
• Significant variability across studies (e.g., in techniques
used)
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Clinical Questions
1. What are the indications for sentinel lymph node
biopsy?
2. What is the role of completion lymph node dissection?
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Recommendation 1
• What are the indications for sentinel lymph node biopsy?
Intermediate-thickness melanomas. SLN biopsy is
recommended to patients with intermediate-thickness
cutaneous melanomas (1 to 4 mm Breslow thickness) of
any anatomic site. Routine use of SLN biopsy in this
population provides accurate staging, with high estimates
for PSM, and acceptable estimates for FNR, PTPN, and
PVP.
(continued on next slide)
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Recommendation 1, cont’d
Thick melanomas. While there are few studies focusing
specifically on patients with thick melanomas (T4; > 4 mm
Breslow thickness), the use of SLN biopsy in this population may
be recommended for staging purposes and to facilitate regional
disease control.
Thin melanoma. There is insufficient evidence to support routine
SLN biopsy for patients with thin melanoma (T1; < 1 mm Breslow
thickness), although it may be considered in selected cases with
high risk features, when the benefits of pathologic staging may
outweigh the potential risks of the procedure. Such risk factors
may include ulceration or mitotic rate ≥ 1/mm2, especially in the
subgroup of patients with Breslow thickness 0.75 mm to 0.99
mm.
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Recommendation 2
• What is the role of completion lymph node dissection?
Recommendation
CLND is recommended for all patients with a positive SLN
biopsy. CLND achieves regional disease control, although
whether or not CLND following a positive SLN biopsy
improves survival is the subject of the ongoing Multicenter
Selective Lymphadenectomy Trial II (MSLT II).
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
PATIENT AND CLINICIAN
COMMUNICATION
• Patient counseling is essential for informed decision-making
• Key question: What additional information necessary to guide
a choice of treatment will SLN biopsy likely provide?
• Conduct an open dialogue that:
– Discusses scientific evidence (in lay terms)
– Weighs individual risks with potential harms and benefits
– Considers patient values and preferences
• Consider Using ASCO Treatment Plan Template on asco.org.
{http://www.asco.org/ASCOv2/Practice+%26+Guidelines/Quality+Care/Quality+Meas
urement+%26+Improvement/Chemotherapy+Treatment+Plan+and+Summary/Cancer
+Treatment+Plan+and+Summary+Resources}
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Future Directions
• Determining precise criteria for patient selection for SLN
biopsy.
• Determining whether early identification of metastases in
the SLN improves survival or is just “lead time bias.”
• Identifying criteria for individualized risks best inform
appropriate risk stratification for patients at high risk for
relapse, and those for whom CLND and/or adjuvant
therapy are suitable.
• Establishing the role of prognostic markers from primary
melanoma and SLN for appropriate risk stratification.
• Development of prediction-based models to aid in
individualized decision-making.
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
The Bottom Line
Intervention
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SLN biopsy for patients with newly diagnosed melanoma
Target Audience
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Surgical Oncologists, Medical Oncologists, Dermatologists, Primary Care Physicians,
Pathologists, Nuclear Medicine Specialists
Key Recommendations
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Intermediate-thickness melanomas: SLN biopsy is recommended to patients with
cutaneous melanomas with 1 to 4 mm Breslow thickness of any anatomic site.
Thick melanomas: SLN biopsy may be recommended for staging purposes and to facilitate
regional disease control for patients with melanomas that are T4 or > 4 mm Breslow
thickness.
Thin melanomas: There is insufficient evidence to support SLN biopsy for patients with
melanomas that are T1 or < 1mm Breslow thickness, although it may be considered in
selected high-risk cases.
Completion lymph node dissection is recommended for all patients with a positive SLN
biopsy.
Methods
•
An Expert Panel was convened to develop guideline recommendations based on their
review of evidence from a systematic review of the medical literature.
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Guideline Methodology:
Panel Members
Panel Members
Affiliation/Institution
Sandra L. Wong, MD, Co-Chair
University of Michigan
Gary H. Lyman, MD, MPH, Co-Chair
Duke University
Sanjiv S. Agarwala, MD
St. Luke’s Cancer Center
Timothy J. Akhurst, MD
Peter MacCallum Cancer Institute
Charles M. Balch, MD
University of Texas Southwestern
Alistair Cochran, MD
UCLA Center for Health Services
Janice N. Cormier, MD, MPH
Mark Gorman
University of Texas MD Anderson Cancer
Center
National Coalition for Cancer Survivorship
Theodore Y. Kim, DO, MS
Skagit Valley Regional Cancer Center
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Guideline Methodology:
Panel Members, cont’d
Panel Members
Affiliation/Institution
Kelly McMasters, MD, PhD
University of Louisville
R. Dirk Noyes, MD
Huntsman Cancer Institute
Lynn Mara Schuchter, MD
University of Pennsylvania
Matias E. Valsecchi, MD
Thomas Jefferson University
Donald L. Weaver, MD
University of Vermont College of Medicine
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
Additional ASCO Resources
• The Executive Summary of the full Guideline includes the
clinical questions, recommendations, a brief summary of the
literature, and discussions. (JCO and the Annals of Surgical
Oncology jointly published this.)
• The full Guideline (which includes a comprehensive
discussion of the literature, a description of the methodology,
and a complete reference list), along with a Data Supplement,
an Appendix, and clinical tools and resources, can be found at
http://www.asco.org/guidelines/snbmelanoma or online at the SSO website
• Meta-analysis and systematic review was published
(Valsecchi ME, Silbermins D, de Rosa N, et al: Lymphatic
mapping and sentinel lymph node biopsy in patients with
melanoma: a meta-analysis. J Clin Oncol 29:1479-87, 2011)
• A patient guide is available at http://www.cancer.net
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.
ASCO Guidelines
This resource is a practice tool for physicians based on an
ASCO® practice guideline. The practice guideline and this
presentation are not intended to substitute for the
independent professional judgment of the treating
physician. Practice guidelines do not account for individual
variation among patients and may not reflect the most
recent evidence. This presentation does not recommend
any particular product or course of medical treatment. Use
of the practice guideline and this resource is voluntary. The
full practice guideline and additional information are
available at http://www.asco.org/guidelines/snbmelanoma.
Copyright © 2012 by American Society of Clinical
Oncology®. All rights reserved.
www.asco.org/guidelines/snbmelanoma ©American Society of Clinical Oncology 2011. All rights reserved.