Lymph node management in melanoma has been controversial for over 100 years. Earlier findings of our study group have contributed to current understanding of several cancers and have established current standards for treatment of melanoma with improved prognostic assessment, identification of patients for appropriate interventions, and prevention of treatment-related morbidity. The current proposal will complete the definition of optimal surgical therapy of regional lymph nodes.
These aims will be achieved through the second Multicenter Selective Lymphadenectomy Trial (MSLT2).
Aim 1) To determine if immediate completion lymph node dissection enhances the outcomes of patients with melanoma sentinel node metastases The primary endpoint of MSLT2 is melanoma-specific survival comparing patients with positive sentinel lymph nodes (SLN) who are treated by immediate completion lymph node dissection (CLND) to those who are followed using clinical and ultrasound examination. Secondary endpoints include disease-free survival, time to recurrence in the regional lymph node basin, quality of life, and safety.
Aim 2) To establish and validate optimal methods of SLN evaluation and prognosis determination Although SLN biopsy has improved staging accuracy in melanoma, """"""""gold standard"""""""" methods for SLN evaluation are not established. The rich data available in trial databases have allowed evaluation of several leading candidate parameters for nodal assessment and prognosis. MSLT2 will validate the methods and allow more precise determination of the need for more therapy or follow up.
Aim 3) To determine the utility of novel, currently non-standard evaluation measures: 3a) RT-PCR evaluation of SLN: Some patients with SLN that are negative by standard pathologic evaluation recur and die of melanoma. Retrospective studies suggest that RT-PCR evaluation of lymph nodes can discriminate patients who are or are not at substantial risk of recurrence. Validation of these data prospectively in MSLT2 has the potential to revolutionize SLN evaluation. 3b) Ultrasound follow up of at-risk nodal basins: MSLT2 is systematically evaluating the utility of serial ultrasound of lymph node basins in which a positive sentinel node was identified. The significance of these objectives cannot be overstated. MSLT1 has spared many patients unnecessary surgery, morbidity, anxiety and expense. The current trial will establish a similar standard for patients with sentinel node metastases and either confirm the need for immediate CLND or allow the majority of patients to avoid it.

Public Health Relevance

Current standard treatment for patients who have had melanoma metastasize to initial or sentinel lymph nodes incudes remove of the remaining lymph nodes in the same area, called completion lymph node dissection. The current proposal will determine through a prospective, randomized, Phase III trial whether that surgery is necessary or if close observation of the area is sufficient. It will also establish the optimal method of determining prognosis in these patients and the possible utility of additional testing including reverse- transcriptase polymerase chain reaction (RT-PCR) and lymph node ultrasound.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project (R01)
Project #
Application #
Study Section
Special Emphasis Panel (ZCA1-RPRB-B (M1))
Program Officer
Song, Min-Kyung H
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
John Wayne Cancer Institute
Santa Monica
United States
Zip Code
Jones, Maris S; Jones, Peter C; Stern, Stacey L et al. (2017) The Impact of Smoking on Sentinel Node Metastasis of Primary Cutaneous Melanoma. Ann Surg Oncol 24:2089-2094
Nelson, Daniel W; Stern, Stacey; Elashoff, David E et al. (2017) Impact of Time Between Diagnosis and SLNB on Outcomes in Cutaneous Melanoma. J Am Coll Surg 225:302-311
Jones, Maris S; Lee, Jihey; Stern, Stacey L et al. (2017) Is Pregnancy-Associated Melanoma Associated with Adverse Outcomes? J Am Coll Surg 225:149-158
Deutsch, Gary B; Flaherty, Devin C; Kirchoff, Daniel D et al. (2017) Association of Surgical Treatment, Systemic Therapy, and Survival in Patients With Abdominal Visceral Melanoma Metastases, 1965-2014: Relevance of Surgical Cure in the Era of Modern Systemic Therapy. JAMA Surg 152:672-678
Faries, Mark B; Thompson, John F; Cochran, Alistair J et al. (2017) Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma. N Engl J Med 376:2211-2222
Ozao-Choy, Junko; Nelson, Daniel W; Hiles, Jason et al. (2017) The prognostic importance of scalp location in primary head and neck melanoma. J Surg Oncol 116:337-343
Karakousis, Giorgos; Gimotty, Phyllis A; Bartlett, Edmund K et al. (2017) Thin Melanoma with Nodal Involvement: Analysis of Demographic, Pathologic, and Treatment Factors with Regard to Prognosis. Ann Surg Oncol 24:952-959
Lee, David Y; Lau, Briana J; Huynh, Kelly T et al. (2016) Impact of Completion Lymph Node Dissection on Patients with Positive Sentinel Lymph Node Biopsy in Melanoma. J Am Coll Surg 223:9-18
Jones, Maris S; Torisu-Itakura, Hitoe; Flaherty, Devin C et al. (2016) Second Primary Melanoma: Risk Factors, Histopathologic Features, Survival, and Implications for Follow-Up. Am Surg 82:1009-1013
Lee, David Y; Huynh, Kelly T; Teng, Annabelle et al. (2016) Predictors and Survival Impact of False-Negative Sentinel Nodes in Melanoma. Ann Surg Oncol 23:1012-8

Showing the most recent 10 out of 25 publications