Impact of Gene Expression Profiling on Decision-Making in Clinically Node Negative Melanoma Patients after Surgical Staging openaccess articles

February 2018 | Volume 17 | Issue 2 | Original Article | 196 | Copyright © 2018

Darryl Schuitevoerder MBBS,a Michael Heath MS,c Robert W. Cook PhD,e Kyle R. Covington PhD,e Jeanine Fortino HIMA,b Sancy Leachman MD PhD,d and John T. Vetto MD FACSa,b

Fortino HIMA,b Sancy Leachman MD PhD,d and John T. Vetto MD FACSa,b aDepartment of Surgery, Oregon Health & Science University, Portland, OR; bDivision of Surgical Oncology, Oregon Health & Science University, Portland, OR; cSchool of Medicine, Oregon Health & Science University, Portland, OR; dDepartment of Dermatology, Oregon Health & Science University, Portland, OR; eCastle Biosciences Inc., Friendswood, TX

Abstract

INTRODUCTION: The surgeon’s role in the follow-up of pathologic stage I and II melanoma patients has traditionally been minimal. Melanoma genetic expression profile (GEP) testing provides binary risk assessment (Class 1-low risk, Class 2-high risk), which can assist in predicting metastasis and formulating appropriate follow up. We sought to determine the impact of GEP results on the management of clinically node negative cutaneous melanoma patients staged with sentinel lymph node biopsy (SLNB). METHODS: A retrospective review of prospectively gathered data consisting of patients seen from September 2015 - August 2016 was performed to determine whether GEP class influenced follow-up recommendations. Patients were stratified into four groups based on recommended follow-up plan: Dermatology alone, Surgical Oncology, Surgical Oncology with recommendation for adjuvant clinical trial, or Medical and Surgical Oncology. RESULTS: Of ninety-one patients, 38 were pathologically stage I, 42 stage II, 10 stage III, and 1 stage IV. Combining all stages, GEP Class 1 patients were more likely to be followed by Dermatology alone and less like to be followed by Surgical Oncology with recommendation for adjuvant trial compared to Class 2 patients (P less than 0.001). Among stage 1 patients, Class 1 were more likely to follow up with Dermatology alone compared to Class 2 patients (82 vs. 0%; P less than 0.001). Among stage II patients, GEP Class 1 were more likely to follow up with Dermatology alone (21 vs 0%) and more Class 2 patients followed up with surgery and recommendations for adjuvant trial (36 vs 64%; P less than 0.05). There was no difference in follow up for stage III patients based on the GEP results (P=0.76). CONCLUSION: GEP results were significantly associated with the management of stage I-II melanoma patients after staging with SLNB. For node negative patients, Class 2 results led to more aggressive follow up and management. J Drugs Dermatol. 2018;17(2):196-199. THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

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INTRODUCTION

  1. The incidence of cutaneous melanoma in the U.S. continues to increase, rising from 1 in 250 persons in 1980 to 1 in 53 in 2010.1 The American Cancer Society reports 87,110 new cases and 9,730 deaths are predicted in the U.S. for 2017.2 The majority of patients with melanoma are diagnosed with localized disease (stage I or II) for which surgical management can be curative.3 However, outcomes and survival of early stage disease are highly variable, with 5-year survival rates for stage I and stage II disease ranging from 92-97% and 53-81% respectively.2 Furthermore, it is recognized that the majority of patients who die from melanoma are initially diagnosed with sentinel lymph node (SLN) negative disease.4,5,6 Reasons for this discrepancy include false negative rates associated with SLN biopsy (SLNB), the high numbers of SLN-negative patients, benefits of therapy for SLN-positive patients, and the metastasis of tumor cells through hematogenous rather than lymphatic routes (non-Halstedian model).7
Molecular gene expression profiling (GEP) for risk assessment has become standard of care for patients with breast cancer, prostate cancer, and ocular melanoma.8-10 For cutaneous melanoma, a 23-gene GEP test that classifies melanocytic lesions as benign or malignant has been developed to enhance diagnostic accuracy.11 Additionally, a prognostic 31-gene GEP test that classifies patients as low risk (Class 1) or high risk (Class 2) for developing metastasis has been reported and independently validated.12,13 The test accurately identifies over 70% of patients who developed distant metastasis or died from their disease as Class 2, has a negative predictive value of 94% and a positive predictive value of 67% among stage I-II patients, and has been shown

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