Establishing an evidence-based decision point for clinical use of the 31-gene expression profile test in cutaneous melanoma
Main Article Content
Keywords
melanoma, prognosis, gene expression profiling
Abstract
Treatment plans for cutaneous melanoma are based upon individual risk of recurrence. Decisions made post-diagnosis include recommendation for a sentinel lymph node biopsy (SLNB), followed by management decisions such as surveillance, frequency of follow-up, and interdisciplinary consultations including possible adjuvant therapy use. These have traditionally been guided by clinicopathologic factors, but discordance exists, as a substantial number of melanoma deaths occur in patients diagnosed with disease considered to be early stage by such factors, including a negative SLNB. Molecular testing can be used to apply an objective approach that optimizes individualized patient care. The 31-gene expression profile (31-GEP) test has been validated in nearly 1600 patients as an independent predictor of risk of recurrence, distant metastasis and death in Stage I-III melanoma and can guide SLNB decisions in patient subgroups, as demonstrated in 1421 patients. While clinical use of the 31-GEP test has been adopted into routine practice, an evidence-based analysis of a decision point for use in thin, T1 tumors would be clinically useful. To help define an appropriate population for 31-GEP testing, we evaluated changes in patient management, cumulative differential risk across Breslow thicknesses based on a large dataset, and 31-GEP subclass distribution in a clinically tested cohort. Based on this, appropriate use of the 31-GEP test for management decisions was found to be in cutaneous melanoma tumors ≥0.3 mm thick.
References
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2. Gerami P, Cook RW, Wilkinson J, et al. Development of a prognostic genetic signature to predict the metastatic risk associated with cutaneous melanoma. Clin Cancer Res. 2015;21: 175-183.
3. Gastman BR, Gerami P, Kurley SJ, Cook RW, Leachman S, Vetto JT. Identification of patients at risk of metastasis using a prognostic 31-gene expression profile in subpopulations of melanoma patients with favorable outcomes by standard criteria. J Am Acad Dermatol. 2019;80: 149-157 e144.
4. Zager JS, Gastman BR, Leachman S, et al. Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients. BMC Cancer. 2018;18: 130.
5. Gerami P, Cook RW, Russell MC, et al. Gene expression profiling for molecular staging of cutaneous melanoma in patients undergoing sentinel lymph node biopsy. J Am Acad Dermatol. 2015;72: 780-785 e783.
6. Greenhaw BN, Zitelli JA, Brodland DG. Estimation of Prognosis in Invasive Cutaneous Melanoma: An Independent Study of the Accuracy of a Gene Expression Profile Test. Dermatol Surg. 2018;44: 1494-1500.
7. Hsueh EC, DeBloom JR, Lee J, et al. Interim analysis of survival in a prospective, multi-center registry cohort of cutaneous melanoma tested with a prognostic 31-gene expression profile test. J Hematol Oncol. 2017;10: 152.
8. Keller J, Schwartz TL, Lizalek JM, et al. Prospective validation of the prognostic 31-gene expression profiling test in primary cutaneous melanoma. Cancer Med. 2019.
9. Podlipnik S, Carrera C, Boada A, et al. Early outcome of a 31-gene expression profile test in 86 AJCC stage IB-II melanoma patients. A prospective multicentre cohort study. J Eur Acad Dermatol Venereol. 2019.
10. Berger AC, Davidson RS, Poitras JK, et al. Clinical impact of a 31-gene expression profile test for cutaneous melanoma in 156 prospectively and consecutively tested patients. Curr Med Res Opin. 2016;32: 1599-1604.
11. Dillon LD, Gadzia JE, Davidson RS, et al. Prospective, Multicenter Clinical Impact Evaluation of a 31-Gene Expression Profile Test for Management of Melanoma Patients. SKIN. 2018;2: 111-121.
12. Schuitevoerder D, Heath M, Cook RW, et al. Impact of Gene Expression Profiling on Decision-Making in Clinically Node Negative Melanoma Patients after Surgical Staging. J Drugs Dermatol. 2018;17: 196-199.
13. Cook RW, Middlebrook B, Wilkinson J, et al. Analytic validity of DecisionDx-Melanoma, a gene expression profile test for determining metastatic risk in melanoma patients. Diagn Pathol. 2018;13: 13.
14. Ferris LK, Farberg AS, Middlebrook B, et al. Identification of high-risk cutaneous melanoma tumors is improved when combining the online American Joint Committee on Cancer Individualized Melanoma Patient Outcome Prediction Tool with a 31-gene expression profile-based classification. J Am Acad Dermatol. 2017;76: 818-825 e813.
15. Shaikh WR, Dusza SW, Weinstock MA, Oliveria SA, Geller AC, Halpern AC. Melanoma Thickness and Survival Trends in the United States, 1989 to 2009. J Natl Cancer Inst. 2016;108.
16. Gershenwald JE, Scolyer RA, Hess KR, et al. Melanoma staging: Evidence-based changes in the American Joint Committee on Cancer eighth edition cancer staging manual. CA Cancer J Clin. 2017;67: 472-492.
17. Greenhaw BN, Hsueh EC, Covington KR, Plasseraud KM, Cook RW, Gastman BR. Meta-analysis of the Prognostic 31-gene Expression Profile Test in 1261 Cutaneous Melanoma Cases. American Association of Dermatology. Washington, D. C. , 2019.
18. Farberg AS, Glazer AM, White R, Rigel DS. Impact of a 31-gene Expression Profiling Test for Cutaneous Melanoma on Dermatologists' Clinical Management Decisions. J Drugs Dermatol. 2017;16: 428-431.
19. Gimotty PA, Elder DE, Fraker DL, et al. Identification of high-risk patients among those diagnosed with thin cutaneous melanomas. J Clin Oncol. 2007;25: 1129-1134.
20. Landow SM, Gjelsvik A, Weinstock MA. Mortality burden and prognosis of thin melanomas overall and by subcategory of thickness, SEER registry data, 1992-2013. J Am Acad Dermatol. 2017;76: 258-263.
21. Whiteman DC, Baade PD, Olsen CM. More people die from thin melanomas (1 mm) than from thick melanomas (>4 mm) in Queensland, Australia. J Invest Dermatol. 2015;135: 1190-1193.
22. Vetto JT, Hsueh EC, Gastman BR, et al. Guidance of sentinel lymph node biopsy decisions in patients with T1-T2 melanoma using gene expression profiling. Future Oncol. 2019;15: 1207-1217.