Management Decisions Made by Physician Assistants and Nurse Practitioners in Cutaneous Malignant Melanoma Patients: Impact of a 31-Gene Expression Profile Test

November 2018 | Volume 17 | Issue 11 | Original Article | 1220 | Copyright © November 2018


Rachel S. Mirsky BA,a Giselle Prado MD,b Ryan M. Svoboda MD MS,c Alex M. Glazer MD,d Darrell S. Rigel MD MSe

aMedical Student, Albert Einstein College of Medicine, Bronx, NY bClinical Research Fellow, National Society for Cutaneous Medicine, New York, NY cClinical Research Fellow, Department of Dermatology, Duke University School of Medicine, Durham, NC dResident, Division of Dermatology, University of Arizona, Tucson, AZ eClinical Professor, Department of Dermatology, NYU School of Medicine, New York, NY

The results of this study indicate that the additional information provided by a 31-GEP test alters the management decisions made by dermatology PA/NPs in a variety of clinical situations. In most situations, a lower risk 31-GEP result was associated with a significant reduction in recommendations for SLNBx and further imaging, as well as a propensity to lengthen the recommended follow-up interval. This has the potential to reduce costs and patient burden. It also offers the potential to avoid complications related to SLNBx in a population with a very low rate of SLNBx positivity.14,15 Compared to baseline, a higher risk result was associated with a significant increase in recommendation for SLNBx, further imaging, and a shorter follow-up interval in all cases. These patients are at the highest risk for development of subsequent metastases and might benefit from closer monitoring than would typically be recommended for patients with Stage I or II disease. The results from this study suggests that 31-GEP test results could lead to targeted redistribution of resources to those patients at highest risk for recurrence.When the results of this study are considered in the context of prior studies demonstrating similar changes in management among dermatologists and dermatology residents,11,12 it is clear that a 31-GEP test can be appropriately applied by all dermatology professionals. These findings indicate that changes in real-world management due to 31-GEP test results have the potential to benefit both lower risk patients who could undergo fewer unnecessary tests and higher risk patients who could receive closer follow-up. In the current age of accountable care, where providers are increasingly assessed on the value of care provided, these findings are particularly meaningful.Limitations to this study include the possibility that the clinical vignettes used are not comprehensive representations of real-world patient cases. Additionally, the sample of PA/NPs attending the national conference may not accurately represent the larger population of dermatology PA/NPs practicing in the United States.

CONCLUSIONS

The results of this study demonstrate that the availability of 31-GEP test results significantly influenced the decisions of dermatology PA/NPs to recommend SLNBx, radiologic imaging, and follow-up interval. Furthermore, in the majority of cases, respondents utilized the information to alter management in the appropriate direction (eg, decreased SLNBx and imaging with a lower risk result and increased SLNBx and imaging with a higher risk result), while remaining in the context of existing guidelines. This indicates that the assay has clinical utility among PA/NPs and suggests that the improved prognostic information provided by the test would have an appropriate impact on patient management, potentially leading to more efficient resource allocation.

DISCLOSURE

Dr. Rigel served as a consultant to Castle Biosciences Inc. Drs. Glazer, Svoboda, and Prado participated in a research fellowship which was partially funded by Castle Biosciences Inc.

REFERENCES

  1. Morton DL, Thompson JF, Cochran AJ, et al. Final trial report of sentinel-node biopsy versus nodal observation in melanoma. N Engl J Med. 2014;370(7):599- 609.Acad Dermatol. 2017;76(5):818-825.e813.
  2. National Comprehensive Cancer Network. NCCN Guidelines in Melanoma. Version 2.2018. Published January 19, 2018.
  3. Bichakjian CK, Halpern AC, Johnson TM, Foote Hood A, Grichnik JM, Swetter SM, et al.Guidelines of care for the management of primary cutaneous melanoma. J Am Acad Dermatol. 2011 Nov;65(5):1032-47.
  4. 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(1):152.
  5. Hsueh EC, Schwartz TL, Lizalek JM, Hunborg PS, Hurley MY, Hinyard LJ. Prospective validation of gene expression profiling in primary cutaneous melanoma. In: American Society of Clinical Oncology; 2016.
  6. Greenhaw B, Brodland D, Zitelli J. Estimation of prognosis in invasive melanoma using a gene expression profile test. Amer Coll Mohs Surg. 2016.
  7. 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(5):780-785.e783.
  8. 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(1):175-183.
  9. 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(1):130.
  10. 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(5):818-825.e813.
  11. 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(5):428-431.
  12. Svoboda RM, Glazer AM, Farberg AS, Rigel DS. Factors affecting dermatologists' use of a 31-gene expression profiling test as an adjunct for predicting metastatic risk in cutaneous melanoma. J Drugs Dermatol. 2018;17(5):544- 547.
  13. Adamson AS, Suarez EA, McDaniel P, Leiphart PA, Zeitany A, Kirby JS. Geographic Distribution of Nonphysician Clinicians Who Independently Billed Medicare for Common Dermatologic Services in 2014. JAMA Derm. 2018;154(1):30-36.
  14. Cordeiro E, Gervais MK, Shah PS, Look hong NJ, Wright FC. Sentinel lymph node biopsy in thin cutaneous melanoma: A systematic review and meta-analysis. Ann Surg Oncol. 2016;23(13):4178-4188.
  15. Cook RW, Johnson C, Monzon FA. Determination of sentinel lymph node biopsy eligibility using a 31-gene expression profile test in melanoma patients. Poster presented at: American College of Mohs Surgeons Annual Meeting; May 3, 2018; Chicago, IL.

AUTHOR CORRESPONDENCE

Giselle Prado, MD drgiselleprado@gmail.com