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Prospective Multi-Institutional Study of Reverse Transcriptase Polymerase Chain Reaction for Molecular Staging of Melanoma

Charles R. Scoggins, Merrick I. Ross, Douglas S. Reintgen, R. Dirk Noyes, James S. Goydos, Peter D. Beitsch, Marshall M. Urist, Stephan Ariyan, B. Scott Davidson, Jeffrey J. Sussman, Michael J. Edwards, Robert C.G. Martin, Angela M. Lewis, Arnold J. Stromberg, Andrew J. Conrad, Lee Hagendoorn, Jeffrey Albrecht, Kelly M. McMasters

From the Division of Surgical Oncology, Department of Surgery, University of Louisville, James Graham Brown Cancer Center and Center for Advanced Surgical Technologies (CAST); Advertek Inc, Louisville, KY; Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston; Department of Surgery, Dallas Surgical Group, Dallas, TX; Lakeland Regional Cancer Center, Lakeland, FL; Department of Surgery, LDS Hospital, Salt Lake City, UT; Cancer Institute of New Jersey, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, NJ; Department of Surgery, University of Alabama, Birmingham, AL; Melanoma Unit of the Yale Cancer Center, Department of Surgery, Yale University School of Medicine, New Haven, CT; Albany Surgical PC, Albany, GA; Department of Surgery, University of Cincinnati, Cincinnati, OH; Department of Surgery, University of Arkansas for Medical Sciences, Little Rock, AK; and the National Genetics Institute, Los Angeles, CA

Address reprint requests to Kelly M. McMasters, MD, PhD, Department of Surgery, 315 E Broadway, Room 305, University of Louisville, Louisville, KY 40292; e-mail: mcmasters{at}louisville.edu

PURPOSE: To evaluate the prognostic significance of molecular staging using reverse transcriptase polymerase chain reaction (RT-PCR) in detecting occult melanoma cells in sentinel lymph nodes (SLNs) and circulating bloodstream.

PATIENTS AND METHODS: In this multicenter study, eligibility criteria included patient age 18 to 71 years, invasive melanoma 1.0 mm Breslow thickness, and no clinical evidence of metastasis. SLN biopsy and wide excision of the primary tumor were performed. SLNs were examined by serial-section histopathology and S-100 immunohistochemistry. A portion of each SLN was frozen for RT-PCR. In addition, RT-PCR was performed on peripheral-blood mononuclear cells (PBMCs). RT-PCR analysis was performed using four markers: tyrosinase, MART1, MAGE3, and GP-100. Disease-free survival (DFS), distant–DFS (DDFS), and overall survival (OS) were analyzed.

RESULTS: A total of 1,446 patients with histologically negative SLNs underwent RT-PCR analysis. At a median follow-up of 30 months, there was no difference in DFS, DDFS, or OS between the RT-PCR–positive (n = 620) and RT-PCR–negative (n = 826) patients. Analysis of PBMC from 820 patients revealed significant differences in DFS and DDFS, but not OS, for patients with detection of more than one RT-PCR marker in peripheral blood.

CONCLUSION: In this large, prospective, multi-institutional study, RT-PCR analysis on SLNs and PBMCs provides no additional prognostic information beyond standard histopathologic analysis of SLNs. Detection of more than one marker in PBMC is associated with a worse prognosis. RT-PCR remains investigational and should not be used to direct adjuvant therapy at this time.

Supported by a grant from Schering Oncology-Biotech and the Center for Advanced Surgical Technologies-Norton Hospital, Louisville, KY. Schering Oncology-Biotech had no access to data, no input into the analysis of the data, and has not participated in the preparation or review of the manuscript.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Related Correspondence

• What Is the Role of Sequential Reverse-Transcriptase Polymerase Chain Reaction Analysis of Melanoma-Specific mRNA in the Peripheral Blood of Melanoma Patients?
  Pietro Quaglino, Simona Osella-Abate, Paola Savoia, Maria Grazia Bernengo, Nazario Cappello, and Franco Cavallo
  JCO 2007 25: 1140-1141 [Full Text]

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