Originally published as JCO Early Release 10.1200/JCO.2003.01.128 on January 3 2003

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Prognostic Value of Circulating Melanoma Cells Detected by Reverse Transcriptase–Polymerase Chain Reaction

Giuseppe Palmieri, Paolo A. Ascierto, Francesco Perrone, Sabrina M.R. Satriano, Alessandro Ottaiano, Antonio Daponte, Maria Napolitano, Corrado Caracò, Nicola Mozzillo, Maria T. Melucci, Antonio Cossu, Francesco Tanda, Ciro Gallo, Rocco A. Satriano, Giuseppe Castello

From the Institute of Genetics of Populations, Consiglio Nazionale delle Ricerche, Alghero (Sassari); Division of Clinical Immunology, Clinical Trials Unit, Division of Medical Oncology A, and Division of Surgical Oncology B, National Cancer Institute of Naples; Institute of Pathology, University of Sassari; and Medical Statistics and Department of Dermatology, Second University, Naples, Italy.

Address reprint requests to Paolo A. Ascierto, Division of Clinical Immunology, National Cancer Institute, Via M. Semmola, 80131 Naples, Italy; email: pasciert{at}tin.it.

Purpose: Factors that are predictive of prognosis in patients who are diagnosed with malignant melanoma (MM) are widely awaited. Detection of circulating melanoma cells (CMCs) by reverse transcriptase-polymerase chain reaction (RT-PCR) has recently been postulated as a possible negative prognostic factor. Two main questions were addressed: first, whether the presence of CMCs, defined as the patient being positive for any of the three markers, had a prognostic role; and second, what the predictive value of each individual marker was.

Patients and Methods: A consecutive series of 200 melanoma patients observed between January 1997 and December 1997, with stage of disease ranging from I to IV, was analyzed by semiquantitative RT-PCR. Tyrosinase, p97, and MelanA/MART1 were used as markers to CMCs on baseline peripheral blood samples. Progression-free survival (PFS) was used as a unique end point and was described by the product limit method. Multivariable analysis was applied to verify whether the auspicated prognostic value of these markers was independent of the stage of disease, and a subgroup analysis was performed that excluded patients with stage IV disease.

Results: Overall, 32% (64 of 200) of patients progressed, and a median PFS of 52 months in the whole series was observed. The presence of CMCs and the markers individually or combined was predictive of prognosis in the univariate analysis but did not provide additional prognostic information to the stage of disease in multivariable models. In the subgroup analysis of stage (ie, I–III subgroup), similar results were observed.

Conclusion: Detection of CMCs in peripheral blood samples at the time of MM diagnosis by semiquantitative RT-PCR does not add any significant predictive value to the stage of disease. Thus, this approach should not be used in clinical practice, and further studies are required to determine its usefulness.

This article was published ahead of print at www.jco.org.

Supported by Italian Ministry of Health, Health Department of Campania Region (Italy), and Regione Autonoma della Sardegna. The Clinical Trials Unit is partially supported by AIRC (Associazione Italiana per la Ricerca sul Cancro). Both G.P. and P.A. contributed equally to this work.

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