Abstract
Detection of circulating tumor cells (CTCs) might improve current staging procedures by identifying a subgroup of patients with minimal residual disease and thus a higher risk of disease recurrence. Forty patients with ≥2‐mm‐thick cutaneous melanoma with or without lymph node metastasis were enrolled. After standard radical surgery and adjuvant therapy in case of lymph node metastasis, patients were followed up with routine physical and radiologic assessments as well as serial PCR‐based analysis of CTCs using 2 melanoma markers (tyrosinase and Melan‐A/Mart‐1). After a median follow‐up of 30 months, 18 patients had disease recurrence and 28 were PCR‐positive before the disease became clinically evident. The sensitivity of the molecular test was 83%. Median time to PCR positivity and median PCR‐to‐relapse time were 12 and 8 months, respectively. At multivariate analysis, PCR positivity was an independent predictor of disease recurrence (hazard ratio = 2.06, 95% CI 1.07–3.35; p = 0.03). Among high‐risk melanoma patients, serial PCR‐based analysis of CTCs can identify a subgroup at higher risk of disease recurrence, with clinically significant advance. Therefore, CTC detection might be employed for the selection of patients for adjuvant treatment and during follow‐up for early indication of therapeutic failure. © 2004 Wiley‐Liss, Inc.