Gene expression profiling (GEP) has been integrated into cancer treatment decision‐making in multiple neoplasms.,We prospectively evaluated the prognostic utility of the 31‐GEP test (DecisionDx‐Melanoma, Castle Biosciences, Inc) in cutaneous melanoma (CM) patients undergoing sentinel node biopsy (SNB).,One hundred fifty‐nine patients (age 26‐88) diagnosed with melanoma between 01/2013 and 8/2015 underwent SNB and concurrent GEP testing.,GEP results were reported as low‐risk Class 1 (subclasses 1A and 1B) or high‐risk Class 2 (subclasses 2A and 2B).,Statistical analyses were performed with chi‐square analysis, t tests, log‐rank tests, and Cox proportional hazard models.,Recurrence‐free survival (RFS) and distant metastasis‐free survival (DMFS) were estimated using Kaplan‐Meier method.,Median follow‐up was 44.9 months for event‐free cases.,Median Breslow thickness was 1.4 mm (0.2‐15.0 mm).,There were 117 Class 1 and 42 Class 2 patients.,Gender, age, Breslow thickness, ulceration, SNB positivity, and AJCC stage were significantly associated with GEP classification (P < 0.05 for all).,Recurrence and distant metastasis rates were 5% and 1% for Class 1 patients compared with 55% and 36% for Class 2 patients.,Sensitivities of Class 2 and SNB for recurrence were 79% and 34%, respectively.,Of 10 SNB‐positive/Class 2 patients, 9 recurred.,By multivariate analysis, only SNB result and GEP class were statistically associated with both RFS (P = 0.008 and 0.0001) and DMFS (P = 0.019 and 0.001).,Gene expression profiling Class 2 result and SNB positivity were independently associated with recurrence and distant metastasis in primary CM patients.,GEP testing may have additive prognostic utility in initial staging work‐up of these patients.
Despite of highly effective new therapeutic strategies, chemotherapy still is an important treatment option in metastatic melanoma.,Since predictors of chemotherapy response are rare, drugs and regimens are currently chosen arbitrarily.,The present study was aimed at the identification of molecular markers predicting the outcome of chemotherapy in melanoma.,Tumor biopsies from metastatic lesions were collected from 203 stage IV melanoma patients prior to chemotherapy onset and used for gene expression profiling (n = 6; marker identification set), quantitative real-time PCR (n = 127; validation set 1), and immunohistochemistry on tissue microarrays (n = 70; validation set 2).,The results were correlated to the tumors' in-vitro chemosensitivity and to the patients' in-vivo chemotherapy outcome.,SERPINB1 was found to correlate to the in-vitro sensitivity to cisplatin-containing chemotherapy regimens (p = 0.005).,High SERPINB1 gene expression was associated with favorable tumor response (p = 0.012) and prolonged survival (p = 0.081) under cisplatin-based chemotherapy.,High SERPINB1 protein expression in tumor tissue from cisplatin-treated patients was associated with a favorable survival (p = 0.011), and proved as an independent predictor of survival (p = 0.008) by multivariate analysis.,We conclude, that SERPINB1 expression, although not functionally involved, is predictive for the outcome of cisplatin-based chemotherapy in melanoma, and thus may be useful to personalize melanoma chemotherapy.