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Reck M.,Lung Clinic Grosshansdorf GmbH | Hagiwara K.,Jichi Medical University | Han B.,Shanghai JiaoTong University | Tjulandin S.,Russian Cancer Research Center | And 9 more authors.
Journal of Thoracic Oncology | Year: 2016

Introduction: To offer patients with EGFR mutation- positive advanced NSCLC appropriate EGFR tyrosine kinase inhibitor treatment, mutation testing of tumor samples is required. However, tissue/cytologic samples are not always available or evaluable. The large, noninterventional diagnostic ASSESS study (NCT01785888) evaluated the utility of circulating free tumor-derived DNA (ctDNA) from plasma for EGFR mutation testing. Methods: ASSESS was conducted in 56 centers (in Europe and Japan). Eligible patients (with newly diagnosed locally advanced/metastatic treatment-naive advanced NSCLC) provided diagnostic tissue/cytologic and plasma samples. DNA extracted from tissue/cytologic samples was subjected to EGFR mutation testing using local practices; designated laboratories performed DNA extraction/mutation testing of blood samples. The primary end point was level of concordance of EGFR mutation status between matched tissue/cytologic and plasma samples. Results: Of 1311 patients enrolled, 1288 were eligible. Concordance ofmutation status in 1162matched sampleswas 89% (sensitivity 46%, specificity 97%, positive predictive value 78%, and negative predictive value 90%). A group of 25 patients with apparent false-positive plasma results was overrepresented for cytologic samples, use of less sensitive tissue testing methodologies, and smoking habits associated with high EGFR mutation frequency, indicative of falsenegative tumor results. In cases in which plasma and tumor samples were tested with identical highly sensitive methods, positive predictive value/sensitivitywere generally improved. Conclusions: These real-world data suggest that ctDNA is a feasible sample for EGFR mutation analysis. It is important to conduct mutation testing of both tumor and plasma samples in specialized laboratories, using robust/sensitive methods to ensure that patients receive appropriate treatments that target the molecular features of their disease. © 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc.


Alameda F.,Hospital of the Sea | Alameda F.,Autonomous University of Barcelona | Juanpere N.,Hospital of the Sea | Pijuan L.,Hospital of the Sea | And 8 more authors.
Cancer Cytopathology | Year: 2012

BACKGROUND: The sensitivity of urinary cytology for the diagnosis of urothelial carcinomas is low, particularly in lowgrade carcinomas. The UroVysion test is a fluorescent in situ hybridization multiprobe assay that increases the sensitivity of urinary cytology. However, this test is not widely available. P16INK4a, a protein involved in cell cycle progression, is overexpressed in urothelial carcinoma. Immunocytochemical expression of p16 INK4a has been examined in biopsy samples from urothelial carcinomas, but few studies have addressed this protein in urine cytology. METHODS: The authors compared the results of p16INK4a immunoreactivity in cytology and biopsy samples from 83 cases, including low-grade urothelial carcinomas, reactive epithelial lesions, and negative cases. RESULTS: p16INK4a assessment of in urine cytology samples showed a sensitivity of 66.7% and a specificity of 82.8% in the diagnosis of low-grade urothelial carcinomas. CONCLUSIONS: On the basis of these results, the authors propose that immunocytochemical detection of p16INK4a is a reliable tool in urine cytology, both for the diagnosis of low-grade urothelial carcinomas and for follow-up purposes. More retrospective and prospective studies are required to verify these results. © 2012 American Cancer Society.


PubMed | Hospital of the Sea
Type: Journal Article | Journal: Cancer cytopathology | Year: 2012

The sensitivity of urinary cytology for the diagnosis of urothelial carcinomas is low, particularly in low-grade carcinomas. The UroVysion test is a fluorescent in situ hybridization multiprobe assay that increases the sensitivity of urinary cytology. However, this test is not widely available. P16(INK4a) , a protein involved in cell cycle progression, is overexpressed in urothelial carcinoma. Immunocytochemical expression of p16(INK4a) has been examined in biopsy samples from urothelial carcinomas, but few studies have addressed this protein in urine cytology.The authors compared the results of p16(INK4a) immunoreactivity in cytology and biopsy samples from 83 cases, including low-grade urothelial carcinomas, reactive epithelial lesions, and negative cases.p16(INK4a) assessment of in urine cytology samples showed a sensitivity of 66.7% and a specificity of 82.8% in the diagnosis of low-grade urothelial carcinomas.On the basis of these results, the authors propose that immunocytochemical detection of p16(INK4a) is a reliable tool in urine cytology, both for the diagnosis of low-grade urothelial carcinomas and for follow-up purposes. More retrospective and prospective studies are required to verify these results.

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