title: Comparison of a gene expression profiling strategy to standard clinical work-up for determination of tumour origin in cancer of unknown primary (CUP).
abstract: CupPrint® is a genomic signature able to identify 47 different cancer types. The aim of our study was to compare the accuracy of this genomic signature to that of a full clinical work-up in diagnosing the primary tumour site. Patients with newly diagnosed, untreated metastatic tumours were eligible for this trial. The clinical work-up and gene expression profiling on a biopsy from a metastatic site were started at the same time. The study was planned using a one-stage Fleming design. Patients in whom no primary site was diagnosed by the clinical work-up were excluded. Out of the 67 patients registered, the primary site was identified by clinical work-up in 36 patients, and diagnosis with CupPrint was obtained in 53. There were 31 evaluable patients with both clinical and CupPrint diagnoses, and out of these a similar diagnosis was obtained in 11 patients, i.e. the concordance rate was 35% (95% confidence interval: 19-55%). The median time to diagnosis through the clinical work-up was 48 days, and 10 days with CupPrint (P<0·001). We concluded that in patients with newly diagnosed metastatic tumours, CupPrint has low accuracy in diagnosing the primary cancer site.
authors.affiliation: Medical Oncology Clinic, Institut Jules Bordet, Université Libre de Bruxelles ULB, Brussels, Belgium.
authors.forename: Felipe
authors.initials: F
authors.lastname: Ades
authors.forename: Evandro
authors.initials: E
authors.lastname: de Azambuja
authors.forename: Gedske
authors.initials: G
authors.lastname: Daugaard
authors.forename: Lieveke
authors.initials: L
authors.lastname: Ameye
authors.forename: Camilo
authors.initials: C
authors.lastname: Moulin
authors.forename: Marianne
authors.initials: M
authors.lastname: Paesmans
authors.forename: Daphne
authors.initials: D
authors.lastname: De Jong
authors.forename: Lore
authors.initials: L
authors.lastname: Decoster
authors.forename: Jacques
authors.initials: J
authors.lastname: De Greve
authors.forename: Gustavo
authors.initials: G
authors.lastname: Ismael
authors.forename: Anne Kirstine
authors.initials: AK
authors.lastname: Møller
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D020869:Gene Expression Profiling / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000235:genetics / Q000473:pathology*; D011446:Prospective Studies; D012680:Sensitivity and Specificity