title: New ARCHITECT plasma pro-gastrin-releasing peptide assay for diagnosing and monitoring small-cell lung cancer.
abstract: BACKGROUND
  Progastrin-releasing peptide (ProGRP) is a potential marker for small-cell lung cancer (SCLC) in serum; however, it may be more stable in plasma. We investigated a new plasma assay (ProGRPp) and its usefulness in diagnosing and monitoring SCLC.
  
  
  METHODS
  The marker concentrations were determined on the ARCHITECT i system.
  
  
  RESULTS
  The assay could distinguish SCLC from non-small-cell lung cancer (NSCLC: area under the curve 0.931, 95% CI 0.893-0.969; cross-validated accuracy 0.813; sensitivity 84.0%, specificity 96.3%; at 140 pg ml(-1) cutoff). The probability of SCLC when ProGRPp was >140 pg ml(-1) was 91.8%, after adjusting for age, gender, and renal dysfunction. The NSCLC patients with ProGRPp >140 pg ml(-1) were at high risk (odds ratio=37.0, P<0.001) for tumours with neuroendocrine features. False negatives in SCLC were associated with a lack of thyroid transcription factor-1 (P<0.001). A decrease of ProGRPp to <140 pg ml(-1) during chemotherapy was significantly associated with the image-based response (P<0.001), and independently affected progression-free survival (PFS, relative risk=2.51, P=0.04) and overall survival (OS, relative risk=4.38, P=0.003), after adjustment for imaging response, performance status, and stage.
  
  
  CONCLUSIONS
  The ProGRPp assay is specific and sensitive for diagnosing SCLC. Changes in ProGRPp during chemotherapy are significantly associated with image-based response, PFS, and OS.
authors.affiliation: Department of Oncology, Hadassah and Hebrew University Medical Centre, P.O. Box 12000, Jerusalem 91120, Israel.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Nisman
authors.affiliation: Department of Oncology, Hadassah and Hebrew University Medical Centre, P.O. Box 12000, Jerusalem 91120, Israel.
authors.forename: Hovav
authors.initials: H
authors.lastname: Nechushtan
authors.affiliation: Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Haim
authors.initials: H
authors.lastname: Biran
authors.affiliation: Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Nir
authors.initials: N
authors.lastname: Peled
authors.affiliation: Department of Oncology, Hadassah and Hebrew University Medical Centre, P.O. Box 12000, Jerusalem 91120, Israel.
authors.forename: Hadas
authors.initials: H
authors.lastname: Gantz-Sorotsky
authors.affiliation: Department of Pathology, Hadassah and Hebrew University Medical Centre, Jerusalem, Israel.
authors.forename: Victoria
authors.initials: V
authors.lastname: Doviner
authors.affiliation: Thoracic Pathology Unit, Pathology Institute, Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Marina
authors.initials: M
authors.lastname: Perelman
authors.affiliation: Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Jair
authors.initials: J
authors.lastname: Bar
authors.affiliation: Institute of Oncology, Sheba Medical Center, Tel Hashomer, Israel.
authors.forename: Amir
authors.initials: A
authors.lastname: Onn
authors.affiliation: Department of Oncology, Hadassah and Hebrew University Medical Centre, P.O. Box 12000, Jerusalem 91120, Israel.
authors.forename: Beatrice
authors.initials: B
authors.lastname: Uziely
authors.affiliation: Department of Oncology, Hadassah and Hebrew University Medical Centre, P.O. Box 12000, Jerusalem 91120, Israel.
authors.forename: Tamar
authors.initials: T
authors.lastname: Peretz
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000097:blood*; D016022:Case-Control Studies; D003937:Diagnosis, Differential; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000379:methods; D010446:Peptide Fragments / Q000097:blood*; D011994:Recombinant Proteins; D055752:Small Cell Lung Carcinoma / Q000097:blood* / Q000175:diagnosis / Q000188:drug therapy
chemical_list: D014408:Biomarkers, Tumor; D010446:Peptide Fragments; D011994:Recombinant Proteins; C087079:pro-gastrin-releasing peptide (31-98)
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