title: Novel high-sensitive D-dimer determination predicts chemotherapy-associated venous thromboembolism in intermediate risk lung cancer patients.
abstract: BACKGROUND
  We hypothesized that the use of a novel high sensitivity (HS) assay for D-dimer determination might ameliorate venous thromboembolism (VTE) risk prediction in intermediate risk lung cancer patients in whom chemotherapy could act as a trigger for VTE onset.
  
  
  METHODS
  Pretreatment HS D-dimer levels were retrospectively evaluated in 108 lung cancer outpatients using a novel automated latex enhanced turbidimetric immunoassay. All patients were at the start of a new platinum-based chemotherapy regimen and were classified as intermediate risk according to Khorana's assessment model. Patients were followed-up for a median period of 6.9 months.
  
  
  RESULTS
  Receiver operating characteristic (ROC) curves and corresponding Bayesian analysis showed that the best performance was obtained at a cutoff level of 1500 ng/mL, which resulted in a sensitivity of 81%, a specificity of 69%, a positive predictive value (PPV) of 31%, a negative predictive value (NPV) of 96%, and an accuracy of 70%. Patients with HS D-dimer levels above the cutoff had a worse VTE-free survival (60%) compared with those with levels below the cutoff (95%; P = .0001). Multivariate Cox proportional hazards survival analysis confirmed that pretreatment HS D-dimer levels were able to significantly predict VTE with a hazard ratio of 11 (95% confidence interval, 2.62-46.2; P = .001), independently of classic VTE risk factors.
  
  
  CONCLUSIONS
  The use of HS D-dimer determination prior to chemotherapy might allow for VTE risk stratification of intermediate risk cancer patients, helping in identifying those individuals who could benefit from thromboprophylaxis.
authors.affiliation: Department of Laboratory Medicine and Advanced Biotechnologies, IRCCS San Raffaele, Rome, Italy. patrizia.ferroni@sanraffaele.it
authors.forename: Patrizia
authors.initials: P
authors.lastname: Ferroni
authors.forename: Francesca
authors.initials: F
authors.lastname: Martini
authors.forename: Ilaria
authors.initials: I
authors.lastname: Portarena
authors.forename: Gioia
authors.initials: G
authors.lastname: Massimiani
authors.forename: Silvia
authors.initials: S
authors.lastname: Riondino
authors.forename: Francesca
authors.initials: F
authors.lastname: La Farina
authors.forename: Sabrina
authors.initials: S
authors.lastname: Mariotti
authors.forename: Fiorella
authors.initials: F
authors.lastname: Guadagni
authors.forename: Mario
authors.initials: M
authors.lastname: Roselli
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D057205:Automation, Laboratory; D001499:Bayes Theorem; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000378:metabolism*; D005500:Follow-Up Studies; D006801:Humans; D007118:Immunoassay; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D009391:Nephelometry and Turbidimetry / Q000379:methods; D010045:Outpatients; D017671:Platinum Compounds / Q000008:administration & dosage; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012372:ROC Curve; D012189:Retrospective Studies; D012307:Risk Factors; D012680:Sensitivity and Specificity; D015996:Survival Rate; D054556:Venous Thromboembolism / Q000139:chemically induced / Q000175:diagnosis*
chemical_list: D005338:Fibrin Fibrinogen Degradation Products; D017671:Platinum Compounds; C036309:fibrin fragment D