title: The impact of a fourteen-gene molecular assay on physician treatment decisions in non-small-cell lung cancer.
abstract: BACKGROUND
  Five-year survival in early-stage, non-squamous, non-small-cell lung cancer (NSCLC) remains poor compared with other solid tumors, even after complete resection. Post-operative management depends on prognostic staging to identify individuals at highest risk for death, and therefore with the greatest need for further intervention. A 14-gene quantitative RT-PCR test successfully differentiates stage I-III NSCLC patients who are at high-, intermediate-, or low-risk for 5-year mortality. This study assesses the impact of the assay's prognostic information on physician decisions regarding adjuvant chemotherapy.
  
  
  METHODS
  We invited 115 physicians who ordered the test to participate in an on-line survey. The primary outcome measure was the proportion of patients with different pre- and post-test chemotherapy recommendations.
  
  
  RESULTS
  Fifty-eight physicians (50 %) completed the survey on 120 stage I or II NSCLC patients. Ninety-one patients (76 %) had stage I lung cancer; 27 (23 %), 39 (33 %), and 54 (45 %) patients had low-, intermediate-, and high-risk scores, respectively. Physicians' chemotherapy recommendations were changed post-testing in 37 patients (30.8 %, 95 % CI 22.7-39.9 %). High-risk patients were more likely to have a change in treatment recommendation (44.4 %, 95 % CI 30.9-58.6 %) than low risk patients (3.7 %, 95 % CI 0.1-19.0 %); a substantial number of changes were observed in both stage I (33.0 %, 95 % CI 23.5-43.6 %) and stage II (24.1 %, 95 % CI 10.3-43.5 %).
  
  
  CONCLUSIONS
  Our data show that the assay resulted in a significant impact on physician treatment decisions in early-stage NSCLC, and that the nature of treatment changes generally correlated with the test's assessment of risk.
authors.affiliation: Valley Medical Oncology Consultants, 2940 Whipple Ave., Redwood City, CA, USA.
authors.forename: Shane
authors.initials: S
authors.lastname: Dormady
authors.forename: Michael S
authors.initials: MS
authors.lastname: Broder
authors.forename: Girish V
authors.initials: GV
authors.lastname: Putcha
authors.forename: Robert H
authors.initials: RH
authors.lastname: Dumanois
authors.forename: Alison H
authors.initials: AH
authors.lastname: DeCristofaro
authors.forename: Eunice
authors.initials: E
authors.lastname: Chang
authors.forename: Paul R
authors.initials: PR
authors.lastname: Billings
authors.forename: Thierry
authors.initials: T
authors.lastname: Jahan
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001681:Biological Assay / Q000379:methods; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics* / Q000473:pathology; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003657:Decision Making; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis