title: The role of lymphadenectomy in endometrial cancer: was the ASTEC trial doomed by design and are we destined to repeat that mistake?
abstract: OBJECTIVE
  This study examines the design of previous and future trials of lymph node dissection in endometrial cancer.
  
  
  METHODS
  Data from previous trials were used to construct a decision analysis modeling the risk of lymphatic spread and the effects of treatment on patients with endometrial cancer. This model was then applied to previous trials as well as other future trial designs that might be used to address this subject.
  
  
  RESULTS
  Comparing the predicted and actual results in the ASTEC trial, the model closely mimics the survival results with and without lymph node dissection for the low and high risk groups. The model suggests a survival difference of less than 2% between the experimental and control arms of the ASTEC trial under all circumstances. Sensitivity analyses reveal that these conclusions are robust. Future trial designs were also modeled with hysterectomy only, hysterectomy with radiation in intermediate risk patients, and staging with radiation only with node positive patients. Predicted outcomes for these approaches yield survival rates of 88%, 90%, and 93% in clinical stage I patients who have a risk of pelvic node involvement of approximately 7%. These estimates were 78%, 82%, and 89% in intermediate risk patients who have a risk of nodal spread of approximately 15%.
  
  
  CONCLUSIONS
  This model accurately predicts the outcome of previous trials and demonstrates that even if lymph node dissection was therapeutic, these trials would have been negative due to study design. Furthermore, future trial designs that are being considered would need to be conducted in high-intermediate risk patients to detect any difference.
authors.affiliation: Division of Gynecologic Oncology, The Blumenthal Cancer Center at Carolinas Medical Center, 1025 Morehead Medical Drive, Suite 600, Charlotte, NC 28203, USA. wnaumann@mac.com
authors.forename: R Wendel
authors.initials: RW
authors.lastname: Naumann
mesh_terms: D003663:Decision Trees; D016889:Endometrial Neoplasms / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008198:Lymph Nodes / Q000473:pathology / Q000601:surgery*; D015233:Models, Statistical; D009367:Neoplasm Staging; D011379:Prognosis; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012307:Risk Factors