title: Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study.
abstract: OBJECTIVE
  The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of uterine cancer.
  
  
  METHODS
  Patients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n = 1,696) versus laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy.
  
  
  RESULTS
  With a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence rates were substantially lower than anticipated, resulting in an estimated 3-year recurrence rate of 11.4% with laparoscopy and 10.2% with laparotomy, or a difference of 1.14% (90% lower bound, -1.28; 95% upper bound, 4.0). The estimated 5-year overall survival was almost identical in both arms at 89.8%.
  
  
  CONCLUSIONS
  This study previously reported that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay end points. The potential for increased risk of cancer recurrence with laparoscopy versus laparotomy was quantified and found to be small, providing accurate information for decision making for women with uterine cancer.
authors.affiliation: University of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA. joan-walker@ouhsc.edu
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.forename: Marion R
authors.initials: MR
authors.lastname: Piedmonte
authors.forename: Nick M
authors.initials: NM
authors.lastname: Spirtos
authors.forename: Scott M
authors.initials: SM
authors.lastname: Eisenkop
authors.forename: John B
authors.initials: JB
authors.lastname: Schlaerth
authors.forename: Robert S
authors.initials: RS
authors.lastname: Mannel
authors.forename: Richard
authors.initials: R
authors.lastname: Barakat
authors.forename: Michael L
authors.initials: ML
authors.lastname: Pearl
authors.forename: Sudarshan K
authors.initials: SK
authors.lastname: Sharma
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007044:Hysterectomy / Q000009:adverse effects / Q000379:methods*; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods; D008197:Lymph Node Excision; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000473:pathology; D009367:Neoplasm Staging; D010052:Ovariectomy / Q000009:adverse effects / Q000379:methods*; D011446:Prospective Studies; D012008:Recurrence; D015996:Survival Rate; D014594:Uterine Neoplasms / Q000473:pathology / Q000601:surgery*; D055815:Young Adult