Recurrence and Survival After Random Assignment to Laparoscopy Versus Laparotomy for Comprehensive Surgical Staging of Uterine Cancer: Gynecologic Oncology Group LAP2 Study

TLDR

Overall survival at 5 years was nearly identical (≈90%) in both laparoscopy and laparotomy arms, while laparoscopy had previously shown advantages in short‑term safety and length of stay. The study aimed to determine whether laparoscopy was noninferior to laparotomy for recurrence after comprehensive surgical staging of uterine cancer. Patients with stage I–IIA disease were randomized 2:1 to laparoscopy or laparotomy for hysterectomy, salpingo‑oophorectomy, pelvic cytology, and pelvic and para‑aortic lymphadenectomy, with the primary endpoint being a noninferiority margin of ≤40 % increased recurrence risk. Laparoscopy did not meet the noninferiority criterion (hazard ratio 1.14, 90 % lower bound 0.92), but recurrence rates were low and similar (11.4 % vs 10.2 % at 3 years) and 5‑year overall survival was essentially identical (≈90 %), indicating only a small potential increase in recurrence risk.

Abstract

The primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of uterine cancer.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.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%.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.