Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study.

By Joan L. Walker, M. Piedmonte, N. Spirtos, S. Eisenkop, J. Schlaerth, Robert S. Mannel, R. Barakat, M. Pearl, Sudarshan K. Sharma. Journal of Clinical Oncology, 2012

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

Subfields: Obstetrics and Gynecology, Surgery

View Paper: https://www.semanticscholar.org/paper/d254512de62f85b46310959659be24a1be213b93

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Citations in the corpus

ESMO-ESGO-ESTRO Consensus Conference on Endometrial Cancer (2015, background): “Long-term outcomes of the randomised controlled LAP2 trial were published in 2012.(81) The primary endpoint was noninferiority of the recurrence-free interval.”
ESMO-ESGO-ESTRO consensus conference on endometrial cancer: Diagnosis, treatment and follow-up. (2015, background): “Long-term outcomes of the randomised controlled LAP2 trial were published in 2012 [81].”
ESGO/ESTRO/ESP guidelines for the management of patients with endometrial carcinoma (2020, background): “► The definition of prognostic risk groups is presented in Table 2 for both situations when molecular classification is known or unknown.”