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LAP2

Needs review

Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2

Phase 3N = 2,616NCT00002706

Population
Patients with clinical stage I to IIA uterine cancer
Design
Randomised (two to one) comparison of laparoscopy (n = 1,696) with open laparotomy (n = 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology and pelvic and para-aortic lymphadenectomy in patients with clinical stage I to IIA uterine cancer. The 2009 report covered short-term outcomes (6-week morbidity and mortality, hospital stay, conversion). The 2012 report's primary endpoint was non-inferiority of the recurrence-free interval, defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy.
Primary endpoint
Recurrence-free interval
Arms
  • Laparoscopy (experimental, n = 1,696): Laparoscopic hysterectomy, salpingo-oophorectomy, pelvic cytology and pelvic and para-aortic lymphadenectomy
  • Laparotomy (control, n = 920): Open hysterectomy, salpingo-oophorectomy, pelvic cytology and pelvic and para-aortic lymphadenectomy
People
Walker JL, Gynecologic Oncology Group
Δ Moderate to severe postoperative adverse events−7 pointsΔ Hospital stay longer than 2 days−42 pointsRecurrence-free intervalHR 1.14Δ 3-year recurrence rate+1.2 points
Show the numbers
Results reported for LAP2
EndpointAnalysisLaparoscopyLaparotomyEffect
Moderate to severe postoperative adverse eventsRandomised patients (analysis population not stated in the abstract)primaryWalker 200914%21%P<.0001Intraoperative complication rates were similar; median operative time was longer with laparoscopy (204 vs 130 minutes, P < .001).
Laparoscopy completed without conversionPatients in whom laparoscopy was initiated (n = 1,682)primaryWalker 200974.2%—1,248 of 1,682. Reasons for conversion to laparotomy: poor visibility 14.6%, metastatic cancer 4.1%, bleeding 2.9%, other cause 4.2%.
Hospital stay longer than 2 daysRandomised patients (analysis population not stated in the abstract)primaryWalker 200952%94%P<.0001
Recurrence-free intervalRandomised patients (1,696 laparoscopy, 920 laparotomy)primarymedian follow-up 59 monthsWalker 2012——HR 1.14Hazard ratio for laparoscopy relative to laparotomy, reported with a 90% lower bound of 0.92 and a 95% upper bound of 1.46 (not a two-sided 95% interval); this fell short of the protocol-specified definition of non-inferiority. 309 recurrences (210 laparoscopy, 99 laparotomy) and 350 deaths (229, 121); the median follow-up of 59 months is for 2,181 patients still alive.
3-year recurrence rateRandomised patients (1,696 laparoscopy, 920 laparotomy)primaryWalker 201211.4%10.2%Estimated rates; difference 1.14% (90% lower bound -1.28; 95% upper bound 4.0). The abstract states that actual recurrence rates were substantially lower than anticipated.
Results reported for LAP2
EndpointAnalysisLaparoscopyLaparotomyEffect
Moderate to severe postoperative adverse eventsRandomised patients (analysis population not stated in the abstract)primaryWalker 200914%21%P<.0001Intraoperative complication rates were similar; median operative time was longer with laparoscopy (204 vs 130 minutes, P < .001).
Laparoscopy completed without conversionPatients in whom laparoscopy was initiated (n = 1,682)primaryWalker 200974.2%—1,248 of 1,682. Reasons for conversion to laparotomy: poor visibility 14.6%, metastatic cancer 4.1%, bleeding 2.9%, other cause 4.2%.
Hospital stay longer than 2 daysRandomised patients (analysis population not stated in the abstract)primaryWalker 200952%94%P<.0001
Recurrence-free intervalRandomised patients (1,696 laparoscopy, 920 laparotomy)primarymedian follow-up 59 monthsWalker 2012——HR 1.14Hazard ratio for laparoscopy relative to laparotomy, reported with a 90% lower bound of 0.92 and a 95% upper bound of 1.46 (not a two-sided 95% interval); this fell short of the protocol-specified definition of non-inferiority. 309 recurrences (210 laparoscopy, 99 laparotomy) and 350 deaths (229, 121); the median follow-up of 59 months is for 2,181 patients still alive.
3-year recurrence rateRandomised patients (1,696 laparoscopy, 920 laparotomy)primaryWalker 201211.4%10.2%Estimated rates; difference 1.14% (90% lower bound -1.28; 95% upper bound 4.0). The abstract states that actual recurrence rates were substantially lower than anticipated.
Primary publication: Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27(32):5331-6. PubMedDOI

Appears in

Sources

  1. Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, et al. Laparoscopy compared with laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009;27(32):5331-6.

    PubMedDOI

  2. Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, et al. Recurrence and survival after random assignment to laparoscopy versus laparotomy for comprehensive surgical staging of uterine cancer: Gynecologic Oncology Group LAP2 Study. J Clin Oncol. 2012;30(7):695-700.

    PubMedDOI