Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial: trial

Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial

Population

Eligible patients with preoperative FIGO stage I endometrial carcinoma

Design

Randomised trial. From 1 October 1996 through 31 March 2006, 514 eligible patients with preoperative FIGO stage I endometrial carcinoma were randomly assigned to hysterectomy with bilateral salpingo-oophorectomy plus pelvic systematic lymphadenectomy (n = 264) or the same operation without lymphadenectomy (n = 250). Survival was analysed with the log-rank test and Cox multivariable regression; median follow-up was 49 months.

Arms

No lymphadenectomy (control, n = 250): Standard hysterectomy with bilateral salpingo-oophorectomy, without lymphadenectomy
Pelvic systematic lymphadenectomy (experimental, n = 264): Standard hysterectomy with bilateral salpingo-oophorectomy plus pelvic systematic lymphadenectomy

People

Benedetti Panici P

DFSHR 1.10 (95% CI 0.70–1.71)Δ 60-month DFS−0.7 pointsOSHR 1.20 (95% CI 0.70–2.07)Δ 60-month OS−4.1 pointsΔ Lymph node metastases found at surgery+10.1 points

Show the numbers

Results reported for Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial
Endpoint	Analysis	Pelvic systematic lymphadenectomy	No lymphadenectomy	Effect
DFSRandomised eligible patients; 5-year rates in an intention-to-treat analysis, hazard ratio unadjustedHazard ratio is for first event (recurrence or death)	primarymedian follow-up 49 monthsBenedetti 2008	81% at 5 y	81.7% at 5 y	HR 1.10 (95% CI 0.70–1.71)P=.6878 events (recurrence or death) at a median follow-up of 49 months. Hazard ratio is lymphadenectomy vs none.
OSRandomised eligible patients; 5-year rates in an intention-to-treat analysis, hazard ratio unadjusted	primarymedian follow-up 49 monthsBenedetti 2008	85.9% at 5 y	90% at 5 y	HR 1.20 (95% CI 0.70–2.07)P=.5053 patients had died at a median follow-up of 49 months. Hazard ratio is lymphadenectomy vs none.
Lymph node metastases found at surgeryRandomised eligible patients (514)	primaryBenedetti 2008	13.3%	3.2%	P<.001Difference 10.1% (95% CI 5.3% to 14.9%). The median number of lymph nodes removed was 30 (interquartile range 22-42) with lymphadenectomy and 0 without.

Results reported for Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial
Endpoint	Analysis	Pelvic systematic lymphadenectomy	No lymphadenectomy	Effect
DFSRandomised eligible patients; 5-year rates in an intention-to-treat analysis, hazard ratio unadjustedHazard ratio is for first event (recurrence or death)	primarymedian follow-up 49 monthsBenedetti 2008	81% at 5 y	81.7% at 5 y	HR 1.10 (95% CI 0.70–1.71)P=.6878 events (recurrence or death) at a median follow-up of 49 months. Hazard ratio is lymphadenectomy vs none.
OSRandomised eligible patients; 5-year rates in an intention-to-treat analysis, hazard ratio unadjusted	primarymedian follow-up 49 monthsBenedetti 2008	85.9% at 5 y	90% at 5 y	HR 1.20 (95% CI 0.70–2.07)P=.5053 patients had died at a median follow-up of 49 months. Hazard ratio is lymphadenectomy vs none.
Lymph node metastases found at surgeryRandomised eligible patients (514)	primaryBenedetti 2008	13.3%	3.2%	P<.001Difference 10.1% (95% CI 5.3% to 14.9%). The median number of lymph nodes removed was 30 (interquartile range 22-42) with lymphadenectomy and 0 without.

Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.

Data table

Endpoint	HR	95% CI
DFS	1.1	0.7–1.71
OS	1.2	0.7–2.07

Appears in

2008 Systematic lymphadenectomy: no survival benefit shown in two trials

Sources

Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M, Scambia G, et al. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst. 2008;100(23):1707-16.
PubMed DOI