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

BACKGROUND: Pelvic lymph nodes are the most common site of extrauterine tumor spread in early-stage endometrial cancer, but the clinical impact of lymphadenectomy has not been addressed in randomized studies. We conducted a randomized clinical trial to determine whether the addition of pelvic systematic lymphadenectomy to standard hysterectomy with bilateral salpingo-oophorectomy improves overall and disease-free survival. METHODS: From October 1, 1996, through March 31, 2006, 514 eligible patients with preoperative International Federation of Gynecology and Obstetrics stage I endometrial carcinoma were randomly assigned to undergo pelvic systematic lymphadenectomy (n = 264) or no lymphadenectomy (n = 250). Patients' clinical data, pathological tumor characteristics, and operative and early postoperative data were recorded at discharge from hospital. Late postoperative complications, adjuvant therapy, and follow-up data were collected 6 months after surgery. Survival was analyzed by use of the log-rank test and a Cox multivariable regression analysis. All statistical tests were two-sided. RESULTS: The median number of lymph nodes removed was 30 (interquartile range = 22-42) in the pelvic systematic lymphadenectomy arm and 0 (interquartile range = 0-0) in the no-lymphadenectomy arm (P < .001). Both early and late postoperative complications occurred statistically significantly more frequently in patients who had received pelvic systematic lymphadenectomy (81 patients in the lymphadenectomy arm and 34 patients in the no-lymphadenectomy arm, P = .001). Pelvic systematic lymphadenectomy improved surgical staging as statistically significantly more patients with lymph node metastases were found in the lymphadenectomy arm than in the no-lymphadenectomy arm (13.3% vs 3.2%, difference = 10.1%, 95% confidence interval [CI] = 5.3% to 14.9%, P < .001). At a median follow-up of 49 months, 78 events (ie, recurrence or death) had been observed and 53 patients had died. The unadjusted risks for first event and death were similar between the two arms (hazard ratio [HR] for first event = 1.10, 95% CI = 0.70 to 1.71, P = .68, and HR for death = 1.20, 95% CI = 0.70 to 2.07, P = .50). The 5-year disease-free and overall survival rates in an intention-to-treat analysis were similar between arms (81.0% and 85.9% in the lymphadenectomy arm and 81.7% and 90.0% in the no-lymphadenectomy arm, respectively). CONCLUSION: Although systematic pelvic lymphadenectomy statistically significantly improved surgical staging, it did not improve disease-free or overall survival.

Lymph node mapping and sentinel node detection in patients with cervical carcinoma: a 2-year experience.

OBJECTIVE: To describe our experience with the sentinel lymph node biopsy in cervical cancer patients, using a laparotomic approach and blue dye technique. METHODS: Between January 2003 and January 2005, patients with histologically proven FIGO stage IA2 to IIA carcinoma of the uterine cervix were submitted to SLN procedure if they were scheduled to have radical abdominal hysterectomy and pelvic lymphadenectomy. The SLN mapping was done after intracervical methylene blue (4 ml) injection. Final pathologic evaluation of SLNs included serial step sections and wide spectrum cytokeratin immunohistochemical analysis. RESULTS: Fifty patients were accrued to this prospective observational double-center study. A total of 86 SLNs (mean 1.9) were identified in the 45 patients with fruitful quest for SLN detection. The SLN detection rate per patient was 90%, and for the side of dissection, 72%. Bilateral SLNs were detected in 60% of cases. SLNs were identified in the external iliac and obturator areas in 55% and 38%, respectively; 5 isolated SLNs were discovered in the common iliac region. Ten patients (20%) had lymph node metastases; one of these had false-negative SLN. The false-negative rate and the negative predictive value, calculated by patient and by side of dissection, were 10% and 97.2%, and 8.3% and 98.4%, respectively. CONCLUSIONS: SLN detection with blue dye is a feasible procedure, particularly useful as a surgical staging procedure in young patients with small tumors. The true morbidity-sparing role of this technique in cervical cancer treatment is yet to be found.