Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis

Abstract

No randomised trials have addressed the value of systematic aortic and pelvic lymphadenectomy (SL) in ovarian cancer macroscopically confined to the pelvis. This study was conducted to investigate the role of SL compared with lymph nodes sampling (CONTROL) in the management of early stage ovarian cancer. A total of 268 eligible patients with macroscopically intrapelvic ovarian carcinoma were randomised to SL (N ¼ 138) or CONTROL (N ¼ 130). The primary objective was to compare the proportion of patients with retroperitoneal nodal involvement between the two groups. Median operating time was longer and more patients required blood transfusions in the SL arm than the CONTROL arm (240 vs 150 min, Po0.001, and 36 vs 22%, P ¼ 0.012, respectively). More patients in the SL group had positive nodes at histologic examination than patients on CONTROL (9 vs 22%, P ¼ 0.007). Postoperative chemotherapy was delivered in 66% and 51% of patients with negative nodes on CONTROL and SL, respectively (P ¼ 0.03). At a median follow-up of 87.8 months, the adjusted risks for progression (hazard ratio [HR] ¼ 0.72, 95%CI ¼ 0.46 -1.21, P ¼ 0.16) and death (HR ¼ 0.85, 95%CI ¼ 0.49 -1.47, P ¼ 0.56) were lower, but not statistically significant, in the SL than the CONTROL arm. Five-year progression-free survival was 71.3 and 78.3% (difference ¼ 7.0%, 95% CI ¼ -3.4 -14.3%) and 5-year overall survival was 81.3 and 84.2% (difference ¼ 2.9%, 95% CI ¼ À7.0 -9.2%) respectively for CONTROL and SL. SL detects a higher proportion of patients with metastatic lymph nodes. This trial may have lacked power to exclude clinically important effects of SL on progression free and overall survival.

Feasibility of Upfront Debulking Surgery versus Neoadjuvant Chemotherapy Followed by Interval Debulking Surgery for Advanced Ovarian Cancer

“…Neoadjuvant chemotherapy decreases tumor volume and facilitates surgical procedures especially chemosensitive tumor which had completed or partial clinical response achievement in 76% of patients with less residual volume which had an impact of decrease morbidity and mortality and improving clinical outcome [16]- [23]. Analysis of our data showed significant improvement in both progression-free survival and overall survival in those underwent NACT-IDS compared to PDS-ACTR these results comparable to those published by Kuhn et al [24] [25], Rose et al, and Muggia et al [6] [24] [25] [26], they showed prolonged survival times and significantly better median survival in NACT group than the conventional PDS-ACTR. According to data published by Onnis et al [18] and Surwit et al…”

“…≤30% of the patients with apparently early epithelial ovarian cancer might be upstaged after comprehensive surgical staging [3] [4]. Previous reports by Cass et al and Maggioni et al showed that patients with even early ovarian tumor confined to ovary might have pelvic or even Para aortic lymph nodes metastases which making systemic lymphadenectomy improving progression-free survival and disease-free survival [5] [6]. Although advances in diagnosis and management of epithelial ovarian cancer have changed in the last 25 years, the overall survival has not been improved as approximately 65% to 70% of all ovarian cancer continues to be diagnosed with advanced stage (III or IV).…”

The potential therapeutic role of lymph node resection in epithelial ovarian cancer: a study of 13 918 patients

“…In another randomised trial of 268 patients with epithelial ovarian cancer macroscopically confined to the pelvis after cytoreductive surgery, Maggioni et al (2006) compared the effects of a systematic lymphadenectomy to random sampling of retroperitoneal lymph nodes. These authors revealed that systematic lymphadenectomy was associated with an improvement in both progression-free and overall survival; however, neither was statistically significant.…”

Advanced Ovarian Cancer: Primary or Interval Debulking? Five Categories of Patients in View of the Results of Randomized Trials and Tumor Biology: Primary Debulking Surgery and Interval Debulking Surgery for Advanced Ovarian Cancer

“…Although systemic lymphadenectomy is part of the staging procedure in EOC [30][31][32][33][34], two large RCTs in AOC failed to show a significantsurvivaladvantageofsystemiclymphadenectomy [33,34]. However, both trials showed a trend toward a longer progressionfree interval.…”

“…However, both trials showed a trend toward a longer progressionfree interval. Complete lymphadenectomy is advised when optimal debulking is possible in the peritoneal cavity [1,33,34].…”