Their randomized trial addressed a question that’s been somewhat controversial for years, that is, whether survival is better with systematic aortic and pelvic lymphadenectomy — which involves removing at least 40 nodes — instead of selective lymph node removal.
In the new study, overall survival at five years was 67.4% vs. 63.5%, respectively, with removal of only suspicious nodes vs systematic aortic and pelvic lymphadenectomy (SAPL) after primary debulking and chemotherapy.
At ten years, overall survival was 56.2% vs. 54.2% in the two groups.
The authors say they undertook the study because some prior retrospective research had suggested that removing large numbers of nodes led to improved survival. But Dr. J.B. Trimbos, who chairs the gynecology department at Leiden University, The Netherlands told Reuters Health via email that SAPL “is nowadays for the greater part abandoned.”
Starting in 1991 and continuing through 2001, researchers at six hospitals enrolled 322 women with epithelial ovarian cancer stages IA-IV at the time of their first surgery who had good performance status and were younger than 75 years old.
During second-look operations, the women were randomly assigned to have selective or systematic lymphadenectomy once the surgeon was sure there was less than 1 cm of residual tumor. In the selective group, surgeons excised all suspicious nodes of 1 cm or larger.
Baseline patient tumor and clinical parameters, including stages of disease, were not significantly different between the selective and systematic groups, and prior chemotherapy regimens were also similar.
The final intention to treat analysis was performed on 150 patients in the control group and 158 in the SAPL group.
The SAPL arm had similar cytoreductive surgery but (not surprisingly) more complete aortic and pelvic lymphadenectomy, with at least 25 nodes excised during the pelvic dissection and 15 nodes removed for the aortic area. The median number of aortic and pelvic nodes removed in the SAPL group was 44 vs. eight for the controls.
The extent of debulking surgery was similar in the two groups, but systematic aortic and pelvic lymphadenectomy resulted in significantly longer operations and hospital stays, and more blood loss and transfusions.
At least one positive pelvic or aortic node was detected in 38 women in the SAPL arm and 20 in the control group (24.2% vs. 13.3%; p=0.02).
But at a median follow-up of 111 months, 74 women in the control group (49.3%) and 89 in the SAPL group (56.3%) had recurrences, which was not a statistically significant difference.
Progression free survival rates were also statistically similar at five years (53.8% in controls vs. 40.9% in SAPL patients) and 10 years (44.4% vs. 39.4%).
The authors of the study did not respond to requests for comment. Dr. Trimbos, however, says SAPL is “certainly” uncalled-for in a second-look setting. “In primary surgery, its use is debated and there is some evidence that focused lymph node sampling from various sites is equally effective,” he said.
He feels that at primary surgery for early ovarian cancer (Stages I and II), when it’s necessary to establish a prognosis, either SAPL or just focused sampling from different sites could be the standard of care. For Stages III and IV, where node excision is considered therapeutic, the optimal lymph node procedure is still uncertain.
The study was published online August 13th in the British Journal of Cancer.