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A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms

New England Journal of Medicine Mar 05, 2019

Harter P, et al. - The efficacy of lymphadenectomy in patients with advanced ovarian cancer was assessed in this randomized trial. According to findings, no benefit from systematic pelvic and paraaortic lymphadenectomy was seen in overall or progression-free survival in patients with advanced ovarian cancer who had undergone intraabdominal macroscopically complete resection and had normal lymph nodes both before and during surgery vs those who did not undergo lymphadenectomy. Furthermore, a higher incidence of postoperative complications was seen among those who underwent lymphadenectomy.

Methods

  • Participants were patients with newly diagnosed advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage IIB through IV) who had undergone macroscopically complete resection and had normal lymph nodes both before and during surgery.
  • Researchers intraoperatively randomly assigned the participants to either undergo or not undergo lymphadenectomy.
  • Overall survival was assessed as primary end point.

Results

  • This study included 647 patients, who were randomized from December 2008 through January 2012 to either undergo lymphadenectomy (323 patients) or not undergo lymphadenectomy (324 patients).
  • A median number of 57 nodes (35 pelvic and 22 paraaortic nodes) were removed in patients who had lymphadenectomy.
  • The no-lymphadenectomy group and the lymphadenectomy group had median overall survival of 69.2 months and 65.5 months, respectively (hazard ratio for death in the lymphadenectomy group, 1.06; 95% confidence interval [CI], 0.83 to 1.34; P=0.65), and each group had median progression-free survival of 25.5 months (hazard ratio for progression or death in the lymphadenectomy group, 1.11; 95% CI, 0.92 to 1.34; P=0.29).
  • Patients in the lymphadenectomy group more frequently experienced serious postoperative complications (eg, incidence of repeat laparotomy, 12.4% vs 6.5% [P=0.01]; mortality within 60 days after surgery, 3.1% vs 0.9% [P=0.049]).
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