Many women undergoing surgery for ovarian cancer also undergo systematic pelvic and para-aortic lymphadenectomy, often despite a macroscopically complete resection with no evidence of lymph node enlargement. Now, data from a randomized controlled trial demonstrate that lymphadenectomy does not improve the outcomes of this patient population.
A total of 1,895 women were assessed for trial eligibility, 1,245 of whom were excluded predominantly owing to incomplete resection, enlarged lymph nodes or other histological findings that met the exclusion criteria. A total of 650 eligible patients were randomly assigned (1:1) to undergo surgery with or without lymphadenectomy. The primary end point was overall survival (OS); secondary end points included progression-free survival (PFS) and quality of life.
No significant differences in OS (HR for death in the lymphadenectomy group 1.06, 95% CI 0.83–1.34; P = 0.65) or PFS (HR 1.11, 95% CI 0.92–1.34; P = 0.29) were observed between the groups. However, patients in the no lymphadenectomy group had a decreased risk of almost all post-operative complications, including the need for repeat laparotomy (12.4% versus 6.5% of patients; P = 0.01) and risk of death within 60 days of surgery (3.1% versus 0.9%; P = 0.049). The finding of no significant difference in OS or PFS is of particular interest given that analysis of lymph node specimens from patients in the lymphadenectomy group revealed the presence of microscopic metastases in 55.7% of patients.
These results contradict the findings of a previous trial, and this difference is largely attributed to the prior prospective evaluation of surgical performance of participating centres and the exclusion of all patients with bulky lymph nodes, for whom lymphadenectomy is clearly necessary. In conclusion, this trial provides level 1 evidence that patients with no obvious signs of lymph node metastases during surgery can safely forego lymphadenectomy.
Harter, P. et al. A randomized trial of lymphadenectomy in patients with advanced ovarian neoplasms. N. Engl. J. Med. 380, 822–832 (2019)
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Sidaway, P. Lymphadenectomy is not always required. Nat Rev Clin Oncol 16, 337 (2019). https://doi.org/10.1038/s41571-019-0200-x