Philipp Harter, MD, PhD
SYSTEMATIC LYMPHADENECTOMY in patients with advanced ovarian cancer and complete resection offered no improvement in progression-free or overall survival in the Gynecologic Cancer Intergroup’s LION trial, reported at the 2017 ASCO Annual Meeting by Philipp Harter, MD, PhD, of the German Gynecological Oncology Group and Kliniken Essen-Mitte in Germany.1 “Our data indicate that systematic lymphadenectomy of clinically negative lymph nodes in patients with advanced ovarian cancer and complete resection should be omitted,” Dr. Harter concluded.
The study aimed to settle the question of whether lymphadenectomy has value in patients with primary advanced ovarian cancer who undergo macroscopic complete resection and who have no evidence of nodal involvement. Results of previous studies have been mixed, according to Dr. Harter. In the current long-term study, patients who underwent lymphadenectomy had more postoperative complications and greater 60-day mortality while deriving no survival benefit.
BETWEEN 2008 and 2012, the international LION trial enrolled 650 patients from centers that had been required to demonstrate adequate surgical skills. Patients had newly diagnosed advanced (stage IIb/IV) epithelial ovarian cancer, underwent macroscopic complete resection, and had clinically and radiographically negative lymph nodes. Patients were randomized to receive either systematic pelvic and para-aortic lymphadenectomy or no lymphadenectomy.
The groups were well matched; median age was 60 years, most patients had grade 2/3 serous histology and a very good performance status, and most (approximately 80%) received adjuvant platinum/taxane-based chemotherapy.
OF THE 323 women who underwent lymphadenectomy, a median of 57 lymph nodes were removed (35 pelvic, 22 para-aortic), and 55.7% of these resected nodes had micrometastases. The procedure added an additional 1 hour to the duration of surgery (P < .001) and resulted in greater blood loss (P < .001) and more need for transfusions (P = .005).
Following surgery, lymphadenectomy was associated with significantly higher rates of re-laparotomy for complications (12.4% vs 6.5%; P = .01), infections (25.8% vs. 18.6%; P = .03), and 60-day mortality (3.1% vs 0.9%; P = .049), Dr. Harter reported.
Lymphadenectomy offered no apparent benefit. For the entire population, median progression-free survival was 25.5 months, median overall survival was 67.2 months (65.5 months for lymphadenectomy vs 69.2 months without; P = .65), and the 5-year overall survival rate was 55.9%. Quality-of-life outcomes at various time points were also virtually identical. ■
DISCLOSURE: Dr. Harter has received honoraria from AstraZeneca and Roche; served as a consultant or advisor to AstraZeneca, Clovis Oncology, PharmaMar, Roche, Sotio, and Tesaro; and has received travel expenses from Medac.
1. Harter P, Sehouli J, Lorusso D, et al: LION: Lymphadenectomy in ovarian neoplasms. 2017 ASCO Annual Meeting. Abstract 5500. Presented June 2, 2017.
Ritu Salani, MD, MBA
STUDY DISCUSSANT Ritu Salani, MD, MBA, of The Ohio State University Wexner Medical Center, Columbus, agreed with the LION trial investigators.
“Omitting systemic lymph node dissection in patients who have both radiographic and clinically negative lymph nodes is...!-->!-->