by The ASCO Post Staff
Some people with advanced epithelial ovarian cancer may safely avoid having their lymph nodes removed during surgery without it impacting their survival outcomes, helping to reduce the risk of postoperative complications. This research was presented by Classe et al at the 2024 ASCO Annual Meeting (Abstract LBA5505).
About the CARACO Study
The phase III CARACO trial enrolled 379 patients with advanced epithelial ovarian cancer whose lymph nodes did not show signs of cancer before or during surgery to remove their primary cancer. Between December 2008 and March 2020, participants in the CARACO study were randomly assigned to either undergo a lymphadenectomy (n = 181) or not undergo the procedure (n = 187). Most patients—75%—received chemotherapy before their surgery.
Following surgery, most patients in both groups had no signs of cancer remaining, with 88% of those who received a lymphadenectomy showing no signs of disease vs 86% of those who did not. Patients in the lymphadenectomy group had a median of 28 lymph nodes removed during surgery; about half of these individuals had cancer in the lymph nodes, with a median of 3 lymph nodes affected.
Key Findings
After a median follow-up of 9 years, researchers found that omitting lymphadenectomy did not impact survival outcomes. In patients who did not receive a lymphadenectomy, progression-free survival was 14.8 months, compared to 18.5 months for those who underwent lymphadenectomy. The median overall survival was also similar between groups, with half of the participants who did not receive a lymphadenectomy still alive at 48.9 months vs 58 months for those who did. Neither of these results were statistically significant.
Participants who received a lymphadenectomy experienced more serious complications following surgery than those who did not, including needing additional surgery to manage complications from the initial operation, such as bleeding or fluid buildup (8.3% of participants who received a lymphadenectomy vs 3.2% of participants who did not) and needing a transfusion (34% vs 25%, respectively). However, the percentage of participants who died within 60 days of surgery was relatively similar between groups (1.1% vs 0.5%, respectively).
“We already had similar results in patients treated for advanced ovarian cancer with primary surgery followed with adjuvant chemotherapy from the LION trial, which was published [by Harter et al in The New England Journal of Medicine] in 2019. Today, the more frequent strategy in the case of advanced ovarian cancer is interval surgery…. After the publication of the LION trial, the remaining question was: what is the best strategy for considering the removal of the lymph nodes after neoadjuvant chemotherapy? CARACO helps answer this question for some patients,” said lead study author Jean-Marc Classe, MD, PhD, of Institut de Cancerologie de l’Ouest, Nantes University, Nantes, France.
Next Steps
The researchers plan to evaluate whether lymphadenectomy is useful for patients with advanced epithelial ovarian cancer who have signs of cancer in the lymph nodes prior to surgery.
ASCO Perspective
“This randomized phase III clinical trial shows that patients undergoing surgery for advanced ovarian cancer may be able to safely avoid having additional lymph nodes removed that do not appear to be involved with the primary cancer. While this study’s conclusion does not definitively show a difference between the two groups of patients, this is an important example of surgeons working to decrease the morbidity of surgery without compromising outcomes for people with cancer. There is still a need for better systemic therapies to improve outcomes in patients with advanced ovarian cancer,” commented Michael C. Lowe, MD, MA, of Emory University School of Medicine.
Disclosure: The CARACO study was funded by a national grant from the National Institute of Cancer in France. For full disclosures of the study authors, visit coi.asco.org.
This article was published by: The ASCO Post