The addition of retroperitoneal lymphadenectomy (removal of the lymph nodes at the back of the abdomen) to cytoreductive surgery (removal of cancer from the abdomen) during primary surgery or after neoadjuvant (presurgical) chemotherapy among patients with advanced ovarian cancer did not improve progression-free survival or overall survival, according to results from the phase 3 CARACO trial presented in a press briefing at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
The median progression-free survival (PFS; the time a patient lives without their disease spreading or worsening) for those who did not receive retroperitoneal lymphadenectomy was 14.8 months versus 18.6 months for those who did. The median overall survival (OS; the time a patient lives following treatment, regardless of disease status) was 48.9 months for those who did not receive retroperitoneal lymphadenectomy versus 58.8 months for those who did.
“[The] CARACO trial is the only prospectively randomized trial asking the question of the impact of systematic lymphadenectomy in case of neoadjuvant therapy,” Dr. Jean-Marc Classe, head of the oncological surgery department at the Western Cancer Institute, said during the presentation.
In the multicenter, phase 3 CARACO trial, patients were assigned to receive either surgery with or without lymphadenectomy. Patients were included if they were older than 18 years, had epithelial ovarian cancer and no suspicious retroperitoneal lymph nodes being 2 centimeters or more. Additionally, patients needed to have stage 3 to 4A disease and feasible optimal primary surgery (surgery that can be used as the main means of treatment) to enroll. If optimal primary surgery was not feasible, interval surgery (surgery performed after chemotherapy or another treatment) after neoadjuvant chemotherapy was required for enrollment.
Patients were excluded from treatment if they had nonepithelial carcinoma/borderline carcinoma, previous retroperitoneal lymph node resection, and pelvic CT or MRI scan with nodes of more than 2 centimeters before any treatment. Residual tumors of more than 1 centimeter and complete surgery not being feasible after three of four cycles with neoadjuvant chemotherapy were also grounds for exclusion from the trial.
A total of 450 patients were enrolled, 379 were randomly assigned, and 314 events were observed. Of note, 22 events were missing from the final analysis.
Among patients who received retroperitoneal lymphadenectomy, the median number of resected (surgically removed) lymph nodes was 28. Additionally, 43% of patients had one or more lymph nodes involved with cancer.
Within 30 days of surgery, 29.7% of patients in the non-retroperitoneal lymphadenectomy arm had a transfusion or blood loss compared with 39.3% of patients who had the retroperitoneal lymphadenectomy. Reintervention was noted in 3.1% versus 8.3% of patients, and urinary injury was also highlighted in 0% versus 3.8%. A digestive fistula was observed in 1.1% versus 2.2%, a pulmonary embolism in 3.7% versus 1.6% and death in 0.5% versus 1.1%.
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