Sentinel lymph node biopsy new standard of care for early-stage cervical cancer

medwireNews: Among women with early-stage cervical cancer, sentinel lymph node biopsy alone is noninferior to lymphadenectomy with regard to disease-free survival (DFS), a Chinese phase 3 trial has demonstrated.

Moreover, it was superior to lymphadenectomy in terms of surgical outcomes and complications, report Jihong Liu (Sun Yat-sen University Cancer Center, Guangzhou, China) and co-investigators in The New England Journal of Medicine.

“Therefore, our findings support the use of sentinel-lymph-node biopsy as a new standard for surgical management of early-stage cervical cancer,” they write.

The researchers explain that although pelvic lymphadenectomy “has maintained its role as the standard procedure” for the treatment of early-stage cervical cancer for more than a century, it “has inherent limitations,” such as prolonging operative duration and increasing the risk for complications.

To evaluate whether sentinel lymph node biopsy alone could yield comparable outcomes, they launched the PHENIX trial, recruiting patients with stage IA1 (with lymphovascular invasion), IA2, IB1, or IIA1 disease according to 2009 FIGO criteria from 11 hospitals in China.

All participants underwent sentinel lymph node biopsy at the time of surgery, and this report focuses on cohort I of the trial, which comprised patients with negative nodes, who were randomly assigned intraoperatively to either undergo (n=418) or not undergo (n=420) lymphadenectomy.

After a median follow-up of 62.8 months, the primary endpoint of DFS at 3 years was 96.9% for sentinel lymph node biopsy alone and 94.6% for lymphadenectomy, equating to a difference of 2.3 percentage points.

“[T]he upper limit of the confidence interval for the between-group difference in 3-year disease-free survival (0.5 percentage points) was below the prespecified noninferiority margin of 5 percentage points,” thus demonstrating the noninferiority of biopsy alone, report the study authors.

Of note, patients in the biopsy alone group did not experience retroperitoneal nodal recurrences, whereas they occurred in 2.2% of those in the lymphadenectomy group. And the respective 3-year cancer-specific survival rates were 99.2% and 97.8%, which gave a hazard ratio for death in competing risks analysis of 0.37 in favor of biopsy alone.

Surgical outcomes and safety data back efficacy findings

The mean operative duration was shorter in the biopsy alone than lymphadenectomy group (189 vs 222 min) as was the hospital stay (6.3 vs 6.6 days). There was also less blood loss during surgery (mean 130 vs 159 mL), a lower incidence of intraoperative complications (1.2 vs 3.8%), and a shorter duration of antibiotic use (mean 3.4 vs 3.7 days).

Additionally. postoperative adverse events occurred significantly less frequently among participants who underwent biopsy alone, at a rate of 58.1% compared with 71.3% for those who underwent lymphadenectomy.

The differences were significant with respect to the incidences of lymphocyst (8.3 vs 22.0%), lymphedema (5.2 vs 19.1%), hypoalbuminemia (6.4 vs 12.9%), paresthesia (4.0 vs 8.4%), and pain (2.6 vs 7.9%), report Liu and colleagues.

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N Engl J Med 2025; 393: 1463–1474