In a Chinese phase III trial (PHENIX) reported in The New England Journal of Medicine, Tu et al found that sentinel lymph node biopsy (SLNB) alone was noninferior in disease-free survival vs lymphadenectomy in women with early-stage cervical cancer and was associated with fewer surgical complications.
Study Details
Patients were enrolled into the open-label multicenter trial between December 2015 and December 2023. Biopsy was performed at time of surgery and followed by examination of frozen sections. A total of 838 patients with negative sentinel lymph nodes were intraoperatively assigned in a 1:1 ratio not to undergo pelvic lymphadenectomy (biopsy-only group, n = 420) or to undergo lymphadenectomy (lymphadenectomy group, n = 418). All patients underwent hysterectomy, with adjuvant therapy being provided according to a specified protocol. The primary endpoint was disease-free survival at 3 years, with a noninferiority margin of 5 percentage points in the upper limit of the confidence interval (CI) for the difference between the lymphadenectomy group and the biopsy-only group.
Key Findings
Median follow-up was 62.8 months. Disease-free survival at 3 years was 94.6% in the lymphadenectomy group vs 96.9% in the biopsy-only group (difference = −2.3 percentage points, 95% CI = −5.0% to 0.5%, P < .001 for noninferiority).
Cervical cancer–specific survival at 3 years was 99.2% in the biopsy-only group vs 97.8% in the lymphadenectomy group (hazard ratio for cancer death in competing-risks analysis = 0.37, 95% CI = 0.15–0.95).
Retroperitoneal nodal recurrences occurred in no patients in the biopsy-only group vs nine (2.2%) in the lymphadenectomy group.
Compared with the lymphadenectomy group, the biopsy-only group had a lower incidence of lymphocyst (8.3% vs 22.0%, P < .001), lymphedema (5.2% vs 19.1%, P < .001), paresthesia (4.0% vs 8.4%, P = .009), and pain (2.6% vs 7.9%, P = .001).
The investigators concluded: “In patients with early-stage cervical cancer, SLNB alone was noninferior to lymphadenectomy with respect to disease-free survival and was associated with fewer complications.”
Jihong Liu, MD, PhD, of Sun Yat-sen University Cancer Center, Guangzhou, China, is the corresponding author for The New England Journal of Medicine article.
Disclosure: The study was funded by Guangzhou Municipal Science and Technology and others. For full disclosures of all study authors, visit nejm.org.
