Non-inferior disease-free survival after sentinel lymph node biopsy in cervical cancer

The phase 3 PHENIX trial demonstrated that sentinel lymph node biopsy (SLNB) in participants with early-stage cervical cancer was non-inferior to pelvic lymphadenectomy (PL) concerning disease-free survival (DFS).

PL has been in practice for over a century in the treatment of cervical cancer. However, the incidence of lymph node metastasis in early-stage cervical cancer is relatively low, and PL comes with increased morbidity. However, evidence from randomised trials that would support the omission of PL in patients with negative SLNB remains insufficient [1].

The phase 3 PHENIX/CSEM 010 trial (NCT02642471) compared survival outcomes in participants with a negative (PHENIX-I cohort) or positive (PHENIX-II cohort) SLNB, following either SLNB alone or SLNB followed by PL. In PHENIX-I, 838 participants with cervical cancer (FIGO stage IA1, IA2, IB1, IIA1) were 1:1 randomised to undergo radical hysterectomy with or without PL. Participants in PHENIX-II received concurrent adjuvant chemoradiotherapy; however, this part of the trial was terminated early (n=70). The primary endpoint was DFS. Prof. Jihong Liu (Sun Yat-sen University Cancer Center, China) thus presented the results of PHENIX-I only [2].

The 3-year DFS was 96.9% in participants without PL versus 94.6% in those with PL (HR 0.61; 95% CI 0.33–1.14; P<0.001 for non-inferiority). The 3-year cancer-specific survival was significantly higher in participants without PL, reaching 99.2% compared to 97.8% (HR 0.37; 95% CI 0.15–0.95). Participants without PL-intervention also experienced fewer adverse events, particularly significantly fewer cases of lymphoedema, paraesthesia, and pain. Additionally, the omission of PL was associated with significantly shorter operative duration, less blood loss, and a shorter duration of hospitalisation.

Prof. Liu concluded: “SLNB demonstrated non-inferior DFS but superior surgical outcomes compared to PL in early-stage cervical cancer participants.”

1. Parpinel G, et al. Int J Gynecol Cancer. 2023;33(12):1853–1860.
2. Liu J, et al. Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multicentre randomized phase III trial (the PENIX trial). Abstract LBA5501, ASCO Annual Meeting 2025, May 30–June 3, Chicago, IL, USA.

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Posted on 30 July 2025