Dr. Nicolò Bizzarri | Surgical Trials in Cervical Cancer

Join Nicolò Bizzarri from Policlinico Agostino Gemelli, Rome, as he presents key 2025 updates in surgical trials for cervical cancer at the OncoAlert Colloquium 2026.

In this session, Dr. Bizzarri reviews practice-changing data on sentinel lymph node strategies, de-escalation of radical surgery, minimally invasive approaches, and the launch of the new LASH trial in low-risk disease.

Key topics covered:

1️⃣ Sentinel lymph node trials – SENTIX & PHENIX:
• SENTIX (single-arm): bilateral sentinel node biopsy with strict ultrastaging and central pathology review.
• 24-month recurrence rate 6.1%, non-inferior to historical lymphadenectomy controls.
• PHENIX (randomized, 838 patients): SLN biopsy alone vs SLN + lymphadenectomy.
• No difference in 3-year DFS or cancer-specific survival.
• SLN-only approach reduced lymphocyst, lymphedema, paresthesia, and pain.
• Conclusion: Sentinel lymph node biopsy alone is oncologically safe in early-stage cervical cancer (≤4 cm).

2️⃣ GOG 278 – Non-radical surgery:
• Included stage IA1–IB1 patients after conization with negative margins (less than 10 mm invasion).
• Compared simple hysterectomy vs cone biopsy + lymphadenectomy.
• Very low grade ≥3 adverse events (4.6% hysterectomy; 1.4% cone).
• 4.4% recurrence rate, observed only after conization; none in hysterectomy group.
• Conclusion: Non-radical surgery appears safe with low perioperative morbidity; close surveillance required after fertility-sparing approaches.

3️⃣ SHAPE trial paradigm shift (published 2024):
• Low-risk tumors (less than 2 cm, limited stromal invasion).
• No survival difference between radical and simple hysterectomy.
• Established simple hysterectomy as new standard of care in low-risk cervical cancer.

4️⃣ SHAPE sub-analyses (2025):
• Surgical approach: no significant survival difference between minimally invasive and open simple hysterectomy.
• Not powered for surgical approach → need for dedicated trial.
• Conization before hysterectomy (174 patients with negative margins): recurrence rate 1.4%.
• No extra-pelvic recurrences or cervical cancer deaths in this subgroup.
• Best outcomes observed in patients undergoing conization with clear margins before surgery.

5️⃣ LASH trial – ongoing:
• Single-arm study of minimally invasive simple hysterectomy after conization with negative margins.
• Includes low-risk cervical cancer patients.
• Primary endpoint: 3-year disease-free survival.
• Planned enrollment: 974 patients.
• Designed to address unanswered question of minimally invasive safety in this population.

6️⃣ Practice-changing conclusions (2025):
• Sentinel lymph node biopsy alone is a safe alternative to systematic pelvic lymphadenectomy.
• Surgical de-escalation with simple hysterectomy is appropriate in low-risk disease.
• Minimally invasive simple hysterectomy appears safe but requires prospective validation.
• Conization with negative margins before hysterectomy is associated with the lowest recurrence risk.