The SHAPE trial established that a simple hysterectomy was non-inferior to a radical hysterectomy in women with low risk cervical cancer. The non-inferiority boundary of this trial was a 4% difference in the pelvic recurrence risk at 3 years between arms 1 1. Plante, M. ∙ Kwon, J.S. ∙ Ferguson, S. ... Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer N. Engl. J. Med. 2024; 390 :819-829 Google Scholar . Eligible patients had FIGO 2009 stage IA2 or stage IB1 squamous, adenosquamous, or adenocarcinoma of the cervix with a tumor size of ≤2 cm. The depth of invasion had to be less than 10 mm on an excisional biopsy or less than 50% invasion into the cervical stroma on MRI. This study included all tumor grades, and about one-third of the tumors were noted to have lymph vascular space invasion. Patients with stage IB tumors were required to have an MRI with no evidence of nodal involvement. The arms were well balanced between the simple hysterectomy and the radical hysterectomy groups with respect to factors such as the use of sentinel lymph node biopsy (37.3% vs 38.2%) and the use of adjuvant radiation (9.2% vs 8.4%). The positive margin rate was low and similar between the two types of surgery (1.18% vs 1.74%).
R. Wendel Naumann (Sun,) studied this question.