FEBRUARY 29, 2024 | Marie Plante, M.D., Janice S. Kwon, M.D., Sarah Ferguson, M.D., Vanessa Samouëlian, M.D., Gwenael Ferron, M.D., Amandine Maulard, M.D., Cor de Kroon, M.D., Willemien Van Driel, M.D., John Tidy, M.D., Karin Williamson, M.D., Sven Mahner, M.D., Stefan Kommos, M.D., Frederic Goffin, M.D., Karl Tamussino, M.D., Brynhildur Eyjólfsdóttir, M.D., Jae-Weon Kim, M.D., Noreen Gleeson, M.D., Lori Brotto, Ph.D., Dongsheung Tu, Ph.D., and Lois E. Shepherd, M.D., for the CX.S SHAPE investigators
This multicenter, randomized, noninferiority trial compared simple hysterectomy with radical hysterectomy in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). The primary outcome was pelvic recurrence at 3 years, with a prespecified noninferiority margin of 4 percentage points. Among 700 patients (350 in each group), the majority had stage IB cancer. The incidence of pelvic recurrence at 3 years was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group (absolute difference: 0.35 percentage points; 90% CI, −1.62 to 2.32). The incidence of urinary incontinence and retention was lower in the simple hysterectomy group within 4 weeks and beyond. The trial concluded that simple hysterectomy was noninferior to radical hysterectomy in terms of pelvic recurrence and was associated with fewer urologic complications.This multicenter, randomized, noninferiority trial compared simple hysterectomy with radical hysterectomy in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). The primary outcome was pelvic recurrence at 3 years, with a prespecified noninferiority margin of 4 percentage points. Among 700 patients (350 in each group), the majority had stage IB cancer. The incidence of pelvic recurrence at 3 years was 2.52% in the simple hysterectomy group and 2.17% in the radical hysterectomy group (absolute difference: 0.35 percentage points; 90% CI, −1.62 to 2.32). The incidence of urinary incontinence and retention was lower in the simple hysterectomy group within 4 weeks and beyond. The trial concluded that simple hysterectomy was noninferior to radical hysterectomy in terms of pelvic recurrence and was associated with fewer urologic complications.