TY - JOUR T1 - 92 Non-inferiority prospective randomized controlled trial on simple hysterectomy versus radical hysterectomy in early stage cervical cancer. An interim analyzis of lesser trial JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer SP - A48 LP - A48 DO - 10.1136/ijgc-2019-IGCS.92 VL - 29 IS - Suppl 3 AU - V Carneiro AU - T Paulo Batista AU - M Rodrigues de Andrade Neto AU - A Vieira Barros AU - A Licio Rocha Bezerra AU - L de Olanda Lima Dornelas Camara AU - N Moreira Ramalho AU - M Angelica Lucena AU - D Fontão AU - R Tancredi AU - T César Silva Júnior AU - G Baiocchi Y1 - 2019/09/01 UR - http://ijgc.bmj.com/content/29/Suppl_3/A48.1.abstract N2 - Objectives To analyze if simple hysterectomy does not have less efficacy and safety compared to radical hysterectomy in treatment of early stage cervical cancer.Methods An open label non-inferiority prospective randomized controlled trial included 40 patients with stages IA2 to IB1 (≤2cm) cervical cancer. The patients were randomized 1:1 in simple hysterectomy or modified radical hysterectomy and pelvic lymphadenectomy between May 2015 and April 2018. Health-related quality of life was assessed (EORTC QLQ-C30). Primary endpoint was disease free survival in 3 years and secondary endpoints was overall survival, morbidity, and quality of life.Results Clinical and pathological characteristics were well balanced between treatment groups. Thirty-two (80%) patients were squamous cell carcinomas and 3 (7.5%) cases had metastatic lymph node. The median surgical time was greater for the radical hysterectomy group (150 vs. 199.5 minutes;p=0.003). Postoperative bladder catheterization days were also higher after radical hysterectomy (p=0.043). There was no postoperative mortality and postoperative complication rate was not statistically different (15% and 20%;p=1,0). Global health, quality of life and physical functioning scores were not different between groups until 6 months of follow-up. There was no difference in adjuvant treatment between groups (30% and 20%;p=0.48). The median follow-up time was 16.2 months and the 2-year disease free survival was 95% and 100% for the simple hysterectomy and modified radical groups, respectively (p=0.405). There was only 1 death due to cancer in the simple hysterectomy arm.Conclusions This interim analysis suggests low morbidity and safety for simple hysterectomy for early stage cervical cancer compared to radical hysterectomy. ER -