Open Versus Minimally Invasive Radical Trachelectomy in Early-Stage Cervical Cancer: International Radical Trachelectomy Assessment Study

Abstract Background Minimally invasive radical trachelectomy has emerged as an alternative to open radical hysterectomy for patients with early-stage cervical cancer desiring future fertility. Recent data suggest worse oncologic outcomes after minimally invasive radical hysterectomy than after open radical hysterectomy in stage I cervical cancer. Objective To compare 4.5-year disease-free survival after open versus minimally invasive radical trachelectomy. Study Design This was a collaborative, international retrospective study (International Radical Trachelectomy Assessment Study) of patients treated during 2005-2017 at 18 centers in 12 countries. Eligible patients had squamous, adenocarcinoma, or adenosquamous carcinoma; had preoperative tumor size ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). Exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, prior lymphadenectomy or pelvic retroperitoneal surgery, pregnancy, stage IA1 disease with lymphovascular space invasion, aborted trachelectomy (conversion to radical hysterectomy), or vaginal approach. Surgical approach, indication, and adjuvant therapy regimen were at the discretion of the treating institution. A total of 715 consecutive patients were entered in the study database. Sixty-nine patients were excluded, leaving 646 in the analysis. Endpoints were the 4.5-year disease-free survival rate (primary), 4.5-year overall survival rate (secondary), and recurrence rate (secondary). Kaplan-Meier methods were used to estimate disease-free survival and overall survival. A post hoc weighted analysis was conducted to compare the recurrence rate between surgical approaches, with open surgery considered standard and minimally invasive surgery considered experimental. Results Of the 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 years (20-42) for open surgery versus 31 years (18-45) for minimally invasive surgery (P=0.11). Median (range) pathologic tumor size tumor size was 15 mm (0-31) for open surgery and 12 mm (0.8-40) for minimally invasive surgery (P=0.33). The rate of pelvic nodal involvement was 5.3% (19/358) for open surgery and 4.9% (14/288) for minimally invasive surgery (P=0.81). Median (range) follow-up time was 5.5 years (0.2-16.7) for open surgery and 3.1 years (0.02-11.1) for minimally invasive surgery (P Conclusions The 4.5-year disease-free survival rate did not differ between open and minimally invasive radical trachelectomy. However, recurrence rates in each group were low. Ongoing prospective studies of conservative management of early-stage cervical cancer may help guide future management.