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: We aimed to compare 4.5-year disease-free survival after open vs 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 carcinoma, adenocarcinoma, or adenosquamous carcinoma; had a preoperative tumor size of ≤2 cm; and underwent open or minimally invasive (robotic or laparoscopic) radical trachelectomy with nodal assessment (pelvic lymphadenectomy and/or sentinel lymph node biopsy). The exclusion criteria included neoadjuvant chemotherapy or preoperative pelvic radiotherapy, previous 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 patients were entered into the study database. However, 69 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 performed, comparing the recurrence rates between surgical approaches, with open surgery being considered as standard and minimally invasive surgery as experimental. RESULTS: Of 646 patients, 358 underwent open surgery, and 288 underwent minimally invasive surgery. The median (range) patient age was 32 (20-42) years for open surgery vs 31 (18-45) years for minimally invasive surgery (P=.11). Median (range) pathologic tumor size was 15 (0-31) mm for open surgery and 12 (0.8-40) mm for minimally invasive surgery (P=.33). The rates of pelvic nodal involvement were 5.3% (19 of 358 patients) for open surgery and 4.9% (14 of 288 patients) for minimally invasive surgery (P=.81). Median (range) follow-up time was 5.5 (0.20-16.70) years for open surgery and 3.1 years (0.02-11.10) years for minimally invasive surgery (P<.001). At 4.5 years, 17 of 358 patients (4.7%) with open surgery and 18 of 288 patients (6.2%) with minimally invasive surgery had recurrence (P=.40). The 4.5-year disease-free survival rates were 94.3% (95% confidence interval, 91.6-97.0) for open surgery and 91.5% (95% confidence interval, 87.6-95.6) for minimally invasive surgery (log-rank P=.37). Post hoc propensity score analysis of recurrence risk showed no difference between surgical approaches (P=.42). At 4.5 years, there were 6 disease-related deaths (open surgery, 3; minimally invasive surgery, 3) (log-rank P=.49). The 4.5-year overall survival rates were 99.2% (95% confidence interval, 97.6-99.7) for open surgery and 99.0% (95% confidence interval, 79.0-99.8) for minimally invasive surgery. CONCLUSION: The 4.5-year disease-free survival rates did not differ between open radical trachelectomy 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.

1st Obstetrics and Gynecology Clinic George Emil Palade University of Medicine Pharmacy Science and Technology of Târgu Mureş Târgu Mureş Romania

Almazov National Medical Research Centre North Western State Medical University named after 1 1 Mechnikov Saint Petersburg Russia

Department of Biostatistics The University of Texas MD Anderson Cancer Center Houston TX

Department of Gynecologic Oncology AC Camargo Cancer Center São Paulo Brazil

Department of Gynecologic Oncology and Reproductive Medicine The University of Texas MD Anderson Cancer Center Houston TX

Department of Gynecologic Oncology Astorga Clínica de Oncología Medellín Colombia; Instituto Nacional de Cancerología Bogotá Colombia

Department of Gynecologic Oncology Fudan University Shanghai Cancer Center Shanghai China

Department of Gynecologic Oncology Hospital Erasto Gaertner Curitiba Brazil

Department of Gynecologic Oncology Hospital Israelita Albert Einstein São Paulo Brazil; Department of Gynecologic Oncology Barretos Cancer Hospital Barretos Brazil

Department of Gynecologic Oncology Hospital Israelita Albert Einstein São Paulo Brazil; Department of Gynecologic Oncology Hospital Erasto Gaertner Curitiba Brazil; Department of Gynecologic Oncology Pilar Hospital Curitiba Brazil

Department of Gynecologic Oncology Instituto de Cancerología Las Américas Auna Medellín Colombia

Department of Gynecologic Oncology Kazakh Institute of Oncology and Radiology Almaty Kazakhstan

Department of Gynecologic Oncology N N Petrov National Medical Research Center of Oncology Saint Petersburg Russia

Department of Gynecologic Oncology Renji Hospital School of Medicine Shanghai Jiao Tong University Shanghai China

Department of Gynecology University Hospital Copenhagen Rigshospitalet Copenhagen Denmark

Department of Obstetrics and Gynecology Skåne University Hospital Lund Sweden; Department of Clinical Sciences Faculty of Medicine Lund University Lund Sweden

Department of Surgery and Cancer Imperial College London and West London Gynaecological Cancer Centre Imperial College NHS Trust London United Kingdom

Department of Surgery Memorial Sloan Kettering Cancer Center New York NY

Department of Women's and Children's Health Karolinska Institutet Stockholm Sweden

Gynecologic Oncology Center Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University Prague and General University Hospital Prague Prague Czech Republic

Northern Gynaecological Oncology Centre Queen Elizabeth Hospital Gateshead United Kingdom

Servicio de Ginecología Hospital Italiano de Buenos Aires Buenos Aires Argentina

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