Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study

Salvo G. Ramirez P.T. Leitao M.M. Cibula D. Wu X. Falconer H. Persson J. Perrotta M. Mosgaard B.J. Kucukmetin A. Berlev I. Rendon G. Liu K. Vieira M. Capilna M.E. Fotopoulou C. Baiocchi G. Kaidarova D. Ribeiro R. Pedra-Nobre S. Kocian R. Li X. Li J. Pálsdóttir K. Noll F. Rundle S. Ulrikh E. Hu Z. Gheorghe M. Saso S. Bolatbekova R. Tsunoda A. Pitcher B. Wu J. Urbauer D. Pareja R.
January 2022 Elsevier Inc.

American Journal of Obstetrics and Gynecology
2022 #226 Issue 1 97.e1 - 97.e16 pp.

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.

disease-free survival , fertility , hysterectomy , laparoscopy , minimally invasive surgical procedures , recurrence , retrospective studies , robotic surgical procedures , trachelectomy , uterine cervical neoplasms

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Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, United States
Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, United States
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Prague, Czech Republic
Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
Department of Womens and Childrens Health, Karolinska Institutet, Stockholm, Sweden
Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden
Department of Clinical Sciences, Faculty of Medicine, Lund University Lund, Sweden
Servicio de Ginecología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
Department of Gynecology, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark
Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead, United Kingdom
Department of Gynecologic Oncology, N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, Russian Federation
Department of Gynecologic Oncology, Instituto de Cancerología Las Américas Auna, Medellín, Colombia
Department of Gynecologic Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
Department of Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil
Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil
First Obstetrics and Gynecology Clinic, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureş, Târgu Mureş, Romania
Department of Surgery and Cancer, Imperial College London and West London Gynaecological Cancer Centre, Imperial College NHS Trust, London, United Kingdom
Department of Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil
Department of Gynecologic Oncology, Kazakh Institute of Oncology and Radiology, Almaty, Kazakhstan
Department of Gynecologic Oncology, Hospital Erasto Gaertner, Curitiba, Brazil
Almazov National Medical Research Centre, North-Western State Medical University named after I. I. Mechnikov, Saint Petersburg, Russian Federation
Department of Gynecologic Oncology, Pilar Hospital, Curitiba, Brazil
Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States
Department of Gynecologic Oncology, Astorga Clínica de Oncología, Medellín, Colombia
Instituto Nacional de Cancerología, Bogotá, Colombia

Department of Gynecologic Oncology and Reproductive Medicine
Department of Surgery
Gynecologic Oncology Center
Department of Gynecologic Oncology
Department of Womens and Childrens Health
Department of Obstetrics and Gynecology
Department of Clinical Sciences
Servicio de Ginecología
Department of Gynecology
Northern Gynaecological Oncology Centre
Department of Gynecologic Oncology
Department of Gynecologic Oncology
Department of Gynecologic Oncology
Department of Gynecologic Oncology
Department of Gynecologic Oncology
First Obstetrics and Gynecology Clinic
Department of Surgery and Cancer
Department of Gynecologic Oncology
Department of Gynecologic Oncology
Department of Gynecologic Oncology
Almazov National Medical Research Centre
Department of Gynecologic Oncology
Department of Biostatistics
Department of Gynecologic Oncology
Instituto Nacional de Cancerología

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