Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study - 05/10/21

Doi : 10.1016/j.ajog.2021.08.029

Gloria Salvo, MD ^a,^⁎ , Pedro T. Ramirez, MD ^a, Mario M. Leitao, MD ^b, David Cibula, MD ^c, Xiaohua Wu, MD ^d, Henrik Falconer, MD ^e, Jan Persson, MD ^f,^g, Myriam Perrotta, MD ^h, Berit J. Mosgaard, MD ⁱ, Ali Kucukmetin, MD ^j, Igor Berlev, MD ^k, Gabriel Rendon, MD ^l, Kaijiang Liu, MD ^m, Marcelo Vieira, MD ^n,^o, Mihai E. Capilna, MD ^p, Christina Fotopoulou, MD ^q, Glauco Baiocchi, MD ^r, Dilyara Kaidarova, MD ^s, Reitan Ribeiro, MD ^t, Silvana Pedra-Nobre, MD ^b, Roman Kocian, MD ^c, Xiaoqi Li, MD ^d, Jin Li, MD ^d, Kolbrún Pálsdóttir, MD ^e, Florencia Noll, MD ^h, Stuart Rundle, MD ^j, Elena Ulrikh, MD ^u, Zhijun Hu, MD ^m, Mihai Gheorghe, MD ^p, Srdjan Saso, MD ^q, Raikhan Bolatbekova, MD ^s, Audrey Tsunoda, MD ^n,^t,^v, Brandelyn Pitcher, MS ^w, Jimin Wu, MS ^w, Diana Urbauer, MS ^w, Rene Pareja, MD ^x,^y
^a Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX
^b Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY
^c 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
^d Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, Shanghai, China
^e Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden
^f Department of Obstetrics and Gynecology, Skåne University Hospital, Lund, Sweden
^g Department of Clinical Sciences, Faculty of Medicine, Lund University Lund, Sweden
^h Servicio de Ginecología, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
ⁱ Department of Gynecology, University Hospital Copenhagen, Rigshospitalet, Copenhagen, Denmark
^j Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead, United Kingdom
^k Department of Gynecologic Oncology, N.N. Petrov National Medical Research Center of Oncology, Saint Petersburg, Russia
^l Department of Gynecologic Oncology, Instituto de Cancerología Las Américas Auna, Medellín, Colombia
^m Department of Gynecologic Oncology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China
ⁿ Department of Gynecologic Oncology, Hospital Israelita Albert Einstein, São Paulo, Brazil
^o Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos, Brazil
^p First Obstetrics and Gynecology Clinic, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureş, Târgu Mureş, Romania
^q Department of Surgery and Cancer, Imperial College London and West London Gynaecological Cancer Centre, Imperial College NHS Trust, London, United Kingdom
^r Department of Gynecologic Oncology, AC Camargo Cancer Center, São Paulo, Brazil
^s Department of Gynecologic Oncology, Kazakh Institute of Oncology and Radiology, Almaty, Kazakhstan
^t Department of Gynecologic Oncology, Hospital Erasto Gaertner, Curitiba, Brazil
^u Almazov National Medical Research Centre, North-Western State Medical University named after I. I. Mechnikov, Saint Petersburg, Russia
^v Department of Gynecologic Oncology, Pilar Hospital, Curitiba, Brazil
^w Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX
^x Department of Gynecologic Oncology, Astorga Clínica de Oncología, Medellín, Colombia
^y Instituto Nacional de Cancerología, Bogotá, Colombia

^∗Corresponding author: Gloria Salvo, MD.

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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

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.

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

Plan

Introduction

Materials and Methods

Results

Comment

Principal findings

Results in context of what is known

Clinical implications

Research implications

Strengths and limitations

Conclusion

	M.M.L. performs ad hoc consulting or speaking for Intuitive Surgical and serves on the advisory boards of Ethicon, Medtronic, and Takeda. H.F. has received honoraria for proctoring and money for educational lectures from Intuitive Surgical. J.P. has received honoraria for lectures and proctoring from Intuitive Surgical. M.V. has received honoraria for lectures from Johnson & Johnson (J&J). C.F. has received honoraria for advisory board service from Tesaro, GlaxoSmithKline, Clovis, Merck Sharp & Dohme (MSD) and AstraZeneca (AZ), Ethicon, Sequana, and Roche. A.T. has received honoraria for educational lectures and advisory board service from Roche, AZ, MSD, and J&J. The remaining authors report no conflict of interest.
	This study was supported by the National Cancer Institute (award number P30CA016672), which supports the MD Anderson Cancer Center Clinical Trials Office.
	Cite this article as: Salvo G, Ramirez PT, Leitao MM, et al. Open vs minimally invasive radical trachelectomy in early-stage cervical cancer: International Radical Trachelectomy Assessment Study. Am J Obstet Gynecol 2021;XX:x.ex–x.ex.