Dataset Information

International radical trachelectomy assessment: IRTA study.

ABSTRACT:

Background

Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy.

Primary objective

To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy.

Study hypothesis

We hypothesize that minimally invasive radical trachelectomy has similar oncologic outcomes to those of the open approach.

Study design

This is a collaborative, multi-institutional, international, retrospective study. Patients who underwent a radical trachelectomy and lymphadenectomy between January 1, 2005 and December 31, 2017 will be included. Institutional review board approval will be required. Each institution will be provided access to a study-specific REDCap (Research Electronic Data Capture) database maintained by MD Anderson Cancer Center and will be responsible for entering patient data.

Inclusion criteria

Patients with squamous, adenocarcinoma, or adenosquamous cervical cancer FIGO (2009) stages IA2 and IB1 (≤2 cm) will be included. Surgery performed by the open approach or minimally invasive approach (laparoscopy or robotics). Tumor size ≤2 cm, by physical examination, ultrasound, MRI, CT, or positron emission tomography (at least one should confirm a tumor size ≤2 cm). Centers must contribute at least 15 cases of radical trachelectomy (open, minimally invasive, or both).

Exclusion criteria

Prior neoadjuvant chemotherapy or radiotherapy to the pelvis for cervical cancer at any time, prior lymphadenectomy, or pelvic retroperitoneal surgery, pregnant patients, aborted trachelectomy (intra-operative conversion to radical hysterectomy), or vaginal approach.

Primary endpoint

The primary endpoint is disease-free survival measured as the time from surgery until recurrence or death due to disease. To evaluate the primary objective, we will compare disease-free survival among patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive radical trachelectomy.

Sample size

An estimated 535 patients will be included; 256 open and 279 minimally invasive radical trachelectomy. Previous studies have shown that recurrence rates in the open group range from 3.8% to 7.6%. Assuming that the 4.5-year disease-free survival rate for patients who underwent open surgery is 95.0%, we have 80% power to detect a 0.44 HR using α level 0.10. This corresponds to an 89.0% disease-free survival rate at 4.5 years in the minimally invasive group.

SUBMITTER: Salvo G

PROVIDER: S-EPMC8215901 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

International radical trachelectomy assessment: IRTA study.

Salvo Gloria G Ramirez Pedro T PT Leitao Mario M Cibula David D Fotopoulou Christina C Kucukmetin Ali A Rendon Gabriel G Perrotta Myriam M Ribeiro Reitan R Vieira Marcelo M Baiocchi Glauco G Falconer Henrik H Persson Jan J Wu Xiaohua X Căpilna Mihai Emil ME Ioanid Nicolae N Mosgaard Berit Jul BJ Berlev Igor I Kaidarova Dilyara D Olawaiye Alexander Babatunde AB Liu Kaijiang K Nobre Silvana Pedra SP Kocian Roman R Saso Srdjan S Rundle Stuart S Noll Florencia F Tsunoda Audrey Tieko AT Palsdottir Kolbrun K Li Xiaoqi X Ulrikh Elena E Hu Zhijun Z Pareja Rene R

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 20190213 3

<h4>Background</h4>Radical trachelectomy is considered a viable option for fertility preservation in patients with low-risk, early-stage cervical cancer. Standard approaches include laparotomy or minimally invasive surgery when performing radical trachelectomy.<h4>Primary objective</h4>To compare disease-free survival between patients with FIGO (2009) stage IA2 or IB1 (≤2cm) cervical cancer who underwent open versus minimally invasive (laparoscopic or robotic) radical trachelectomy.<h4>Study hyp ...[more]

PMID: 30765489

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Project description:BackgroundMinimally 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.ObjectiveWe aimed to compare 4.5-year disease-free survival after open vs minimally invasive radical trachelectomy.Study designThis 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.ResultsOf 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.ConclusionThe 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.

Project description:ObjectiveTo assess surgical, oncologic, and pregnancy outcomes in patients undergoing radical vaginal, abdominal, or laparoscopic trachelectomy for the treatment of early-stage cervical cancer, using a methodic review of published literature.Data sourcesPubMed, EMBASE, and Cochrane Library sources, including ClinicalTrials.gov, were searched from 1990-2019 with terms "cervical cancer" and "(vaginal, abdominal, open, minimally invasive, or laparoscopic) radical trachelectomy." Grey literature and unpublished data were omitted.Methods of study selectionAfter removal of duplicates from a combined EndNote library of results, 490 articles were reviewed using Covidence software. Two reviewers screened titles and abstracts, and then screened full texts. Selection criteria included articles that reported radical trachelectomy with lymph node assessment as primary therapy for cervical carcinoma, with stated follow-up intervals and recurrences.Tabulation, integration, and resultsVariables of interest were manually extracted into an electronic database. A total 47 articles that reported on 2,566 women met inclusion criteria. Most tumors were of squamous histology (68.5%), stage IB1 (74.8%), 2 cm or less (69.2%), and without lymphovascular invasion (68.8%). Of planned trachelectomies, 9% were converted intraoperatively to hysterectomy. Separated by route of trachelectomy, 58.1%, 37.2%, and 4.7% were performed using radical vaginal, abdominal, and laparoscopic approaches, respectively. With median follow-up of 48 months (range 2-202 months) across studies, median recurrence rate was 3.3% (range 0-25%); median time to recurrence was 26 months (range 8-44 months). Median 5-year recurrence-free and overall survival were 94.6% (range 88-97.3%) and 97.4% (range 95-99%), respectively. The posttrachelectomy pregnancy rate was 23.9%, with a live-birth rate of 75.1%.ConclusionRadical trachelectomy for fertility-preserving treatment of cervical cancer is widely reported in the literature, though publications are mainly limited to case reports and case series. Reported follow-up periods infrequently meet standard oncologic parameters but show encouraging recurrence-free and overall survival rates and pregnancy outcomes. Higher-level evidence needed for meta-analysis is lacking.Systematic review registrationPROSPERO, CRD42019132443.

Dataset Information

International radical trachelectomy assessment: IRTA study.

Background

Primary objective

Study hypothesis

Study design

Inclusion criteria

Exclusion criteria

Primary endpoint

Sample size

Publications

International radical trachelectomy assessment: IRTA study.

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