Dataset Information

Radical Trachelectomy for the Treatment of Early-Stage Cervical Cancer: A Systematic Review.

ABSTRACT:

Objective

To 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 sources

PubMed, 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 Grey literature and unpublished data were omitted.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 selection

After 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 results

Variables 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%.

Conclusion

Radical 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 registration

PROSPERO, CRD42019132443.

SUBMITTER: Smith ES

PROVIDER: S-EPMC7528402 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:Objective: To provide updated evidence on comparative efficacy for clinical outcomes of radical trachelectomy and radical hysterectomy in patients with early-stage cervical cancer. Methods: A systematic search was conducted in the PubMed, Scopus, Cochrane Database of Systematic Reviews, and Google scholar databases. Studies were done in patients with early-stage cervical cancer that compared the outcomes between radical trachelectomy (RT) and hysterectomy (RH) were considered for inclusion in the review. The outcomes of interest were operative time, the volume of blood loss, need for blood transfusion, any complications, length of hospital stay, risk of recurrence, and survival. The strength of association was presented in the form of pooled relative risk (RR), hazards risk (HR), and weighted mean difference (WMD). Statistical analysis was done using STATA version 16.0. Results: A total of 12 articles were included in the meta-analysis. The majority were retrospective cohort-based studies. Compared to RH, the operative time (in min) was comparatively higher in RT (WMD 23.43, 95% CI: 5.63, 41.24). Patients undergoing RT had blood loss (in ml) similar to those undergoing RT (WMD -81.34, 95% CI: -170.36, 7.68). There were no significant differences in the risk of intra-operative (RR 1.61, 95% CI: 0.49, 5.28) and post-operative complications (RR 1.13, 95% CI: 0.54, 2.40) between the two groups. Patients in the RT group had lesser duration of post-operative hospital stay (in days) (WMD -1.65, 95% CI: -3.22, -0.09). There was no statistically significant difference in the risk of recurrence (HR 1.21, 95% CI: 0.68, 2.18), 5-year overall survival (HR 1.00, 95% CI: 0.99, 1.02), and recurrence-free survival (HR 0.99, 95% CI: 0.96, 1.01) between the two groups. Conclusion: Among the patients with early-stage cervical cancer, RT is similar to RH in safety and clinical outcomes. Future studies with a randomized design and larger sample sizes are needed to further substantiate these findings.

Project description:ObjectiveTo propose an ideal patient candidate with early-stage cervical cancer for undergoing fertility-sparing trachelectomy.MethodsThis nationwide, multicenter, retrospective study was conducted by the Japan Society of Obstetrics and Gynecology involving women aged <45 years with clinical stage I-II cervical cancer who had planned fertility-sparing trachelectomy and pelvic lymphadenectomy between 2009 and 2013 (n = 393). Ideal candidates were defined to have a tumor size of ≤2 cm, no lymph node metastasis, no deep stromal invasion, and no high-risk histology (n = 284, 69.6%). Less-ideal candidates were defined to have any one of these four characteristics (n = 109, 30.4%). Propensity score inverse probability of treatment weighting was used to assess survival outcomes.ResultsLess-ideal candidates were more likely to undergo hysterectomy conversion (22.9% versus 3.2%), receive postoperative radiotherapy (11.9% versus 0.4%), or chemotherapy (32.1% versus 3.2%) compared with ideal candidates (all, P < 0.05). The weighted model revealed that among those who underwent trachelectomy (ideal candidates, n = 275 and less-ideal candidates, n = 84), less-ideal candidates had significantly decreased disease-free survival (5-year rates: 85.5% versus 95.5%; HR 3.93, 95% CI 1.99-7.74; P < 0.001) and cause-specific survival (92.5% versus 98.6%; HR 5.47, 95% CI 1.68-17.8, P = 0.001) compared with ideal candidates. Similarly, less-ideal candidates were significantly associated with decreased disease-free survival compared with ideal candidates among those who were young age, had small tumors or squamous histology, and underwent surgery alone (all, P < 0.05).ConclusionLess-ideal candidates had approximately four-fold higher recurrence risk and cancer mortality compared with ideal candidates. Ideal candidates for fertility-sparing trachelectomy for early-stage cervical cancer proposed in our study may be useful as the future framework for developing guidelines for fertility-sparing trachelectomy in Japan.

Project description:BackgroundA recent trial demonstrated decreased survival in women with early-stage cervical cancer who underwent radical hysterectomy via minimally invasive surgery compared with laparotomy; however, outcomes following trachelectomy have yet to be studied.ObjectiveTo examine trends, characteristics, and survival of reproductive-aged women with early-stage cervical cancer who underwent minimally invasive trachelectomy.Study designThis is a retrospective study examining the National Cancer Database between 2010 and 2015. Women aged <50 years who underwent trachelectomy for stage IA2-IB cervical cancer were grouped by mode of surgery. Clinicopathologic characteristics and outcomes were compared between minimally invasive surgery and laparotomy groups.ResultsA total of 246 women were included, 144 (58.5%, 95% confidence interval, 52.4%-64.7%) of whom had trachelectomy with a minimally invasive surgery approach. Median age was similar between the minimally invasive surgery and laparotomy groups (median, 31 vs 29 years, P = .20). There was a significant increase in the use of minimally invasive surgery from 29.3% in 2010 to 75.0% in 2015 (P < .001). Specifically, minimally invasive surgery became the dominant approach for trachelectomy by year 2011 (54.8%). Hospitals registered in the West (75.0% vs 25.0%) were more likely, whereas those registered in the Midwest (46.9% vs 53.1%) were less likely, to perform minimally invasive surgery (P = .02). Median follow-up was 37 months (interquartile range, 23-51) for the minimally invasive surgery group and 40 months (interquartile range, 26-67) for the laparotomy group. During follow-up, there were 11 (5.3%) deaths, 4 (3.5%) in the minimally invasive surgery group and 7 (7.6%) in the laparotomy group (P = .25).ConclusionMinimally invasive surgery has become the dominant modality for trachelectomy in reproductive-aged women with stage IA2-IB cervical cancer after year 2011. Survival of women with stage IA2-IB cervical cancer who underwent trachelectomy is generally good regardless of surgical modality. Although our study showed no difference in survival between the minimally invasive surgery and laparotomy approaches, effects of MIS on survival remain unknown and further study is warranted.

Project description:BACKGROUND:Trachelectomy is the treatment of choice for reproductive-aged women with early-stage cervical cancer who desire future fertility. Comprehensive population-based statistics have been missing to date. OBJECTIVE:We sought to compare characteristics and survival of reproductive-aged women who underwent trachelectomy for early-stage cervical cancer to those who had hysterectomy. STUDY DESIGN:This is a retrospective observational study examining the Surveillance, Epidemiology, and End Results program from 1998 through 2014. Women <45 years of age with stage IA and IB1 (tumor size ≤2 cm) cervical cancer who underwent trachelectomy were compared to those who underwent hysterectomy. Multivariable models were used to identify clinicopathological factors associated with trachelectomy. Survival was compared between the 2 groups after propensity score matching. RESULTS:Among 6359 women, 190 (3.0%; 95% confidence interval, 2.6-3.4) underwent trachelectomy. The median age of the trachelectomy group was 31 years (interquartile range, 28-34). The proportion of women who underwent trachelectomy significantly increased during the study period (1.2% in 1998 through 2002, 3.0% in 2003 through 2008, and 4.5% in 2009 through 2014, P < .001). Younger age, nonblack race, single marital status, eastern registry area, recent disease diagnosis, nonsquamous histology, and higher stage were independent factors associated with trachelectomy use (all, adjusted P < .05). After propensity score matching, 5-year cause-specific survival (96.9% vs 96.6%; hazard ratio, 0.73; 95% confidence interval, 0.23-2.30; P = .59) and overall survival (96.1% vs 96.6%; hazard ratio, 0.76; 95% confidence interval, 0.26-2.20; P = .61) were similar between the trachelectomy group and the hysterectomy group. CONCLUSION:Our study found that there was a significant increase in the proportion of reproductive-aged women with stage IA or IB1 (≤2 cm) cervical cancer who underwent trachelectomy in recent years. Survival with trachelectomy was similar to those who had hysterectomy in this population.

Project description:ImportanceMinimally invasive techniques are increasingly common in cancer surgery. A recent randomized clinical trial has brought into question the safety of minimally invasive radical hysterectomy for cervical cancer.ObjectiveTo quantify the risk of recurrence and death associated with minimally invasive vs open radical hysterectomy for early-stage cervical cancer reported in observational studies optimized to control for confounding.Data sourcesOvid MEDLINE, Ovid Embase, PubMed, Scopus, and Web of Science (inception to March 26, 2020) performed in an academic medical setting.Study selectionIn this systematic review and meta-analysis, observational studies were abstracted that used survival analyses to compare outcomes after minimally invasive (laparoscopic or robot-assisted) and open radical hysterectomy in patients with early-stage (International Federation of Gynecology and Obstetrics 2009 stage IA1-IIA) cervical cancer. Study quality was assessed with the Newcastle-Ottawa Scale and included studies with scores of at least 7 points that controlled for confounding by tumor size or stage.Data extraction and synthesisThe Meta-analysis of Observational Studies in Epidemiology (MOOSE) checklist was used to abstract data independently by multiple observers. Random-effects models were used to pool associations and to analyze the association between surgical approach and oncologic outcomes.Main outcomes and measuresRisk of recurrence or death and risk of all-cause mortality.ResultsForty-nine studies were identified, of which 15 were included in the meta-analysis. Of 9499 patients who underwent radical hysterectomy, 49% (n = 4684) received minimally invasive surgery; of these, 57% (n = 2675) received robot-assisted laparoscopy. There were 530 recurrences and 451 deaths reported. The pooled hazard of recurrence or death was 71% higher among patients who underwent minimally invasive radical hysterectomy compared with those who underwent open surgery (hazard ratio [HR], 1.71; 95% CI, 1.36-2.15; P < .001), and the hazard of death was 56% higher (HR, 1.56; 95% CI, 1.16-2.11; P = .004). Heterogeneity of associations was low to moderate. No association was found between the prevalence of robot-assisted surgery and the magnitude of association between minimally invasive radical hysterectomy and hazard of recurrence or death (2.0% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -3.4% to 7.7%]) or all-cause mortality (3.7% increase in the HR for each 10-percentage point increase in prevalence of robot-assisted surgery [95% CI, -4.5% to 12.6%]).Conclusions and relevanceThis systematic review and meta-analysis of observational studies found that among patients undergoing radical hysterectomy for early-stage cervical cancer, minimally invasive radical hysterectomy was associated with an elevated risk of recurrence and death compared with open surgery.

Project description:BACKGROUND:Minimally invasive surgery was adopted as an alternative to laparotomy (open surgery) for radical hysterectomy in patients with early-stage cervical cancer before high-quality evidence regarding its effect on survival was available. We sought to determine the effect of minimally invasive surgery on all-cause mortality among women undergoing radical hysterectomy for cervical cancer. METHODS:We performed a cohort study involving women who underwent radical hysterectomy for stage IA2 or IB1 cervical cancer during the 2010-2013 period at Commission on Cancer-accredited hospitals in the United States. The study used inverse probability of treatment propensity-score weighting. We also conducted an interrupted time-series analysis involving women who underwent radical hysterectomy for cervical cancer during the 2000-2010 period, using the Surveillance, Epidemiology, and End Results program database. RESULTS:In the primary analysis, 1225 of 2461 women (49.8%) underwent minimally invasive surgery. Women treated with minimally invasive surgery were more often white, privately insured, and from ZIP Codes with higher socioeconomic status, had smaller, lower-grade tumors, and were more likely to have received a diagnosis later in the study period than women who underwent open surgery. Over a median follow-up of 45 months, the 4-year mortality was 9.1% among women who underwent minimally invasive surgery and 5.3% among those who underwent open surgery (hazard ratio, 1.65; 95% confidence interval [CI], 1.22 to 2.22; P=0.002 by the log-rank test). Before the adoption of minimally invasive radical hysterectomy (i.e., in the 2000-2006 period), the 4-year relative survival rate among women who underwent radical hysterectomy for cervical cancer remained stable (annual percentage change, 0.3%; 95% CI, -0.1 to 0.6). The adoption of minimally invasive surgery coincided with a decline in the 4-year relative survival rate of 0.8% (95% CI, 0.3 to 1.4) per year after 2006 (P=0.01 for change of trend). CONCLUSIONS:In an epidemiologic study, minimally invasive radical hysterectomy was associated with shorter overall survival than open surgery among women with stage IA2 or IB1 cervical carcinoma. (Funded by the National Cancer Institute and others.).