Dataset Information

Association of Radical Hysterectomy Surgical Volume and Survival for Early-Stage Cervical Cancer.

ABSTRACT:

Objective

To examine the association between surgical volume and survival of women with early-stage cervical cancer who underwent radical hysterectomy.

Methods

This is a nationwide multicenter retrospective study examining consecutive women with clinical stage IB1-IIB cervical cancer who underwent radical hysterectomy and pelvic lymphadenectomy from 2004 to 2008 (N=5,964). The surgical volume per site over the 5-year period was defined as low-volume (fewer than 32 surgeries, 46 [39.7%] institutions, n=649 [10.9%]), mid-volume (32-104 surgeries, 60 [51.7%] institutions, n=3,662 [61.4%]), and high-volume (105 surgeries or more, 10 [8.6%] institutions, n=1,653 [27.7%]). Surgical volume-specific survival was examined with multivariable analysis and propensity score matching.

Results

The median number of surgeries per site was 44 (interquartile range, 17-65). The 5-year disease-free survival rates among stage IB1-IIB disease were 77.2%, 79.9%, and 84.5% for low-, mid-, and high-volume groups, respectively. On multivariable analysis, women in high-volume centers had a decreased risk of recurrence (adjusted hazard ratio [HR] 0.69, 95% CI 0.58-0.82, P<.001) and all-cause mortality (adjusted HR 0.73, 95% CI 0.59-0.90, P=.003) compared with those in mid-volume centers. Specifically, women in high-volume centers had a decreased risk of local recurrence (adjusted HR 0.62, 95% CI 0.49-0.78, P<.001) but not distant recurrence (adjusted HR 0.85, 95% CI 0.67-1.06, P=.142) compared with those in mid-volume centers. Among 1,700 women with clinical stage IB1 disease treated with surgery alone, surgery at high-volume centers was associated with a decreased risk of recurrence (adjusted HR 0.45, 95% CI 0.25-0.79, P=.006) and all-cause mortality (adjusted HR 0.29, 95% CI 0.11-0.76, P=.013) compared with surgery at mid-volume centers on multivariable analysis. After propensity score matching, surgery at high-volume centers remained an independent prognostic factor for decreased recurrence (adjusted HR 0.69, 95% CI 0.57-0.84, P<.001) and all-cause mortality (adjusted HR 0.75, 95% CI 0.59-0.95, P=.016) compared with surgery at mid- and low-volume centers on multivariable analysis.

Conclusion

Hospital volume for radical hysterectomy may be a prognostic factor for early-stage cervical cancer. Surgery at high-volume centers is associated with decreased local recurrence risk and improved survival.

SUBMITTER: Matsuo K

PROVIDER: S-EPMC9045958 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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.).

Project description:ObjectiveMinimally invasive radical hysterectomy (MIS-RH) for early-stage cervical cancer is a relatively new surgical procedure with increased utilization in the mid-/late-2000s. This study examined the association between hospital surgical volume for MIS-RH and perioperative outcomes for early-stage cervical cancer in the period of early adoption.MethodsThis population-based retrospective study queried the National Inpatient Sample from 2007 to 2011. Cervical cancer cases treated with MIS-RH were examined (n = 2202 from 163 hospitals). Annualized hospital surgical volume was defined as the average number of procedures performed per year in which at least one case was performed. Characteristics and outcomes related to MIS-RH use were assessed. The comparator cohort included RH by laparotomy (Open-RH; n = 11,187 from 405 hospitals).ResultsAmong MIS-RH-offering centers, 42.3% had average 1 case/year and surgical volume of >4 cases/year represented the top decile. When stratified by MIS-RH types, on average 31.3 centers performed robotic-assisted approach per year versus 11.5 centers for the traditional approach. Small bed capacity centers were most likely to perform robotic-assisted RH (adjusted-odds ratio 4.07, P < 0.001). In the traditional MIS-RH group, higher hospital surgical volume was associated with lower surgical morbidity (P = 0.025) whereas in the robotic-assisted approach higher hospital surgical volume was associated with higher surgical morbidity (P < 0.001). In the Open-RH cohort, higher hospital surgical volume was significantly associated with decreased surgical morbidity and mortality (both, P < 0.001).ConclusionIn the mid-/late-2000s, MIS-RH surgical volume was modest in the United States. Small bed capacity centers adopted robotic-assisted MIS-RH more frequently, and there was a statistically significant association of increased perioperative complications among higher volume centers. In contrast, higher surgical volume was associated with improved perioperative outcomes with the traditional MIS-RH and open-RH approaches.

Project description:BackgroundRadical hysterectomy is one of the standard treatments for stage Ia2 to IIa cervical cancer. Bladder dysfunction caused by disruption of the pelvic autonomic nerves is a common complication following standard radical hysterectomy and can affect quality of life significantly. Nerve-sparing radical hysterectomy is a modified radical hysterectomy, developed to permit resection of oncologically relevant tissues surrounding the cervical lesion, while preserving the pelvic autonomic nerves.ObjectivesTo evaluate the benefits and harms of nerve-sparing radical hysterectomy in women with stage Ia2 to IIa cervical cancer.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 4), MEDLINE via Ovid (1946 to May week 2, 2018), and Embase via Ovid (1980 to 2018, week 21). We also checked registers of clinical trials, grey literature, reports of conferences, citation lists of included studies, and key textbooks for potentially relevant studies.Selection criteriaWe included randomised controlled trials (RCTs) evaluating the efficacy and safety of nerve-sparing radical hysterectomy compared to standard radical hysterectomy for women with early stage cervical cancer (stage Ia2 to IIa).Data collection and analysisWe applied standard Cochrane methodology for data collection and analysis. Two review authors independently selected potentially relevant RCTs, extracted data, evaluated risk of bias of the included studies, compared results and resolved disagreements by discussion or consultation with a third review author, and assessed the certainty of evidence.Main resultsWe identified 1332 records as a result of the search (excluding duplicates). Of the 26 studies that potentially met the review criteria, we included four studies involving 205 women; most of the trials had unclear risks of bias. We identified one ongoing trial.The analysis of overall survival was not feasible, as there were no deaths reported among women allocated to standard radical hysterectomy. However, there were two deaths in among women allocated to the nerve-sparing technique. None of the included studies reported rates of intermittent self-catheterisation over one month following surgery. We could not analyse the relative effect of the two surgical techniques on quality of life due to inconsistent data reported. Nerve-sparing radical hysterectomy reduced postoperative bladder dysfunctions in terms of a shorter time to postvoid residual volume of urine ≤ 50 mL (mean difference (MD) -13.21 days; 95% confidence interval (CI) -24.02 to -2.41; 111 women; 2 studies; low-certainty evidence) and lower volume of postvoid residual urine measured one month following operation (MD -9.59 days; 95% CI -16.28 to -2.90; 58 women; 2 study; low-certainty evidence). There were no clear differences in terms of perioperative complications (RR 0.55; 95% CI 0.24 to 1.26; 180 women; 3 studies; low-certainty evidence) and disease-free survival (HR 0.63; 95% CI 0.00 to 106.95; 86 women; one study; very low-certainty evidence) between the comparison groups.Authors' conclusionsNerve-sparing radical hysterectomy may lessen the risk of postoperative bladder dysfunction compared to the standard technique, but the certainty of this evidence is low. The very low-certainty evidence for disease-free survival and lack of information for overall survival indicate that the oncological safety of nerve-sparing radical hysterectomy for women with early stage cervical cancer remains unclear. Further large, high-quality RCTs are required to determine, if clinically meaningful differences of survival exist between these two surgical treatments.

Project description:BackgroundSince the release of the LACC trial results in 2018, the safety of laparoscopic radical hysterectomy (LRH) for cervical cancer has received huge attention and heated discussion. We developed modified laparoscopic radical hysterectomy (MLRH) incorporating a series of measures to prevent tumor spillage, which has been performed in our center since 2015.ObjectivePresent study retrospectively analyzed relevant indicators of MLRH and evaluated disease-free survival (DFS) primarily in the treatment of early cervical cancer compared with open surgery.MethodsPatients with 2014 International Federation of Gynecology and Obstetrics clinical stages 1B1 and 2A1 cervical cancer who underwent radical hysterectomy in the gynecological department of our hospital from October 2015 to June 2018 were enrolled retrospectively in this study. Patients were divided into two groups based on the surgical procedure: open radical hysterectomy (ORH) group (n = 336) and MLRH group (n = 302). Clinical characteristics, surgical indices, and survival prognosis were analyzed, including 2.5-year overall survival (OS) rate, 2.5-year DFS rate, recurrence rate, and recurrence pattern.ResultsCompared to the ORH group, the MLRH group exhibited a longer operative time, longer normal bladder function recovery time, less intraoperative blood loss volume, and more harvested pelvic lymph nodes (P < 0.05). No significant differences were observed in postoperative complications, the 2.5-year OS, 2.5-year DFS, and recurrence rate between the two groups (P > 0.05); however, the recurrence pattern was significantly different (P < 0.05). The MLRH group mainly exhibited local single metastasis (7/11), whereas the ORH group mainly exhibited distant multiple metastases (14/16). Stratified analysis revealed that overall survival rate was higher in the MLRH group than in the ORH group in patients with stage 1B1 and middle invasion (P < 0.05).ConclusionMLRH does not show a survival disadvantage in the treatment of early-stage cervical cancer when compared with open surgery. In addition, MLRH shows a survival advantage in patients with stage 1B1 and middle 1/3 invasion. Considering this is a retrospective study, further prospective study is necessary for more sufficient data support.Trial registrationPresent research is a retrospective study. The study had retrospectively registered on Chinese Clinical Trial Registry ( http://www.chictr.org.cn/ ), and the registered number is ChiCTR1900026306.

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.