Radical Hysterectomy In Patients Research Articles

Rationale for early rehabilitation of patients with uterine corpus cancer

To study the dynamics of hemorheologic changes and the frequency of early complications of laparoscopic radical hysterectomy in patients with uterine corpus cancer depending on conducting rehabilitation activities in the early postoperative period. The number of patients with uterine corpus cancer equal 49 (mean age 54.8±2.2 years), divided into 2 comparable groups, was examined: experimental group - 23 patients, who received local magnetotherapy since the first day after surgery for 5-6 days, and control group - 26 patients without physiotherapy. Comparative group included 24 healthy women. The basic rheological parameters, namely blood viscosity at high and low shear rate, hematocrit, erythrocytes' aggregation and deformability, erythrocytes and platelets electrophoretic mobility, were evaluated in all patients initially, on the 1st and 5th days after surgery and in comparison group. There were changes in the rheological properties of the blood before surgery in patients of both groups: increase of blood viscosity, enhancement of aggregation activity of its formed elements, decrease of erythrocytes' deformability properties. The laparoscopic radical hysterectomy was accompanied by the exacerbation of these disorders. The early magnetotherapy in patients reduced hemorheological abnormalities up to the preoperative parameters (p<0.05) for 5 days, as well as reduced the incidence of early postoperative complications by 2.4 times compared to the control group. The application of local low-frequency low-intensity magnetotherapy since the first postoperative day allows to reduce the level of postoperative hemorheological abnormalities up to the level of preoperative parameters, as well as the frequency of early postoperative complications.

Role of Adjuvant Radiotherapy in Patients with Cervical Cancer Undergoing Radical Hysterectomy.

The benefit of adjuvant radiotherapy (RT) after radical hysterectomy in patients with cervical cancer remains controversial. The aim of this study was to determine adjuvant RT's impact on survival in accordance with Sedlis criteria. Patients with early-stage cervical cancer undergoing radical hysterectomy between 2005 and 2022 at a single tertiary care institution were included. A multivariate analysis was performed to determinate if RT was an independent prognostic factor for recurrence or death. We also analysed whether there was a statistically significant difference in overall survival (OS) between patients who met only one or two Sedlis criteria, depending on whether they received adjuvant RT or not. 121 patients were included in this retrospective study, of whom 48 (39.7%) received adjuvant RT due to the presence of unfavourable pathological findings. In multivariate analysis, RT was not found to be a statistically significant prognostic factor for OS (p = 0.584) or disease-free survival (DFS) (p = 0.559). When comparing patients who met one or two Sedlis criteria, there were no statistically significant differences in OS between RT and no adjuvant treatment in either group. Since the selection of patients with cervical cancer eligible for surgery is becoming more accurate, adjuvant RT might not be necessary for patients with intermediate risk factors.

Intratumoral and peritumoral MRI radiomics nomogram for predicting parametrial invasion in patients with early-stage cervical adenocarcinoma and adenosquamous carcinoma.

To develop a comprehensive nomogram based on MRI intra- and peritumoral radiomics signatures and independent risk factors for predicting parametrial invasion (PMI) in patients with early-stage cervical adenocarcinoma (AC) and adenosquamous carcinoma (ASC). A total of 460 patients with IB to IIB cervical AC and ASC who underwent preoperative MRI examination and radical trachelectomy/hysterectomy were retrospectively enrolled and divided into primary, internal validation, and external validation cohorts. The original (Ori) and wavelet (Wav)-transform features were extracted from the volumetric region of interest of the tumour (ROI-T) and 3mm- and 5mm-peritumoral rings (ROI-3 and ROI-5), respectively. Then the Ori and Ori-Wav feature-based radiomics signatures from the tumour (RST) and 3 mm- and 5 mm-peritumoral regions (RS3 and RS5) were independently built and their diagnostic performances were compared to select the optimal ones. Finally, the nomogram was developed by integrating optimal intra- and peritumoral signatures and clinical independent risk factors based on multivariable logistic regression analysis. FIGO stage, disruption of the cervical stromal ringon MRI (DCSRMR), parametrial invasion on MRI (PMIMR), and serum CA-125 were identified as independent risk factors. The nomogram constructed by integrating independent risk factors, Ori-Wav feature-based RST, and RS5 yielded AUCs of 0.874 (0.810-0.922), 0.885 (0.834-0.924), and 0.966 (0.887-0.995) for predicting PMI in the primary, internal and external validation cohorts, respectively. Furthermore, the nomogram was superior to radiomics signatures and clinical model for predicting PMI in three cohorts. The nomogram can preoperatively, accurately, and noninvasively predict PMI in patients with early-stage cervical AC and ASC. The nomogram can preoperatively, accurately, and noninvasively predict PMI and facilitate precise treatment decisions regarding chemoradiotherapy or radical hysterectomy in patients with early-stage cervical AC and ASC. The accurate preoperative prediction of PMI in early-stage cervical AC and ASC can facilitate precise treatment decisions regarding chemoradiotherapy or radical hysterectomy. The nomogram integrating independent risk factors, Ori-Wav feature-based RST, and RS5 can preoperatively, accurately, and noninvasively predict PMI in early-stage cervical AC and ASC. The nomogram was superior to radiomics signatures and clinical model for predicting PMI in early-stage cervical AC and ASC.

Conization before radical hysterectomy in patients with early-stage cervical cancer: A Korean multicenter study (COBRA-R)

ObjectiveTo investigate the impact of conization on survival outcomes and to identify a specific population that might benefit from conization before radical hysterectomy (RH) in patients with early-stage cervical cancer. MethodsFrom six institutions in Korea, we identified node-negative, margin-negative, parametria-negative, 2009 FIGO stage IB1 cervical cancer patients who underwent primary type C RH between 2006 and 2021. The patients were divided into multiple groups based on tumor size, surgical approach, and histology. We performed a series of independent 1:1 propensity score matching and compared the survival outcomes between the conization and non-conization groups. ResultsIn total, 1254 patients were included: conization (n = 355) and non-conization (n = 899). Among the matched patients with a tumor size of >2 cm, the conization group showed a significantly better 3-year disease-free survival (DFS) rate compared with the non-conization group when RH was conducted via minimally invasive surgery (MIS), in those with squamous cell carcinoma (96.3% vs. 87.4%, P = 0.007) and non-squamous cell carcinoma (97.0% vs. 74.8%, P = 0.021). However, no difference in DFS was observed between the two groups among the matched patients with a tumor size of ≤2 cm, regardless of surgical approach or histological type. In patients who underwent MIS RH, DFS significantly worsened as the residual tumor size increased (P < 0.001). ConclusionCervical conization was associated with a lower recurrence rate in patients with early-stage cervical cancer with a tumor size of >2 cm who underwent primary MIS RH. Cervical conization may be performed prior to MIS RH to minimize the uterine residual tumor.

Survival outcomes of minimally invasive versus open radical hysterectomy in patients with early-stage IB1 to IIA2 cervical cancer: A single-center retrospective study.

This study aimed to investigate the survival outcomes and prognostic factors associated with the surgical approach in patients with early-stage cervical cancer. We retrospectively analyzed 245 patients with stage IB1 to IIA2 cervical cancer who underwent radical hysterectomy with pelvic lymphadenectomy between 2004 and 2019 at Dong-A University Hospital. A total of 59 patients underwent minimally invasive surgery (MIS), and 186 patients underwent open surgery. There were no significant differences between the 2 groups, except for stromal invasion (P < .001), lymphovascular invasion (P = .001), and requirement for adjuvant therapy (P < .001). There were no significant differences in disease-free survival (DFS) and overall survival (OS) based on the surgical approach. However, multivariate analyses showed MIS was an independent poor prognostic factor of DFS (adjusted hazard ratio [HR]: 230; 95% confidence interval [CI]: 086-0.614, P = .003) and OS (adjusted HR: 135; 95% CI: 041-0.451, P = .001). Adjuvant therapy was a poor prognostic factor for DFS (adjusted HR: 6.546; 95% CI: 1.384-30.952; P = .018), and deep stromal invasion was a poor prognostic factor for OS (adjusted HR: 8.715; 95% CI: 1.636-46.429; P = .01). MIS may be an independent poor prognostic factor for DFS and OS in patients who undergo radical hysterectomy for early-stage cervical cancer.

Abdominal type B vs. type C radical hysterectomy in early-stage cervical cancer: A matched single center cohort report.

To compare survival outcomes of type B radical hysterectomy (RH) and type C RH in patients with early-stage cervical cancer. We retrospectively identified continuous cervical cancer patients with FIGO stage IA2-IB2 and IIA1 who underwent either type B RH (n = 278) or type C RH (n = 148) performed by the same group of surgeons between 2009 and 2018. Propensity score matching was carried out to minimize selection biases. Intraoperative photographs, immediate postoperative questionnaire and specimen measurements were used to accurately determine the extensive of surgery. We further narrowed the study population to patients with specific histological subtypes and patients with deep stromal invasion. The median follow-up period was 42.41 ± 24.60 months. After adjusting, no differences in the 5-year overall survival (OS) and disease-free survival (DFS) were found between the type B group and the type C group (OS: 87.8% vs. 89.4%, P = 0.814; DFS: 84.9% vs. 85.6%, P = 0.898). In further analysis of patients with squamous-cell carcinoma, adenocarcinoma, adenosquamous carcinoma, similar 5-year OS and DFS rates were found between two groups (OS: 88.7% vs. 97.1%, P = 0.250; DFS: 84.7% vs. 92.3%, P = 0.541). Consistent results were found in patients with deep stromal invasion (OS: 81.8% vs. 100%, P = 0.144; DFS: 82.8% vs. 100%, P = 0.128). Type B RH could be used to treat FIGO stage IA2-IB2 and IIA1 cervical cancer to get equivalent 5-year OS and DFS. Further randomized controlled trials are warranted.

Comparison of survival outcomes following radiotherapy versus radical hysterectomy in patients with stage IIA cervical squamous cell carcinoma

This study explored the differences in survival outcomes of cervical squamous cell carcinoma (SCC) patients diagnosed with stage IIA who underwent radical hysterectomy (RH) versus radiotherapy (RT). Eligible stage IIA cervical SCC cases were screened from the C4 database. They were divided into RH and RT groups based on their treatments and in a 1:2 ratio utilizing propensity score matching (PSM). Their 5-year overall survival (OS) and disease-free survival (DFS) before and after PSM were compared. Before PSM analysis, the results showed that patients from the RT group (n = 421) had significantly poorer 5-year OS and DFS rates compared with the RH group (n = 761) (OS: 77.2%vs. 85.6%, p &lt; 0.001, HR = 1.789; DFS: 74.9% vs. 80.0%, p = 0.006, HR = 1.447). After stratification in a 1:2 ratio, PSM analysis results showed that the 5-year OS and DFS rates of stage IIA1 patients from the RT group (n = 226) were significantly poorer than the RH group (n = 429) (OS: 78.1% vs. 87.2%, p &lt; 0.001, HR = 2.203; DFS: 78.2% vs. 83.7%, p = 0.011, HR = 1.681), while no significant difference in 5-year OS and DFS rates were observed between the RT (n = 173) and RH (n = 266) groups (OS: 75.2% vs. 83.8%, p = 0.054; DFS: 71.4% vs. 79.5%, p = 0.070) of stage IIA2 patients. RH was associated with better OS and DFS outcomes than RT in cervical SCC patients diagnosed with stage IIA disease. Subgroup analyses showed that RH had superior OS and DFS benefits than RT in stage IIA1 cases, while no significant difference in survival was observed for stage IIA2 patients.

Comparison of long-term bowel symptoms after laparoscopic radical hysterectomy versus abdominal radical hysterectomy in patients with cervical cancer

Introduction and hypothesisThe objective of this study was to compare the long-term bowel symptoms between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patients with cervical cancer.MethodsA total of 207 patients who underwent radical hysterectomy (79 underwent LRH and 128 underwent ARH) at Peking University First Hospital from January 2010 to August 2020 were enrolled and their bowel symptoms were investigated using the Colorectal Anal Distress Inventory-8 (CRADI-8) of the Pelvic Floor Distress Inventory-20. The prevalence and severity of bowel symptoms were compared in the LRH and ARH groups, and multivariate analysis was performed to determine the factors associated with bowel symptoms.ResultsThere was no difference in the CRADI-8 scores between the two groups. However, the prevalence of straining at stool was significantly higher in the ARH group than in the LRH group (19.5% versus 1.3%, p<0.001), and the score was significantly higher in the ARH group than in the LRH group too (0.4 versus 0, p<0.001). The prevalence of incomplete defecation was significantly higher in the ARH group than in the LRH group (13.3% versus 3.8%, p=0.029), and the ARH group also had a significantly higher score than the LRH group (0.3 versus 0.1, p=0.028). Multivariate analysis showed that ARH and postoperative interval were independent risk factors for the development of straining at stool.ConclusionsPatients with cervical cancer who underwent ARH may be more likely to develop symptoms related to constipation than those who underwent LRH. This finding has to be interpreted with caution owing to the study design.

Oncologic outcomes of neoadjuvant chemotherapy followed by radical hysterectomy for locally advanced cervical cancer (311)

Objectives: To investigate the utilization and oncologic outcomes of neoadjuvant chemotherapy followed by radical hysterectomy for patients with locally advanced cervical cancer. Methods: Patients diagnosed between 2004-2015 with FIGO 2009 stage IB2-II squamous cell, adenocarcinoma, or adenosquamous cervical carcinoma with at least one month of follow-up with no history of another tumor were selected from the National Cancer Database. Patients who received neoadjuvant chemotherapy (defined as receipt of chemotherapy without radiation up to six months prior to surgery) followed by radical hysterectomy and those who received definitive chemoradiation (defined as external beam radiation therapy of at least 45 Gy, with same day concurrent chemotherapy and without adjuvant hysterectomy) were identified. Clinical-pathologic and demographic characteristics were compared. Overall survival (OS) was estimated following the generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for a priori selected confounders. Results: A total of 182 patients who received NACT followed by radical hysterectomy and 3859 patients who had definitive chemoradiation were identified. For patients who had a radical hysterectomy, the rate of positive margins was 7%, median hospital stay was 3 days and rate of unplanned re-admission within 30 days from discharge was 5.1% while most of them (90.1%) received adjuvant radiation, with 85 (46.7%) of them receiving brachytherapy. Compared to patients who received chemoradiation, those who had NACT/radical hysterectomy were younger (median 47 vs 50 years, p=0.001), and more likely to have stage IB2 disease (40.1% vs 23.2%, p<0.001) and adenocarcinoma (30.8% vs 13.9%, p<0.001). There was no difference in OS between the NACT/radical hysterectomy and chemoradiation groups (p=0.91); 5-year OS rates were 70.2% and 68.5%. There was no difference in OS for patients with stage IB2 (p=0.73) or stage II disease (p=0.39). After controlling for patient age, race, presence of comorbid conditions, tumor histology, and stage, NACT/radical hysterectomy was not associated with better OS (HR: 1.05, 95% CI: 0.80, 1.38). Conclusions: Neoadjuvant chemotherapy followed by radical hysterectomy is rarely utilized in the United States. Overall survival appears to be comparable to primary chemoradiation. Given no survival advantage and potentially increased morbidity, primary chemoradiation should remain the preferred treatment modality in a high- resource setting. Objectives: To investigate the utilization and oncologic outcomes of neoadjuvant chemotherapy followed by radical hysterectomy for patients with locally advanced cervical cancer. Methods: Patients diagnosed between 2004-2015 with FIGO 2009 stage IB2-II squamous cell, adenocarcinoma, or adenosquamous cervical carcinoma with at least one month of follow-up with no history of another tumor were selected from the National Cancer Database. Patients who received neoadjuvant chemotherapy (defined as receipt of chemotherapy without radiation up to six months prior to surgery) followed by radical hysterectomy and those who received definitive chemoradiation (defined as external beam radiation therapy of at least 45 Gy, with same day concurrent chemotherapy and without adjuvant hysterectomy) were identified. Clinical-pathologic and demographic characteristics were compared. Overall survival (OS) was estimated following the generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for a priori selected confounders. Results: A total of 182 patients who received NACT followed by radical hysterectomy and 3859 patients who had definitive chemoradiation were identified. For patients who had a radical hysterectomy, the rate of positive margins was 7%, median hospital stay was 3 days and rate of unplanned re-admission within 30 days from discharge was 5.1% while most of them (90.1%) received adjuvant radiation, with 85 (46.7%) of them receiving brachytherapy. Compared to patients who received chemoradiation, those who had NACT/radical hysterectomy were younger (median 47 vs 50 years, p=0.001), and more likely to have stage IB2 disease (40.1% vs 23.2%, p<0.001) and adenocarcinoma (30.8% vs 13.9%, p<0.001). There was no difference in OS between the NACT/radical hysterectomy and chemoradiation groups (p=0.91); 5-year OS rates were 70.2% and 68.5%. There was no difference in OS for patients with stage IB2 (p=0.73) or stage II disease (p=0.39). After controlling for patient age, race, presence of comorbid conditions, tumor histology, and stage, NACT/radical hysterectomy was not associated with better OS (HR: 1.05, 95% CI: 0.80, 1.38). Conclusions: Neoadjuvant chemotherapy followed by radical hysterectomy is rarely utilized in the United States. Overall survival appears to be comparable to primary chemoradiation. Given no survival advantage and potentially increased morbidity, primary chemoradiation should remain the preferred treatment modality in a high- resource setting.

Fertility-sparing surgery in early-stage cervical cancer: laparoscopic versus abdominal radical trachelectomy

BackgroundRadical trachelectomy is an acceptable alternative to radical hysterectomy for patients with early-stage cervical cancer who wish to preserve reproductive function. This study is designed to compare the laparoscopic versus abdominal radical trachelectomy and provide oncological and obstetric outcome data on patients who have undergone fertility-sparing surgery.MethodsWe retrospectively analyzed all early-stage cervical cancer patients who underwent abdominal radical trachelectomy (ART) or laparoscopic radical trachelectomy (LRT) between January 2005 and June 2017 in West China Second University Hospital, Sichuan University. Patients' clinical details and follow-up were obtained from hospital records.ResultsA total of 33 patients (5 with IA1, 2 with IA2, and 26 with 1B1) were included, including 18 patients treated with ART and 15 patients treated with LRT. The median age at initial diagnosis was 30.00 ± 4.30 years (range 22–39). The mean follow-up time was 74.67 months. Among the 33 patients, 2 patients (6.06%, 1 abdominal/1 laparoscopic) developed recurrence, and there are no evidence of disease for the remaining 31 patients till now. The overall survival rate 96.99% (32/33). The LRT group had a shorter hospital stay (P = 0.01) and less blood loss (P < 0.01) than the ART group. There is no significant difference in the length of operative time (P = 0.48) between the two surgical routes. Overall, 15/33 patients (45.45%) have tried to conceive. 6 (40.00%) patients were pregnant and 6 (40.00%) patients were infertility. The ART group had a higher clinical pregnancy rate (P = 0.03) than the LRT group.ConclusionsThere is no statistically significant difference in oncological outcome between the two surgical approaches. The clinical pregnancy rate in the ART group was significant higher than that in the LRT group. However, LRT resulted in less blood loss and decreased length of hospital stay.

Comparison of Survival Outcomes between Minimally Invasive Surgery and Open Radical Hysterectomy in Early-Stage Cervical Cancer.

Simple SummaryRadical hysterectomy is one of the most crucial treatments for early-stage cervical cancer. However, which surgical approach is better, either minimally invasive surgery (MIS) or laparotomy, is still debatable. This study showed comparative survival outcomes between MIS and laparotomy radical hysterectomy and provided some viewpoints on selected cases. Subgroup analyses showed favorable survival outcomes in patients who received robotic-assisted surgery and had pathologic tumor size ≤ 2cm. With advancements in surgical technologies and comprehensions of pelvic anatomy regarding to the parametrium and the paracolpium, MIS has gradually become an alternative for early-stage cervical cancer. Moreover, for patients with tumor size > 2cm, laparotomy radical hysterectomy showed good radicality in the resection of parametrium. We concluded that precise clinical evaluations and tailored surgical approaches for patients with early-stage cervical cancer were of great significance.Objectives: To compare the survival outcomes between minimally invasive surgery (MIS) and laparotomy radical hysterectomy in patients with early-stage cervical cancer. Methods: We conducted a retrospective study involving women who received a radical hysterectomy for cervical cancer, stage IA1 with lymphovascular invasion, IA2, IB1, IB2, or IIA from 2008 to 2016. Clinicopathologic and perioperative outcomes were compared using appropriate statistical methodologies. Results: Oncologic survival outcomes were analyzed using the Kaplan–Meier method. Among the 105 cases identified, 58 (55.2%) and 47 (44.8%) women underwent MIS and open radical hysterectomy, respectively. Over a median follow-up period of 62 months, women who underwent MIS and open radical hysterectomy had a 5-year overall survival rate of 87.9% and 89.4% (p = 0.845) and a 5-year disease-free survival rate of 82.5% and 86.7% (p = 0.624), respectively. Conclusions: For early-stage cervical cancer, patients who underwent MIS radical hysterectomy had survival outcomes that were comparable to those who underwent open surgery at our institute.

Minimally invasive versus open surgery for women with stage 1A1 and stage 1A2 cervical cancer: A retrospective database cohort study

BackgroundRecent studies comparing minimally invasive versus open radical hysterectomy in patients with early-stage cervical cancer have reported a worse overall survival with minimally invasive surgery (MIS). However, in the patients with microscopic disease, there was no survival difference and the optimal surgical approach for microscopic cervical cancer remains unclear. MethodsUsing the National Cancer Database, we identified a cohort of women who underwent hysterectomy as the primary treatment for stage IA1/IA2 cervical cancer between January 2010 and December 2016. Using multivariable logistic regression, our primary outcome was to compare overall survival between the open and MIS groups. The data was stratified for simple and radical hysterectomies. Secondary endpoint was comparison of readmission rates and length of stay (LOS). ResultsWe identified 6230 patients with stage IA1 and IA2 cervical cancer that underwent hysterectomy as primary treatment. 4054 of these women (65%) underwent MIS. There was no difference in age, lympho-vascular invasion, number of lymph nodes retrieved and histology between the two groups. In the overall cohort, there was no difference in survival between the open and the MIS group (Hazard ratio for the open group 1.23; CI 0.92–1.63). Post-operative radiation therapy was more common in the open group (5.24% vs 4.09%, p value < 0.02). The mean LOS (1.35 days vs 3.08 days) was shorter in MIS group (p value < 0.0001). No difference was found in the readmission rates (60% for the MIS group vs 55% for the open group; p value 0.14). ConclusionsOur data suggest that MIS is associated with similar overall survival and shorter length of hospital stay compared to the open hysterectomy in women with stage IA cervical cancer. Based on this large data set, MIS appears to be a safe and effective surgical approach for women with stage IA1/IA2 cervical cancer.

SUCCOR cone study: conization before radical hysterectomy

ObjectiveTo evaluate disease-free survival of cervical conization prior to radical hysterectomy in patients with stage IB1 cervical cancer (International Federation of Gynecology and Obstetrics (FIGO) 2009).MethodsA multicenter retrospective observational cohort...

A proof-of-concept randomized phase 2 non-inferiority trial on simple versus modified radical hysterectomy in IA2-IB1 cervical cancer ≤2cm (LESSER)

Objectives: To evaluate the safety and efficacy of simple hysterectomy in early stage cervical cancer. Methods: The LESSER (LESs Surgical radicality for EaRly stage cervical cancer) study was a proof of concept randomized phase 2 non-inferiority trial evaluating the safety and efficacy of simple hysterectomy compared to modified radical hysterectomy in patients with stages IA2-IB1 cervical cancer and tumors of ≤2cm in size. Primary end-point was 3y-DFS rates and secondary endpoints were 3y-OS (3-year overall survival), surgical morbidity, indication of adjuvant therapy, and QoL (EORTC QLQ-C30). The study was registered at ClinicalTrials. gov (NCT02613286). Results: A total of 40 patients were randomized 1:1 from May 2015 to April 2018 in 3 oncological centers from Northeast Brazil. All cases had pelvic systematic lymph node dissection. Overall, 10% of patients underwent MIS procedures, 80% of tumors were SCC and 7.5% had lymph node metastasis, whereas inaccuracies for clinical tumor size estimation, LVSI and stromal invasion > 1 cm were found in 20%, 22.5% and 30% of cases, respectively. Clinical and pathological characteristics were well balanced between treatment arms, but the length of surgery and the time for bladder catheterization removal were higher after radical hysterectomy (p=0.003 and p=0.043, respectively). There was no postoperative mortality and rates of any grade postoperative complication were not statistically different between arms (15% and 20%; p=1.00). No major differences in the QoL over time were also observed. A quarter of patients received adjuvant therapy, with no significant difference between groups (30% vs. 20%, p=0.48). There was one death at 25 months of follow-up due to pelvic recurrence in the simple hysterectomy arm. A pathological review of this case found tumor embolus in the lymphovascular space of left parametrium that was missed at the time of former anatomopathological analysis. Another patient died of lung metastasis from a second primary thyroid cancer at 54.4 months of follow-up in the radical hysterectomy arm. A major late complication was also recorded after 3 months from radical surgery in a patient with distal urethral stenosis that was treated with segmental resection and psoas-hitch ureteroneocystostomy. Survival outcomes with a minimum of 3y follow-up will be mature for presentation during the SGO 2021 Annual Meeting on Women's Cancer. Conclusions: Simple hysterectomy is a promising substitute for modified radical hysterectomy in stage IA2-IB1 cervical cancer ≤2cm. To evaluate the safety and efficacy of simple hysterectomy in early stage cervical cancer. The LESSER (LESs Surgical radicality for EaRly stage cervical cancer) study was a proof of concept randomized phase 2 non-inferiority trial evaluating the safety and efficacy of simple hysterectomy compared to modified radical hysterectomy in patients with stages IA2-IB1 cervical cancer and tumors of ≤2cm in size. Primary end-point was 3y-DFS rates and secondary endpoints were 3y-OS (3-year overall survival), surgical morbidity, indication of adjuvant therapy, and QoL (EORTC QLQ-C30). The study was registered at ClinicalTrials. gov (NCT02613286). A total of 40 patients were randomized 1:1 from May 2015 to April 2018 in 3 oncological centers from Northeast Brazil. All cases had pelvic systematic lymph node dissection. Overall, 10% of patients underwent MIS procedures, 80% of tumors were SCC and 7.5% had lymph node metastasis, whereas inaccuracies for clinical tumor size estimation, LVSI and stromal invasion > 1 cm were found in 20%, 22.5% and 30% of cases, respectively. Clinical and pathological characteristics were well balanced between treatment arms, but the length of surgery and the time for bladder catheterization removal were higher after radical hysterectomy (p=0.003 and p=0.043, respectively). There was no postoperative mortality and rates of any grade postoperative complication were not statistically different between arms (15% and 20%; p=1.00). No major differences in the QoL over time were also observed. A quarter of patients received adjuvant therapy, with no significant difference between groups (30% vs. 20%, p=0.48). There was one death at 25 months of follow-up due to pelvic recurrence in the simple hysterectomy arm. A pathological review of this case found tumor embolus in the lymphovascular space of left parametrium that was missed at the time of former anatomopathological analysis. Another patient died of lung metastasis from a second primary thyroid cancer at 54.4 months of follow-up in the radical hysterectomy arm. A major late complication was also recorded after 3 months from radical surgery in a patient with distal urethral stenosis that was treated with segmental resection and psoas-hitch ureteroneocystostomy. Survival outcomes with a minimum of 3y follow-up will be mature for presentation during the SGO 2021 Annual Meeting on Women's Cancer. Simple hysterectomy is a promising substitute for modified radical hysterectomy in stage IA2-IB1 cervical cancer ≤2cm.

Minimally invasive versus open surgery for stage 1A1 and 1A2 cervical cancer

<h3>Objectives:</h3> Recent studies comparing minimally invasive versus open radical hysterectomy in patients with early stage cervical cancer have reported a worse overall survival with minimally invasive surgery (MIS). However, in the patients with microscopic disease, there was no survival difference and the optimal surgical approach for microscopic cervical cancer remains unclear. Our aim was to compare the overall survival and surgical outcomes between open and MIS in a large cohort of women with stage IA1/IA2 cervical cancer. <h3>Methods:</h3> Using the National Cancer Database, we identified a cohort of women who underwent hysterectomy as the primary treatment for stage IA1/IA2 cervical cancer between January 2010 and December 2016. Outcomes were compared between the cohorts using the Mann-Whitney U test, the chi- squared test or Fisher's exact test. Multivariable logistic regression was used to determine clinical characteristics that were statistically significant predictors of outcome. P values <0.05 were significant. The data was stratified for radical and simple hysterectomy. We also compared the readmission rates and length of stay (LOS) among the groups. <h3>Results:</h3> We identified 6230 patients with stage IA1 and IA2 cervical cancer that underwent hysterectomy as primary treatment. 4054 of these women (65%) underwent MIS and 1931 women had a radical hysterectomy. In this group, 1152 had a minimally invasive radical hysterectomy. In the overall cohort, there was no difference in survival between the open and the MIS group (Hazard ratio for the open group 1.23; CI 0.92-1.63). When stratified, the data showed no difference in overall survival for stage IA1 cases (HR 1.15; CI 0.77-1.73). For women with stage IA2, there was a trend towards decreased overall survival in the open group that did not reach statistical significance (HR 1.64; CI 0.84-3.23). Of note, post-operative radiation therapy was more common in the open group (5.24% vs 4.09%, p value <0.02). The mean LOS (1.35 days vs 3.08 days) was shorter in MIS group (pvalue <0.0001). No statistical significance was found in the readmission rates (60% for the MIS group vs 55% for the open group; p value 0.14). For the women who underwent a radical hysterectomy, there was no difference in survival between the open and the MIS cohort (p value 0.31) and as expected, the MIS group was associated with a decreased length of stay. <h3>Conclusions:</h3> Our data suggest that MIS is associated with similar overall survival and shorter length of hospital stay compared to the open hysterectomy in women with stage IA cervical cancer. When the data was stratified to simple and radical hysterectomy, the results were the same. Those women having open surgery were more likely to get post-operative radiation therapy. Based on this large data set, MIS appears to be a safe and effective surgical approach for women with stage IA1/IA2 cervical cancer.

Minimally-invasive hysterectomy versus open radical hysterectomy in early-stage cervical cancer: a cost-effective analysis of the LACC trial

<h3>Objectives:</h3> To determine the cost-effectiveness of minimally-invasive hysterectomy versus open radical hysterectomy in patients with early-stage cervical cancer. <h3>Methods:</h3> We created a model to evaluate the cost-effectiveness of minimally-invasive radical hysterectomy compared to open radical hysterectomy in women with newly diagnosed stage 1A1 (with lymphovascular invasion) thru IB2 (FIGO 2018) cervical cancer. We included 6,000 patients in the model which approached cost from a societal perspective. Surgical costs were calculated using the average Medicare reimbursement for the procedures with and without associated complications. Lost wages were calculated using return to normal daily activity per surgical approach and information from the Bureau of Labor Statistics. Estimated complication rates were calculated using the LACC trial data. Effectiveness was calculated as disease-free survival (DFS) at 4.5 years. We calculated incremental cost-effectiveness ratios (ICERs) to determine the cost per 4.5 year survivor. Univariate sensitivity analyses were performed. The willingness to pay threshold was $100,000 per year of DFS. <h3>Results:</h3> In the minimally-invasive radical hysterectomy cohort, the cost was $87.4 million (M) and yielded 5,160 4.5 year survivors. Comparatively, open radical hysterectomy cost $108.1 M and resulted in 5,760 4.5 year survivors. The ICER for open radical hysterectomy compared to minimally-invasive radical hysterectomy was $32,824 which fell well below our predetermined willingness to pay threshold of $450,000 per 4.5 year survivor. Sensitivity analyses were performed to determine the effect of complication rates on the model. The baseline rate of major complications with open radical hysterectomy was similar to minimally invasive radical hysterectomy (18.0 vs 16.0%). In order to evaluate the impact of medically compromised patients (comorbidities, obesity, and age >65), we varied the complication rates from 10-80% in the sensitivity analysis. With increasing complication rates in the open radical hysterectomy cohort, both the total costs and ICER increases ($64,044) but remains below the willingness to pay threshold. <h3>Conclusions:</h3> For patients with early-stage cervical cancer, open radical hysterectomy is cost-effective relative to minimally-invasive hysterectomy. Medical comorbidities and complication rates do not impact the results of the model. Open radical hysterectomy appears to be the preferred surgical approach for all patients with early-stage cervical cancer.

Machine Learning Models to Predict Survival Outcomes According to the Surgical Approach of Primary Radical Hysterectomy in Patients with Early Cervical Cancer

Simple SummaryAn increased risk of relapse and death from minimally invasive radical hysterectomy has been reported in some patients with early cervical cancer. Thus, the development of an intuitive and precise decision-aid tool, which estimates recurrence and mortality rates by surgical approach, is necessary. To develop models predicting survival outcomes according to the surgical approach, we collected clinicopathologic and survival data of patients with 2009 FIGO stage IB cervical cancer who underwent a radical hysterectomy. Using only variables that could be obtained preoperatively, we developed various models predicting the probability of 5-year progression-free survival and overall survival. Among them, hybrid ensemble models, combined with logistic regression and multiple machine learning models, achieved the best predictive performance. The developed models are expected to help physicians’ and patients’ decision making related to the surgical approach for primary radical hysterectomy.We purposed to develop machine learning models predicting survival outcomes according to the surgical approach for radical hysterectomy (RH) in early cervical cancer. In total, 1056 patients with 2009 FIGO stage IB cervical cancer who underwent primary type C RH by either open or laparoscopic surgery were included in this multicenter retrospective study. The whole dataset consisting of patients’ clinicopathologic data was split into training and test sets with a 4:1 ratio. Using the training set, we developed models predicting the probability of 5-year progression-free survival (PFS) and overall survival (OS) with tenfold cross validation. The developed models were validated in the test set. In terms of predictive performance, we measured the area under the receiver operating characteristic curve (AUC) values. The logistic regression models comprised of preoperative variables yielded AUCs of 0.679 and 0.715 for predicting 5-year PFS and OS rates, respectively. Combining both logistic regression and multiple machine learning models, we constructed hybrid ensemble models, and these models showed much improved predictive performance, with 0.741 and 0.759 AUCs for predicting 5-year PFS and OS rates, respectively. We successfully developed models predicting disease recurrence and mortality after primary RH in patients with early cervical cancer. As the predicted value is calculated based on the preoperative factors, such as the surgical approach, these ensemble models would be useful for making decisions when choosing between open or laparoscopic RH.

Minimally invasive surgery and abdominal radical hysterectomy in patients with early‐stage cervical cancer: A meta‐analysis

To compare risk of recurrence and death related to minimally invasive surgery (MIS) and abdominal radical hysterectomy (ARH) in early-stage cervical cancer (CC) patients. All relevant literatures in databases were retrieved from the built time of databases to October 2020. Observational studies comparing MIS and ARH in early-stage CC patients were involved. Newcastle-Ottawa Scale was used for quality assessment, including studies with a score of at least 6. Main outcomes involved overall survival (OS) and disease-free survival (DFS). Twenty-two studies were involved, including 14894 patients, among which 7213 (48.6%) underwent MIS. The OS (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.03-1.43) and DFS (HR 1.25, 95% CI 1.07-1.42) of patients undergoing MIS was obviously shortened compared with those of patients undergoing ARH. Subgroup analysis revealed that OS (HR 1.42, 95% CI 1.10-1.74) and DFS (HR 1.46, 95% CI 1.18-1.74) of patients with a tumor ≥2cm in diameter were significantly reduced by MIS. Overall survival and DFS after MIS for early-stage CC treatment were worse than those after ARH, especially for patients with a tumor ≥2cm in diameter.

The long-term urinary dysfunction after type C2 radical hysterectomy in patients with cervical cancer

Radical hysterectomy (RH) may cause lower urinary tract symptoms (LUTS) for patients with cervical cancer. Few data are available on the long-term LUTS of these patients and whether the symptoms relate to the route of surgery remain unclear. Here, we assessed the long-term urinary dysfunction in cervical cancer patients after RH based on a self-reported questionnaire. A total of 168 patients after type C2 RH, either by laparoscopy (LRH) or laparotomy (ARH), were analysed. The median length of follow-up was 54 ± 8.35 months. The total incidence of urinary dysfunction was around 40%. Patients with LRH had more intermittent stream and feeling of incomplete emptying than those in ARH group. Our data indicate the irreversible damage of RH to urinary function of cervical cancer patients, who should be informed of the long-term and high incidence of urinary dysfunction after RH when they choose surgical treatment. Impact Statement What is already known on this subject? Radical hysterectomy (RH) with pelvic lymphadenectomy is standard surgical care for patients with cervical cancer. RH could induce urinary dysfunction, including bladder sensation loss, hypertonic and hypotonic bladder, urinary incontinence, etc. Studies mainly focus on short- or mid-term urinary dysfunction and stated that spontaneous recovery of urinary function is to be expected within 6–12 months after surgery. What the results of this study add? The lower urinary tract symptoms last for years after type C2 RH, indicating the irreversible damage of RH to urinary function of cervical cancer patients. The incidence of bladder dysfunction is increased in patients submitted to laparoscopic RH compared to abdominal RH. What the implications are of these findings for clinical practice and/or further research? Cervical cancer patients should be informed of the long-term and high incidence of urinary dysfunction after RH when they choose surgical treatment.

Laparoscopic Radical Hysterectomy Results in Higher Recurrence Rate Versus Open Abdominal Surgery for Stage IB1 Cervical Cancer Patients With Tumor Size Less Than 2 Centimeter: A Retrospective Propensity Score-Matched Study.

ObjectiveTo compare the oncologic outcomes between laparoscopic and open radical hysterectomy in patients with stage IB1 cervical cancer lesion less than 2 cm.MethodsPatients diagnosed FIGO (2009) stage IB1 (tumor diameter <2 cm) and underwent radical hysterectomy in our hospital between March 2008 and November 2018 were studied. A propensity-matched comparison (1:2) was conducted to minimize selection biases. Demographic and baseline oncologic characteristics were balanced between groups. Overall survival (OS) and disease-free survival (DFS) were assessed using the Kaplan–Meier model, along with univariable and multivariable regression analysis.ResultsA total of 261 patients were enrolled in this study after propensity-matching, with 174 in the open group and 87 in the laparoscopic group. Disease relapsed in seven patients in laparoscopy group, and the recurrence rate was 8.0% (7/87). There were eight patients underwent abdominal radical hysterectomy experienced recurrence, and the recurrence rate was 4.6% (8/174). The multivariate analysis model revealed that laparoscopic operation was associated with higher risk of recurrence than abdominal radical hysterectomy (HR, 3.789; 95% CI, 1.143–12.559; p = 0.029). There were five patients or 2.9% (5/174) died in open surgery group and the corresponding percentage in laparoscopy group was 2.3% (2/87). No difference was found in OS between the two groups (HR, 1.823; 95% CI, 0.2673–12.44; log-rank p = 0.5398). All the recurrence occurred within two years after operation in the laparoscopy group, among which pelvic recurrence (85.7%) was dominant.ConclusionTraditional laparotomy radical hysterectomy has a lower recurrence rate when compared with laparoscopic operation in those cervical cancer patients with a foci diameter less than 2 cm. However, no detrimental effect on survival was found in minimal invasive operation group. Further multi-center prospective trials are needed to confirm our results on a large scale.