Outcomes of Radical Hysterectomy for Early-Stage Cervical Carcinoma, with or without Prior Cervical Excision Procedure.

OBJECTIVE: To investigate the impact of a prior cervical excisional procedure on the oncologic outcomes of patients with apparent early-stage cervical carcinoma undergoing radical hysterectomy. METHODS: The National Cancer Database (2004-2015) was accessed, and patients with FIGO 2009 stage IB1 cervical cancer who had a radical hysterectomy with at least 10 lymph nodes (LNs) removed and a known surgical approach were identified. Patients who did and did not undergo a prior cervical excisional procedure (within 3 months of hysterectomy) were selected for further analysis. Overall survival (OS) was evaluated following the generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control a priori-selected confounders. RESULTS: A total of 3159 patients were identified; 37.1% (n = 1171) had a prior excisional procedure. These patients had lower rates of lymphovascular invasion (29.2% vs. 34.9%, p = 0.014), positive LNs (6.7% vs. 12.7%, p < 0.001), and a tumor size >2 cm (25.7% vs. 56%, p < 0.001). Following stratification by tumor size, the performance of an excisional procedure prior to radical hysterectomy was associated with better OS even after controlling for confounders (aHR: 0.45, 95% CI: 0.30, 0.66). The rate of minimally invasive surgery was higher among patients who had a prior excisional procedure (61.5% vs. 53.2%, p < 0.001). For these patients, performance of minimally invasive radical hysterectomy was not associated with worse OS (aHR: 1.37, 95% CI: 0.66, 2.82). CONCLUSIONS: For patients undergoing radical hysterectomy, preoperative cervical excision may be associated with a survival benefit. For patients who had a prior excisional procedure, minimally invasive radical hysterectomy was not associated with worse overall survival.

Role of systematic lymphadenectomy at the time of interval debulking surgery for patients with advanced-stage epithelial ovarian carcinoma who achieved complete gross resection.

OBJECTIVE: To evaluate the role of systematic lymphadenectomy at the time of interval cytoreductive surgery for patients with advanced-stage epithelial ovarian carcinoma who achieved complete gross resection. METHODS: The National Cancer DataBase was accessed, and patients diagnosed between 2010 and 2015 with advanced-stage ovarian carcinoma who underwent interval cytoreductive surgery and achieved complete gross resection were identified. Patients who did not undergo lymphadenectomy and those who underwent systematic lymphadenectomy (defined as at least 20 lymph nodes removed) were selected for further analysis. Median overall survival was compared with the log-rank test and controlled for a priori selected confounders. RESULTS: A total of 1060 patients were identified. Systematic lymphadenectomy was performed for 125 (11.8%) patients with a median of 29 lymph nodes (range 20-72) removed. Rate of lymph node metastasis was 62.4%. Patients who underwent systematic lymphadenectomy had higher rate of unplanned readmission (8.9% vs 1.6%, p<0.001), and median hospital stay (6 vs 4 days, p<0.001). Median overall survival for patients who did and did not undergo systematic lymphadenectomy was 44.2 and 40.4 months, respectively, p=0.40. After controlling for confounders, performance of systematic lymphadenectomy was not associated with better survival (HR=0.98, 95% CI 0.80 to 1.19). CONCLUSION: Systematic lymphadenectomy is rarely performed at the time of interval cytoreductive surgery and not associated with a survival benefit for patients who achieved complete gross resection.

Impact of delayed interval cytoreductive surgery on the survival of patients with advanced stage high-grade epithelial ovarian carcinoma.

OBJECTIVE: Our objective was to use real-world data to investigate the impact of delayed interval cytoreductive surgery on the survival of patients with advanced stage high-grade ovarian carcinoma. METHODS: We accessed the National Cancer Database and identified patients diagnosed between 2004-2015 with advanced stage high-grade ovarian carcinoma who received neoadjuvant chemotherapy and underwent interval cytoreductive surgery. Based on timing between surgery and chemotherapy administration patients were categorized into standard (9-13.0 weeks) and delayed (13.01-26 weeks) interval cytoreductive surgery groups. Overall survival was compared with the log-rank test and a Cox model was constructed to control for a priori selected confounders. RESULTS: We identified a total of 5051 patients; 2389 (47.3%) and 2662 (52.7%) in the standard and delayed interval cytoreductive surgery groups respectively. There was no difference in complete gross resection rates (53.2% vs 54.5%, p=0.51). Patients in the delayed interval cytoreductive surgery group were less likely to undergo complex surgery (39.3% vs 45.6%, p<0.001) and had lower rates of unplanned re-admission (4.1% vs 2.6%, p=0.003). There was no difference in overall survival between the standard and delayed interval cytoreductive surgery groups, p=0.13 (median 34.3 vs 33.9 months) even after controlling for confounders (hazard ratio (HR) 1.04, 95% confidence intervals (CIs): 0.97, 1.12). There was no difference in overall survival between the two groups for patients with no gross residual (p=0.95; median overall survival 40.08 vs 39.8 months) or gross residual disease (p=0.16; median overall survival 32.89 and 32.16 months). CONCLUSION: For patients with advanced stage ovarian cancer delayed interval cytoreductive surgery may not be associated with worse overall survival.

The utility of self-expanding metal stents in benign biliary strictures- a retrospective case series.

BACKGROUND: Benign biliary strictures can have a significant negative impact on patient quality of life. There are several modalities which can be utilized with the goal of stricture resolution. These techniques include balloon dilatation, placement of multiple plastic stents and more recently, the use of metal stents. The aim of this study was to evaluate the local success of self-expanding metal stents in successfully resolving benign biliary strictures. METHODS: This was a single institution, retrospective case series. Patients included in our study were patients who underwent endoscopic retrograde cholangiopancreatography with placement of self expanding metal stents for benign biliary strictures at our institution between 2016-2022. Patients were excluded for the following: malignant stricture, and inability to successfully place metal stent. Data was evaluated using two-sided t-test with 95% confidence interval. RESULTS: A total of 31 patients underwent placement of 43 self-expanding metal stents and met inclusion criteria. Mean age of patients was 59 ± 10 years, and were largely male (74.2% vs. 25.8%). Most strictures were anastomotic stricture post liver transplant (87.1%), while the remainder were secondary to chronic pancreatitis (12.9%). Complications of stent placement included cholangitis (18.6%), pancreatitis (2.3%), stent migration (20.9%), and inability to retrieve stent (4.7%). There was successful stricture resolution in 73.5% of patients with anastomotic stricture and 33.3% of patients with stricture secondary to pancreatitis. Resolution was more likely if stent duration was > / = 180 days (73.3% vs. 44.4%, p < 0.05). There was no demonstrated added benefit when stent duration was > / = 365 days (75% vs. 60.9%, p = 0.64). CONCLUSIONS: This study demonstrates that self expanding metal stents are a safe and effective treatment for benign biliary strictures, with outcomes comparable to plastic stents with fewer interventions. This study indicates that the optimal duration to allow for stricture resolution is 180-365 days.

Extent of Lymph Node Harvest: A Retrospective Cohort Comparison of Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy.

Background: Minimally invasive surgery has been demonstrated to have clear advantages in colon cancer management, with a decrease in the morbidity and mortality associated with surgery. With the introduction of intracorporeal anastomosis (ICA), the entire mesenteric dissection and division is performed under vision laparoscopically and may lead to superior lymph node harvest. The aim of our study is to evaluate lymph node harvest in patients undergoing totally laparoscopic right hemicolectomy with ICA compared to laparoscopic-assisted right hemicolectomy with extracorporeal anastomosis (ECA). Methods: This is a single institution retrospective cohort study. Eligible patients underwent laparoscopic right hemicolectomy at our institution between 2012 and 2022. Patients were identified using a hospital database, and surgeon office databases. Patients included underwent laparoscopic right hemicolectomy for neoplastic lesions (colon cancer/unresectable polyps), or benign etiologies. We excluded patients who underwent laparotomy (intra-operative conversion), resection without anastomosis, resection for IBD, or lack of documented lymph node number. Data were compared using two-sided t-test evaluation with a 95% confidence interval. Results: A total of 679 patients were included, 493 ECA (72.6%) and 186 ICA (27.4%). Patient demographics (age, biologic sex, American Society of Anesthesiologists and body mass index) were not significantly different. Lymph node harvest was significantly higher in those with ICA (24 ± 14 versus 21 ± 1, P < .05). In subgroup analysis, this difference was maintained in patients with malignant processes (27 ± 14 versus 23 ± 10, P < .05). Conclusions: In our experience, ICA has higher lymph node harvest in comparison to ECA. This may improve outcomes and options for adjuvant therapies in malignant indications.

Laparoscopic Right Hemicolectomy for Inflammatory Bowel Disease: Is Intracorporeal Anastomosis Feasible? A Retrospective Cohort Comparison Study.

Background: Inflammatory bowel disease (IBD) affects all ages and backgrounds, and many individuals require surgical intervention during their disease course. The adoption of laparoscopic techniques in this patient population has been slow, including intracorporeal anastomosis (ICA). The aim of our study was to determine if ICA was feasible and safe in patients with IBD undergoing laparoscopic right hemicolectomy (LRHC). Methods: This is a retrospective, single institution cohort study of elective and emergent cases of LRHC at a single academic center. Patients included underwent LRHC or ileocolic resection for IBD. Exclusion criteria: conversion to laparotomy, resection without anastomosis, or unconfirmed diagnosis of IBD. Main outcomes studied were anastomotic leak rate, surgical site infection (SSI), postoperative length of stay, 30-day readmission/reoperation, and operative time. Secondary outcomes were incisional hernia rates and rates of disease recurrence. Results: A total of 70 patients were included, 12 underwent ICA and 58 extracorporeal anastomosis. Anastomotic leak rate (intracorporeal 8.3% [n = 1], extracorporeal 8.6% [n = 5], P = .97), and SSI rates (intracorporeal 0%, extracorporeal 6.9% [n = 4], P = .36) were similar. Mean postoperative length of stay, rates of 30-day readmission/reoperation and diagnosis of hernia at 1 year were not significantly different. Rates of IBD recurrence and location of recurrence at 1 year were similar. However, operative time was significantly longer in those undergoing ICA (intracorporeal 187 minutes versus extracorporeal 139 minutes, P = < .05). Conclusions: ICA is a safe option in patients with IBD undergoing LRHC.

Next generation sequencing reveals a high prevalence of pathogenic mutations in homologous recombination DNA damage repair genes among patients with uterine sarcoma.

OBJECTIVE: Investigate the incidence of homologous recombination DNA damage response (HR-DDR) genomic alterations among patients with uterine sarcoma. METHODS: The American Association for Cancer Research GENIE v13.0 database was accessed and patients with uterine leiomyosarcoma, adenosarcoma, undifferentiated uterine sarcoma, high-grade endometrial stromal sarcoma, low-grade endometrial stromal sarcoma, and endometrial stromal sarcoma not otherwise specified were identified. We determined the incidence of pathogenic alterations in the following genes involved in HR-DDR: ATM, ARID1A, ATRX, BAP1, BARD1, BLM, BRCA2, BRCA1, BRIP1, CHEK2, CHEK1, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCL, MRE11, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, WRN. Data from the OncoKB database, as provided by cBioPortal, was utilized to determine the presence of pathogenic genomic alterations. RESULTS: A total of 509 patients contributing with 525 samples were identified. Median patient age at sample collection was 56 years while the majority were White (80.7%). The most common histologic subtype was leiomyosarcoma (63.8%) followed by adenosarcoma (12.3%). The overall incidence of HR-DDR genomic alterations was 28.2%. The most commonly altered genes were ATRX (18.2%), BRCA2 (4%), and RAD51B (2.6%). The highest incidence of HR-DDR genomic alterations was observed among patients with leiomyosarcoma (35.4%), adenosarcoma (27%) and undifferentiated uterine sarcoma (30%), while those with low-grade endometrial stromal sarcoma had the lowest (2.9%) incidence. CONCLUSIONS: Approximately 1 in 3 patients with uterine sarcoma harbor a pathogenic alteration in HR-DDR genes. Incidence is high among patients with uterine leiomyosarcoma and adenosarcoma.

A retrospective case series of Mohs micrographic surgery and interdisciplinary management of female genital skin cancers: Local recurrence rates and patient-reported outcomes.

BACKGROUND: Conventional excision of female genital skin cancers has high rates of local recurrence and morbidity. Few publications describe local recurrence rates (LRRs) and patient-reported outcomes (PROs) after Mohs micrographic surgery (MMS) for female genital skin cancers. OBJECTIVE: To evaluate LRRs, PROs, and interdisciplinary care after MMS for female genital skin cancers. METHODS: A retrospective case series was conducted of female genital skin cancers treated with MMS between 2006 and 2021 at an academic center. The primary outcome was local recurrence. Secondary outcomes were PROs and details of interdisciplinary care. RESULTS: Sixty skin cancers in 57 patients were treated with MMS. Common diagnoses included squamous cell cancer (n = 26), basal cell cancer (n = 12), and extramammary Paget disease (n = 11). Three local recurrences were detected with a mean follow-up of 61.1 months (median: 48.8 months). Thirty-one patients completed the PROs survey. Most patients were satisfied with MMS (71.0%, 22/31) and reported no urinary incontinence (93.5%, 29/31). Eight patients were sexually active at follow-up and 75.0% (6/8) experienced no sexual dysfunction. Most cases involved interdisciplinary collaboration 71.7% (43/60). LIMITATIONS: Limitations include the retrospective single-center design, heterogeneous cohort, and lack of preoperative function data. CONCLUSIONS: Incorporating MMS into interdisciplinary teams may help achieve low LRRs and satisfactory function after genital skin cancer surgery.

Facility level variation in the utilization of neoadjuvant chemotherapy is associated with higher surgical morbidity for patients with advanced stage epithelial ovarian carcinoma.

OBJECTIVE: Investigate outcomes for advanced stage epithelial ovarian cancer (EOC) patients based on facility-level utilization of neoadjuvant chemotherapy (NACT). METHODS: Stage III-IV EOC patients diagnosed between 2010 and 2016 were identified in the National Cancer Database. Percentage of patients managed with NACT was calculated for facilities, reporting ≥120 patients. Facilities with lowest and highest quartile of NACT rate comprised the low and high-utilizing groups. Clinico-pathological characteristics were collected, and appropriate statistical analysis performed. RESULTS: High- and low-utilizing facilities managed on average 54.1% and 25.4% of patients with NACT respectively. Patients managed at high-utilizing facilities were significantly more likely to be >65 (p = 0.029), have stage IV disease (p < 0.001) and comorbidities (p < 0.001). Patients managed with primary debulking surgery (PDS) at low-utilizing facilities were significantly more likely to be >65, have stage IV disease, and have comorbidities (all, p < 0.001). Patients undergoing PDS at low-utilizing facilities were significantly less likely to achieve complete gross resection (p < 0.001), and were significantly more likely to experience 90-day mortality (p < 0.001), and unplanned 30-day readmission (p < 0.001). After controlling for age, comorbidities, race, insurance status, stage, grade and histology, high-utilizing facilities trended towards better overall survival (OS) (HR: 0.92, 95% CI: 0.85-0.99). Overall, patients undergoing PDS had better OS compared to those who had NACT (median 42 vs 27 months, p < 0.001). CONCLUSIONS: Despite treating an EOC population with more advanced disease and comorbidities, high-utilizing facilities have lower surgical morbidity and mortality with no detrimental impact on long-term survival. Careful patient selection to minimize the morbidity and mortality associated with PDS is pivotal.

Laparoscopic right colectomies with intracorporeal compared to extracorporeal anastomotic techniques are associated with reduced post-operative incisional hernias.

BACKGROUND: Owing to important differences in surgical technique, laparoscopic right colectomy with intracorporeal (ICA) compared to extracorporeal (ECA) anastomotic technique may result in improved patient outcomes. We aimed to compare both techniques according to incisional hernias and other pertinent perioperative characteristics, post-operative complications, and oncologic quality markers. METHODS: All adult patients undergoing laparoscopic right colectomies between 2015 and 2020 at a single institution were included. ICA and ECA techniques were compared based on selected outcomes using univariable and multivariable statistical analyses, as appropriate. Subgroup analyses were restricted to patients with neoplastic indications for surgery and non-urgent operations. RESULTS: A total of 517 patients met inclusion criteria, of which 139 (26.9%) underwent ICA and 378 (73.1%) underwent ECA. ICA and ECA patients had similar baseline characteristics. At two years of follow-up, a lower proportion of ICA patients developed a hernia at the extraction incision (1.5% vs. 7.1%, p = 0.02) and ICA was associated with an 80% reduction in extraction incision hernias (aHR 0.20, p = 0.03). These results were stable through subgroup and sensitivity analyses. Median operative time was longer in the ICA group (186 min vs. 135 min, p < 0.001), but the gap in operative time narrowed during the study period. Median length of stay was one calendar day shorter in the ICA group (3 days vs. 4 days, p = 0.007) and ICA was associated with a 13% decrease in the length of stay (aRR 0.87, p = 0.02). The incidence of superficial wound infections, anastomotic leaks and re-interventions was lower in ICA patients, but this difference was not statistically significant. 90-day unscheduled visits, readmissions, and mortalities were similar across both groups, as were oncologic outcomes. CONCLUSION: Laparoscopic right colectomies with intracorporeal anastomoses are associated with a reduction in incisional hernias and shorter hospital lengths of stay without compromising on patient safety or oncologic principles.

[18F]FluorThanatrace ([18F]FTT) PET Imaging of PARP-Inhibitor Drug-Target Engagement as a Biomarker of Response in Ovarian Cancer, a Pilot Study.

PURPOSE: PARP inhibitors have become the standard-of-care treatment for homologous recombination deficient (HRD) high-grade serous ovarian cancer (HGSOC). However, not all HRD tumors respond to PARPi. Biomarkers to predict response are needed. [18F]FluorThanatrace ([18F]FTT) is a PARPi-analog PET radiotracer that noninvasively measures PARP-1 expression. Herein, we evaluate [18F]FTT as a biomarker to predict response to PARPi in patient-derived xenograft (PDX) models and subjects with HRD HGSOC. EXPERIMENTAL DESIGN: In PDX models, [18F]FTT-PET was performed before and after PARPi (olaparib), ataxia-telangiectasia inhibitor (ATRi), or both (PARPi-ATRi). Changes in [18F]FTT were correlated with tumor volume changes. Subjects were imaged with [18F]FTT-PET at baseline and after ∼1 week of PARPi. Changes in [18F]FTT-PET uptake were compared with changes in tumor size (RECISTv1.1), CA-125, and progression-free survival (PFS). RESULTS: A decrease in [18F]FTT tumor uptake after PARPi correlated with response to PARPi, or PARPi-ATRi treatment in PARPi-resistant PDX models (r = 0.77-0.81). In subjects (n = 11), percent difference in [18F]FTT-PET after ∼7 days of PARPi compared with baseline correlated with best RECIST response (P = 0.01), best CA-125 response (P = 0.033), and PFS (P = 0.027). All subjects with >50% reduction in [18F]FTT uptake had >6-month PFS and >50% reduction in CA-125. Utilizing only baseline [18F]FTT uptake did not predict such responses. CONCLUSIONS: The decline in [18F]FTT uptake shortly after PARPi initiation provides a measure of drug-target engagement and shows promise as a biomarker to guide PARPi therapies in this pilot study. These results support additional preclinical mechanistic and clinical studies in subjects receiving PARPi ± combination therapy. See related commentary by Liu and Zamarin, p. 1384.

Predictive value of 5-Factor modified frailty index in Oncologic and benign hysterectomies.

Background: The 5-factor modified frailty index (mFI-5) has been validated against the original 11-factor modified frailty index in gynecologic surgery, however its utility has not been evaluated between benign versus gynecologic oncology patient populations. Objective: To evaluate the predictive value of the mFI-5 in identifying women at increased risk for major postoperative complications, readmission, or death within 30 days of hysterectomy for benign and oncologic indications. Methods: Patients who underwent hysterectomy between 2015 and 2017 were identified from the NSQIP database and stratified into benign or malignant indications. Demographic and mFI-5 variables were extracted. The mFI-5 was calculated by dividing the sum of all affirmative variables by the total number of input variables in the database. Logistic regression modeling was performed adjusting for confounders. C-statistic with 95% CI was obtained post-regression. Results: 80,293 hysterectomies (59,078 benign and 21,215 oncologic) were identified. The benign group was more likely to have an mFI-5 score of 0 (70 % vs 50 %, p = 0.001) and had shorter operative times (p = 0.001). In the benign group, mFI-5 was a strong predictor of mortality (c = 0.819, CI 0.704-0.933). Within the oncology group, the mFI-5 was a strong predictor of mortality (c = 0.801, CI 0.750-0.851), particularly for uterine and cervical cancers. It was moderately predictive of readmission (c = 0.671, CI 0.656-0.686) and strongly predictive of Clavien-Dindo class III and IV complications (c = 0.732, CI 0.713-0.750). Conclusion: The mFI-5 is a strong predictor of 30-day mortality and serious postoperative complications. These findings have the potential to improve identification of high-risk patients in the preoperative setting.

Bariatric Center Designation and Outcomes Following Repeat Abdominal Surgery in Bariatric Patients.

INTRODUCTION: Repeat abdominal surgery in the bariatric surgery patient population may be challenging for non-bariatric-accredited institutions. The impact of regionalized bariatric care on clinical outcomes for bariatric surgery patients requiring repeat abdominal surgery is currently unknown. This study aims to investigate the association between bariatric center designation and clinical outcomes following hepatobiliary, hernia, and upper and lower gastrointestinal operations among patients with prior bariatric surgery. METHODS: This is a cohort study of a large sample of Ontario residents who underwent primary bariatric surgery between 2010 and 2017. A comprehensive list of eligible abdominal operations was captured using administrative data. The primary outcome was 30-d complications. Secondary outcomes included 30-d mortality, readmission, and length of stay. RESULTS: Among the 3301 study patients, 1305 (40%) received their first abdominal reoperation following bariatric surgery at a designated bariatric center. Nonbariatric center designation was not associated with significantly higher rates of 30-d complications (5.73% versus 5.72%), mortality (0.80% versus 0.77%), readmissions (1.11% versus 1.85%), or median postoperative length of stay (4 versus 4 d). After grouping the category of reoperations, upper gastrointestinal (odds ratio [OR] 0.66, confidence interval [CI] 0.39-1.11) and abdominal wall hernia surgery (OR 0.52, CI 0.27-0.99) showed a lower adjusted OR for complications among bariatric centers. CONCLUSIONS: Our study demonstrates that after adjustment for case-mix and patient characteristics, bariatric surgery patients undergoing repeat abdominal surgery at nonbariatric centers is not associated with higher proportion of complications or mortality. Complex hernia surgery may be considered the most appropriate for referral.

Addition of External Beam Radiation Therapy to Adjuvant Chemotherapy for Patients With Stage IIIC Uterine Endometrioid Carcinoma: Utilization and Outcomes.

OBJECTIVES: Evaluate whether the addition of external beam radiation (EBRT) to adjuvant chemotherapy with or without vaginal brachytherapy is associated with better survival for patients with stage IIIC endometrioid endometrial carcinoma. MATERIALS AND METHODS: Patients diagnosed between 2010 and 2015 with apparent early-stage endometrioid adenocarcinoma, without a history of another tumor, who underwent hysterectomy with lymphadenectomy and had positive lymph nodes were identified in the National Cancer Database. Those who received adjuvant chemotherapy (defined as receipt of treatment within 6 mo from surgery) and had at least 1 month of follow-up were selected for further analysis. Overall survival was compared between patients who did and did not receive EBRT within 6 months from surgery with the log-rank test. A Cox model was also constructed to control for confounders. RESULTS: A total of 3116 patients were identified; 1458 (46.8%) received chemotherapy without and 1658 (53.2%) with EBRT. Pathologic characteristics (tumor grade, size, endocervical, and lymph-vascular invasion) were comparable between the two groups. Patients who received external beam radiation had better survival compared with those who did not, P =0.001; 5-year overall survival rates were 83.1% and 77.9%, respectively. After controlling for patient age, race, presence of comorbidities, insurance status, tumor size, grade and endocervical invasion, and the presence of lymph-vascular invasion, the addition of EBRT was associated with a survival benefit (HR: 0.75, 95% CI: 0.62, 0.91). CONCLUSIONS: For patients with endometrioid adenocarcinoma metastatic to the lymph nodes, addition of external beam radiation to adjuvant chemotherapy may be associated with a survival benefit.

Safety of ovarian preservation for premenopausal patients with FIGO stage I grade 2 and 3 endometrioid endometrial adenocarcinoma.

OBJECTIVE: To investigate the utilization and outcomes of ovarian preservation for premenopausal patients with International Federation of Gynecology and Obstetrics (FIGO) stage I grade 2 and 3 endometrioid endometrial carcinoma undergoing hysterectomy. METHODS: The National Cancer Database was accessed; patients aged ≤45 years diagnosed between January 2004 and December 2015 with FIGO stage I grade 2 or 3 endometrioid endometrial carcinoma, who underwent hysterectomy with or without bilateral salpingo-oophorectomy and had at least 1 month of follow-up, were identified. Overall survival was assessed following generation of Kaplan-Meier curves and compared with the log-rank test. A Cox model was constructed to control for a priori selected variables. RESULTS: A total of 2941 patients who met the inclusion criteria were identified; 200 (6.8%) patients did not undergo bilateral salpingo-oophorectomy. Rate of ovarian preservation was comparable between patients with grade 2 (n=163, 6.6%) and grade 3 (n=37, 7.7%) tumors (p=0.38). Patients who did not undergo bilateral salpingo-oophorectomy were younger (median 39 vs 41 years, p<0.001) and less likely to undergo surgical lymph node assessment (52% vs 76.2%, p<0.001). There was no difference in overall survival between patients who did and did not undergo bilateral salpingo-oophorectomy (p=0.94); 5 year overall survival rates were 96.6% and 97%, respectively. After controlling for confounders, including tumor grade, ovarian preservation was not associated with worse overall survival (HR 0.92, 95% CI 0.47 to 1.84). CONCLUSIONS: For patients with grade 2 and 3 FIGO stage I endometrioid carcinoma undergoing hysterectomy, ovarian preservation is rarely performed while no clear detrimental effect on overall survival was found.

Oncologic outcomes of surgical para-aortic lymph node staging in patients with advanced cervical carcinoma undergoing chemoradiation.

OBJECTIVES: We aimed to evaluate the utilization and impact of surgical para-aortic lymph node staging on the survival of patients with locally advanced stage cervical carcinoma receiving definitive chemoradiation. METHODS: We identified patients in the National Cancer Database diagnosed between January 2010 and December 2015 with locally advanced (FIGO 2009 stage IB2-IVA) cervical carcinoma who did not undergo hysterectomy, received primary chemoradiation and had at least 1 month of follow-up. Two groups of patients were formed based on the assessment method of para-aortic lymph node status - radiologic assessment only versus surgical lymphadenectomy. Overall survival was compared with the log-rank test after Kaplan-Meier curves were generated. A Cox model was constructed to control for a priori selected confounders. RESULTS: We identified a total of 3540 patients who met the inclusion criteria. Para-aortic staging was performed in 333 (9.4%) patients. These patients were younger (median age 46 vs 52 years, p<0.001), less likely to have co-morbidities (8.7% vs 15.6%, p<0.001), more likely to have private insurance (48.9% vs 37.8%, p<0.001) and receive brachytherapy (76.9% vs 70.9%, p=0.022). The rate of para-aortic lymphadenectomy was comparable between patients with stage IB2-II and III-IVA disease (9.4% for both groups, p=0.98). Patients who underwent para-aortic lymphadenectomy were also more likely to have lymph nodes categorized as positive compared with those who had imaging only (27.3% vs 13.2%, p<0.001). There was no difference in overall survival between patients who underwent radiologic only or surgical para-aortic lymph node assessment (p=0.80 from log-rank test); 4 year overall survival rates were 62.9% and 63%. After controlling for confounders, performance of para-aortic lymphadenectomy was not associated with a survival benefit (HR 1.07, 95% CIs: 0.88 to 1.31). CONCLUSIONS: In a large cohort of patients with locally advanced stage cervical carcinoma, para-aortic lymphadenectomy was rarely performed and not associated with a survival benefit.

Adjuvant chemotherapy for stage I high-intermediate risk endometrial carcinoma with lymph-vascular invasion.

OBJECTIVE: The goal of this study was to evaluate if addition of adjuvant chemotherapy to radiation therapy improves overall survival in patients with high-intermediate risk stage I endometrial carcinoma with lymphovascular invasion. METHODS: Patients diagnosed between January 2010 and December 2015 with FIGO (International Federation of Gynecology and Obstetrics) stage I endometrioid endometrial carcinoma with lymphovascular invasion who underwent hysterectomy with lymphadenectomy and met the GOG-99 criteria for high-intermediate risk were identified in the National Cancer Database. Patients who received adjuvant radiotherapy with or without adjuvant chemotherapy (administered within 6 months of surgery) and had at least 1 month of follow-up were selected for further analysis. Overall survival was compared with the log-rank test following stratification by type of radiation treatment. A Cox model was constructed to control for a priori selected confounders. RESULTS: A total of 2881 patients who met the inclusion criteria were identified; 2417 (83.9%) patients received radiation therapy alone while 464 (16.1%) received chemoradiation. Rate of adjuvant chemotherapy administration was comparable between patients who received vaginal brachytherapy alone (16.2%), and external beam radiation therapy (with or without vaginal brachytherapy) (15.8%), p=0.78. Rate of chemoradiation was higher for patients with grade 3 (28.8%) tumors compared with those with grade 2 (9.9%) and grade 1 (8.3%) tumors, p<0.001. After controlling for confounders for patients receiving external beam radiation, addition of chemotherapy was not associated with improved overall survival (HR 0.90, 95% CI 0.56 to 1.46). For patients receiving vaginal brachytherapy addition of chemotherapy was associated with better overall survival (HR 0.644, 95% CI 0.45 to 0.92). Benefit was limited to patients with grade 3 tumors, p=0.026; 4-year overall survival rate was 81.1% versus 74.9%. CONCLUSIONS: In patients with high-intermediate risk FIGO stage I endometrioid endometrial carcinoma and lymphovascular invasion, addition of chemotherapy to radiation therapy was associated with a survival benefit for patients with grade 3 tumors receiving vaginal brachytherapy.

Delay in adjuvant chemotherapy administration for patients with FIGO stage I epithelial ovarian carcinoma is associated with worse survival; an analysis of the National Cancer Database.

OBJECTIVE: The administration of adjuvant chemotherapy within 42 days from surgery is one of the proposed quality measures for patients with epithelial ovarian cancer (EOC). The aim of the present study was to evaluate the impact of chemotherapy delay in the survival of patients with stage I EOC. METHODS: The National Cancer Database was accessed, and patients diagnosed between 2004 and 2015 with FIGO stage I EOC who received multi-agent chemotherapy were identified. Overall survival (OS) was compared between patients who received chemotherapy <6 weeks and 6-12 weeks from surgery with the log-rank test following generation of Kaplan-Meier curves. Cox model was constructed to control for a priori selected confounders. RESULTS: A total of 8549 patients who received adjuvant chemotherapy at a median 35 days from surgery (interquartile range 19) were identified; 67.7% received adjuvant chemotherapy <6 weeks from surgery while 32.3% experienced a delay. Patients who experienced a delay were more likely to have comorbidities (18.4% vs 14.9%, p < 0.001), and be managed in non-academic facilities (57.1% vs 53.2%, p = 0.001). Patients who experienced a delay had worse OS compared to those who did not, p < 0.001; 5-year OS rates 85.7% and 89.7%, respectively. For patients with high-grade serous tumors, those who experienced a delay had a 5-yr OS of 81.9% compared to 88.6% for those who did not, p < 0.001. After controlling for age, race, presence of comorbidities, insurance status, tumor histology and grade, performance of lymphadenectomy and substage, chemotherapy delay was associated with worse survival (HR: 1.25, 95% CI: 1.10, 1.42). CONCLUSIONS: For patients with early stage EOC administration of adjuvant chemotherapy within 6 weeks from surgery was associated with better overall survival, especially for those with stage IC disease.

Pilot Evaluation of a Novel, Low-Cost, Simulation Model for Training and Assessment of Laparoscopic Intracorporeal Continuous Suturing.

Background: Laparoscopic intracorporeal continuous suturing is being employed in a growing number of minimally invasive procedures. However, there is a lack of adequate bench models for gaining proficiency in this complex task. The purpose of this study was to assess a novel simulation model for running suture. Methods: Participants were grouped as novice (LSN) or expert (LSE) at laparoscopic suturing based on prior experience and training level. A novel low-cost bench model was developed to simulate laparoscopic intracorporeal continuous closure of a defect. The primary outcome measured was time taken to complete the task. Videos were scored by independent raters for Global Operative Assessment of Laparoscopic Skills (GOALS). Results: Sixteen subjects (7 LSE and 9 LSN) participated in this study. LSE completed the task significantly faster than LSN (430 ± 107 vs 637 ± 164 seconds, P ≤ .05). LSN scored higher on accuracy penalties than LSE (Median 30 vs 0, P ≤ .05). Mean GOALS score was significantly different between the 2 groups (LSE 20.64 ± 2.64 vs LSN 14.28 ± 1.94, P < .001) with good inter-rater reliability (ICC ≥ .823). An aggregate score using the formula: Performance Score = 1200-time(sec)-(accuracy penalties x 10) was significantly different between groups with a mean score of 741 ± 141 for LSE vs 285 ± 167 for LSN (P < .001). Conclusion A novel bench model for laparoscopic continuous suturing was able to significantly discriminate between laparoscopic experts and novices. This low-cost model may be useful for both training and assessment of laparoscopic continuous suturing proficiency.

Structural and psychological empowerment and organizational commitment among staff nurses in Jordan.

AIM: The purpose of this study was to examine the relationships between structural empowerment, psychological empowerment, and organizational commitment in Jordanian staff nurses. BACKGROUND: Empowering nurses is one of the most effective strategies for increasing efficiency. Therefore, studying the contribution of structural and psychological empowerment to organizational commitment will provide a base for future interventions to improve nurses' working environment. MATERIALS AND METHODS: This cross-sectional study used snowball sampling to recruit staff nurses working in Jordanian public and private hospitals. The sample consisted of 180 nurses. Data were collected using three valid and reliable self-reporting questionnaires that were distributed in electronic format. RESULTS: Nurses reported a moderate level of both structural and psychological empowerment, and a high level of organizational commitment. Significant positive relationships were found between structural empowerment and psychological empowerment and organizational commitment (r = .62, p < .001) and (r = .57, p < .001) respectively. CONCLUSION: Staff nurses reported moderate levels of both structural and psychological empowerment, and have a high level of organizational commitment. Positive relationships between structural empowerment, psychological empowerment, and organizational commitment were found among Jordanian staff nurses.