Search

Background: Ovarian cancer with extensive metastatic disease involving pelvic structures often requires rectosigmoid resection for complete gross resection; however, it is associated with increased surgical morbidity. There are limited data, and none in ovarian cancer, on near-infrared assessment of perfusion in rectosigmoid resections with anastomosis., Primary Objective: To compare the rate of pelvic complications (pelvic abscesses, anastomotic leaks, and infections) within 30 days of surgery with and without near-infrared assessment of perfusion at time of rectosigmoid resection and re-anastomosis in patients undergoing cytoreductive surgery for ovarian cancer., Study Hypothesis: We hypothesize the use of near-infrared technology (intravenous indocyanine green and endoscopic near-infrared fluorescence imaging), compared with standard intra-operative assessment, to evaluate anastomotic perfusion at time of rectosigmoid resection and re-anastomosis will result in lower rates of post-operative pelvic complications., Trial Design: This is a planned multicenter randomized controlled trial. Patients who undergo rectosigmoid resection as part of their ovarian cytoreductive surgery will be randomized 1:1 to standard assessment of anastomosis with the surgeon's usual technique (control arm) or assessment with near-infrared angiography using indocyanine green and endoscopic fluorescence imaging (experimental arm). Randomization will occur after rectosigmoid resection has been completed and the surgeon declares their plan to create a diverting ostomy. Randomization will be stratified by plan for diverting ostomy., Major Inclusion/exclusion Criteria: Main inclusion criteria include patients with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer who are scheduled for cytoreductive surgery with suspected need for low-anterior rectosigmoid resection., Primary Endpoint: Rate of 30-day post-operative pelvic complications., Sample Size: 310 (155 per arm) ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Q2 2027 and Q4 2027, respectively., Trial Registration: NCT04878094., Competing Interests: Competing interests: Dr Leitao reports personal fees from Medtronic, Intuitive Surgical, J&J/Ethicon, and Immunogen. Dr Abu-Rustum reports research funding paid to the institution from GRAIL. Memorial Sloan Kettering Cancer Center also has equity in GRAIL. Dr Chi reports personal fees from AstraZeneca, UptoDate, Biom’Up, Apyx Medical Corp, and Verthemia, as well as stock ownership in Doximity., (© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Patients undergoing oncologic surgery at major referral centers frequently experience postdischarge care fragmentation, which has been associated with poor outcomes. This report describes and evaluates the outcomes of an intervention at Memorial Sloan Kettering Cancer Center (MSKCC) to decentralize postdischarge postoperative acute care within our health care system., Methods: In 2018, MSKCC completed the addition of six regional acute care clinics called symptom care clinics (SCCs) to existing regional outpatient clinics. Acute care was previously only available within our system at a single centralized urgent care center (UCC). All patients undergoing surgery in our system between January 1, 2019, and June 30, 2021, were followed for 90 days. The exposure was the site of initial acute care presentation-UCC or SCC-and outcomes included utilization, access, financial toxicity, and mortality. Mortality was adjusted using hierarchical modeling at the level of the region., Results: A total of 6,992 postsurgical patients experienced 10,525 acute care visits in our system within 90 days of surgery. Twenty-nine percent of these patients presented to the SCC first. These patients were older but had fewer comorbidities and shorter index length of stay compared with UCC patients. Utilization of SCCs increased substantially while UCC utilization decreased during a period of stable case volume. SCCs were closer to patients' homes, and wait times were shorter. Rates of financial toxicity were similar between groups. Of this high-risk cohort accessing acute care postoperatively, 90-day mortality was similar for UCC and SCC patients ( P = .731)., Conclusion: This model of decentralized acute care after oncologic surgery was increasingly used over time with comparable patient safety. Health systems should emphasize patient-centered care by supporting safe strategies for regionalized care even when treatments are delivered at centralized referral centers.

Objective: To describe patient-reported postoperative symptoms and to evaluate the use of digital symptom tracking and alerts to detect postoperative complications., Methods: We retrospectively reviewed patients who underwent a minimally invasive hysterectomy and enrolled in our Recovery Tracker program from 4/5/17-12/31/21. The Recovery Tracker is an at-home virtual tool used to track patient-reported postoperative symptoms for 10 days. Predefined thresholds for "red" and "yellow" alerts are based on symptom severity and timing. Data on patient demographics, surgery, and postoperative course were collected to evaluate the association of alerts with complications and compare outcomes of patients who did/did not enroll in the program., Results: Of 2362 eligible patients, 1694 (71.7%) enrolled in the Recovery Tracker program. Pain was the most severe symptom, followed by fatigue. Eighty-seven patients experienced 102 complications (5.1% complication rate) and 32 experienced 39 grade ≥ 2 complications (1.9% severe complication rate). Excluding complications that occurred prior to Recovery Tracker use, 1673 patients experienced 28 grade ≥ 2 complications. Of 345 patients (20.6%) who triggered a red alert, 13 (3.8%) had a grade ≥ 2 complication. Of 1328 patients (79.4%) with no red alerts, 15 (1.13%) had a grade ≥ 2 complication. Relative risk of a grade ≥ 2 complication if a red alert was triggered was 3.25 (95% CI: 1.6-6.9, P = .002). Rate of severe complications was significantly higher among patients who did not use the tool (3.3% vs 1.9%; P = .04)., Conclusions: The Recovery Tracker tool may assist in early identification of postoperative symptoms after minimally invasive hysterectomy., Competing Interests: Declaration of Competing Interest D. Chi reports personal fees from Apyx Medical, Verthermia Inc., Biom ‘Up, and AstraZeneca, as well as recent or current stock/options ownership of Apyx Medical, Verthemia, Intuitive Surgical, Inc., TransEnterix, Inc., Doximity, Moderna, and BioNTech SE. N. Abu-Rustum reports grant funding from GRAIL paid to the institution. M. M. Leitao is an ad hoc speaker for Intuitive Surgical, Inc.; outside the submitted work, he is on the Advisory Board of Ethicon/Johnson & Johnson and Takeda; and reports grants paid to the institution by KCI/Acelity. E. Jewell reports personal fee from Covidien/Medtronic. J. Cracchiolo reports personal fees from Medscape for a lecture. All other authors have no potential conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: Gynecologic cancers, especially ovarian cancer, are associated with a high incidence of venous thromboembolism (VTE). Recent data have shown the risk of VTE development is not only limited to the postoperative period; there also appears to be an increased risk during neoadjuvant chemotherapy (NACT) administration, prompting the need for better risk stratification in this setting. We sought to assess the risk of VTE development in patients with ovarian cancer undergoing NACT., Methods: We performed a PubMed literature review using the following medical terms: advanced ovarian cancer, advanced peritoneal cancer, advanced fallopian tube cancer, thrombosis, thromboembolic events, and neoadjuvant chemotherapy. Eligible studies included patients with advanced ovarian, fallopian tube, or peritoneal cancer who underwent NACT and had VTE. VTE was defined as either a deep venous thrombosis or a pulmonary embolism., Results: Seven relevant studies were identified; all 7 were published between 2017 and 2021. Across these studies, we identified 1427 patients who underwent NACT and either had VTE at presentation or developed VTE during their treatment course. Of these patients, 1171 underwent NACT and were at risk for VTE development and were included in our pooled analysis. Of these patients, 144 (12.3%) developed VTE., Conclusions: VTE prophylaxis may be considered in patients with ovarian cancer undergoing NACT., Competing Interests: Declaration of Competing Interest Outside the submitted work, Dr. Jewell reports personal fees from Covidien/Medtronic. All other authors have no potential conflicts of interest to disclose., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To determine the relationship between bowel preparation and surgical-site infection (SSI) incidence following colorectal resection during gynecologic oncology surgery., Methods: This post-hoc analysis used data from a randomized controlled trial of patients enrolled from 03/01/2016-08/20/2019 with presumed gynecologic malignancy investigating negative-pressure wound therapy among those requiring laparotomy. Patients were treated preoperatively without bowel preparation, oral antibiotic bowel preparation (OABP), or OABP plus mechanical bowel preparation (MBP) per surgeon preference. Univariate and multivariable analyses with stepwise model selection for SSI were performed for confirmed gynecologic malignancies requiring colorectal resection., Results: Of 161 cases, 15 (9%) had no preparation, 39 (24%) OABP only, and 107 (66%) OABP+MBP. The overall SSI rate was 19% (n = 31)-53% (n = 8/15) in the no preparation, 21% (n = 8/39) in the OABP alone, and 14% (n = 15/107) in the OABP+MBP groups (P = 0.003). The difference between OABP and OABP+MBP was non-significant (P = 0.44). The median length of stay was 9 (range, 6-12), 6 (range, 5-8), and 7 days (range, 6-10), respectively (P = 0.045). The overall complication rate (34%; n = 54) did not significantly vary by preparation type (P = 0.23). On univariate logistic regression analysis, OABP (OR, 0.23; 95% CI: 0.06-0.80) and OABP+MBP (OR, 0.14; 95% CI: 0.04-0.45) were associated with decreased SSI risk compared to no preparation (P = 0.004). On multivariate analysis, both methods of preparation retained a significant impact on SSI rates (P = 0.004)., Conclusion: Bowel preparation is associated with reduced SSI incidence and is beneficial for patients undergoing gynecologic oncology surgery with anticipated colorectal resection. Further investigation is needed to determine whether OABP alone is sufficient., Competing Interests: Declaration of Competing Interest Dr. Leitao reports personal fees from J&J/Ethicon and Takeda, and grants from KCI/Acelity. Dr. Chi reports personal fees from Apyx Medical, Verthermia Inc., Biom ‘Up, and AstraZeneca, as well as recent or current stock/options ownership of Apyx Medical, Verthemia, Intuitive Surgical, Inc., TransEnterix, Inc., Doximity, Moderna, and BioNTech SE. Dr. Abu-Rustum reports research funding paid to the institution by GRAIL. Dr. Jewel reports personal fees from Covidien/Medtronic. The other authors do not have potential conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: To compare outcomes of patients with premalignant endometrial pathology undergoing hysterectomy with or without sentinel lymph node (SLN) removal. Outcomes of interest included surgical adverse events (AEs), cancer status on final pathology, postoperative treatment, and The Cancer Genome Atlas (TCGA) molecular risk profiles., Methods: We retrospectively identified patients with premalignant pathology on preoperative endometrial biopsy who underwent hysterectomy with or without SLN mapping/excision at our institution from 01/01/2017-12/31/2021. Clinical, pathologic, surgical, and TCGA profiling data were abstracted. Appropriate statistical tests were used., Results: Of 221 patients identified, 161 (73%) underwent hysterectomy with SLN excision and 60 (27%) underwent hysterectomy without SLN excision. Median age and body mass index were similar between groups. Median operative time was 130 min for those who underwent SLN mapping/excision versus 136 min for those who did not (p = 0.6). Thirty-day postoperative AE rates were 9% (n = 15/161) and 13% (n = 8/60), respectively (p = 0.9). Ninety-eight (44%) of 221 patients had grade 1-2 endometrioid endometrial cancer on final pathology (4 [4%] were stage IB or higher). Ten (10%) of 98 patients, all within the SLN group, received adjuvant treatment. Among all patients, of 33 (15%) with TCGA molecular classification data, 27 (82%) had copy number-low, 3 (9%) microsatellite instability-high, 2 (6%) POLE-ultramutated, and 1 (3%) copy number-high disease., Conclusions: SLN assessment appears safe, detects a small number of occult nodal metastases for those upstaged, and provides additional staging information that can guide adjuvant treatment. SLN mapping should be discussed in preoperative counseling and offered using a shared decision-making approach., Competing Interests: Declaration of Competing Interest Outside the submitted work, Dr. Jewell reports personal fee from Covidien/Medtronic; Dr. Abu-Rustum reports grant money from GRAIL paid to the institution; and Dr. Leitao reports personal fees from Medtronic, Intuitive Surgical, Inc., and JnJ/Ethicon., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Gastric-type endocervical adenocarcinoma (GEA) is a rare form of cervical cancer not associated with human papilloma virus (HPV) infection. We summarize our experience with GEA at a large cancer center., Methods: Clinical and demographic information on all patients diagnosed with GEA between June 1, 2002 and July 1, 2019 was obtained retrospectively from clinical charts. Kaplan-Meier survival analysis was performed to describe progression-free survival (PFS) and overall survival (OS). Tumors from a subset of patients underwent next generation sequencing (NGS) analysis., Results: A total of 70 women with GEA were identified, including 43 who received initial treatment at our institution: of these 4 (9%) underwent surgery alone, 15 (35%) underwent surgery followed by adjuvant therapy, 10 (23%) were treated with definitive concurrent chemoradiation (CCRT), 7 (16%) with chemotherapy alone, and 3 (7%) with neoadjuvant CCRT and hysterectomy with or without chemotherapy. One-third (n = 14) of patients experienced disease progression, of whom 86% (n = 12) had prior CCRT. The median PFS and OS for patients with stage I GEA were 107 months (95% CI 14.8-199.2 months) and 111 months (95% CI 17-205.1 months) respectively, compared to 17 months (95% CI 5.6-28.4 months) and 33 months (95% CI 28.2-37.8 months) for patients with stages II-IV, respectively. On NGS, 4 patients (14%) had ERBB2 alterations, including 2 patients who received trastuzumab., Conclusions: GEA is an aggressive form of cervical cancer with poor PFS and OS when diagnosed at stage II or later. Further investigation is needed to identify the optimal management approach for this rare subtype., Competing Interests: Declaration of Competing Interest Outside the submitted work, B. Weigelt reports ad hoc membership in the scientific advisory board of Repare Therapeutics, outside the scope of the study. C. Friedman reports participation in the scientific advisory boards for Merck (LYNK-002) and Genentech (MyPathway) without compensation, consulting for Seagen and Bristol Myers Squibb, and institutional research funds from Genentech/Roche, Bristol Myers Squibb, Merck, AstraZeneca, and Daiichi. E. Jewell reports personal fee from Covidien/Medtronic. K. Cadoo reports grant funding from the Irish Cancer Society, MSD, and Immunogen; consulting fees from Nextcure, MJH Life Sciences, and GSK; payments/honoraria from GSK, AstraZeneca, and MSD; financial support to attend meetings from Roche, Pfizer, and MSD; advisory board participation at MSD, AstraZeneca, GSK, and Eisai; a voluntary advisory role at the National Cancer Control Programme Ireland; and a voluntary board member at ARC Cancer Support Centers. N. Abu-Rustum reports grant funding from GRAIL paid to the institution. S. issa Bhaloo reports stock or stock options in BioNTech, Moderna, Inc., Inovio, Relief Therapeutics Holding SA, Cansino Biologics, Inc., and Pfizer, Inc. M. Leitao reports personal fees from Medtronic, Intuitive Surgical, Inc., and JnJ/Ethicon. C. Aghajanian has received research grants from Abbvie, Clovis, Genentech, and Astra Zeneca and served on advisory boards for Abbvie, AstraZeneca/Merck, Eisai/Merck, Mersana Therapeutics, Repare Therapeutics, and Roche/Genentech. R. O'Cearbhaill reports honoraria from GSK, Bayer, Regeneron, SeaGen, Fresenius Kabi, Immunogen, MJH Life Sciences and Curio. C. Kyi reports grant funding from Conquer Cancer Foundation; grant funding paid to the institution from Merus, Gritstone, and BMS; and consulting fees from Scenic Immunology B.V. and OncLive. D. Zamarin is an inventor on a patent related to the use of oncolytic Newcastle Disease Virus for cancer therapy, and reports grant funding paid to the institution from AstraZeneca, Roche, Plexxikon, and Synthekine; consulting fees from Memgen, Celldex, Agenus, Astellas, AstraZeneca, Crown Biosciences, Roche, GSK, Hookpia, ImmunOS, Kalvir, Synlogic Therapeutics, Synthekine, Takeda, Targovax, Tessa Therapeutics, and Xencor; stock options in Accurius Therapeutics, Immunos Therapeutics and Calidi Biotherapeutics; and a Merck licensed patent (with personal payments and payments to the institution). All other authors have no potential conflicts of interest to disclose., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objective: To evaluate postoperative and oncologic outcomes associated with pelvic exenteration for non-ovarian gynecologic malignancies., Methods: This was a retrospective review of patients who underwent pelvic exenteration for non-ovarian gynecologic malignancies at our institution from 1/1/2010-12/31/2019. Palliative exenteration cases were excluded from survival analysis. Postoperative complications were early (≤30 days) or late (31-180 days). Complications were graded using a validated institutional scale. Major complications were considered grade ≥ 3. Categorical variables were compared using the chi-square test, and the Kaplan-Meier method was used for survival analysis., Results: Of 100 patients identified, 89 underwent pelvic exenteration for recurrent disease, 5 for palliation, 5 for primary disease, and 1 for persistent disease. Thirty percent had cervical, 27% vulvar, 24% uterine, and 19% vaginal cancer. Sixty-two percent underwent total, 30% anterior, and 8% posterior exenteration. No deaths occurred intraoperatively or within 30 days of surgery. Six patients died after 30 days. Ninety-seven experienced a perioperative complication-49 early, 1 late, and 47 both. Fifty experienced a major complication-22 (44%) early, 19 (38%) late, and 9 (18%) both. No variables were statistically associated with complication development. The 3-year progression-free survival rate was 61.0%; the 3-year overall survival rate was 61.6%. Of 58 surviving patients, 16 (28%) and 4 (7%) were alive after 5 and 10 years, respectively., Conclusion: The overall complication rate for pelvic exenteration remains high. No variables demonstrated association with complication development as the rate was nearly 100%. The low rate of perioperative mortality is likely due to improved perioperative care., Competing Interests: Declaration of Competing Interest Dr. Leitao is an ad hoc speaker for Intuitive Surgical, Inc.; outside the submitted work, he is on the Advisory Board of Ethicon/Johnson & Johnson and Takeda; and reports grants paid to the institution by KCI/Acelity. Dr. Abu-Rustum reports research funding paid to the institution by GRAIL; and Dr. Jewell reports personal fees from Covidien/Medtronic. The other authors do not have potential conflicts of interest to declare., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: The cost of cancer care is high and rising. Evidence of increased patient cost burden is prevalent in the medical literature and has been defined as "financial toxicity," the financial hardship and financial concerns experienced by patients because of a disease and its related treatments. With targeted therapies and growing out-of-pocket costs, patient financial toxicity is a growing concern among patients with gynecologic cancer., Objective: This study aimed to determine the prevalence of financial toxicity and identify its risk factors in patients with gynecologic cancer treated at a large cancer center using objective data., Study Design: Using institutional databases, we identified patients with gynecologic cancer treated from January 2016 to December 2018. Patients with a preinvasive disease were excluded. Financial toxicity was defined according to institutionally derived metrics as the presence of ≥1 of the following: ≥2 bills sent to collections, application or granting of a payment plan, settlement, bankruptcy, financial assistance program enrollment, or a finance-related social work visit. Clinical characteristics were gathered using a 2-year look-back from the time of the first financial toxicity event or a randomly selected treatment date for those not experiencing toxicity. Risk factors were assessed using chi-squared tests. All significant variables on univariate analysis were included in the logistic regression model., Results: Of the 4655 patients included in the analysis, 1155 (25%) experienced financial toxicity. In the univariate analysis, cervical cancer (35%), stage 3 or 4 disease (24% and 30%, respectively), younger age (35% for age <30 years), nonpartnered marital status (31%), Black (45%) or Hispanic (37%) race and ethnicity, self-pay (48%) or commercial insurance (30%), clinical trial participation (31%), more imaging studies (39% for ≥9), ≥1 emergency department visit (36%), longer inpatient stays (36% for ≥20 days), and more outpatient clinician visits (41% for ≥20 visits) were significantly associated with financial toxicity (P<.01). In multivariate analysis, younger age, nonpartnered marital status, Black and Hispanic race and ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits were significantly associated with financial toxicity., Conclusion: Financial toxicity is an increasing problem for patients with gynecologic cancer. Our analysis, using objective measures of financial toxicity, has suggested that demographic factors and healthcare utilization metrics may be used to proactively identify at-risk patients for financial toxicity., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data., Materials and Methods: The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations., Results: From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports., Conclusion: The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up., Competing Interests: Nadeem R. Abu-RustumHonoraria: Prime OncologyResearch Funding: Stryker/Novadaq (Inst), GRAIL (Inst)Travel, Accommodations, Expenses: Prime Oncology Ling Y. ChenEmployment: Lyra Andrew J. VickersStock and Other Ownership Interests: OPKO HealthConsulting or Advisory Role: OPKO Diagnostics, Insightec, Steba BiotechPatents, Royalties, Other Intellectual Property: I am named on a patent for a statistical method to detect prostate cancer. This method has been commercialized by OPKO as the 4Kscore. I receive royalties from sales of the 4KscoreTravel, Accommodations, Expenses: OPKO Health Vance BroachOpen Payments Link: https://openpaymentsdata.cms.gov/physician/1162364 Dennis S. ChiLeadership: CSurgeriesStock and Other Ownership Interests: Bovie Medical, Verthermia, Intuitive Surgical, TransenterixHonoraria: Biom'UpConsulting or Advisory Role: Bovie Medical, Verthermia, Biom'upTravel, Accommodations, Expenses: Biom'Up Ginger J. GardnerHonoraria: BioAscentTravel, Accommodations, Expenses: BioAscent Elizabeth L. JewellHonoraria: SurvivornetConsulting or Advisory Role: Intuitive Surgical, Covidien/MedtronicResearch Funding: Summit Biomedical Mario M. Leitao JrHonoraria: Intuitive SurgicalConsulting or Advisory Role: Intuitive Surgical, Ethicon/Johnson & Johnson, Medtronic, TakedaResearch Funding: KCITravel, Accommodations, Expenses: Intuitive Surgical Yukio SonodaPatents, Royalties, Other Intellectual Property: Pending patent for a surgical instrument (uterine manipulator)No other potential conflicts of interest were reported.

Objectives: To explore pre-operative factors and their impact on overall survival (OS) in a modern cohort of patients who underwent pelvic exenteration (PE) for gynecologic malignancies., Methods: A retrospective review was performed for all patients who underwent a PE from 1/1/2010 through 12/31/2018 at our institution. Inclusion criteria were exenteration due to recurrent or progressive carcinoma of the uterus, cervix, vagina or vulva, with histologically confirmed complete surgical resection of the malignancy. Exclusion criteria included PE for palliation of symptoms without recurrence, and for ovarian or rare histologic malignancies. Univariable and multivariable analysis were performed to identify factors predicting prolonged survival., Results: Overall, 71 patients met the inclusion criteria. Median age at time of exenteration was 62 years (range, 28-86 years). Vulvar cancer was the most common primary diagnosis (32%); 30% had cervical cancer; 23%, uterine cancer; 15%, vaginal cancer. Median OS was 55.1 months (95% confidence interval (CI): 36-not estimable) with a median follow-up time of 40.8 months (95% CI: 1-116.1). On univariable analysis, age > 62 years (hazard ratio (HR) 2.71, 95% CI 1.27-5.79), American Society of Anesthesia (ASA) 3-4 (HR: 3.41 (95% CI 1.03-11.29), and vulvar cancer (HR 4.19 (95% CI 1.17-14.96) predicted worse OS. Tumor size and prior progression-free interval (PFI) did not meet statistical significance in OS analyses. On multivariable analysis, there were no significant factors associated with worse OS., Conclusions: PE performed with curative intent may be considered a treatment option in well-counseled, carefully selected patients, irrespective of tumor size and PFI before exenteration., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: To determine the incidence of venous thromboembolism (VTE) and define clinical risk factors associated with the development of new-onset VTE in patients receiving neoadjuvant chemotherapy (NACT) for ovarian cancer (OC)., Methods: An institutional ovarian cancer database was used to identify all OC patients receiving NACT from 04/2015-09/2018. VTE events were recorded and included clinically diagnosed deep venous thrombosis (DVT) and/or pulmonary embolism (PE). The incidence of VTE events was categorized according to treatment phases (P): P0) First visit/prior to induction of NACT; P1) during NACT before interval debulking surgery (IDS); P2) intraoperative through day 28 post-IDS; P3) during adjuvant chemotherapy., Results: A total of 290 patients were identified during the study period. Seventy-five (25.9%) developed a VTE at some point from time of presentation through the peri-operative period. Forty (13.8%) presented with VTE prior to initiation of NACT. An additional 27 (11.6%) developed a VTE during NACT (P1); 6 (3.9%) during the intraoperative and 28-day post-operative period (P2); and 2 (1.3%) during the adjuvant period (P3). The overall VTE rate was 25.9% (n = 75). FIGO stage IV disease was the only factor associated with increased risk for a new-onset VTE [Odds Ratio (OR): 3.9 (95% Confidence Interval [CI] = 1.2-13.6; p = 0.03]., Conclusions: Patients receiving NACT for advanced OC are at extremely high risk for developing thromboembolic events, either at initial presentation or during induction of NACT, a treatment phase that is traditionally without use of prophylactic anticoagulation. Since Khorana scoring is not predictive in this population, clinicians might need to consider increased screening or use of prophylactic anticoagulation in patients receiving NACT for OC, particularly in advanced metastatic disease., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: The purpose of this phase II study was to evaluate hyperthermic intraperitoneal chemotherapy (HIPEC) with carboplatin for recurrent ovarian cancer during secondary cytoreductive surgery., Materials and Methods: Patients were intraoperatively randomly assigned to carboplatin HIPEC (800 mg/m 2 for 90 minutes) or no HIPEC, followed by five or six cycles of postoperative IV carboplatin-based chemotherapy, respectively. Based on a binomial single-stage pick-the-winner design, an arm was considered winner if ≥ 17 of 49 patients were without disease progression at 24 months post-surgery. Secondary objectives included postoperative toxicity and HIPEC pharmacokinetics., Results: Of 98 patients, 49 (50%) received HIPEC. Complete gross resection was achieved in 82% of the HIPEC patients and 94% of the standard-arm patients. Bowel resection was performed in 37% of patients in the HIPEC arm compared with 65% in the standard ( P = .008). There was no perioperative mortality and no difference in use of ostomies, length of stay, or postoperative toxicity. At 24 months, eight patients (16.3%; 1-sided 90% CI, 9.7 to 100) were without progression or death in the HIPEC arm and 12 (24.5%; 1-sided 90% CI, 16.5 to 100) in the standard arm. With a medium follow-up of 39.5 months, 82 patients progressed and 37 died. The median progression-free survival in the HIPEC and standard arms were 12.3 and 15.7 months, respectively (hazard ratio, 1.54; 95% CI, 1 to 2.37; P = .05). There was no significant difference in median overall survival (52.5 v 59.7 months, respectively; hazard ratio, 1.39; 95% CI, 0.73 to 2.67; P = .31). These analyses were exploratory., Conclusion: HIPEC with carboplatin was well tolerated but did not result in superior clinical outcomes. This study does not support the use of HIPEC with carboplatin during secondary cytoreductive surgery for platinum-sensitive recurrent ovarian cancer., Competing Interests: Dennis S. ChiLeadership: CSurgeriesStock and Other Ownership Interests: Bovie Medical, Verthermia, Intuitive Surgical, TransenterixConsulting or Advisory Role: Bovie Medical, Verthermia, Biom'up Alexia IasonosStock and Other Ownership Interests: Bristol Myers Squibb/SanofiConsulting or Advisory Role: Mylan, BrightPath Biotheraputics, Intelligencia Jason A. KonnerConsulting or Advisory Role: Immunogen, AstraZeneca, Tesaro, AbbVieResearch Funding: Genentech/RocheTravel, Accommodations, Expenses: AstraZeneca Vicky MakkerHonoraria: Eisai, Merck, Karyopharm Therapeutics, IBM Watson HealthConsulting or Advisory Role: Eisai, Merck, Karyopharm Therapeutics, Takeda, ArQule, IBM Watson Health, GlaxoSmithKline, Clovis Oncology, FaethResearch Funding: Lilly, AstraZeneca, Eisai, Merck, Bristol Myers Squibb, Karyopharm Therapeutics, Takeda, Clovis Oncology, Bayer, ZymeworksTravel, Accommodations, Expenses: Eisai, Merck, Karyopharm TherapeuticsOther Relationship: IBM Rachel N. GrishamConsulting or Advisory Role: Mateon Therapeutics, Clovis Oncology, Regeneron, GlaxoSmithKlineResearch Funding: Context TherapeuticsTravel, Accommodations, Expenses: EMD SeronoOther Relationship: Prime Oncology, MCM Education, OncLive, Aptitude HealthUncompensated Relationships: Verastem Amy K. BrownSpeakers' Bureau: TesaroResearch Funding: Tesaro, AstraZeneca John P. DiazSpeakers' Bureau: AstraZeneca Carrie L. LangstraatOther Relationship: Eight Medical, Covidien/Medtronic, ConMed Yulia LakhmanStock and Other Ownership Interests: Y-mAbs Therapeutics Krysten SoldanConsulting or Advisory Role: EisaiTravel, Accommodations, Expenses: Clovis Oncology Ginger J. GardnerHonoraria: BioAscentTravel, Accommodations, Expenses: BioAscent Elizabeth L. JewellHonoraria: SurvivornetConsulting or Advisory Role: Intuitive Surgical, Covidien/MedtronicResearch Funding: Summit Biomedical Tiffany Troso-SandovalHonoraria: Bio AscendTravel, Accommodations, Expenses: Bio Ascend Stuart M. LichtmanConsulting or Advisory Role: Remedy One, Magellan Health Nadeem R. Abu-RustumHonoraria: Prime OncologyResearch Funding: Stryker/Novadaq, GrailTravel, Accommodations, Expenses: Prime Oncology Carol AghajanianConsulting or Advisory Role: Mersana, Eisai, Roche, AbbVie, Eisai, AstraZeneca/Merck, Roche/Genentech, Repare TherapeuticsResearch Funding: Genentech/Roche, AbbVie, Clovis Oncology, AstraZeneca Jan BeumerEmployment: Voisin ConsultingStock and Other Ownership Interests: GlaxoSmithKlineConsulting or Advisory Role: GNS HealthcareResearch Funding: AbbVie, Spectrum Pharmaceuticals, TriSalus Life SciencesPatents, Royalties, Other Intellectual Property: Sulphoraphane for Melanoma ChemopreventionExpert Testimony: PfizerUncompensated Relationships: Qrono Yukio SonodaPatents, Royalties, Other Intellectual Property: Pending Patent for a surgical instrument (uterine manipulator) Roisin E. O'CearbhaillHonoraria: GlaxoSmithKlineConsulting or Advisory Role: GlaxoSmithKlineResearch Funding: Juno Therapeutics, Sellas Life Sciences, Ludwig Institute for Cancer Research, Stem CentRx, TapImmune Inc, TCR2 Therapeutics, Regeneron, Genmab, Atara Biotherapeutics, GlaxoSmithKline, AstraZeneca/Merck, Syndax, Genentech, Kite/Gilead, Gynecologic Oncology Group FoundationTravel, Accommodations, Expenses: AstraZenecaOpen Payments Link: https://openpaymentsdata.cms.gov/physician/785539No other potential conflicts of interest were reported.

Objective: Since the approval of pembrolizumab for advanced or recurrent PD-L1 positive (CPS > 1%) cervical cancer, the clinical characteristics associated with response have remained undefined. We sought to characterize the clinicopathologic features of patients with advanced cervical cancer at our institution who derived durable clinical benefit from treatment with pembrolizumab., Methods: We conducted a retrospective cohort study of 14 patients with recurrent or metastatic cervical cancer who received pembrolizumab monotherapy from August 2017 to November 2019 and were followed until November 1, 2020. Reviewed clinical data included age, histology, tumor molecular profiling results, stage at diagnosis, treatment history, baseline pattern of metastatic disease at initiation of anti-PD-1 therapy, and outcomes. Treatment response was evaluated by computed tomography using RECIST v1.1 criteria., Results: The objective response rate was 21% (n = 3), including two partial responses and one complete response. Two patients (14%) had stable disease of six months or greater, for an observed durable clinical benefit rate of 36%. When stratified by those who derived clinical benefit, metastatic spread to lung and/or lymph node only at baseline was associated with improved response to pembrolizumab (n = 7, p = 0.02) and associated with significantly improved PFS and OS. Tumor mutational burden was higher in those with durable clinical benefit compared to non-responders (median 12.7 vs. 3.5 mutations/megabase, p = 0.03)., Conclusions: Our findings highlight clinical features that may select for a population most likely to benefit from pembrolizumab monotherapy and underscores the need for identification of additional biomarkers of response., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2021 The Authors. Published by Elsevier Inc.)

Objective: To estimate the effectiveness of prophylactic negative pressure wound therapy in patients undergoing laparotomy for gynecologic surgery., Methods: We conducted a randomized controlled trial. Eligible, consenting patients, regardless of body mass index (BMI), who were undergoing laparotomy for presumed gynecologic malignancy were randomly allocated to standard gauze or negative pressure wound therapy. Patients with BMIs of 40 or greater and benign disease also were eligible. Randomization, stratified by BMI, occurred after skin closure. The primary outcome was wound complication within 30 (±5) days of surgery. A sample size of 343 per group (N=686) was planned., Results: From March 1, 2016, to August 20, 2019, we identified 663 potential patients; 289 were randomized to negative pressure wound therapy (254 evaluable participants) and 294 to standard gauze (251 evaluable participants), for a total of 505 evaluable patients. The median age of the entire cohort was 61 years (range 20-87). Four hundred ninety-five patients (98%) underwent laparotomy for malignancy. The trial was eventually stopped for futility after an interim analysis of 444 patients. The rate of wound complications was 17.3% in the negative pressure wound therapy (NPWT) group and 16.3% in the gauze group, absolute risk difference 1% (90% CI -4.5 to 6.5%; P=.77). Adjusted odds ratio controlling for estimated blood loss and diabetes was 0.99 (90% CI 0.62-1.60). Skin blistering occurred in 33 patients (13%) in the NPWT group and in three patients (1.2%) in the gauze group (P<.001)., Conclusion: Negative pressure wound therapy after laparotomy for gynecologic surgery did not lower the wound complication rate but did increase skin blistering., Clinical Trial Registration: ClinicalTrials.gov, NCT02682316., Funding Source: The protocol was supported in part by KCI/Acelity., Competing Interests: Financial Disclosure Dr. Leitao reports personal fees from Intuitive Surgical, Inc. and JNJ/Ethicon; Dr. Jewell reports personal fees from Covidien/Medtronic; Dr. Chi reports personal fees from Bovie Medical Co., Verthermia Inc. (now Apyx Medical Corp.), C Surgeries, and Biom ‘Up, as well as previous stock ownership in Intuitive Surgical, Inc. and TransEnterix, Inc. Dr. Abu-Rustum reports grants from Stryker/Novadaq, Olympus, and GRAIL. Dr. Iasonos reports personal fees from Mylan. Dr. Martino is a patient safety consultant for Intuitive, Surgical, Inc., JNJ, Medtronic, and CMR, as well as an education speaker for GlaxoSmithKline and a peer reviewer for UpToDate. Dr. Lambrou is a consultant for Ethicon and Intuitive Surgical, Inc. Dr. Diaz is a speaker and has research grant support from Merck and AstraZeneca, and he is a consultant for ConMed. Dr. Cosin is a consultant for Medtronic. The other authors did not report any potential conflicts of interest., (Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: To assess the feasibility and efficacy of a non-hormonal hyaluronic acid (HLA) vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in postmenopausal women with a history of hormone receptor-positive (HR+) cancer., Methods: For this single-arm, prospective longitudinal trial, we identified disease-free patients with a history of HR+ breast cancer treated with aromatase inhibitors or HR+ endometrial cancer treated with surgery and postoperative radiation. Participants used HLA daily for the first 2 weeks, and then 3×/week until weeks 12-14; dosage was then increased to 5×/week for non-responders. Vulvovaginal symptoms and pH were assessed at 4 time points (baseline [T1], 4-6 weeks [T2], 12-14 weeks [T3], 22-24 weeks [T4]) with clinical evaluation, the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Female Sexual Function Index (FSFI), and Menopausal Symptom Checklist (MSCL)., Results: Of 101 patients, mean age was 55 years (range, 31-78), 68% (n = 69) were partnered, and 60% (n = 61) were sexually active. In linear mixed models, VAS/VuAS scores significantly improved at all assessment points (all p < 0.001). MSCL scores similarly improved (all p < 0.001). FSFI scores significantly improved from T1 to T2 (p < 0.03), T3 (p < 0.001), and T4 (p < 0.001). Severe vaginal pH (> 6.5) decreased from 26% at T1 to 19% at T4 (p = 0.18)., Conclusions: HLA moisturization improved vulvovaginal health/sexual function of cancer survivors. While HLA administration 1-2×/week is recommended for women in natural menopause, a 3-5×/week schedule appears to be more effective for symptom relief in cancer survivors.

Purpose: We sought to evaluate whether provider volume or other factors are associated with chemotherapy guideline compliance in elderly patients with epithelial ovarian cancer (EOC)., Methods: We queried the SEER-Medicare database for patients ≥66 years, diagnosed with FIGO stage II-IV EOC from 2004 to 2013 who underwent surgery and received chemotherapy within 7 months of diagnosis. We compared NCCN guideline compliance (6 cycles of platinum-based doublet) and chemotherapy-related toxicities across provider volume tertiles. Factors associated with guideline compliance and chemotherapy-related toxicities were assessed using logistic regression. Overall survival (OS) was compared across volume tertiles and Cox proportional-hazards model was created to adjust for case-mix., Results: 1924 patients met inclusion criteria. The overall rate of guideline compliance was 70.3% with a significant association between provider volume and compliance (64.5% for low-volume, 72.2% for medium-volume, 71.7% for high-volume, p = .02). In the multivariate model, treatment by low-volume providers and patient age ≥ 80 years were independently associated with worse chemotherapy-guideline compliance. In the survival analysis, there was a significant difference in median OS across provider volume tertiles with median survival of 32.8 months (95%CI 29.6, 36.4) low-volume, 41.9 months (95%CI 37.5, 46.7) medium-volume, 42.1 months (95%CI 38.8, 44.2) high-volume providers, respectively (p < .01). After adjusting for case-mix, low-volume providers were independently associated with higher rates of mortality (aHR 1.25, 95%CI: 1.08, 1.43)., Conclusions: In a modern cohort of elderly Medicare patients with advanced EOC, we found higher rates of non-compliant care and worse survival associated with treatment by low-volume Medicare providers. Urgent efforts are needed to address this volume-outcomes disparity., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Purpose: The frail are considered at higher risk for unfavorable surgical outcomes (major complications/mortality). We assessed the safety of and outcomes associated with robotic surgery in the frail elderly undergoing gynecologic procedures., Methods: We identified patients aged ≥ 65 years who underwent a robotic procedure between May 2007 and December 2016. Frailty was defined as the presence of at least three of five frailty factors-more than five comorbidities, low physical activity, weight loss, exhaustion, and fatigue. Perioperative outcomes were recorded. We compared variables among frail and non-frail patients and performed a multivariate logistic regression to detect variables associated with major complications (≥ grade 3) or 90-day mortality., Results: We identified 982 patients: 71 frail and 911 non-frail patients. Median age was 71 years. Median BMI was 29.8 kg/m 2 . Thirty-four patients (3.5%) had a 30-day readmission. Seventy-seven (7.8%) had a postoperative complication, of which 23 (2.3%) were major. Ninety-day mortality was 0.5%. There were significant differences with regard to age (P < 0.001), body mass index (BMI) (P < 0.001) and performance status (P < 0.001); the frail were more likely to have had surgery for oncologic reasons (P = 0.047). There were differences in hospital stay (P < 0.001), postoperative (P = 0.042) and major complications (P = 0.007), and 90-day mortality (P = 0.05). At multivariable logistic regression, age ≥ 85 was associated with major complications. BMI, performance status, and major complications were associated with 90-day mortality., Conclusions: The frail elderly have longer hospital stays and more complications after surgery than the general population, consistent with the reported literature. Careful selection of surgical candidates is required.

Objective: The aim of this study was to compare perioperative and oncologic outcomes between minimally invasive and open surgery in the treatment of endometrial carcinosarcoma., Methods: We retrospectively identified all patients with newly diagnosed endometrial carcinosarcoma who underwent primary surgery via any approach at our institution from January 2009 to January 2018. Patients with known bulky disease identified on preoperative imaging were excluded. The χ 2 and Mann-Whitney U tests were used to compare categorical and continuous variables, respectively. Kaplan-Meier curves were used to estimate survival, and compared using the log rank test., Results: We identified 147 eligible patients, of whom 37 (25%) underwent an open approach and 110 (75%) underwent minimally invasive surgery. Within the minimally invasive group, 92 (84%) of 110 patients underwent a robotic procedure and 14 (13%) underwent a laparoscopic procedure. Four minimally invasive cases (4%) were converted to open procedures. Median age, body mass index, operative time, stage, complication grade, and use of adjuvant treatment were clinically and statistically similar between groups. Median length of hospital stay in the open group was 4 days (range 3-21) compared with 1 day (range 0-6) in the minimally invasive group (p<0.001). The rates of any 30-day complication were 46% in the open and 8% in the minimally invasive group (p<0.001). The rates of grade 3 or higher complications were 5.4% and 1.8%, respectively (p=0.53). Median follow-up for the entire cohort was 30 months (range 0.4-121). Two-year progression-free survival rates were 52.8% (SE±8.4) in the open group and 58.5% (SE±5.1) in the minimally invasive group (p=0.7). Two-year disease-specific survival rates were 66.1% (SE±8.0) and 81.4% (SE±4.1), respectively (p=0.8)., Conclusions: In patients with clinical stage I endometrial carcinosarcoma, minimally invasive compared with open surgery was not associated with poor oncologic outcomes, but with a shorter length of hospital stay and a lower rate of overall complications., Competing Interests: Competing interests: ML is an ad hoc speaker for Intuitive Surgical, Inc. Outside the submitted work, ML reports personal fees from JNJ/Ethicon. EJ reports personal fees from Covidien/Medtronic. DSC reports personal fees from Bovie Medical Co, Verthermia Inc (now Apyx Medical Corp), C Surgeries, and Biom ‘Up. NRA-R reports grants from Stryker/Novadaq, Olympus, and GRAIL., (© IGCS and ESGO 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the efficacy of non-hormonal, hyaluronic acid (HLA)-based vaginal gel in improving vulvovaginal estrogen-deprivation symptoms in women with a history of endometrial cancer., Methods: For this single-arm, prospective, longitudinal trial, we enrolled disease-free women with a history of endometrial cancer who underwent surgery (total hysterectomy) and postoperative radiation. Participants used HLA daily for the first 2 weeks, and then 3×/week until weeks 12-14; dosage was then increased to 5×/week for non-responders. Vulvovaginal symptoms and pH were assessed at 4 time points (baseline [T1]; 4-6 weeks [T2]; 12-14 weeks [T3]; 22-24 weeks [T4]) with clinical evaluation, the Vaginal Assessment Scale (VAS), Vulvar Assessment Scale (VuAS), Female Sexual Function Index (FSFI), and Menopausal Symptom Checklist (MSCL)., Results: Of 43 patients, mean age was 59 years (range, 38-78); 54% (23/43) were partnered; and 49% (21/43) were sexually active. VAS, VuAS, MSCL, and SAQ (Sexual Activity Questionnaire) scores significantly improved from baseline to each assessment point (all p < .002). FSFI total mean scores significantly increased from T1 to T2 (p < .05) and from T1 to T4 (p < .03). At T1, 41% (16/39) felt confident about future sexual activity compared to 68% (17/25) at T4 (p = .096). Severely elevated vaginal pH (>6.5) decreased from 30% (13/43) at T1 to 19% (5/26) at T4 (p = .41)., Conclusion: The HLA-based gel improved vulvovaginal health and sexual function of endometrial cancer survivors in perceived symptoms and clinical exam outcomes. HLA administration 1-2×/week is recommended for women in natural menopause; a 3-5×/week schedule appears more effective for symptom relief in cancer survivors., Competing Interests: Declaration of competing interest Outside the submitted work, Dr. Jewell reports personal fees from Covidien/Medtronic. All other authors have no conflicts of interest to report., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To compare oncologic and perioperative outcomes in patients who underwent minimally invasive surgery (MIS) compared to laparotomy for newly diagnosed early-stage cervical carcinoma., Methods: We retrospectively identified patients who underwent radical hysterectomy for stage IA1 with lymphovascular invasion (LVI), IA2, or IB1 cervical carcinoma at our institution from 1/2007-12/2017. Clinicopathologic characteristics and surgical and oncologic survival outcomes were compared using appropriate statistical testing. Multivariable Cox regression analysis was used to control for potential confounders., Results: We identified 196 evaluable cases-117 MIS (106 robotic [90.6%]) and 79 laparotomy cases. Cohorts had similar age, BMI, substage, histologic subtype, clinical and pathologic tumor size, positive margins, and presence of LVI. The MIS group had more cases with no residual tumor in the hysterectomy (24.8% vs. 10.1%, P = 0.01). The laparotomy group had more cases with positive nodes (29.1% vs. 17.1%, P = 0.046) and more patients who received adjuvant therapy (53.2% vs. 33.3%, P = 0.006). Median follow-up was ~4 years. Five-year disease-free survival (DFS) rates were 87.0% in the MIS group and 86.6% in the laparotomy group (P = 0.92); 5-year disease-specific survival (DSS) rates were 96.5% and 93.9%, respectively (P = 0.93); and 5-year overall survival (OS) rates were 96.5% and 87.4%, respectively (P = 0.15). MIS was not associated with DFS, DSS, or OS on multivariable regression analysis. The rate of postoperative complications was significantly lower in the MIS cohort (11.1% vs. 20.3%; P = 0.04)., Conclusions: MIS radical hysterectomy for cervical carcinoma did not confer worse oncologic outcomes in our single-center and concurrent series of patients with early-stage cervical carcinoma., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objective: To compare the prevalence of patient-reported lower-extremity lymphedema (LEL) with sentinel lymph node (SLN) mapping versus comprehensive lymph node dissection (LND) for the surgical management of newly diagnosed endometrial carcinoma., Methods: Patients who underwent primary surgery for endometrial cancer from 01/2006-12/2012 were mailed a survey that included a validated 13-item LEL screening questionnaire in 08/2016. Patients diagnosed with LEL prior to surgery and those who answered ≤6 survey items were excluded., Results: Of 1275 potential participants, 623 (49%) responded to the survey and 599 were evaluable (180 SLN, 352 LND, 67 hysterectomy alone). Median BMI was similar among cohorts (P = 0.99). External-beam radiation therapy (EBRT) was used in 10/180 (5.5%) SLN and 35/352 (10%) LND patients (P = 0.1). Self-reported LEL prevalence was 27% (49/180) and 41% (144/352), respectively (OR, 1.85; 95% CI, 1.25-2.74; P = 0.002). LEL prevalence was 51% (23/45) in patients who received EBRT and 35% (170/487) in those who did not (OR, 1.95; 95% CI, 1.06-3.6; P = 0.03). High BMI was associated with increased prevalence of LEL (OR, 1.04; 95% CI, 1.02-1.06; P = 0.001). After controlling for EBRT and BMI, LND retained independent association with an increased prevalence of LEL over SLN (OR, 1.8; 95% CI, 1.22-2.69; P = 0.003). Patients with self-reported LEL had significantly worse QOL compared to those without self-reported LEL., Conclusions: This is the first study to assess patient-reported LEL after SLN mapping for endometrial cancer. SLN mapping was independently associated with a significantly lower prevalence of patient-reported LEL. High BMI and adjuvant EBRT were associated with an increased prevalence of patient-reported LEL., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: Mutations in DNA mismatch repair (MMR) genes and PTEN, diagnostic of Lynch and Cowden syndromes, respectively, represent the only established inherited predisposition genes in endometrial cancer to date. The prevalence of other cancer predisposition genes remains unclear. We sought the prevalence of pathogenic germline variants in unselected patients with endometrial cancer attending for surgical consultation., Patients and Methods: Patients were prospectively consented (4/2016-5/2017) to an IRB-approved protocol of tumor-normal sequencing via a custom next-generation sequencing panel (MSK-IMPACT) with return of germline results for >75 cancer predisposition genes. Tumors were assessed for microsatellite instability (MSI). Per institutional standards, all tumors underwent Lynch syndrome screening via IHC for MMR proteins., Results: Of 156 patients who consented to germline genetic testing, 118 (76%) had stage I disease. Tumors were endometrioid in 104 (67%), of which 60 (58%) were grade 1. Twenty-four pathogenic germline variants were identified in 22 patients (14%)-7 (4.5%) with highly penetrant cancer syndromes and 15 (9.6%) with variants in moderate-, low-penetrance, or recessive genes. Of these, 5 (21%) were in Lynch syndrome genes (2 MSH6, 2 PMS2, and 1 MLH1) . All 5 tumors had concordant IHC staining; 2 (40%) were definitively MSI-high by next-generation sequencing. One patient had a known BRCA1 mutation; 1 had SMARCA4 deletion. The remaining 17 variants (71%) were incremental findings in moderate- and low-penetrance variants or genes associated with recessive disease., Conclusion: In unselected patients with predominantly low-risk, early-stage endometrial cancer, germline multi-gene panel testing identifies cancer predisposition gene variants in 14%. This finding may have implications for future cancer screening and risk-reduction recommendations. Universal IHC screening for Lynch syndrome successfully identifies the majority (71%) of high-penetrance germline mutations.

Background: The elderly population is expanding worldwide but is underrepresented in clinical trials. We sought to assess the safety of robotic gynecologic surgery in an elderly cohort and to identify factors associated with unfavorable outcomes., Methods: All patients ≥ 65 years who underwent a robotically assisted procedure at a single institution between May 2007 to December 2016 were divided into three age groups: 65-74 (Group 1); 75-84 (Group 2); ≥ 85 (Group 3). Perioperative outcomes were recorded in patients who did not require conversion to laparotomy. We compared clinical variables among groups and performed multivariate logistic regression to detect variables associated with major complications (≥ Grade 3) or 90-day mortality., Results: We retrospectively identified 982 cases: 685 in Group 1; 249 in Group 2; 48 in Group 3. Median age = 71 years. Median BMI = 28.9. Malignancy was documented in 72.8% of cases; the majority were endometrial cancer (61.8%). Thirty-four patients (3.5%) were readmitted within 30 days. Seventy-seven (7.8%) had a postoperative complication, and 23 (2.3%) had a major complication. Ninety-day mortality was 0.5%. There was significant difference between groups with respect to body mass index (P = 0.026), ECOG PS (P ≤ 0.001), > 5 comorbidities (P = 0.005), hospital stay (P < 0.001), major complications (P = 0.001), and 90-day mortality (P < 0.001). On multivariable logistic regression, age ≥ 85 years was associated with major complications. Body mass index, age ≥ 85 years, and major complications were significantly associated with 90-day mortality., Conclusions: Robotic-assisted surgery appears to be safe in an elderly cohort. The incidence of overall and major complications is consistent with those reported in the literature. Patients ≥ 85 years old appear to be at higher risk of unfavorable outcomes.

Health care in the United States is in the midst of a significant transformation from a "fee for service" to a "fee for value" based model. The Medicare Access and CHIP Reauthorization Act of 2015 has only accelerated this transition. Anticipating these reforms, the Society of Gynecologic Oncology developed the Future of Physician Payment Reform Task Force (PPRTF) in 2015 to develop strategies to ensure fair value based reimbursement policies for gynecologic cancer care. The PPRTF elected as a first task to develop an Alternative Payment Model for thesurgical management of low risk endometrial cancer. The history, rationale, and conceptual framework for the development of an Endometrial Cancer Alternative Payment Model are described in this white paper, as well as directions forfuture efforts., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: To assess the emotional, reproductive, sexual health, and relationship concerns of women treated for gestational trophoblastic neoplasia (GTN) and examine associations with ß-hCG surveillance., Methods: This institutional review board approved study surveyed GTN survivors (n = 51) who received treatment from 1996 to 2008. Fifty-one women, including those actively followed or formerly treated, were surveyed. The survey consisted of background/medical information, the Reproductive Concerns Scale, the Female Sexual Function Index, an item from the Abbreviated Dyadic Adjustment Scale, the Center for Epidemiologic Studies-Depression scale, the Menopausal Symptom Checklist, the Impact of Life Events Scale, and exploratory items., Results: Mean age at diagnosis was 37.1 years; 41.6 years at study enrollment. Twenty-seven patients (56%) expressed worry about treatment harm and 30 (60%) about recurrence. Twenty percent reported significant depressive symptomatology. Mild cancer-related distress, reproductive concerns, sexual dysfunction, and bothersome menopausal symptoms were noted. Nineteen patients (40%) rated their ß-hCG surveillance worry as "high." Among patients who attempted conception after treatment, 3 of 12 (25%) succeeded in the ß-hCG high-worry group versus 13 of 19 (68%) in the ß-hCG low-worry group. Survivors with high ß-hCG worry had greater reproductive concerns than those with low worry (p = 0.002) and reported less sexual desire (p = 0.025). There was no difference in the number of low-worry versus high-worry participants in active surveillance (p = 0.09)., Conclusion: Our study suggests that cancer-specific distress, sexual health, and reproductive concerns continue to impact women years after treatment. High worry about ß-hCG surveillance is negatively associated with the emotional well-being of GTN survivors and possibly influences reproductive attempts and success.

Objectives: To compare the incidence and potential risk factors of trocar site hernia formation in women undergoing robotically assisted versus standard laparoscopic staging (RBT vs. LSC, respectively) for endometrial cancer., Methods: We retrospectively identified all patients who underwent MIS staging for endometrial cancer at our institution from 01/09-12/12. Data collection involved the review of all operative notes, postoperative follow-up visit notes, and postoperative imaging reports. Appropriate statistical tests were used., Results: We identified 760 eligible patients (LSC, 193; RBT, 567). The overall median age was 61years (range, 33-90). The median BMI was 28.5kg/m 2 for LSC (range, 16.6-67.6) and 29.5kg/m 2 for RBT (range, 17.9-66) patients (p=0.8). A trocar site hernia developed in 16 patients (2.1%)-5 (2.6%) of 193 LSC and 11 (1.9%) of 567 RBT patients (p=0.6). Median time to hernia diagnosis was 13months (range, 5-20.5) and 18months (range, 3-49), respectively (p=0.5). All hernias in the LSC cohort developed at the camera trocar site. In the RBT cohort, 10 developed at the camera trocar site and 1 at a lateral trocar site. Only BMI was associated with the development of hernias. A hernia was diagnosed in 7 (6.9%) of 101 patients with a BMI ≥40kg/m 2 compared with 9 (1.4%) of 659 with a BMI <40kg/m 2 (p=0.001)., Conclusion: MIS for endometrial cancer is associated with a low rate of trocar site hernia formation, with similar rates associated with RBT and standard LSC. Higher BMI is associated with the development of postoperative trocar site hernias., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Objectives: The objective of this study was to assess and compare the sentinel lymph node (SLN) detection rate with indocyanine green (ICG) and near-infrared fluorescence imaging versus blue dye using the robotic platform in patients with uterine cancer., Methods: We identified all patients with uterine cancer undergoing SLN mapping using ICG or blue dye on the robotic platform from January 2011 to December 2013. Our institutional SLN algorithm and pathologic processing protocol were adhered to uniformly. We compared detection rates of SLNs stratified by dye used. Appropriate statistical tests were used., Results: A total of 472 patients were identified. ICG was used in 312 patients (66%) and blue dye in 160 patients (34%). Successful mapping was achieved in 425 (90%) of 472 patients. Mapping was bilateral in 352 patients (75%) and unilateral in 73 patients (15%); 47 patients (10%) did not map. Successful mapping was achieved in 295 (95%) of 312 patients using ICG compared with 130 (81%) of 160 patients using blue dye (P < 0.001). Mapping was bilateral in 266 (85%) of 312 patients in the ICG group compared with 86 (54%) of 160 in the blue dye group (P < 0.001). Additional lymph node dissection beyond removal of the SLNs was performed in 122 patients (39%) mapped with ICG compared with 98 patients (61%) mapped with blue dye (P < 0.001)., Conclusions: The SLN detection rate was superior when mapping with ICG rather than blue dye. Bilateral mapping was significantly improved, resulting in a lower rate of additional lymphadenectomy.

Purpose: The aim of this study was to determine the impact of obesity on the rate of successful sentinel lymph node (SLN) mapping in patients with uterine cancer undergoing robotic surgery, and compare SLN detection rates using indocyanine green (ICG) versus blue dye., Methods: We reviewed robotic cases undergoing SLN mapping with a cervical injection from January 2011 to December 2013 using either blue dye or ICG with near-infrared (NIR) fluorescence imaging. Data were stratified by body mass index (BMI) and the dye used. Appropriate statistical tests were applied., Results: Overall, 472 cases were identified. Bilateral mapping was successful in 352 cases (75 %), and unilateral mapping was successful in 73 cases (15 %). Bilateral mapping was achieved in 266 (85 %) of 312 ICG cases compared with 86 (54 %) of 160 blue-dye cases (p < 0.001). Cases with successful bilateral mapping had a median BMI of 29.8 kg/m(2) (range 16.3-65.3 kg/m(2)); cases with no mapping had a median BMI of 34.7 kg/m(2) (range 21.4-60.4 kg/m(2)) (p = 0.001). With increasing BMI, there was a significant decrease in successful bilateral mapping rates for both the ICG (p < 0.001) and blue-dye groups (p = 0.041); however, the use of ICG resulted in better bilateral (p = 0.002) and overall (p = 0.011) mapping rates compared with the use of blue dye in all BMI groups., Conclusions: ICG results in a higher overall and bilateral SLN detection than blue dye in women with uterine cancer. Successful mapping decreases with increasing BMI irrespective of the dye used; however, it is significantly improved with the use of ICG and NIR fluorescence imaging compared with blue dye.

Background: Minimally invasive surgery (MIS) is associated with decreased complication rates, length of hospital stay, and cost compared with laparotomy. Robotic-assisted surgery-a method of laparoscopy-addresses many of the limitations of standard laparoscopic instrumentation, thus leading to increased rates of MIS. We sought to assess the impact of robotics on the rates and costs of surgical approaches in morbidly obese patients with uterine cancer., Methods: Patients who underwent primary surgery at our institution for uterine cancer from 1993 to 2012 with a BMI ≥40 mg/m(2) were identified. Surgical approaches were categorized as laparotomy (planned or converted), laparoscopic, robotic, or vaginal. We identified two time periods based on the evolving use of MIS at our institution: laparoscopic (1993-2007) and robotic (2008-2012). Direct costs were analyzed for cases performed from 2009 to 2012., Results: We identified 426 eligible cases; 299 performed via laparotomy, 125 via MIS, and 2 via a vaginal approach. The rates of MIS for the laparoscopic and robotic time periods were 6 % and 57 %, respectively. The rate of MIS was 78 % in this morbidly obese cohort in 2012; 69 % were completed robotically. The median length of hospital stay was 5 days (range 2-37) for laparotomy cases and 1 day (range 0-7) for MIS cases (P < 0.001). The complication rate was 36 and 15 %, respectively (P < 0.001). The rate of wound-related complications was 27 and 6 %, respectively (P < 0.001). Laparotomy was associated with the highest cost., Conclusions: The robotic platform provides significant health and cost benefits by increasing MIS rates in this patient population.

Purpose: The aim of this study was to characterize treatment patterns and oncologic outcomes in patients with low-volume lymph node metastasis (isolated tumor cells [ITCs] and micrometastasis [MM]) discovered during sentinel lymph node (SLN) mapping for endometrial carcinoma., Methods: We identified endometrial cancer cases treated surgically from September 2005 to April 2013 in which SLN mapping was performed. MM was defined as tumor within a lymph node measuring >0.2 mm but <2.0 mm, and ITCs were those measuring ≤0.2 mm., Results: Overall, 844 patients, with a median age of 61 years (range 30-90), met the inclusion criteria. Histology was as follows: endometrioid, 724 (85.8 %) patients; serous, 104 (12.3 %) patients; and clear cell, 16 (1.9 %) patients. The median number of lymph nodes resected was six (range 0-60), and the median number of SLNs was two (range 0-15). Overall, 753 (89.2 %) patients were node-negative, 23 (2.7 %) had ITCs only, 21 (2.5 %) had MM only, and 47 (5.6 %) had macrometastasis. Adjuvant chemotherapy was administered to 106 (14 %) of 753 node-negative patients, 19 (83 %) of 23 patients with ITCs, 17 (81 %) of 21 patients with MM, and 42 (89 %) of 47 with macrometastasis. Median follow-up was 26 months (range 0-108). Three-year recurrence-free survival was as follows: node-negative patients, 90 % (±1.5); ITCs only, 86 % (±9.4); MM only, 86 % (±9.7); and macrometastasis, 71 % (±7.2) [p < 0.001]., Conclusions: Patients with ITCs and MM frequently received adjuvant chemotherapy and had improved oncologic outcomes in comparison to those with macrometastasis to the lymph nodes. Further prospective study is needed to determine optimal post-resection management in patients with ITCs or MM alone.

Trisegmented Au-Ru-Au and Ru-Au-Ru nanorods catalyze the decomposition of hydrogen peroxide, pumping fluid along their axis as "pullers" and "pushers" respectively. Numerical simulations and experiments with passive tracer particles show that catalytically generated hydrodynamic and electrostatic forces both contribute to pairwise and collective particle assembly.

Objective: To compare the incidence of trocar site hernia in women who underwent robotically assisted laparoscopic surgery (RBT) for endometrial cancer staging with the incidence of ventral hernia formation in patients who underwent laparotomy (LAP) for the same indication. To analyze risk factors for hernia formation in women undergoing RBT for endometrial cancer., Methods: We retrospectively identified all patients who underwent surgical staging for endometrial cancer via RBT or LAP from 2009-2012. Clinicopathologic data were analyzed. Appropriate statistical tests were used., Results: 738 patients were staged via RBT (n=567) or LAP (n=171). Overall median age was 61 years (RBT range, 33-90; LAP range,28-86; p=0.4). Median BMI was 29.5 kg/m(2) (range, 17.9-66) and 30.3 kg/m(2) (range, 16.8-67.2), respectively (p=1.0). Eleven (1.9%) of 567 patients in the RBT cohort developed a trocar site hernia compared with 11 (6.4%) of 171 LAP patients who developed a ventral hernia (p=0.002). Median time to diagnosis was 18 months (range, 3-49) and 17 months (range, 7-30), respectively (p=0.7). Of the 11 RBT patients who developed a trocar site hernia, 10 (91%) were midline defects and 1 (9%) was a lateral defect of a prior inferior epigastric port site. No hernias required emergent operative intervention. Four (0.7%) of 567 RBT patients compared with 2 (1.2%) of 171 LAP patients required surgical hernia repair (p=0.4)., Conclusions: Trocar site herniation after RBT staging for endometrial cancer is uncommon and less likely to occur than ventral hernia formation with LAP staging. Furthermore, surgical revision rates are low., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To assess the ability of the Age-Adjusted Charlson Comorbidity Index (ACCI) to predict perioperative complications and survival in patients undergoing primary debulking for advanced epithelial ovarian cancer (EOC)., Methods: Data were analyzed for all patients with stage IIIB-IV EOC who underwent primary cytoreduction from 1/2001-1/2010 at our institution. Patients were divided into 3 groups based on an ACCI of 0-1, 2-3, and ≥4. Clinical and survival outcomes were assessed and compared., Results: We identified 567 patients; 199 (35%) had an ACCI of 0-1, 271 (48%) had an ACCI of 2-3, and 97 (17%) had an ACCI of ≥4. The ACCI was significantly associated with the rate of complete gross resection (0-1=44%, 2-3=32%, and ≥4=32%; p=0.02), but was not associated with the rate of minor (47% vs 47% vs 43%, p=0.84) or major (18% vs 19% vs 16%, p=0.8) complications. The ACCI was also significantly associated with progression-free (PFS) and overall survival (OS). Median PFS for patients with an ACCI of 0-1, 2-3, and ≥4 was 20.3, 16, and 15.4 months, respectively (p=0.02). Median OS for patients with an ACCI of 0-1, 2-3, and ≥4 was 65.3, 49.9, and 42.3 months, respectively (p<0.001). On multivariate analysis, the ACCI remained a significant prognostic factor for both PFS (p=0.02) and OS (p<0.001)., Conclusions: The ACCI was not associated with perioperative complications in patients undergoing primary cytoreduction for advanced EOC, but was a significant predictor of PFS and OS. Prospective clinical trials in ovarian cancer should consider stratifying for an age-comorbidity covariate., (Copyright © 2015 Elsevier Inc. All rights reserved.)

Objective: Sentinel lymph node biopsy (SLNB) is an acceptable method of evaluating groin lymph nodes in women with vulvar cancer. The purpose of this study is to assess the cost and effectiveness of SLNB compared to universal inguinofemoral lymphadenectomy (LND) for vulvar cancer., Methods: A modified Markov decision model was generated to compare two surgical approaches for newly diagnosed, early-stage vulvar cancer: (1) radical vulvectomy+LND and (2) radical vulvectomy+SLNB. Published data were used to estimate survival outcomes, probability of positive lymph nodes and lymphedema. Costs of surgery and radiation and lymphedema therapies were estimated from published data. Lymphedema's effect on quality of life (QOL) was extrapolated from other disease sites and assigned a utility score of 0.84. Multiple sensitivity analyses were performed., Results: SLNB was less costly ($13,449 versus $14,261) and more effective (4.16 quality-adjusted life years (QALYs) versus 4.00 QALYs) than LND. The model was sensitive to the impact of lymphedema on QOL. Unless the impact of lymphedema on QOL was minimal (utility score>0.975) SLNB dominated LND. Variations in the rate of positive SLNB and probability of lymphedema over clinically reasonable ranges did not alter the results., Conclusions: SLNB is a cost-effective strategy for the treatment of newly diagnosed vulvar cancer, mainly due to the impact of lymphedema on QOL., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To assess the direct costs of three surgical approaches in uterine cancer and the cost-effectiveness of incorporating robot-assisted surgery., Methods: A cost system that allocates the actual cost of resources used to treat each patient, as opposed to borrowing cost data from a billing system, was used to determine direct costs for patients who underwent surgery for uterine cancer from 2009 to 2010. These costs included all aspects of surgical care up to 6 months after discharge. Total amortized direct costs included the capital cost of three dual-console robotic platforms with 5 years of service contracts. Nonamortized costs were also calculated (excluded capital costs). Modeling was performed to estimate the mean cost of surgical care for patients presenting with endometrial cancer from 2007 to 2010., Results: Of 436 cases (132 laparoscopic, 262 robotic, 42 laparotomy), total mean amortized direct costs per case were $20,489 (laparoscopy), $23,646 (robot), and $24,642 (laparotomy) (P<.05 [robot compared with laparoscopy]; P=.6 [robot compared with laparotomy]). Total nonamortized costs per case were $20,289, $20,467, and $24,433, respectively (P=.9 [robot compared with laparoscopy]; P=.03 [robot compared with laparotomy]). The planned surgical approach in 2007 was laparoscopy, 68%; robot, 8%; and laparotomy, 24% compared with 26%, 64%, and 9%, respectively, in 2010 (P<.001). The modeled mean amortized direct costs per case were $21,738 in 2007 and $22,678 in 2010 (+$940). Nonamortized costs were $21,298 in 2007 and $20,573 in 2010 (-$725)., Conclusion: Laparoscopy is least expensive when including capital acquisition costs. Laparoscopy and robotic surgery are comparable if upfront costs are excluded. There is cost neutralization with the robot when it helps decrease laparotomy rates.

Objectives: Our primary objective was to assess the detection rate of sentinel lymph nodes (SLNs) using indocyanine green (ICG) and near-infrared (NIR) fluorescence imaging for uterine and cervical malignancies., Methods: NIR fluorescence imaging for the robotic platform was obtained at our institution in 12/2011. We identified all cases planned for SLN mapping using fluorescence imaging from 12/2011-4/2013. Intracervical ICG was the fluorophobe in all cases. Four cc (1.25mg/mL) of ICG was injected into the cervix alone divided into the 3- and 9-o'clock positions, with 1 cc deep into the stroma and 1 cc submucosally before initiating laparoscopic entry. Blue dye was concurrently injected in some cases., Results: Two hundred twenty-seven cases were performed. Median age was 60 years (range, 28-90 years). Median BMI was 30.2 kg/m(2) (range, 18-60 kg/m(2)). The median SLN count was 3 (range, 1-23). An SLN was identified in 216 cases (95%), with bilateral pelvic mapping in 179 (79%). An aortic SLN was identified in 21 (10%) of the 216 mapped cases. When ICG alone was used to map cases, 188/197 patients mapped, for a 95% detection rate compared to 93% (28/30) in cases in which both dyes were used (P=NS). Bilateral mapping was seen in 156/197 (79%) ICG-only cases and 23/30 (77%) ICG and blue dye cases (P=NS)., Conclusions: NIR fluorescence imaging with intracervical ICG injection using the robotic platform has a high bilateral SLN detection rate and appears favorable to using blue dye alone and/or other modalities. Combined use of ICG and blue dye appears unnecessary., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To describe the learning curve associated with training fellows in completing robotic assisted total laparoscopic hysterectomies., Methods: All patients scheduled to undergo a robotic procedure at our institution from 5/15/07 to 5/22/12 were identified. Fellow participation per procedure was documented. The learning curve of fellows for the time to complete a hysterectomy (from initiation of developing the retroperitoneal space to the completion of the colpotomy) was analyzed., Results: Of the 1754 planned robotic cases, 1626 were completed robotically and 128 were converted to laparotomy. Fifty-seven fellows participated in 99.7% of the cases. Eleven gynecologic oncology fellows completed at least 1 robotic assisted total laparoscopic hysterectomy. From 7/7/08 to 5/21/12, 981 hysterectomies were completed robotically, 254 of these (25.9%) by the 11 fellows. Prior to completing a hysterectomy, the median number of hysterectomies in which a fellow participated was 16 (range, 11-40). Median amount of time for a fellow to complete a hysterectomy decreased from 60 min in 2009 (N=27 cases) to 31 min in 2011 (N=148 cases). Based on the recorded completion times in which the 11 fellows completed a hysterectomy, it required ~33 cases per fellow to be able to perform the hysterectomy and overcome the learning curve., Conclusions: The learning curve associated with hysterectomy requires completion of ~33 cases by the fellow after an initial median experience of 16 cases. Our data suggest that a minimum of 50 total cases is required during fellowship to complete a robotic hysterectomy., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Purpose: Laparoscopy (LSC) offers superior patient outcomes compared to laparotomy. Small retrospective/prospective series have suggested robotics offers further reduction in postoperative pain and pain medication use compared to standard LSC. Our objective was to compare postoperative pain in patients undergoing robotically assisted (RBT) versus standard LSC for newly diagnosed endometrial cancer., Methods: All preoperative endometrial cancer cases scheduled for RBT and LSC from May 1, 2007 to June 9, 2010 were identified. For this analysis, we only included cases not requiring conversion to laparotomy. All patients were offered intravenous (IV) patient-controlled analgesia (PCA) postoperatively. Intraoperative equivalent fentanyl doses (IEFDs) and pain scores in the postanesthesia care unit (PACU) were assessed., Results: IV PCA was used in 206 RBTs (86 %) and 208 LSCs (88 %). Median IEFD was 425 μg for LSCs and 500 μg for RBTs (P = 0.03). Median pain scores on PACU arrival were similar in both groups. Median highest pain score was 5 for LSCs and 4 for RBTs (P = 0.007). Linear regression demonstrated that the IEFD was not correlated with the highest pain score (R = 0.09; P = 0.07). Fentanyl was used postoperatively in 196 of 206 RBTs (95 %) and 187 of 208 LSCs (90 %). The total fentanyl doses were 242.5 (range 0-2705) μg and 380 (range 0-2625) μg, respectively (P < 0.001). The median hourly fentanyl doses were 16.7 (range 0-122.5) μg and 23.5 (range 0-132.4) μg, respectively (P = 0.005). Simultaneous multiple regression analysis further demonstrated RBT was independently associated with a lower total fentanyl dose compared to LSC (P = 0.02)., Conclusions: RBT is independently associated with significantly lower postoperative pain and pain medication requirements compared to LSC. The amount of intraoperative fentanyl analgesia does not appear to correlate with postoperative pain.Endometrial cancer is the most common gynecologic malignancy in the United States, with an estimated 47,130 new cases in 2012.1 An estimated 287,100 women were diagnosed with endometrial cancer worldwide in 2008.2 Surgery is the primary treatment of choice for the majority of these women.3 The standard surgical approach has been total abdominal hysterectomy, bilateral salpingo-oophorectomy, and staging via laparotomy. Multiple retrospective series have shown that a less invasive surgical approach via laparoscopy (LSC) is feasible and safe, and also associated with improved perioperative outcomes compared to laparotomy in these patients.4 The Gynecologic Oncology Group (GOG) published results of the largest randomized trial (LAP2) comparing LSC to laparotomy in patients with newly diagnosed endometrial carcinoma in 2009.5,6 This landmark study essentially changed the accepted standard surgical approach in this group. Postoperative complications, median blood loss, and median length of stay (LOS), despite increased operative time, were significantly lower in LSC patients despite 25 % requiring conversion to laparotomy.5 The first 802 eligible patients randomized in LAP2 also participated in a quality-of-life (QOL) study. Within 6 weeks of surgery, patients assigned to LSC reported significantly better QOL on all scales other than fear of recurrence.6 Overall, during this 6-week postoperative period, patients assigned to LSC had superior QOL, fewer physical symptoms, less pain and pain-related interference with functioning, better physical functioning and emotional state, earlier resumption of normal activities, earlier return to work, and better body image compared to those assigned to laparotomy.6 Recurrence-free and overall survivals were the same in both groups.7 Multiple published retrospective series have shown possible benefits, such as reduced postoperative pain, using the robotic (RBT) platform compared to LSC or laparotomy in patients with endometrial cancer.8-11 In a randomized trial, LSC was found to be associated with less postoperative pain compared to vaginal approaches in patients undergoing hysterectomy for benign gynecologic disease.12 A small retrospective series reported further reductions in postoperative pain in patients who had undergone an RBT hysterectomy compared to a standard total LSC hysterectomy for benign indications.13 A recent cost analysis suggested that patients experienced less pain and required less pain medication use after RBT procedures compared to LSC for endometrial cancer.14 Based on these reports, we sought to analyze postoperative pain and the use of pain medication in patients undergoing RBT compared to standard transperitoneal LSC procedures for newly diagnosed endometrial cancer during a concurrent time period. Of note, current RBT surgery is not truly robotic in that it is not autonomous. A more appropriate term is “computer-assisted surgery,” but to satisfy current convention, we refer to it as “robotic surgery” in this manuscript.

Objectives: Radical trachelectomy has enabled select women with stage I cervical cancer to maintain fertility after treatment. Tumor size greater than 2 cm has been considered a contraindication, and those patients denied trachelectomy. We report our trachelectomy experience with tumors measuring 2 to 4 cm., Methods: We retrospectively reviewed the medical records of all patients planned for fertility-sparing radical trachelectomy. Largest tumor dimension was determined by physical examination, preoperative magnetic resonance imaging, or pathologic evaluation. No patient received neoadjuvant chemotherapy., Results: Twenty-nine (26%) of 110 patients had stage IB1 disease with tumors 2 to 4 cm. Median age was 31 years (range, 22-40 years), and 83% were nulliparous. Thirteen patients (45%) had squamous cell carcinoma, 12 patients (41%) had adenocarcinoma, and 4 patients (14%) had adenosquamous carcinoma. Thirteen (45%) of 29 patients had positive pelvic nodes. All para-aortic nodes were negative. Owing to intraoperative frozen section, 13 patients (45%) underwent immediate hysterectomy and 1 patient (3%) definitive chemoradiation. Owing to high-risk features on final pathology, 6 patients (21%) who had retained their uterus received chemoradiation. Nine patients (31%) underwent a fertility-sparing procedure. At a median follow-up of 44 months (range, 1-90 months), there was one recurrence., Conclusions: Expanding radical trachelectomy inclusion criteria to women with 2- to 4-cm tumors allows for a fertility-sparing procedure in 30% of patients who would otherwise have been denied the option, with no compromise in oncologic outcome.

Objective: Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states., Methods: We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics., Results: Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE., Conclusions: This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Objective: Placental-site trophoblastic tumor (PSTT) is the rarest form of gestational trophoblastic disease (GTD). A risk-adapted treatment approach has been advocated, but controversy exists as to the most important prognostic markers for this disease. Our goal was to determine the prognostic markers for patients with PSTT seen at our center., Methods: We conducted a retrospective analysis of patients with PSTT seen at a single tertiary care center between 1996 and 2011. The association of FIGO stage, interval from antecedent pregnancy, antecedent pregnancy outcome, human chorionic gonadotropin (hCG) level, and age to overall survival was examined using univariate log-rank tests. Presentation, treatment, and outcome were summarized using descriptive statistics., Results: Data from 17 patients were analyzed. Eight (47%) had Stage I/II disease and 9 (53%) had Stage III/IV disease. Median overall survival for the entire cohort was 86 months (range, 2-101 months). Median duration of follow-up for surviving patients was 56 months. Increasing FIGO stage (I-III versus IV) was associated with a worse overall survival (p=0.009). Interval from antecedent pregnancy (≥12months), antecedent pregnancy outcome (full-term), hCG (≥1000 IU/L), and age (≥40) were not associated with worse survival., Conclusion: FIGO stage, specifically Stage IV disease, was the most important predictor of overall survival in our cohort of PSTT patients., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objectives: Uterine adenosarcomas (AS) are rare tumors composed of malignant stromal and benign epithelial components. We sought to evaluate the role of primary surgery, adjuvant treatments, and salvage therapies for patients with uterine adenosarcomas., Methods: We identified all patients diagnosed with AS from 1990 to 2009 at our institution. Patient demographics, surgical procedures, sites of metastatic disease, and histologic features (e.g., presence of sarcomatous overgrowth, and heterologous elements) were collected. Treatment regimens and survival outcomes were evaluated., Results: Thirty-one patients were evaluable for this study: 19 (61%) received up-front treatment at our institution and 12 (39%) received treatment for recurrent disease. Most of the up-front treated patients (15, 79%) were diagnosed with stage I disease and underwent hysterectomy (100%) with bilateral salpingo-oophorectomy (84%). Of the 19 patients treated at our institution from time of initial diagnosis, 5 (26%) patients recurred (median follow-up, 72.9 months; range, 3-154). In 5 patients with sarcomatous overgrowth (AS+SO), the 2-year progression-free and overall survival rates were both 20% versus 100% for 14 patients without sarcomatous overgrowth. Responses to systemic treatment of measurable disease were observed in patients with and without sarcomatous overgrowth, but no optimal treatment strategy could be identified for either groups., Conclusions: Unlike AS without sarcomatous overgrowth, AS+SO is an aggressive disease with a high recurrence rate. In our series, no optimal adjuvant or systemic treatment strategy was identifiable but standard sarcoma chemotherapy regimens appear to have efficacy in both AS and AS+SO., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: A recent phase III trial reported gemcitabine with cisplatin chemoradiation followed by 2 cycles of gemcitabine and cisplatin (G) significantly improved progression-free (PFS) and overall survival (OS) compared to standard cisplatin chemoradiation (C) for locally advanced cervix cancer. We evaluate the cost effectiveness (CE) of these treatment regimens., Methods: A modified Markov model was constructed comparing CE between treatment arms using the published trial's five-year OS and treatment-related toxicity rates. Quality of life (QOL) utility scores during treatment were obtained from published literature and modeled for sensitivity analysis. Cost data was obtained from Medicare reimbursement figures and the Healthcare Cost and Utilization Project. One-way sensitivity analyses assessed variations in cost and adverse events., Results: Mean cost was $41,330 (US$) for C versus $60,974 for G. Incremental cost-effectiveness ratio (ICER) for G compared to C was $33,080 per quality-adjusted life year (QALY). In sensitivity analyses (SA), the ICER increased to common willingness-to-pay thresholds of 50 K and 100 K when QOL utility scores during G active treatment declined to 0.64 and 0.53 (baseline 0.76), respectively. The model was insensitive to changes in adverse event rates, costs of treatment, or adverse event hospitalization costs., Conclusions: Gemcitabine with cisplatin chemoradiation followed by 2 cycles of adjuvant gemcitabine and cisplatin is a cost effective treatment for locally advanced cervix cancer compared to standard cisplatin chemoradiation. Common willingness to pay thresholds are exceeded during sensitivity analyses with realistic declines in QOL. Our results support ongoing investigations of novel adjuvants to standard cisplatin chemoradiation with potentially less toxicity., (Published by Elsevier Inc.)

Objective: To assess the introduction of computer-based surgery (ie, robotic surgery [RBT]) in the treatment of patients with newly diagnosed uterine cancer., Methods: We identified all patients who presented to our institution for initial surgical care of newly diagnosed uterine cancer from 5/1/07-12/31/10. Perioperative outcomes of laparotomy cases were compared to those of laparoscopic (LSC) or RBT cases. Complications within 30 days of surgery were graded., Results: Of 752 patients, the planned approach was laparotomy in 103 (14%), LSC in 302 (40%), and RBT in 347 (46%). The rate of laparotomy for any reason (planned or converted) was 39% in 2007 compared to 18% in 2010 (P<0.001). Preoperative characteristics for LSC and RBT cases were similar, except 10% versus 15%, respectively, were morbidly obese (P=0.049). The extent of procedure, total nodal counts, and overall complications were similar between the LSC and RBT cases. The median length of stay was shorter for RBT cases (P<0.001). The median total room and operative times were longer for RBT cases (P<0.001), mainly due to cases in which the surgeon had less than ~40 RBT cases of experience., Conclusions: Robotics can be efficiently introduced into the surgical care of patients with newly diagnosed uterine cancers. RBT cases require the same operative times as LSC cases after accounting for the 40-case learning curve. Both approaches result in similar excellent patient outcomes and remain reasonable approaches for this disease. The introduction of robotics may lead to further reduction in the rate of laparotomy., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Objective: We assessed the IHC expression of ER and PR and their prognostic significance in uterine leiomyosarcoma (LMS)., Methods: We identified 43 "high-grade" uterine LMS cases from 7/82-7/07 for whom ER/PR IHC analysis was performed at initial diagnosis at our institution., Results: Disease was confined to the uterine body in 20/43 (47%). Eighteen (42%) of 43 were ER(+); 17/42 (41%) were PR(+). At last follow-up, 33 (77%) had recurred or progressed, and 23 (54%) had died. PR expression was associated with improved progression-free survival (PFS; P=0.002) and overall survival (OS; P=0.03) overall; ER expression was not. After adjusting for stage, ER expression was associated with PFS (P=0.01), not OS (P=0.3), and PR expression maintained a significant association with PFS (P=0.002) and approached a significant association with OS (P=0.05). Neither ER nor PR expression was associated with outcome in cases with disease outside the uterine body. In cases with confined disease, median PFS for ER(+) or PR(+) cases was not reached compared to 16.9 months for ER(-) cases (95% CI: 8.1-25.7; P=0.03) and 13.5 months for PR(-) cases (95% CI: 5.9-21.1; P=0.001). Only 1/10 PR(+) cases recurred and died; 9/10 PR(-) cases recurred, and 5 died. Two of 9 ER(+) cases recurred and died; 8/11 ER(-) cases recurred, and 4 died., Conclusion: ER/PR expression is associated with survival outcomes in patients with high-grade uterine LMS confined to the uterine body. PR expression seems capable of identifying cases confined to the uterine body, which have better outcomes., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objectives: Uterine carcinosarcoma (CS) is a rare but aggressive malignancy frequently associated with extrauterine metastasis at the time of diagnosis. The objective of this study was to assess the role of cytoreductive surgery in patients with stage IIIC-IVB uterine CS., Methods: We conducted a retrospective review of all patients with uterine CS treated at our institution from 1990 to 2009. Clinicopathologic factors, surgical procedures, adjuvant therapy, and survival outcomes were collected for all patients. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Factors predictive of survival outcomes were compared using the log-rank test and Cox regression analysis., Results: An analysis of 44 patients was performed (stage IIIC, n=14; stage IVB, n=30). Complete gross resection was achieved in 57% of patients. PFS and OS for the entire cohort were 8.6 months and 18.5 months, respectively. Complete gross resection was associated with a median OS of 52.3 months versus 8.6 months in patients with gross residual disease (P<0.0001). Stage IIIC disease was associated with a median OS of 52.3 months versus 17.5 months for patients with stage IVB disease. In patients who received adjuvant therapy, OS was 30.1 months versus 4.7 months in patients who did not receive adjuvant therapy (P<0.001). On multivariate analysis, only complete gross resection and the ability to receive adjuvant therapy were independently associated with OS., Conclusions: Cytoreductive surgery, with a goal of achieving a complete gross resection, is associated with an improvement in OS among patients with advanced uterine CS., (Copyright © 2011. Published by Elsevier Inc.)