Incidence of postoperative venous thromboembolism in patients with vulvar carcinoma undergoing vulvectomy with or without lymphadenectomy.

OBJECTIVES: The incidence of venous thromboembolism (VTE) following radical surgery for vulvar carcinoma remains poorly characterized, and recommendations for postoperative chemoprophylaxis are varied. Our objective was to assess the incidence of postoperative VTE in patients undergoing surgery for vulvar carcinoma and to determine if VTE incidence differs by radical vulvectomy with or without lymph node assessment. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried for patients with a diagnosis of vulvar cancer undergoing radical vulvectomy with or without lymph node assessment from 2012 to 2020. Clinical characteristics and 30-day incidence of VTE as well as other postoperative outcomes were abstracted. Variables were compared using Chi-square test and Fischer's exact test, as well as Kruskal-Wallis and Wilcoxon rank sum tests where appropriate. RESULTS: A total of 1672 patients underwent radical vulvectomy for vulvar carcinoma. 11 patients (0.7%) experienced postoperative VTE within 30 days of surgery. The incidence of VTE was similar when radical vulvectomy was performed alone or with lymph node dissection by any method (p = 0.116). Longer operative times (p = 0.033) and greater postoperative length of stay (p = 0.001) were associated with increased risk of postoperative VTE. CONCLUSIONS: The incidence of postoperative VTE is low in patients undergoing radical vulvar surgery in this national cohort. Inguinofemoral lymph node dissection by any method does not appear to be a risk factor for VTE when compared to radical vulvectomy alone. Further research is needed to determine if extended VTE prophylaxis is beneficial in this population.

TP53 mutations and the association with platinum resistance in high grade serous ovarian carcinoma.

OBJECTIVES: Alterations in the tumor suppressor TP53 gene are the most common mutations in high grade serous ovarian carcinoma. The impact of TP53 mutations on clinical outcomes and platinum resistance is controversial. We sought to evaluate the genomic profile of high grade serous ovarian carcinoma and explore the association of TP53 mutations with platinum resistance. METHODS: Next generation sequencing data was obtained from our institutional database for patients with high grade serous ovarian carcinoma undergoing primary treatment. Sequencing data, demographic, and clinical information was reviewed. The primary outcome analyzed was time to recurrence or refractory diagnosis. Associations between the primary outcome and different classification schemes for TP53 mutations (structural, functional, hot spot, pathogenicity scores, immunohistochemical staining patterns) were performed. RESULTS: 209 patients met inclusion criteria. TP53 mutations were the most common mutation. There were no differences in platinum response with TP53 hotspot mutations or high pathogenicity scores. Presence of TP53 gain-of-function mutations or measure of TP53 gain-of function activity were not associated with platinum resistance. Immunohistochemical staining patterns correlated with expected TP53 protein function and were not associated with platinum resistance. CONCLUSIONS: TP53 hotspot mutations or high pathogenicity scores were not associated with platinum resistance or refractory disease. Contrary to prior studies, TP53 gain-of-function mutations were not associated with platinum resistance. Estimation of TP53 gain-of-function effect using missense mutation phenotype scores was not associated with platinum resistance. The polymorphic nature of TP53 mutations may be too complex to demonstrate effect using simple models, or response to platinum therapy may be independent of initiating TP53 mutation.

Phase III Trial of Carboplatin and Paclitaxel Compared With Cisplatin and Paclitaxel in Patients With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study.

Purpose: In randomized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer. Although in nonrandomized trials, carboplatin and paclitaxel was a less toxic and highly active combination regimen, there remained concern regarding its efficacy in patients with small-volume, resected, stage III disease. Thus, we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population.Patients and Methods: Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours (arm II).Results: Seven hundred ninety-two eligible patients were enrolled onto the study. Prognostic factors were similar in the two treatment groups. Gastrointestinal, renal, and metabolic toxicity, as well as grade 4 leukopenia, were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II. Neurologic toxicity was similar in both regimens. Median progression-free survival and overall survival were 19.4 and 48.7 months, respectively, for arm I compared with 20.7 and 57.4 months, respectively, for arm II. The relative risk (RR) of progression for the carboplatin plus paclitaxel group was 0.88 (95% confidence interval [CI], 0.75 to 1.03) and the RR of death was 0.84 (95% CI, 0.70 to 1.02).Conclusion: In patients with advanced ovarian cancer, a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity, is easier to administer, and is not inferior, when compared with cisplatin plus paclitaxel.

Beyond post-operative readmissions: analysis of the impact of unplanned readmissions during primary treatment of advanced-stage epithelial ovarian cancer on long-term oncology outcome.

BACKGROUND: Multiple studies have assessed post-operative readmissions in advanced ovarian cancer. OBJECTIVE: To evaluate all unplanned readmissions during the primary treatment period of advanced epithelial ovarian cancer, and the impact of readmission on progression-free survival. METHODS: This was a single institution retrospective study from January 2008 to October 2018. Χ2/Fisher's exact and t-test, or Kruskal-Wallis test were used. Multivariable Cox proportional hazard models were used to assess the effect of covariates in progression-free survival analysis. RESULTS: A total of 484 patients (279 primary cytoreductive surgery, 205 neoadjuvant chemotherapy) were analyzed. In total, 272 of 484 (56%; 37% primary cytoreductive surgery, 32% neoadjuvant chemotherapy, p=0.29) patients were readmitted during the primary treatment period. Overall, 42.3% of the readmissions were surgery related, 47.8% were chemotherapy related, and 59.6% were cancer related but not related to surgery or chemotherapy, and each readmission could qualify for more than one reason. Readmitted patients had a higher rate of chronic kidney disease (4.1% vs 1.0%, p=0.038). Post-operative, chemotherapy, and cancer-related readmissions were similar between the two groups. However, the percentage of inpatient treatment days due to unplanned readmission was twice as high for primary cytoreductive surgery at 2.2% vs 1.3% for neoadjuvant chemotherapy (p<0.001). Despite longer readmissions in the primary cytoreductive surgery group, Cox regression analysis demonstrated that readmissions did not affect progression-free survival (HR=1.22, 95% CI 0.98 to 1.51; p=0.08). Primary cytoreductive surgery, higher modified Frailty Index, grade 3 disease, and optimal cytoreduction were associated with longer progression-free survival. CONCLUSIONS: In this study, 35% of the women with advanced ovarian cancer had at least one unplanned readmission during the entire treatment time. Patients treated by primary cytoreductive surgery spent more days during readmission than those with neoadjuvant chemotherapy. Readmissions did not affect progression-free survival and may not be valuable as a quality metric.

Opportunistic osteoporosis screening using routine computed tomography images to identify bone loss in gynecologic cancer survivors.

OBJECTIVE: Cancer treatment-induced bone loss is a known side effect of cancer therapy. Computed tomography (CT) bone mineral density screening is a novel tool for identifying bone loss. This study aims to use routine CT images to determine long-term bone mineral density changes and osteoporosis risk among women with gynecologic cancers. METHODS: Bone loss was evaluated in a retrospective cohort of women ≤65 years old with gynecologic cancer who underwent oophorectomy from January 2010 to December 2014. Opportunistic CT-based bone mineral density measurements (Hounsfield units, HU) were performed at baseline and intervals up to 5 years after cancer diagnosis. Osteoporosis risk was categorized by HU. Bivariate and multivariate analyses were performed to compare baseline to follow-up bone mineral density at 1, 3, and 5 years and to identify predictors of bone loss following diagnosis. RESULTS: A total of 185 patients (median age 53 years, range 23-65 years, 78.1% ovarian cancer) were included. Bone mineral density significantly decreased between baseline and 1 year (p<0.001), 3 years (p<0.001), and 5 years (p<0.001). Half with normal bone mineral density at baseline had risk for osteopenia or osteoporosis at 5 years. Four percent had osteoporosis risk at baseline compared with 1 year (7.4%), 3 years (15.7%), and 5 years (18.0%). Pre-treatment bone mineral density was a significant predictor at 1 and 5 years (1 year: p<0.01; 5 years: p<0.01). History of chemotherapy predicted bone loss at 1 year (p=0.03). More lifetime chemotherapy cycles were associated with increased risk of osteoporosis at 1 year (p=0.03) and 5 years (p=0.01). CONCLUSIONS: Women with gynecologic cancers may experience accelerated cancer treatment-induced bone loss. Routine CT imaging is a convenient screening modality to identify those at highest risk for osteoporosis who warrant further evaluation with dual-energy X-ray absorptiometry. Routine bone mineral density assessments 1 year following oophorectomy for cancer treatment may be warranted in this population.

Postoperative venous thromboembolism in gynecologic oncology patients undergoing minimally invasive surgery: Does modality matter?

OBJECTIVES: Minimally invasive surgery (MIS) is increasingly utilized for gynecologic cancers. While incidence of venous thromboembolism (VTE) after MIS is low, some guidelines recommend extended chemoprophylaxis for these patients undergoing MIS. Our objectives were to determine incidence of postoperative VTE in patients undergoing MIS, evaluate differences in the incidence by MIS modality and assess the need for extended chemoprophylaxis. METHODS: We conducted a retrospective cohort study including all patients undergoing MIS (robot-assisted, multi-port laparoscopy, single-port laparoscopy) for gynecologic cancers between January 2014 and December 2018 at our institution. Demographic and perioperative variables were collected. Patients <18 years, with benign pathology, or on preoperative anticoagulation were excluded. Chi-square, Fisher's exact test, and one-way ANOVA were performed to determine risk factors related to VTE occurrence. RESULTS: We identified 806 patients who underwent MIS with median age 61. Most had Stage I disease (81.5%) and uterine cancer (81.5%). Five VTE events occurred within 90 days following surgery (0.6%). Incidence of 90-day VTE did not differ between MIS modalities (p = 0.6). Patients with longer OR times (p = 0.004) were more likely to experience VTE. Age, smoking status, BMI, type of cancer and stage were not significant risk factors for VTE. CONCLUSIONS: The incidence of postoperative VTE in patients with gynecologic cancers undergoing MIS is low and does not appear to differ by MIS modality. Given the very low incidence of postoperative VTE, extended chemoprophylaxis is unlikely to benefit patients with gynecologic malignancies undergoing MIS procedures.

Top Ten Tips Palliative Care Clinicians Should Know About Caring for Patients with Cervical Cancer.

Cervical cancer is the most common gynecologic cancer worldwide. Almost all are related to human papillomavirus exposure. Cervical cancer treatment is associated with significant morbidity that is likely to require support from palliative care teams. In these pearls on cervical cancer, we hope to inform providers about the common treatments and issues for cervical cancer patients. Treatment modalities include surgery for early-stage disease, radiation therapy for locally advanced disease, and pelvic exenteration, chemotherapy, or immunotherapy for recurrent disease. Cervical cancer causes pain and bleeding. Radiation can affect ovarian, urinary, and bowel function. Chemotherapy and immunotherapy are associated with fatigue and nausea. Fistulas between the vagina and bowel or bladder can occur due to cancer or to cancer treatments. Physical and emotional supportive care is important for women with cervical cancer.

Bone health and osteoporosis screening in gynecologic cancer survivors.

Cancer treatment-induced bone loss is a known side effect of cancer therapy that increases the risk of osteoporosis and bone fracture. Women with gynecologic cancer are at increased risk of bone loss secondary to the combined effect of oophorectomy and adjuvant therapies. Data regarding bone loss in women with gynecologic cancers are overall lacking compared to other cancer populations. Consequently, guidelines for osteoporosis screening in women with cancer are largely based on data generated among non-gynecologic cancer survivors. This article reviews current available data of bone health in women with gynecologic cancer, summarizes best-available guidelines for screening for osteoporosis in women with cancer, and provides guidance for osteoporosis screening in women with gynecologic cancers based on best available evidence.

Peripartum Blood Transfusion Among Rural Women in the United States.

OBJECTIVE: To evaluate the peripartum transfusion rates for rural women compared with urban women in the United States. METHODS: In this population-based retrospective cohort study, geocoded birth records from 2014 to 2016 from the National Center for Health Statistics were used to examine the rural-urban differences in blood transfusion among nulliparous women delivering singleton, vertex pregnancies at term. We compared transfusion rates across the counties on a continuum from urban to rural. We generated a multivariable logistic regression model controlling for age, race, nativity, education, insurance, prenatal care, maternal health, gestational age, intrapartum care, mode of delivery, peripartum factors, and county of delivery. RESULTS: Among 3,346,816 births, the transfusion rates based on maternal county of residence increased as the counties became more rural: large metropolitan-center (1.9/1,000 live births); large metropolitan-fringe (2.4); medium metropolitan (2.6); small metropolitan (2.6); micropolitan (4.5); and noncore rural (5.3). Rural women living and delivering in a rural county had more transfusions (8.5/1,000 live births) than women in more urban counties (2.5/1,000). After adjusting for key covariates, the odds of transfusion were higher among women living in micropolitan (adjusted odds ratio [aOR] 2.25, 95% CI 2.09-2.43) and noncore rural (aOR 2.59, 95% CI 2.38-2.81) counties when compared with women living in large metropolitan counties. County of delivery had a higher association with transfusion than resident county. After adding delivery county to the regression model, the association of transfusion and living in a micropolitan (aOR 1.39, 95% CI 1.19-1.63) or noncore rural (aOR 1.32, 95% CI 1.12-1.55) county diminished. CONCLUSION: The odds of blood transfusion were higher for women in rural areas. The results indicate that the rurality of the county where the birth occurred was associated with more transfusion. This may reflect differences in maternity and blood banking services in rural hospitals and warrants further study to identify opportunities for intervention.

Preoperative obstructive sleep apnea screening in gynecologic oncology patients.

BACKGROUND: Women with a gynecologic cancer tend to be older, obese, and postmenopausal, characteristics that are associated with an increased risk for obstructive sleep apnea. However, there is limited investigation regarding the condition's prevalence in this population or its impact on postoperative outcomes. In other surgical populations, patients with obstructive sleep apnea have been observed to be at increased risk for adverse postoperative events. OBJECTIVE: We sought to estimate the prevalence of obstructive sleep apnea among gynecologic oncology patients undergoing elective surgery and to investigate for a relationship between obstructive sleep apnea and postoperative outcomes. STUDY DESIGN: Patients referred to an academic gynecologic oncology practice were approached for enrollment in this prospective, observational study. Patients were considered eligible for study enrollment if they were scheduled for a nonemergent inpatient surgery and could provide informed consent. Enrolled patients were evaluated for a preexisting diagnosis of obstructive sleep apnea. Those without a prior diagnosis were screened using the validated, 4-item STOP questionnaire (ie, Snore loudly, daytime Tiredness, Observed apnea, elevated blood Pressure). All patients who screened positive for obstructive sleep apnea were referred for polysomnography. The primary outcome was the prevalence of women with obstructive sleep apnea or those who screened at high risk for the condition. Secondary outcomes examined the correlation between body mass index (kg/m2) with obstructive sleep apnea and assessed for a relationship between obstructive sleep apnea and postoperative outcomes. RESULTS: Over a 22-month accrual period, 383 eligible patients were consecutively approached to participate in the study. A cohort of 260 patients were enrolled. A total of 33/260 patients (13%) were identified as having a previous diagnosis of obstructive sleep apnea. An additional 66/260 (25%) screened at risk for the condition using the STOP questionnaire. Of the patients who screened positive, 8/66 (12%) completed polysomnography, all of whom (8/8 [100%]) were found to have obstructive sleep apnea. The prevalence of previously diagnosed obstructive sleep apnea or screening at risk for the condition increased as body mass index increased (P < .001). Women with untreated obstructive sleep apnea and those who screened at risk for the condition were found to have an increased risk for postoperative hypoxemia (odds ratio, 3.5; 95% confidence interval, 1.8-4.7; P = .011) and delayed return of bowel function (odds ratio, 2.1; 95% confidence interval, 1.3-4.5; P = .009). CONCLUSION: The prevalence of obstructive sleep apnea or screening at risk for the condition is high among women presenting for surgery with a gynecologic oncologist. Providers should consider evaluating a patient's risk for obstructive sleep apnea in the preoperative setting, especially when risk factors for the condition are present.

Impact of histology and surgical approach on survival among women with early-stage, high-grade uterine cancer: An NRG Oncology/Gynecologic Oncology Group ancillary analysis.

OBJECTIVES: We sought to analyze the clinicopathologic features, recurrence patterns and survival outcomes of women with high-grade uterine cancer (UC) enrolled on The Gynecologic Oncology Group (GOG) LAP2 trial. METHODS: This is a post-hoc analysis of LAP-2 patients with grade 3 endometrioid adenocarcinoma (ENDO), uterine serous (USC), clear cell (CC) and carcinosarcoma (CS). Demographics, clinicopathologic features, and recurrence patterns, were compared by histology and surgical approach. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS: Of the 2600 patients enrolled in LAP-2, 753 patients had high-grade UC: 350 had ENDO, 289 had USC, 42 had CC and 72 had CS. Compared with the ENDO cohort, those with other high-grade subtypes were older (p<0.001) and were more likely to have positive peritoneal cytology (p<0.001), positive lymph nodes (p=0.05) and higher disease stage on final pathology (p<0.001). With a median follow-up time of 60months, compared to patients with ENDO, those with USC, CCC and CS subtypes had higher recurrence rates (p<0.001), extra-pelvic recurrences (p<0.001) and poorer PFS (p<0.001) and OS (p<0.001). Those diagnosed with USC and CS experienced the worst survival outcomes (p=0.003). Patterns of recurrence and survival were not different in those staged with LSC vs LAP. On multivariable analysis, age, stage, pelvic washings and Type II histology were independently and adversely associated with survival. CONCLUSIONS: Women with apparent early-stage, USC and CS histologies have poorer outcomes than women with grade 3 endometrioid adenocarcinoma. Patterns of recurrence and survival were not impacted by surgical approach.

Maintaining sexual health throughout gynecologic cancer survivorship: A comprehensive review and clinical guide.

OBJECTIVE: The diagnosis and treatment of gynecologic cancer can cause short- and long-term negative effects on sexual health and quality of life (QoL). The aim of this article is to present a comprehensive overview of the sexual health concerns of gynecologic cancer survivors and discuss evidence-based treatment options for commonly encountered sexual health issues. METHODS: A comprehensive literature search of English language studies on sexual health in gynecologic cancer survivors and the treatment of sexual dysfunction was conducted in MEDLINE databases. Relevant data are presented in this review. Additionally, personal and institutional practices are incorporated where relevant. RESULTS: Sexual dysfunction is prevalent among gynecologic cancer survivors as a result of surgery, radiation, and chemotherapy-negatively impacting QoL. Many patients expect their healthcare providers to address sexual health concerns, but most have never discussed sex-related issues with their physician. Lubricants, moisturizers, and dilators are effective, simple, non-hormonal interventions that can alleviate the morbidity of vaginal atrophy, stenosis, and pain. Pelvic floor physical therapy can be an additional tool to address dyspareunia. Cognitive behavioral therapy has been shown to be beneficial to patients reporting problems with sexual interest, arousal, and orgasm. CONCLUSION: Oncology providers can make a significant impact on the QoL of gynecologic cancer survivors by addressing sexual health concerns. Simple strategies can be implemented into clinical practice to discuss and treat many sexual issues. Referral to specialized sexual health providers may be needed to address more complex problems.

Dynamic and quasi-static mechanical testing for characterization of the viscoelastic properties of human uterine tissue.

Ultrasound elastography is envisioned as an optional modality to augment standard ultrasound B-mode imaging and is a promising technique to aid in detecting uterine masses which cause abnormal uterine bleeding in both pre- and post-menopausal women. In order to determine the effectiveness of strain imaging, mechanical testing to establish the elastic contrast between normal uterine tissue and stiffer masses such as leiomyomas (fibroids) and between softer pathologies such as uterine cancer and adenomyosis has to be performed. In this paper, we evaluate the stiffness of normal uterine tissue, leiomyomas, and endometrial cancers using a EnduraTEC ElectroForce (ELF) system. We quantify the viscoelastic characteristics of uterine tissue and associated pathologies globally by using two mechanical testing approaches, namely a dynamic and a quasi-static (ramp testing) approach. For dynamic testing, 21 samples obtained from 18 patients were tested. The testing frequencies were set to 1, 10, 20, and 30 Hz. We also report on stiffness variations with pre-compression from 1% to 6% for testing at 2%, 3%, and 4% strain amplitude. Our results show that human uterine tissue stiffness is both dependent on percent pre-compression and testing frequencies. For ramp testing, 20 samples obtained from 14 patients were used. A constant strain rate of 0.1% was applied and comparable results to dynamic testing were obtained. The mean modulus contrast at 2% amplitude between normal uterine tissue (the background) and leiomyomas was 2.29 and 2.17, and between the background and cancer was 0.47 and 0.39 for dynamic and ramp testing, respectively.

Thrombocytosis is Predictive of Postoperative Pulmonary Embolism in Patients With Gynecologic Cancer.

OBJECTIVES: The prompt diagnosis of postoperative pulmonary embolism (PE) in gynecologic oncology patients is imperative, but the clinical presentation is nonspecific in this high-risk group. We sought to determine risk factors and clinical findings that may assist clinicians in diagnosing PE in the inpatient setting. METHODS: Radiology data were queried to identify patients with gynecologic cancer who had a postoperative PE evaluation with computed tomography pulmonary angiography (CT-PA). Patient clinical findings at the time of the PE evaluation were abstracted, and univariate and multivariate regression analyses were performed to identify predictors of PE. RESULTS: For 6 years, there were 2498 major gynecologic oncology surgical procedures performed at our institution. Within 14 days of surgery, 107 CT-PA studies were obtained with a positive study rate of 24.3%. In patients with and without PE, there was no significant difference noted for age, oxygen saturations, body mass index and heart rate. After controlling for stage, history of venous thromboembolism (VTE), heart rate, and oxygen saturation, platelet count (odds ratio, 1.26 per 50 counts increase; 95% confidence interval, 1.07-1.48; P = 0.006) and history of VTE (odds ratio, 17.1; 95% confidence interval, 1.77-Inf, P = 0.014) were identified as independent predictors of PE in the multivariate model. CONCLUSIONS: Although clinicians often use tachycardia and low oxygen saturation as triggers to order PE imaging studies, these signs have a very low specificity. Given the findings of our study, accounting for high platelet count and history of VTE increases the pretest probability of CT-PA study.

Intensive postoperative glucose control reduces the surgical site infection rates in gynecologic oncology patients.

OBJECTIVE: SSI rates after gynecologic oncology surgery vary from 5% to 35%, but are up to 45% in patients with diabetes mellitus (DM). Strict postoperative glucose control by insulin infusion has been shown to lower morbidity, but not specifically SSI rates. Our project studied continuous postoperative insulin infusion for 24h for gynecologic oncology patients with DM and hyperglycemia with a target blood glucose of <139 mL/dL and a primary outcome of the protocol's impact on SSI rates. METHODS: We compared SSI rates retrospectively among three groups. Group 1 was composed of patients with DM whose blood glucose was controlled with intermittent subcutaneous insulin injections. Group 2 was composed of patients with DM and postoperative hyperglycemia whose blood glucose was controlled by insulin infusion. Group 3 was composed of patients with neither DM nor hyperglycemia. We controlled for all relevant factors associated with SSI. RESULTS: We studied a total of 372 patients. Patients in Group 2 had an SSI rate of 26/135 (19%), similar to patients in Group 3 whose rate was 19/89 (21%). Both were significantly lower than the SSI rate (43/148, 29%) of patients in Group 1. This reduction of 35% is significant (p = 0.02). Multivariate analysis showed an odd ratio = 0.5 (0.28-0.91) in reducing SSI rates after instituting this protocol. CONCLUSIONS: Initiating intensive glycemic control for 24h after gynecologic oncology surgery in patients with DM and postoperative hyperglycemia lowers the SSI rate by 35% (OR = 0.5) compared to patients receiving intermittent sliding scale insulin and to a rate equivalent to non-diabetics.

Preoperative hypoalbuminemia is an independent predictor of poor perioperative outcomes in women undergoing open surgery for gynecologic malignancies.

OBJECTIVE: To quantify the impact of preoperative hypoalbuminemia on 30-day mortality and morbidity after gynecologic cancer surgery. METHODS: Patients included in the National Surgical Quality Improvement Program (NSQIP) dataset who underwent any non-emergent surgery for gynecologic malignancy between 1/1/2008 and 12/31/2010 were identified. Analysis was conducted with albumin both as a dichotomous variable (<3.5 g/dl was defined as low albumin) and as a continuous variable to determine a clinically relevant cut-off value. RESULTS: Of the total 3171 patients identified, 2110 had preoperative albumin levels available for analysis. In addition, 279 (13.3%) of these patients had low albumin levels. According to multivariate analysis, the low albumin group had significantly higher odds of developing one or more post-operative complications (OR-2,CI: 1.47-2.73, p<0.0001), three or more complications (OR-4.1,CI: 2.31-7.1, p<0.0001), surgical complications (OR-2.39,CI: 1.59-3.58, p<0.0001), thromboembolic complications (OR-2.59,CI: 1.33-5.06, p<0.0001), pulmonary complications (OR-4.06,CI: 2.05-8.03, p<0.0001), or infectious complications (OR-1.84,CI: 1.26-2.69, p<0.0001) and a higher 30-day mortality (OR-6.52,CI: 2.51-16.95, p<0.0001). Upon subgroup analysis, this difference was not found in patients undergoing laparoscopic surgery. In patients undergoing open surgery, the probability of experiencing one or more post-operative complications increased linearly with the decrease in albumin level; however, the probability of patients experiencing three or more complications and 30-day mortality increased sharply as soon as the albumin level decreased below 3g/dl. CONCLUSION: Preoperative albumin levels <3g/dL identify a population of patients at a very high-risk of experiencing perioperative morbidity and 30-day mortality after open surgery.

A new diagnostic test for endometrial cancer?: Cytology analysis of sonohysterography distention media.

OBJECTIVE: During saline-infused sonohysterography (SIS), the distension fluid is typically discarded. If cytology analysis could identify those patients with endometrial cancer, many women would be spared from further procedures. METHODS: Thirty consecutive patients with clinical stage I or II endometrial adenocarcinoma were prospectively recruited preoperatively. Saline-infused sonohysterography was performed by instilling 5 mL of saline, withdrawing and sending for analysis. Saline was reinfused until complete SIS images were obtained and sent separately for cytology. RESULTS: Of the 30 women enrolled, SIS was technically successful in 29. Demographics included mean age (60.5 ± 6.99 years), body mass index (35.55 ± 8.18 kg/m), endometrioid histology (76%), and grade (grade 1, 67%). Prestudy diagnostic method included biopsy (70%), dilatation and curettage (17%), and hysteroscopy (10%). Adequate cytology specimens were obtained in 66% of the 5 mL flushes and 72% of the complete SIS collections. Of adequate specimens, the sensitivities to detect endometrial cancer for the 5-mL, complete, and combined fluid samples were 26% (95% confidence interval, 9%-51%), 36% (17%-59%), and 42% (22%-63%). Sensitivity based on the whole study sample (N = 30) was 33% (17%-53%). Statistical significance was not found in the association between a positive test and age, body mass index, grade, diagnostic method, or volume instilled or aspirated. CONCLUSIONS: Most patients with early endometrial cancer can undergo SIS procedures with adequate cytology specimens obtained from distention media. However, the sensitivity is low, and refinements are necessary before utilizing as a diagnostic test. In cases with positive results, the patient may be able to avoid other costly and painful procedures.

Prolonged postoperative venous thrombo-embolism prophylaxis is cost-effective in advanced ovarian cancer patients.

OBJECTIVE: The purpose of this study was to investigate the cost-effectiveness of prolonged prophylaxis with enoxaparin in high-risk surgical patients with ovarian cancer. In addition, we sought to quantify the impact of prolonged prophylaxis (PP) on the incidence of venous thromboembolism (VTE), its related complications, and overall patient survival. METHODS: A Markov decision analytic model was used to estimate the costs, resource allocation and outcomes associated with the prolonged use of enoxaparin, for a total of four weeks after surgery, in patients undergoing primary debulking surgery for stage IIIC ovarian cancer. We estimated incremental cost per quality-adjusted life-year (QALY) at one and five year intervals; the estimated reduction in VTE episodes, bleeding episodes, and survival at the five year interval for a simulated cohort of 10,000 women. RESULTS: The incremental cost effectiveness ratio (ICER) for prolonged prophylaxis (PP) was $5236/QALY and $-1462/QALY at one and five years respectively. For patients receiving PP, the model estimated a 12% reduction in the clinically evident VTE episodes and a higher five-year survival (31.61% vs. 29.96%; p<0.0001). Resource allocation analysis reveals that 95% of initial investment cost of prolonged enoxaparin is recovered within one year. CONCLUSIONS: In ovarian cancer patients undergoing open abdominal surgery, prolonged VTE prophylaxis not only improves patient outcomes, but is also a cost saving strategy when modeled over five years. A significant reduction in the episodes of VTE and a higher overall survival warrants consideration for the routine use of PP in this patient population.