Impact of Sodium Thiosulfate on Prevention of Nephrotoxicities in HIPEC: An Ancillary Evaluation of Cisplatin-Induced Toxicities in Ovarian Cancer.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin confers a survival benefit in epithelial ovarian cancer (EOC) but is associated with renal toxicity. Sodium thiosulfate (ST) is used for nephroprotection for HIPEC with cisplatin, but standard HIPEC practices vary. METHODS: A prospective, nonrandomized, clinical trial evaluated safety outcomes of HIPEC with cisplatin 75 mg/m2 during cytoreductive surgery (CRS) in patients with EOC (n = 34) and endometrial cancer (n = 6). Twenty-one patients received no ST (nST), and 19 received ST. Adverse events (AEs) were reported according to CTCAE v.5.0. Serum creatinine (Cr) was collected preoperatively and postoperatively (Days 5-8). Progression-free survival (PFS) was followed. Normal peritoneum was biopsied before and after HIPEC for whole transcriptomic sequencing to identify RNAseq signatures correlating with AEs. RESULTS: Forty patients had HIPEC at the time of interval or secondary CRS. Renal toxicities in the nST group were 33% any grade AE and 9% grade 3 AEs. The ST group demonstrated no renal AEs. Median postoperative Cr in the nST group was 1.1 mg/dL and 0.5 mg/dL in the ST group (p = 0.0001). Median change in Cr from preoperative to postoperative levels were + 53% (nST) compared with - 9.6% (ST) (p = 0.003). PFS did not differ between the ST and nST groups in primary or recurrent EOC patients. Renal AEs were associated with downregulation of metabolic pathways and upregulation of immune pathways. CONCLUSIONS: ST significantly reduces acute renal toxicity associated with HIPEC with cisplatin in ovarian cancer patients. As nephrotoxicity is high in HIPEC with cisplatin, nephroprotective agents should be considered.

Integrative review of remote patient monitoring in gynecologic and urologic surgical oncology.

Patients with cancer facing complex and invasive urologic and gynecologic cancer surgery often experience symptoms and rapid declines in functional capacity postoperatively. Remote patient monitoring that leverages patient-generated health data is a potential approach to assess and promote postoperative recovery. This integrative review aims to provide an overview of the current literature and research on remote patient monitoring in gynecologic and urologic surgical oncology.

Paclitaxel, Carboplatin, and Bevacizumab in Advanced and Recurrent Endometrial Carcinoma.

OBJECTIVE: The aim of this study was to evaluate the efficacy of adding bevacizumab to paclitaxel and carboplatin and as maintenance in a larger cohort of patients with advanced or recurrent endometrial carcinoma. METHODS: We retrospectively identified endometrial cancer patients treated with paclitaxel (175 mg/m per 3 hours), carboplatin (area under the curve, 5) and bevacizumab (15 mg/kg) and maintenance bevacizumab treated in a post-protocol treatment cohort and evaluated them with our previously published phase 2 trial of this regimen. RESULTS: Twenty-seven additional patients were identified; 19 received the regimen as first-line therapy, and 8 received the regimen as second-line therapy after prior paclitaxel and carboplatin. The 19 patients who received first-line therapy were analyzed alone and with the 15 patients enrolled on protocol. The 2 cohorts were similar with respect to risk factors. Overall survival curves were not statistically different between the protocol and the postprotocol patients (log-rank test; P > 0.1). Collectively, a total of 266 courses (median, 6 courses; range, 1-20 courses) of carboplatin, paclitaxel, and bevacizumab combination therapy and 305 courses (median, 16 courses; range, 0-45courses) of bevacizumab maintenance therapy were administered as first-line therapy. Collectively, the median progression-free survival was 20 months, and median overall survival was 56 months. Among 29 patients with measurable disease, the response rate was 82.8% (95% confidence interval, 69.0%-96.5%; 15 complete responses and 9 partial responses). Among the 8 patients who received paclitaxel and carboplatin and bevacizumab as second-line therapy after paclitaxel and carboplatin, the response rate was 87.5% (6 complete responses, 1 partial response). Their median progression-free survival and median overall survival were not reached after a median follow-up of 23.5 months. CONCLUSIONS: Although there are inherent limitations to small retrospective studies, this second analysis confirms the high response rate, progression-free survival, and overall survival in the bevacizumab, paclitaxel, and carboplatin regimen as first-line therapy in advanced and recurrent endometrial carcinoma.

Impact of adjuvant chemotherapy and pelvic radiation on pattern of recurrence and outcome in stage I non-invasive uterine papillary serous carcinoma. A multi-institution study.

OBJECTIVES: To determine the impact of adjuvant chemotherapy or pelvic radiation on risk of recurrence and outcome in stage IA non-invasive uterine papillary serous carcinoma (UPSC). METHODS: This is a multi-institutional retrospective study for 115 patients with stage IA non-invasive UPSC (confined to endometrium) treated between 2000 and 2012. Kaplan-Meier and multivariable Cox proportional hazards regression modeling were used. RESULTS: Staging lymphadenectomy and omentectomy were performed in 84% and 57% respectively. Recurrence was seen in 26% (30/115). Sites of recurrences were vaginal in 7.8% (9/115), pelvic in 3.5% (4/115) and extra-pelvic in 14.7% (17/115). Adjuvant chemotherapy did not impact risk of recurrence (25.5% vs. 26.9%, p=0.85) even in subset of patients who underwent lymphadenectomy (20% vs. 23.5%, p=0.80). These findings were consistent for pattern of recurrence. Among those who underwent lymphadenectomy, adjuvant chemotherapy did not impact progression-free survival (p=0.34) and overall survival (p=0.12). However among patients who did not have lymphadenectomy, adjuvant chemotherapy or pelvic radiation was associated with longer progression-free survival (p=0.04) and overall survival (p=0.025). In multivariable analysis, only staging lymphadenectomy was associated with improved progression-free survival (HR 0.34, 95% CI 0.12-0.95, p=0.04) and overall survival (HR 0.35, 95% CI 0.12-1.0, p=0.05). Neither adjuvant chemotherapy nor pelvic radiation were predictors of progression-free or overall survivals. CONCLUSION: In stage IA non-invasive UPSC, staging lymphadenectomy was significantly associated with recurrence and outcome and therefore, should be performed in all patients. Adjuvant chemotherapy or pelvic radiation had no impact on outcome in surgically staged patients but was associated with improved outcome in unstaged patients.

Racial disparity in 30-day morbidity and mortality after surgery for ovarian cancer.

BACKGROUND: The improved survival observed in recent years for women with ovarian cancer (OC) has not been realized among African American (AA) compared with white (W) women. The contribution of immediate postoperative morbidity and mortality to this survival disparity remains unclear. This study aims to examine disparities in postoperative 30-day morbidity and mortality between AA and W women with OC. MATERIALS AND METHODS: Patients with OC were identified from the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) 2005 to 2011. African American and subgroups were studied. Multivariable logistic regression models were performed. RESULTS: Of 1649 women, 1510 (92%) were W and 139 (8%) were AA. The rate of 30-day postoperative complications and mortality among the entire cohort were 30% and 2%, respectively. No differences in postoperative complications were noted between AA and W women (33% vs 30%, P = 0.47) including surgical (29% vs 26%, P = 0.40) and nonsurgical (10% vs 9%, P = 0.75) complications. The mean length of hospital stay was longer in AA women, but there was no difference in surgical re-exploration and operative time. No difference in 30-day mortality was found between AA and W women (3% vs 2%, P = 0.45). African Americans were younger and more likely to be obese, have diabetes, hypertension, preoperative weight loss, higher serum creatinine level greater than or equal to 2 mg/dL, hypoalbuminemia, and anemia. After adjusting for surgical complexity and associated comorbidities, AA race was not an independent predictor of 30-day postoperative complications (odds ratio, 0.99; 95% confidence interval [CI], 0.65-1.5; P = 0.96) or mortality (odds ratio, 0.89; 95% confidence interval, 0.25-2.43; P = 0.83). CONCLUSIONS: African American race was not an independent predictor of poor 30-day outcomes. Interestingly, AAs with OC are underrepresented in quality-seeking hospitals. Efforts to minimize this racial disparity should target optimization of comorbidities and improving access to high-volume centers for AA women.

Postoperative Complications After Distal Pancreatectomy Performed During Cytoreductive Surgery for Gynecologic Malignancies.

OBJECTIVES: To investigate the incidence of pancreatic leak and other postoperative complications after distal pancreatectomy performed during debulking surgery for gynecologic malignancies. METHODS: All patients who underwent distal pancreatectomy during their debulking surgery from 2010 to 2014 were identified. Postoperative complications within 30 days and pancreatic leak within 120 days after surgery were included. RESULTS: Eighteen patients met the inclusion criteria. The median age was 62 years (36-78 years). Four patients (22%) were admitted to the intensive care unit, and the average length of hospital stay was 10 days. Nine patients developed postoperative complications within 30 days after surgery (50%) with no perioperative mortality up to 90 days after surgery. No patients required reexploration. The median time from surgery to initiation of chemotherapy was 39.5 days. Two patients developed pancreatic leak (11%). Among the patients who developed pancreatic leak, the average length of hospital stay was 11.5 days and time to initiation of chemotherapy was 75 days. Conservative management was successful in both cases. CONCLUSION: In this series, the rate of pancreatic leak was lower than previously reported with no perioperative mortality or surgical reexploration. However, the time to initiation of chemotherapy was delayed in those who developed pancreatic leak. These data are important in patient counseling and decision making at the time of debulking surgery. Gynecologic oncologists considering distal pancreatectomy should be familiar with perioperative management of these patients.

The impact of obesity on the 30-day morbidity and mortality after surgery for endometrial cancer.

STUDY OBJECTIVES: To examine the effect of body mass index (BMI) on postoperative 30-day morbidity and mortality after surgery to treat endometrial cancer. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: National Surgical Quality Improvement Program. PATIENTS: Patients with endometrial cancer who underwent surgery from 2005 to 2011. INTERVENTIONS: Women were grouped according to weight, as follows: normal weight (BMI 18 to <30), obese (BMI 30 to <40), and morbidly obese (BMI ≥ 40). Univariate and multivariable logistic regression models were analyzed. MEASUREMENTS AND MAIN RESULTS: Of 3947 patients, 38% were of normal weight, 38% were obese, and 24% were morbidly obese. Of these, 48% underwent laparoscopy and 52% underwent laparotomy. Overall 30-day morbidity and mortality were 13% and 0.7%, respectively. Obesity and morbid obesity were associated with a higher American Society of Anesthesiologists class, diabetes, and hypertension. Preoperatively, elevated serum creatinine concentration, hypoalbuminemia, and leukocytosis were more common in morbidly obese women than those of normal weight. Laparoscopic surgery was performed less frequently in morbidly obese women than in those of normal weight (42.5% vs 50%; p = .001). Morbidly obese patients were more likely to develop postoperative complications (morbidly obese 16% vs normal weight 13% vs obese 11%; p = .001), in particular surgical (morbidly obese 14% vs normal weight 11% vs obese 9%; p < .001) and infectious complications (morbidly obese 10% vs normal weight 5% vs obese 5%; p = .01). After laparotomy, morbidly obese women demonstrated a higher rate of any complication (normal weight 21%, obese 18%, morbidly obese 25%; p = .002), surgical complications (normal weight 18%, obese 14%, morbidly obese 22%; p = .002) and infectious complications (normal weight 6%, obese 10%, morbidly obese 16%; p < .001). After laparoscopy there was no difference in complication rates according to BMI group. The 30-day mortality was not significantly different according to BMI. After adjusting for confounders, obesity and morbid obesity did not independently predict 30-day morbidity or mortality. CONCLUSIONS: Morbidly obese patients with endometrial cancer have more preoperative morbidities and postoperative complications, in particular surgical and infectious complications, and are less likely to undergo minimally invasive surgery. However, obesity was not an independent predictor of perioperative outcomes after controlling for other confounders.

Tumor size is an independent predictor of lymph node metastasis and survival in early stage endometrioid endometrial cancer.

OBJECTIVE(S): To analyze the impact of tumor size (TS) on risk of lymph node metastasis (PLN) and prognosis in endometrioid endometrial cancer grossly confined to the uterus (EEC). METHOD(S): Patients with EEC grossly confined to the uterus were identified from Surveillance, Epidemiology, and End Results dataset from 1988 to 2007. Only surgically treated patients were included. TS was analyzed as a continuous and categorical variable (TS ≤ 2 cm, >2-5 cm and >5 cm). Multivariable logistic regression and Cox proportional hazards models were used. RESULT(S): 19,692 patients met the inclusion criteria. In patients with TS ≤ 2 cm, only 2.7 % (88/3,244) had PLN; this increased to 5.8 % (372/6,355) with TS > 2-5 cm and 11.1 % (195/1,745) with TS > 5 cm. The odds of PLN increased by 14 % for each 1 cm increase in TS after controlling for age, race, depth of myometrial invasion and grade (HR 1.14, 95 % CI 1.10-1.19, p < 0.001). Further, TS was an independent predictor of disease-specific survival (DSS) even after adjusting for age, race, grade, depth of myometrial invasion, lymph node status and adjuvant radiation therapy (HR 1.13 for each 1 cm increment in TS, 95 % 1.08-1.18, p < 0.001). In multivariable analysis, larger TS (>5 cm) was significantly associated with worse DSS (HR 2.09, 95 % 1.31-3.35, p = 0.002); however, there was no significant difference between TS > 2-5 cm versus ≤2 cm (HR 1.25, 95 % 0.85-1.83, p = 0.25). The impact of TS remained significant on DSS in subset of patients who underwent lymphadenectomy with negative lymph nodes. CONCLUSION(S): TS was an independent predictor of lymph node metastasis and disease-specific survival in patients with EEC grossly confined to the uterus. Tumor >5 cm was a predictor of disease-specific survival but no difference in outcome was noted between tumor >2-5 cm and tumor ≤2 cm.

The efficacy of neoadjuvant chemotherapy in different histological types of cervical cancer.

OBJECTIVE: To determine whether the efficacy of neoadjuvant chemotherapy (NACT) is different among cervical cancer types, squamous cell carcinoma (SCC) and non-SCC, including adenocarcinoma of the cervix (ACC) and adenosquamous carcinoma (ASC). METHODS: We searched PubMed, MEDLINE, ScienceDirect, Springerlink and CNKI for studies published between Jan 1987 and Sep 2012 and evaluated the studies published in English and Chinese on NACT and cervical carcinoma based on specific inclusion and exclusion criteria. Because there was a relative lack of relevant randomized controlled trials (RCTs), we included 2 RCTs and 9 observational studies in our analysis. Meta-analysis was applied to calculate the efficacy of NACT in different histological types of cervical cancer with 95% confidence intervals. The risk of bias was assessed by Begg's adjusted rank correlation test and Egger's regression asymmetry tests. RESULTS: As many as 11 articles, 2 RCTs and 9 observational studies, were selected according to the eligibility criteria for a total of 1559 participants. For the short-term efficacy of NACT, either in terms of CR+PR or CR only, there was no difference between SCC and non-SCC when the data were pooled (P>0.05) in stratified studies based on the International Federation of Gynecology and Obstetrics (FIGO) stage (P>0.05) or histological type (P>0.05) or in observational studies (P>0.05). Nevertheless, SCC was associated with a higher short-term response rate than non-SCC in RCTs [6.57 (95%CI 1.72-25.12) in CR+PR]. For the long-term outcome of NACT, patients with SCC experienced a significant 5-year overall survival (OS) and progress-free survival (PFS) when compared to patients with non-SCC in pooled [1.47 (95%CI 1.06-2.06)] and observational studies [1.96 (95%CI 1.61-2.38)] other than RCTs (P>0.05). Moreover, this difference was especially obvious when the subgroup analysis was restricted to patients in stages above IIB [2.06 (95%CI 1.79-2.36)] rather than in stages IB-IIB [1.33 (95%CI 0.99-1.79)]. CONCLUSION: Although no significant differences exist in the short-term efficacy of NACT, the histological type may be used to predict the long-term efficacy of NACT in patients with cervical cancer, especially those with FIGO stages above IIB.

Racial disparity in the 30-day morbidity and mortality after surgery for endometrial cancer.

OBJECTIVES: To examine postoperative 30-day morbidity and mortality in African American (AA) compared to white patients (W) with endometrial cancer (EC). METHODS: Patients with EC were identified from the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2011. AA and W subgroups were studied. Multivariable logistic regression models were performed. RESULTS: Of 3248 patients, 2899 (89%) W and 349 (11%) AA were identified. AA were more likely to have diabetes, hypertension, ascites, neurologic morbidities, weight loss, non-independent functional status, higher ASA class, higher serum creatinine ≥ 2 mg/dl, hypoalbuminemia and anemia. Laparoscopic surgery was performed less frequently in AA than W (41.4% vs. 50.3%, p<0.001). AA had a significantly higher risk of postoperative complications than W (21% vs. 12%, p<0.001) including surgical (17% vs. 10%, p<0.001) and non-surgical complications (7% vs. 4%, p=0.022). Mean length of hospital stay and operative time were longer in AA than W but there was no difference in surgical re-exploration. In multivariable model after adjustment for confounders including surgical complexity and associated morbidities, AA race was not an independent predictor of "any postoperative complications" for both laparotomy group (OR 1.1, 95% CI 0.73-1.61, p=0.65) and laparoscopic group (OR 1.43, 95% CI 0.80-2.45, p=0.21). No difference in 30-day mortality was found between AA and W (1% vs. 1%, p=0.11). CONCLUSIONS: AA patients with EC have more preoperative morbidities, postoperative complications and were less likely to undergo minimally invasive surgery. However, AA race was not an independent predictor of poor 30-day outcomes after controlling for other confounders.

Type II endometrial cancer in Hispanic women: tumor characteristics, treatment and survival compared to non-Hispanic white women.

OBJECTIVES: To compare survival of Hispanic white (HW) and non-Hispanic white (NHW) women with type II endometrial adenocarcinoma (EC). METHODS: Patients with serous, clear cell or grade 3 endometrioid EC were identified from the Surveillance, Epidemiology, and End Results (SEER) program 1988-2009 and were divided into HW and NHW. HW were subdivided into natives and immigrants. RESULTS: Of the 14,434 women, 13,012 (90.2%) were NHW and 1422 (9.8%) were HW. HW were younger than NHW (mean 63 vs. 68years, p<0.001). A higher proportion of HW presented with late stage disease than NHW (43.8% vs. 36.6%, p=0.04). Performing lymphadenectomy was not different but HW were more likely to have positive lymph nodes than NHW (27.6% vs. 23.1%, p=0.02). Further, HW were less likely to receive radiation than NHW (39.5% vs. 42.3%, p=0.04). No difference in clinicopathologic characteristics was found between immigrant and native HW. In multivariate models adjusting for age, stage, histology, surgical treatment, extent of lymphadenectomy, and radiation therapy, no difference in overall survival (OS) (HR 1.06, 95% CI 0.97-1.16, p=0.19) and cancer-specific survival (CSS) (HR 1.02, 95% CI 0.91-1.14, p=0.75) was found between HW and NHW. Interestingly, immigrant HW had better OS (HR 0.74, 95% CI 0.62-0.89, p<0.001) and CSS (HR 0.72, 95% CI 0.58-0.90, P=0.003) than native HW. CONCLUSIONS: Although they were more likely to present with advanced stage and positive nodal disease, no difference in outcome was noted between Hispanic and non-Hispanic whites with EC. Interestingly, immigrant HW had more favorable outcome compared to native HW.

Endometrial cancer in Asian and American Indian/Alaskan Native women: tumor characteristics, treatment and outcome compared to non-Hispanic white women.

OBJECTIVE: The objective of this study is to compare survival of Asian (AS), American Indian/Alaskan Native (AI/AN) and non-Hispanic white (NHW) women with endometrial adenocarcinoma (EC). METHODS: Patients with EC were identified from the Surveillance, Epidemiology, and End Results program from 1988 to 2009. Kaplan-Meier survival methods and Cox proportional hazards regression were performed. RESULTS: Of the 105,083 women, 97,763 (93%) were NHW, 6699 (6.4%) were AS and 621 (0.6%) were AI/AN. AS and AI/AN were younger than NHW with mean age of 57.7 and 56.5 vs. 64.3 years (p < 0.001 and 0.059). Advanced stage and high-risk histology were more prominent in AS than NHW (15.6% vs. 13.3%, p = 0.04, 10.6% vs. 9.6%, p= 0.041). Lymphadenectomy was performed more frequently in AS than NHW (56.7% vs. 48.2%, p < 0.001). Asian immigrants were younger than Asian natives (mean age 57 vs. 60.5 years, p < 0.001). In multivariate analysis, AS had better overall (OS) (HR 0.86, 95% CI 0.81-0.91, p < 0.001) and cancer-specific survival (CSS) (HR 0.92, 95% CI 0.84-1.00, p = 0.05) than NHW. Further, Asian immigrants had better OS (HR 0.83, 95% CI 0.73-0.94, p = 0.002) and CSS (HR 0.66, 95% CI 0.54-0.80, p < 0.001) than Asian natives. In contrast, AI/AN had worse OS (HR 1.35, 95% CI 1.15-1.59, p < 0.001) but no difference in CSS (HR 1.06, 95% CI 0.80-1.40, p = 0.69) than NHW. CONCLUSIONS: Asians were younger at presentation, more likely to have lymphadenectomy and had an improved outcome compared to NHW. Interestingly, Asian immigrants had more favorable outcome than Asians born in the US. Further studies are warranted to find possible explanations for such a difference.

Surgical site infection in women undergoing surgery for gynecologic cancer.

OBJECTIVES: The objectives of this study were to describe the rate and predictors of surgical site infection (SSI) after gynecologic cancer surgery and identify any association between SSI and postoperative outcome. MATERIALS AND METHODS: Patients with endometrial, cervical, or ovarian cancers from 2005 to 2011 were identified from the American College of Surgeons National Surgical Quality Improvement Program. The extent of surgical intervention was categorized into modified surgical complexity scoring (MSCS) system. Univariate and multivariate logistic regression analyses were used. Odds ratios were adjusted for patient demographics, comorbidities, preoperative laboratory values, and operative factors. RESULTS: Of 6854 patients, 369 (5.4%) were diagnosed with SSI. Surgical site infection after laparotomy was 3.5 times higher compared with minimally invasive surgery (7% vs 2%; P < 0.001). Among laparotomy group, independent predictors of SSI included endometrial cancer diagnosis, obesity, ascites, preoperative anemia, American Society of Anesthesiologists class greater than or equal to 3, MSCS greater than or equal to 3, and perioperative blood transfusion. Among laparoscopic cases, independent predictors of SSI included only preoperative leukocytosis and overweight. For patients with deep or organ space SSI, significant predictors included hypoalbuminemia, preoperative weight loss, respiratory comorbidities, MSCS greater than 4, and perioperative blood transfusion for laparotomy and only preoperative leukocytosis for minimally invasive surgery. Surgical site infection was associated with longer mean hospital stay and higher rate of reoperation, sepsis, and wound dehiscence. Surgical site infection was not associated with increased risk of acute renal failure or 30-day mortality. These findings were consistent in subset of patients with deep or organ space SSI. CONCLUSIONS: Seven percent of patients undergoing laparotomy for gynecologic malignancy developed SSI. Surgical site infection is associated with longer hospital stay and more than 5-fold increased risk of reoperation. In this study, we identified several risk factors for developing SSI among gynecologic cancer patients. These findings may contribute toward identification of patients at risk for SSI and the development of strategies to reduce SSI rate and potentially reduce the cost of care in gynecologic cancer surgery.

Predictors of surgical site infection in women undergoing hysterectomy for benign gynecologic disease: a multicenter analysis using the national surgical quality improvement program data.

STUDY OBJECTIVE: To estimate the rate and predictors of surgical site infection (SSI) after hysterectomy performed for benign indications and to identify any association between SSI and other postoperative complications. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: National Surgical Quality Improvement Program data. PATIENTS: Women who underwent abdominal or laparoscopic hysterectomy performed for benign indications from 2005 to 2011. INTERVENTIONS: Univariable and multivariable logistic regression analyses were used to identify predictors of SSI and its association with other postoperative complications. Odds ratios were adjusted for patient demographic data, comorbidities, preoperative laboratory values, and operative factors. MEASUREMENTS AND MAIN RESULTS: Of 28 366 patients, 758 (3%) were diagnosed with SSI. SSI occurred more often after abdominal than laparoscopic hysterectomy (4% vs 2%; p < .001). Among patients who underwent abdominal hysterectomy, predictors of SSI included diabetes, smoking, respiratory comorbidities, overweight or obesity, American Society of Anesthesiologists class ≥ 3, perioperative blood transfusion, and operative time >180 minutes. Among those who underwent laparoscopic hysterectomy, predictors of SSI included perioperative blood transfusion, operative time >180 minutes, serum creatinine concentration ≥ 2 mg/dL, and platelet count ≥ 350 000 cells/mL(3). For patients with deep or organ/space SSI, significant predictors included perioperative blood transfusion and American Society of Anesthesiologists class ≥ 3 for abdominal hysterectomy, and non-white race, renal comorbidities, preoperative or perioperative blood transfusion, and operative time >180 minutes for laparoscopic hysterectomy. SSI was associated with longer hospital stay and higher rates of repeat operation, sepsis, renal failure, and wound dehiscence. SSI was not associated with increased 30-day mortality. CONCLUSIONS: SSI occurred more often after abdominal hysterectomy than laparoscopic hysterectomy performed to treat benign gynecologic disease. SSI was associated with increased postoperative complications but not mortality. Several risk factors for SSI after each abdominal and laparoscopic hysterectomy were identified in this study.

Prevalence and prognostic impact of lymphadenectomy and lymph node metastasis in clinically early-stage ovarian clear cell carcinoma.

OBJECTIVES: The objective of this study was to estimate the prevalence and prognostic impact of lymphadenectomy and lymph node involvement in patients with ovarian clear cell carcinoma (OCCC) grossly confined to the ovary. METHODS: Patients with a diagnosis of OCCC grossly confined to the ovary were identified from Surveillance, Epidemiology, and End Results program from 1988 to 2007. Only surgically treated patients were included. Statistical analysis using Student t test, Kaplan-Meier survival methods, and Cox proportional hazards regression were performed. RESULTS: One thousand eight hundred ninety-seven patients with OCCC who have undergone surgical treatment and deemed at time of the surgery to have disease grossly confined to the ovary were included: 538 (28.3%) had no lymphadenectomy (LND -1), and 1359 (71.7%) had lymphadenectomy. Of the 1359 patients who had lymphadenectomy, 1298 (95.5%) were International Federation of Gynecology and Obstetrics (FIGO) surgical stage I (LND +1), and 61 (4.5%) were upstaged to FIGO stage IIIC due to nodal metastasis (LND +3C). The 5-year disease-specific survival was 84.9% for LND -1, 88.0% for LND +1, and 65.0% for LND +3C (P < 0.001). Among those with histologically negative lymph nodes, the 5-year disease-specific survival was 85% for patients with 1 to 10 nodes removed, and 91% for those with more than 10 nodes removed (P = 0.054). On multivariate analysis after controlling for stage, age, and race, lymph node metastasis was an independent predictor of poor disease-specific survival (hazard ratio, 3.1; 95% confidence interval, 1.86-5.28; P < 0.001). On other hand, there was a trend toward an improved survival when more extensive lymphadenectomy is performed in patients with histologically negative nodes (1-10 vs >10 nodes), but it did not reach statistical significance (hazard ratio, 0.71; 95% confidence interval, 0.49-1.02; P = 0.064). CONCLUSIONS: Lymph node metastasis was uncommon in patients diagnosed with OCCC grossly confined to the ovary; however, patients with positive nodes were more likely to die compared to those with negative nodes. More extensive lymphadenectomy plays an important role in providing accurate staging and prognostic information.

Hyperthermic Intraperitoneal Chemotherapy-Induced Molecular Changes in Humans Validate Preclinical Data in Ovarian Cancer.

PURPOSE: Hyperthermic intraperitoneal chemotherapy (HIPEC) confers a survival benefit in epithelial ovarian cancer (EOC) and in preclinical models. However, the molecular changes induced by HIPEC have not been corroborated in humans. PATIENTS AND METHODS: A feasibility trial evaluated clinical and safety outcomes of HIPEC with cisplatin during optimal cytoreductive surgery (CRS) in patients with EOC diagnosed with stage III, IV, or recurrent EOC. Pre- and post-HIPEC biopsies were comprehensively profiled with genomic and transcriptomic sequencing to identify mutational and RNAseq signatures correlating with response; the tumor microenvironment was profiled to identify potential immune biomarkers; and transcriptional signatures of tumors and normal samples before and after HIPEC were compared to investigate HIPEC-induced acute transcriptional changes. RESULTS: Thirty-five patients had HIPEC at the time of optimal CRS; all patients had optimal CRS. The median progression-free survival (PFS) was 24.7 months for primary patients and 22.4 for recurrent patients. There were no grade 4 or 5 adverse events. Anemia was the most common grade 3 adverse event (43%). Hierarchical cluster analyses identified distinct transcriptomic signatures of good versus poor responders to HIPEC correlating with a PFS of 29.9 versus 7.3 months, respectively. Among good responders, significant HIPEC-induced molecular changes included immune pathway upregulation and DNA repair pathway downregulation. Within cancer islands, % programmed cell death protein 1 expression in CD8+ T cells significantly increased after HIPEC. An exceptional responder (PFS 58 months) demonstrated the highest programmed cell death protein 1 increase. Heat shock proteins comprised the top differentially upregulated genes in HIPEC-treated tumors. CONCLUSION: Distinct transcriptomic signatures identify responders to HIPEC, and preclinical model findings are confirmed for the first time in a human cohort.

Evaluation of a novel single-port robotic platform in the cadaver model for the performance of various procedures in gynecologic oncology.

OBJECTIVES: The purpose of this protocol was to evaluate the feasibility and reproducibility of a dedicated da Vinci® single-port robotic platform in cadavers for the performance of various gynecologic oncology procedures. METHODS: Three fresh frozen female cadavers were used to evaluate the feasibility, reproducibility, and to develop the correct docking of the robotic column and trocars. Procedures performed in this training protocol included (hysterectomy, bilateral salpingo-oophorectomy, modified radical hysterectomy, six pelvic lymph node dissections, and one para-aortic node dissection). A data set was collected for each procedure, operative times were compared between cases and procedures by use of Wilcoxon rank sum test, a p-value <0.05 was considered significant. RESULTS: All the procedures were technically successful with no need of additional ports or conversions to a standard laparoscopy. The median time of port insertion and BMI was 6 min range (4-10) and 33 min range (25-56) respectively. The median time for a left and right pelvic lymph node dissection was 22 min range (22-23) and 28 min range (26-38) respectively. There was significant difference in operating times for symmetrical procedures (pelvic lymphadenectomy), p=0.049. CONCLUSION: This preliminary data demonstrates that the performance of various oncology procedures using the new da Vinci® single-site robotic platform is feasible, and more importantly, reproducible in the cadaver model.

A comparative study of two root-coverage techniques with regard to interdental papilla dimension as a prognostic factor.

This study was designed to evaluate the effectiveness of subepithelial connective tissue graft (SCTG) and acellular dermal matrix allograft (ADMA) in root coverage procedures and to examine the effect of interdental papilla dimensions on the outcome of root coverage using a new approach. This randomized controlled clinical study included 32 gingival recession defects of at least 2 mm classified as Miller Class I or II. Clinical parameters were measured at baseline and 6, 12, and 24 weeks postsurgery. At baseline, all measured clinical parameters were statistically equivalent between the two groups. With regard to the amount of mean root coverage, no significant difference was found between ADMA (85.42%) and SCTG (69.05%) groups. However, the percentage of complete root coverage was significantly greater in the ADMA group (75.0%, versus 31.3% in the SCTG group). Significant positive correlations were found between papilla height and papilla width and mean root coverage, and papilla height of at least 5 mm was associated with complete root coverage. ADMA seems to be a good substitute for SCTG to treat shallow to moderate gingival recessions. In addition, papilla dimensions, as measured using the new method, can help predict the success of future root coverage.

Prognostic impact of lymphadenectomy in uterine clear cell carcinoma.

OBJECTIVE: The aim of this study was to estimate the survival impact of lymphadenectomy in patients diagnosed with uterine clear cell cancer (UCCC). METHODS: Patients with a diagnosis of UCCC were identified from Surveillance, Epidemiology, and End Results (SEER) program from 1988 to 2007. Only surgically treated patients were included. Statistical analysis using Student t-test, Kaplan-Meier survival methods, and Cox proportional hazard regression were performed. RESULTS: One thousand three hundred eighty-five patients met the inclusion criteria; 955 patients (68.9%) underwent lymphadenectomy. Older patients (≥65) were less likely to undergo lymphadenectomy compared with their younger cohorts (64.3% vs. 75.9%, p<0.001). The prevalence of nodal metastasis was 24.8%. Out of 724 women who had disease clinically confined to the uterus and underwent lymphadenectomy, 123 (17%) were found to have nodal metastasis. Lymphadenectomy was associated with improved survival. Patients who underwent lymphadenectomy were 39% (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.52 to 0.72; p<0.001) less likely to die than patient who did not have the procedure. Moreover, more extensive lymphadenectomy correlated positively with survival. Compared to patients with 0 nodes removed, patients with more extensive lymphadenectomy (1 to 10 and >10 nodes removed) were 32% (HR, 0.68; 95% CI, 0.56 to 0.83; p<0.001) and 47% (HR, 0.53; 95% CI, 0.43 to 0.65; p<0.001) less likely to die, respectively. CONCLUSION: The extent of lymphadenectomy is associated with an improved survival of patients diagnosed with UCCC.

Peripartum robotic-assisted laparoscopic hysterectomy after second-trimester pregnancy loss with placenta increta.

BACKGROUND: Peripartum hysterectomy is performed for a variety of indications, including abnormal placentation, retained placenta, uterine rupture, and uterine atony. Most cases are emergent and performed through open laparotomy. CASE: At 20 weeks of gestation, a patient with previous endometrial ablation had ruptured membranes and delivered her fetus but not her placenta. She was hemodynamically stable and underwent robotic hysterectomy. Surgical pathology confirmed placenta increta. CONCLUSION: In appropriate patients, a minimally invasive approach may be considered for peripartum hysterectomy to potentially decrease maternal morbidity.