Assessment of wound perfusion with near-infrared angiography: A prospective feasibility study.

OBJECTIVE: To assess the feasibility of quantitatively measuring skin perfusion before and after suture or staple skin closure of vertical laparotomies using indocyanine green (ICG) uptake with near-infrared angiography. METHODS: This was a prospective, non-randomized feasibility study of patients undergoing surgery with a gynecologic oncology service from 2/2018-8/2019. Feasibility was defined as the ability to quantitatively measure ICG uptake adjacent to the wound at the time of skin closure in ≥ 80% of patients. Patients were assigned suture or staple skin closure in a sequential, non-randomized fashion. Skin perfusion was recorded using a near-infrared imaging system after ICG injection and measured by video analysis at predefined points before and after skin closure. Clinicodemographic, pre- and intraoperative details, and surgical secondary events were recorded. RESULTS: Of 20 participants, 10 were assigned staple closure and 10 suture closure. Two patients (10%) achieved objective quantification of ICG fluorescence before and after laparotomy closure, failing the predefined feasibility threshold of ≥ 80%. Reasons for failed quantification included overexposure (12), insufficient ICG signal uptake (6), and insufficient video quality (2). Near-infrared angiography wound perfusion was subjectively appreciated intraoperatively in 85% (17/20) of patients before and after wound closure. CONCLUSIONS: Objective assessment of laparotomy skin closure with near-infrared angiography-measured perfusion did not meet the pre-specified feasibility threshold. Adjustments to the protocol to minimize overexposure may be warranted. The ability to subjectively appreciate ICG perfusion with near-infrared angiography suggests a possible role for near-infrared angiography in the real-time intraoperative assessment of wound perfusion, particularly in high-risk patients.

Outcomes of incidentally detected ovarian cancers diagnosed at time of risk-reducing salpingo-oophorectomy in BRCA mutation carriers.

OBJECTIVE: Prior data suggested that women with incidentally detected occult invasive ovarian cancer (OIOC) at the time of risk-reducing salpingo-oophorectomy (RRSO) for BRCA mutation may have poorer prognoses than would be expected based on disease stage. We sought to evaluate prevalence and outcomes of patients with OIOC in a tertiary referral center. METHODS: Patients with BRCA mutation undergoing RRSO from 01/2005 to 05/2017 were identified, and their records reviewed. Women with incidentally detected OIOC were included; those with clinical features raising preoperative suspicion for malignancy were excluded. RESULTS: 548 patients with BRCA mutation who underwent RRSO were identified. 26 (4.7%) had an OIOC (median age 55 years; range 42-75); 15(58%) patients, BRCA1; 9(34%), BRCA2; 2(8%) had a mutation in both genes. All OIOCs were high-grade serous: 10 (38%) Stage I; 8 (31%) Stage II; 8(31%) Stage III. 24(92%) patients received adjuvant platinum/taxane therapy. Of Stage III patients, 4 (50%) were identified intraoperatively; the remaining 4 (50%) had microscopic nodal disease on final pathology only. At median follow-up of 67.3 months (28-166) no Stage I patients have recurred; 2 Stage II and 6 Stage III patients recurred. 5-year progression-free survival (PFS) was 72% (95%CI, 50.2-85.7%); median PFS for the cohort was 129 months (95%CI, 75.3-not estimable). 5-year disease-specific survival (DSS) was 96% (95%CI, 76-99%); median DSS not reached. CONCLUSION: Consistent with prior reports, almost 5% of patients had an OIOC at RRSO. The majority with early-stage disease had excellent PFS and DSS outcomes, as would be expected based on disease stage.

Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial.

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.

Genomic Alterations as Potential Therapeutic Targets in Extramammary Paget's Disease of the Vulva.

PURPOSE: To identify genomic alterations as potential therapeutic targets in extramammary Paget disease (EMPD) of the vulva. METHODS: We identified all patients with primary vulvar EMPD who were treated at our institution and underwent paired tumor-normal massively parallel sequencing of 410-468 cancer-related genes (MSK-IMPACT assay). EMPD of the vulva samples sequenced from 2014 to 2019 were reviewed and somatic mutations identified, with specific focus on mutations of potential therapeutic targets. Clinical data were abstracted from electronic medical records. Microsatellite instability (MSI) was assessed by MSIscore. RESULTS: Tumors of 26 patients with EMPD underwent genomic sequencing. At diagnosis, all patients had noninvasive or microinvasive (< 1 mm) disease; invasive disease eventually developed in 2 patients. Primary treatment was surgery for 19 patients (73%) and imiquimod topical therapy for 7 (27%). Seven patients had ≥ 2 surgeries as part of clinical course (1 patient had 5 vulvar resections). Samples had a median of 2 coding mutations in the genes analyzed (range, 0-29). The most common mutations were in PIK3CA (n = 9; 35%), ERBB2 (4 mutations and 3 copy number alterations; 27%), and TP53 (n = 7; 27%). MSIscore was available for 23 samples; all were microsatellite stable. After tumor genomic profiling, a patient who was initially treated with multiple resections and imiquimod was found to have a PIK3CA p.E542K mutation. She underwent PI3K-inhibitor treatment for 18 months before disease progression. CONCLUSION: EMPD of the vulva has a chronic and relapsing course, often requiring multiple surgical resections. Effective topical treatments are lacking. We identified targetable mutations (PIK3CA or ERBB2) in > 25% of a real-world clinical cohort. Additional prospective research implementing targetable therapies for EMPD treatment is warranted.

Impact of provider volume on front-line chemotherapy guideline compliance and overall survival in elderly patients with advanced ovarian cancer.

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.

Hematologic changes after splenectomy for ovarian cancer debulking surgery, and association with infection and venous thromboembolism.

INTRODUCTION: The spleen plays a role in the immune and coagulative responses, yet a splenectomy may be required during ovarian cancer surgery to achieve complete cytoreduction. The aim of the study was to correlate hematologic changes with the development of infection and venous thromboembolism in patients undergoing splenectomy. METHODS: This single-institution retrospective review includes all patients undergoing splenectomy during cytoreductive surgery for advanced ovarian cancer, March 2001 to December 2016. We compared postoperative hematologic changes (evaluated daily before discharge) in patients developing infection within 30 days' post-surgery (Infection group) with those who did not (No-Infection group). We also compared patients developing venous thromboembolism with those without. RESULTS: A total of 265 patients underwent splenectomy. Median age was 64 years (range 22-88): 146 (55%) patients had stage IIIC and 114 (43%) patients had stage IV. The majority, 201 (76%) patients underwent splenectomy during primary debulking. A total of 132 (50%) patients comprised the Infection group (most common: urinary tract infection, 54%). Median time from surgery to infection was 8 days (range, 0-29). After initial rise in white blood cell count in both groups, the Infection group had a second peak on postoperative day 10 (median 16.6K/mcL, IQR 12.5-21.2) not seen in the No-Infection group (median 12K/mcL, IQR 9.3-16.3). A total of 40 (15%) patients developed venous thromboembolism, median time of 6.5 days (range, 1-43). All patients demonstrated a continuous rise in platelets during postoperative days 0-15. Thrombocytosis was present in 38/40 (95%) patients with venous thromboembolism vs 183/225 (81%) patients without (P=0.036). Median days with thrombocytosis was higher in venous thromboembolism (8 days, range 1-15) vs non groups (6 days, range 1-16, P=0.049). CONCLUSION: We identified initial leukocytosis after splenectomy in all patients. The Infection group had a second peak in white blood cell count on postoperative day 10, not present in the No-Infection group. Among patients with venous thromboembolism, thrombocytosis was more frequent and of longer duration.

A multimodality triage algorithm to improve cytoreductive outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center team ovary initiative.

OBJECTIVE: To describe outcomes using a multimodal algorithm to triage patients with advanced epithelial ovarian cancer (EOC) to primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT). METHODS: All patients with EOC treated at our institution from 04/2015-08/2018 were identified. We included patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score. A low risk score for suboptimal cytoreduction was defined as ≤6, and a high risk score ≥7. Patients were triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score. RESULTS: Among 299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score. For patients with a low risk score, management included laparotomy/PDS, 181 (80%); LSC, 43 (19%) (with subsequent triage: PDS, 31; NACT, 12); and NACT, 2 (1%). For patients with a high risk score, management included laparotomy/PDS, 9 (12%); LSC, 51 (70%) (with subsequent triage: PDS, 28; NACT, 23); and NACT, 13 (18%). Overall, 83% underwent PDS, with a 75% CGR rate and 94% optimal cytoreduction rate. Use of the algorithm resulted in a 31% LSC rate and a 6% rate of suboptimal PDS. CONCLUSIONS: The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.

Factors Associated With Use of a High-Volume Cancer Center by Black Women With Ovarian Cancer.

OBJECTIVE: Disparities exist between population subgroups in the use of gynecologic oncologists and high-volume hospitals. The objectives of this study were to explore the experiences of black women obtaining ovarian cancer (OC) care at a high-volume center (HVC) and to identify patient-, provider-, and systems-related factors affecting their access to and use of this level of care. MATERIALS AND METHODS: Twenty-one semistructured interviews were conducted as part of an institutional review board-approved protocol with women who self-identified as black or African American, treated for OC at a single HVC from January 2013 to May 2017. Recurring themes were identified in transcribed interviews through the process of independent and collaborative thematic content analysis. RESULTS: Five themes were identified: (1) internal attributes contributing to black women's ability/desire to be treated at an HVC, (2) pathways to high- and low-volume centers, (3) obstacles to obtaining care, (4) potential barriers for black women interested in treatment at an HVC, and (5) suggestions for improving HVC use by black women. Study participants who successfully accessed care were comfortable navigating the health care system, understood the importance of self-advocacy, and valued the expertise of an HVC. Barriers to obtaining care at an HVC included lack of knowledge about the HVC, lack of referral, transportation difficulties, and lack of insurance coverage. CONCLUSION: In this qualitative study, black women treated at an HVC shared attributes and experiences that helped them access care. There is a need to collaborate with black communities and establish interventions to reduce barriers, facilitate access, and disseminate information about the value of receiving care for OC at an HVC.

Perioperative epidural use and survival outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer.

OBJECTIVE: Epidurals are associated with improved outcomes in some solid tumors, presumably due to their effect on surgical stress response. There are limited data on the prognostic significance of epidural anesthesia in patients undergoing primary debulking surgery (PDS) for advanced ovarian cancer. We sought to assess the impact of epidural anesthesia on the survival outcomes of patients undergoing PDS for advanced ovarian cancer. METHODS: In this retrospective study, consecutive patients with stage IIIB-IV epithelial ovarian, fallopian tube, or peritoneal carcinoma who underwent PDS at our institution from 01/2005-12/2013 were identified. Progression-free survival (PFS) and overall survival (OS) with regard to epidural use were analyzed. RESULTS: Of 648 patients, 435 received an epidural and 213 did not. Patients in the former group were more likely to have higher stage disease (stage IV disease, 26% vs. 16%, respectively; P = .005), carcinomatosis (87% vs. 80%, respectively; P = .027), and bulky upper abdominal disease (66% vs. 58%, respectively; P = .046). Complete gross resection was achieved in 48% and 32%, respectively (P < .001). For the epidural vs. non-epidural groups, median PFS was 20.8 months and 13.9 months, respectively (P = .021); median OS was 62.4 months and 41.9 months, respectively (P < .001). After controlling for confounding factors, including residual disease, epidural use was independently associated with a decreased risk of progression (HR = 1.327; 95% CI, 1.066-1.653) and death (HR = 1.588; 95% CI, 1.224-2.06). CONCLUSIONS: Perioperative epidural use was independently associated with improved PFS and OS in these patients. Epidural anesthesia at the time of PDS may be warranted in this setting.

Continuous improvement in primary Debulking surgery for advanced ovarian cancer: Do increased complete gross resection rates independently lead to increased progression-free and overall survival?

OBJECTIVES: To assess complete gross resection (CGR) rates and survival outcomes in patients with advanced ovarian cancer who underwent primary debulking surgery (PDS) during a 13-year period in which specific changes to surgical paradigm were implemented. METHODS: We identified all patients with stage IIIB-IV high-grade ovarian carcinoma who underwent PDS at our institution, with the intent of maximal cytoreduction, from 1/2001-12/2013. Patients were categorized by year of PDS based on the implementation of surgical changes to our approach to ovarian cancer debulking (Group 1, 2001-2005; Group 2, 2006-2009; Group 3, 2010-2013). RESULTS: Among 978 patients, 78% had stage IIIC disease and 89% had disease of serous histology. Carcinomatosis was found in 81%, and 60% had bulky upper abdominal disease (UAD). Compared to Group 1, those who underwent PDS during the latter 2 time periods had higher ASA scores (p < 0.001), higher-stage disease (p < 0.001), and more often had carcinomatosis (p = 0.015) and bulky UAD (p = 0.009). CGR rates for Groups 1-3 increased from 29% to 40% to 55%, respectively (p < 0.001). Five-year progression-free survival (PFS) rates increased over time (15%, 16%, and 20%, respectively; p = 0.199), as did 5-year overall survival (OS) rates (40%, 44%, and 56%, respectively; p < 0.001). On multivariable analysis, CGR was independently associated with PFS (p < 0.001) and OS (p < 0.001). CONCLUSIONS: Despite higher-stage disease and greater tumor burden, CGR rates, PFS and OS for patients who underwent PDS increased over a 13-year period. Surgical paradigm shifts implemented specifically to achieve more complete surgical cytoreduction are likely the reason for these improvements.

Exploring the impact of income and race on survival for women with advanced ovarian cancer undergoing primary debulking surgery at a high-volume center.

OBJECTIVE: To evaluate patients with advanced ovarian cancer (OC) undergoing primary debulking surgery (PDS) at a high-volume center (HVC), to determine whether socio-demographic disparities in PDS outcome and overall survival (OS) were present. METHODS: All patients with stages IIIB-IV high-grade OC undergoing PDS at our institution from 1/2001-12/2013 were identified. Patients self-identified race/ethnicity as non-Hispanic White (NHW), non-Hispanic Black (NHB), Asian (A), or Hispanic (H). Income level for the entire cohort was estimated using the census-reported income level for each patient's zip code as a proxy for SES. Main outcome measures were PDS outcome and median OS. Cox proportional hazards model was used to examine differences in OS by racial/ethnic and income category, controlling for selected clinical factors. RESULTS: 963 patients were identified for analysis: 855 NHW; 43 A, 34H, 28 NHB, and 3 unknown. PDS outcome was not significantly different among NHB and H as compared to NHW. Compared to NHW, Asians were more likely to have >1cm residual (AOR 2.32, 95%CI 1.1-4.9, p=0.03). Median income for the entire cohort was $85,814 (range $10,926-$231,667). After adjusting for significant prognostic factors, there were no significant differences in PDS outcome between income groups (p=0.7281). Median OS was 55.1mos (95%CI 51.8-58.5) with no significant differences in OS between the income (p=0.628) or racial/ethnic (p=0.615) groups. CONCLUSION: Statistically significant socio-demographic disparities in PDS and survival outcomes were not observed among women with advanced OC treated at this HVC. Increased efforts are needed to centralize care to and increase the diversity of pts treated at HVCs.

Feasibility, safety and clinical outcomes of cardiophrenic lymph node resection in advanced ovarian cancer.

OBJECTIVES: Surgical resection of enlarged cardiophrenic lymph nodes (CPLNs) in primary treatment of advanced ovarian cancer has not been widely studied. We report on a cohort of patients undergoing CPLN resection during primary cytoreductive surgery (CRS), examining its feasibility, safety, and potential impact on clinical outcomes. METHODS: We identified all patients undergoing primary CRS/CPLN resection for Stages IIIB-IV high-grade epithelial ovarian cancer at our institution from 1/2001-12/2013. Clinical and pathological data were collected. Statistical tests were performed. RESULTS: 54 patients underwent CPLN resection. All had enlarged CPLNs on preoperative imaging. Median diameter of an enlarged CPLN: 1.3cm (range 0.6-2.9). Median patient age: 59y (range 41-74). 48 (88.9%) underwent transdiaphragmatic resection; 6 (11.1%) underwent video-assisted thoracic surgery. A median of 3 nodes (range 1-23) were resected. A median of 2 nodes (range 0-22) were positive for metastasis. 51/54 (94.4%) had positive nodes. 51 (94.4%) had chest tube placement; median time to removal: 4d (range 2-12). 44 (81.4%) had peritoneal carcinomatosis. 19 (35%) experienced major postoperative complications; 4 of these (7%) were surgery-related. Median time to adjuvant chemotherapy: 40d (range 19-205). All patients were optimally cytoreduced, 30 (55.6%) without visible residual disease. Median progression-free survival: 17.2mos (95% CI 12.6-21.8); median overall survival: 70.1mos (95% CI 51.2-89.0). CONCLUSIONS: Enlarged CPLNs can be identified on preoperative imaging and may indicate metastases. Resection can identify extra-abdominal disease, confirm Stage IV disease, obtain optimal cytoreduction. In the proper setting it is feasible, safe, and does not delay chemotherapy. In select patients, it may improve survival.

A comparative analysis of prediction models for complete gross resection in secondary cytoreductive surgery for ovarian cancer.

OBJECTIVE: We sought to examine compliance and outcomes using Memorial Sloan Kettering "(MSK) criteria" to predict complete gross resection (CGR) and compare them with the validated Tian and AGO models. METHODS: Patients who underwent SCS for recurrent platinum-sensitive ovarian cancer from 5/2001-6/2014 were identified. The AGO and Tian models were applied to the study population; appropriate statistical tests were used to determine ability to predict CGR. RESULTS: 214 SCS cases were identified. Since the implementation of MSK criteria, the CGR rate has been 86%. The AGO model had a 49% accuracy rate in predicting CGR, and predicted gross residual disease (RD) in 51%; however, CGR was achieved in 86%. The Tian model had an 88% accuracy rate. Of the 4% scored as Tian high risk for gross RD, 33% achieved a CGR. Comparing models, McNemar's p-value was 0.366 between the Tian and MSK models and <0.001 between AGO and MSK criteria. Median PFS was 21.3 (95%CI, 18.2-24.5), 22.5 (95%CI, 19.4-25.3), and 14.1months (95%CI, 9.7-22.1) for the entire cohort, for those achieving CGR, and for those left with RD, respectively (p=0.013). OS was 82.2 (95%CI, 60.2-123.3), 95.6 (95%CI, 63.6-NE), and 57.5months (95%CI, 27.5-113.9), respectively (p=0.014). CONCLUSION: CGR during SCS is associated with extended PFS and OS. We report a high rate of CGR using MSK criteria. There was good concordance between the Tian and MSK models; however, the latter has fewer variables and is more user-friendly. Tian criteria may be applied to intermediate MSK cases for further stratification.

Mucinous Cystadenoma in Children and Adolescents.

STUDY OBJECTIVE: Mucinous cystadenomas (MCAs) are benign epithelial ovarian tumors that occur rarely in children and adolescents. Because children and adolescents typically have their childbearing years ahead of them, conservative therapy is indicated. However, there is concern that ovarian cystectomy might be associated with significant recurrence risk in patients with MCA. Furthermore, guanine nucleotide binding protein, alpha stimulating (GNAS) gene mutations are associated with McCune-Albright syndrome, which is associated with cystic ovaries. We sought to evaluate the outcomes of children and adolescents with MCA treated conservatively. A subset of patients underwent GNAS gene testing. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTIONS: After institutional board review approval, the pathology database of a large urban children's hospital was queried to identify adolescents with MCA between the years 2008 and 2014. Fourteen patients, aged 8-18 years (median, 14), were identified. A buccal swab for genetic testing was obtained from a subset of consenting patients. MAIN OUTCOME MEASURES: MCA recurrence; ovarian return to normal size; GNAS gene variants. RESULTS: Two patients underwent oophorectomies, and the remaining 12 underwent cystectomies. Follow-up ultrasound examination revealed slow return of ovary to normal size. Of the 10 patients with available follow-up data, there were no recurrences at a median of 225 days from surgery. Four patients consented to a buccal swab for genetic testing, and the GNAS gene was noted to have rare variants in 2 patients. CONCLUSION: This series supports the use of ovary-sparing surgery in the treatment of MCA. Further research exploring possible genetic variants such as the GNAS gene in children and adolescents diagnosed with MCA is warranted.

Current status and future prospects of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) clinical trials in ovarian cancer.

The natural history of advanced-stage epithelial ovarian cancer is one of clinical remission after surgery and platinum/taxane-based intravenous (IV) and/or intraperitoneal (IP) chemotherapy followed by early or late recurrence in the majority of patients. Prevention of progression and recurrence remains a major hurdle in the management of ovarian cancer. Recently, many investigators have evaluated the use of normothermic and hyperthermic intraoperative IP drug delivery as a management strategy. This is a narrative review of the current status of clinical trials of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in ovarian cancer and the future directions for this treatment strategy. The existing studies on HIPEC in patients with epithelial ovarian cancer are mostly retrospective in nature, are heterogeneous with regards to combined inclusion of primary and recurrent disease and lack unbiased data. Until data are available from evidence-based trials, it is reasonable to conclude that surgical cytoreduction and HIPEC is a rational and interesting, though still investigative, approach in the management of epithelial ovarian cancer, whose use should be employed within prospective clinical trials.

Electronic patient-reported outcomes from home in patients recovering from major gynecologic cancer surgery: A prospective study measuring symptoms and health-related quality of life.

PURPOSE: We previously reported on the feasibility of a Web-based system to capture patient-reported outcomes (PROs) in the immediate postoperative period. The purpose of this study was to update the experience of these patients and assess patient and provider satisfaction and feedback regarding the system. METHODS: This is a prospective cohort study of patients scheduled to undergo laparotomy for presumed gynecologic malignancy. Patients completed a Web-based Symptom Tracking and Reporting (STAR) questionnaire preoperatively and weekly during a 6-week postoperative period. Email alerts were sent to study nurses when concerning patient responses were entered. The patient and the nurse assessments of STAR's usefulness were measured via an exit survey. RESULTS: The study enrolled 96 eligible patients. Of these, 71 patients (74%) completed at least four of seven total sessions. Of the patients who completed the exit satisfaction survey, 98% found STAR easy to use; 84% found it useful; and 82% would recommend it to other patients. Despite positive feedback from patients, clinical personnel found that the STAR system increased their current workload without enhancing patient care. CONCLUSIONS: Application of an electronic program for PROs in those recovering from major gynecologic cancer surgery is feasible, and acceptable to most patients. While most clinicians did not find STAR clinically helpful, the majority of patients reported a positive experience with the system and would recommend its use. The program helped many patients feel more empowered in their postoperative recovery.

Primary Surgery or Neoadjuvant Chemotherapy in Advanced Ovarian Cancer: The Debate Continues .

Primary debulking surgery (PDS) followed by platinum-based chemotherapy has been the cornerstone of treatment for advanced ovarian cancer for decades. Primary debulking surgery has been repeatedly identified as one of the key factors in improving survival in patients with advanced ovarian cancer, especially when minimal or no residual disease is left behind. Achieving these results sometimes requires extensive abdominal and pelvic surgical procedures and consultation with other surgical teams. Some clinicians who propose a primary chemotherapy approach reported an increased likelihood of leaving no macroscopic disease after surgery and improved patient-reported outcomes and quality-of-life (QOL) measures. Given the ongoing debate regarding the relative benefit of PDS versus neoadjuvant chemotherapy (NACT), tumor biology may aid in patient selection for each approach. Neoadjuvant chemotherapy offers the opportunity for in vivo chemosensitivity testing. Studies are needed to determine the best way to evaluate the impact of NACT in each individual patient with advanced ovarian cancer. Indeed, the biggest utility of NACT may be in research, where this approach provides the opportunity for the investigation of predictive markers, mechanisms of resistance, and a forum to test novel therapies.

A pilot study of topical imiquimod therapy for the treatment of recurrent extramammary Paget's disease.

OBJECTIVE: The objective of this prospective pilot study was to assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease of the vulva. METHODS: Patients with biopsy-proven recurrent extramammary Paget's disease presenting to the gynecology outpatient services at two participating institutions were recruited for conservative treatment with 5% imiquimod cream from 2007 to 2011. The topical cream was to be applied 3 times per week for 12weeks. Punch biopsy and photography were performed at baseline and at the 12-week time point. RESULTS: Eight patients from two institutions were enrolled. Complete clinical and histologic response was achieved in 6 (75%) patients by the 12-week follow-up appointment. Of the two remaining patients, one had a complete clinical response but no significant histologic response; the other patient was removed from the study protocol secondary to intolerable local irritation. Two patients continue to have no evidence of disease after a median follow-up of 35months. Five are alive with disease. No patients progressed to invasive cancer while receiving therapy. CONCLUSION: Topical 5% imiquimod cream is a safe and feasible option for women suffering from recurrent extramammary Paget's disease of the vulva, and should be considered as a viable alternative to surgical management. Given the rare nature of this disease, additional multi-institutional prospective studies should be conducted to explore the efficacy of this treatment regime.

Is It Time to Centralize Ovarian Cancer Care in the United States?

PURPOSE: The purpose of this article was to broadly review the most up-to-date information pertaining to the centralization of ovarian cancer care in the United States (US) and worldwide. METHODS: Much of the present literature pertaining to disparities in, and centralization of, ovarian cancer care in the US and internationally was reviewed, and specifically included original research and review articles. RESULTS: Data show improved optimal debulking rates, National Comprehensive Cancer Network (NCCN) guideline adherence, and overall survival rates in higher-volume, more specialized hospitals, and amongst higher-volume providers. CONCLUSIONS: Patients with invasive epithelial ovarian cancer, especially those with higher stages (III and IV), are better served by centralized care in high-volume hospitals and by high-volume physicians, who adhere to NCCN guidelines wherever possible. More research is needed to determine the policy changes that can increase NCCN guideline adherence in low-volume hospitals and low-provider caseload scenarios. Policy and future research should be aimed at increasing patient access, either directly or indirectly, to high-volume hospital and high-volume providers, especially amongst Medicare, lower socioeconomic status, and minority patients.