Correlation of surgeon radiology assessment with laparoscopic disease site scoring in patients with advanced ovarian cancer.

BACKGROUND: Radiographic triage measures in patients with new advanced ovarian cancer have yielded inconsistent results. OBJECTIVE: To determine the correlation between surgeon radiology assessment and laparoscopic scoring by disease sites in patients with newly diagnosed advanced stage ovarian cancer. METHODS: Fourteen gynecologic oncology surgeons from a single institution performed a blinded review of pre-operative contrast-enhanced CT imaging from patients with advanced stage ovarian cancer. Each of the patients had also undergone laparoscopic scoring assessment, between April 2013 and December 2017, to determine primary resectability using the validated Fagotti scoring method, and assigned a predictive index value score. Surgeons were asked to provide expected predictive index value scores based on their blinded review of the antecedent CT imaging. Linear mixed models were conducted to calculate the correlation between radiologic and laparoscopic score for surgeons individually, and as a group. Once the model was fit, the inter-class correlation and 95% CI were calculated. RESULTS: Radiology review was performed on 20 patients with advanced stage ovarian cancer who underwent laparoscopic scoring assessment. Surgeon faculty rank included assistant professor (n=5), associate professor (p=4), and professor (n=5). The kappa inter-rater agreement was -0.017 (95% CI -0.023 to -0.005), indicating low inter-rater agreement between radiology review and actual laparoscopic score. The inter-class correlation in this model was 0.06 (0.02-0.21), indicating that surgeons do not score the same across all the images. When using a clinical cut-off point for the predictive index value of 8, the probability of agreement between radiology and actual laparoscopic score was 0.56 (95% CI 0.49 to 0.73). Examination of disease site sub-scales showed that the probability of agreement was as follows: peritoneum 0.57 (95% CI 0.51 to 0.62), diaphragm 0.54 (95% CI 0.48 to 0.60), mesentery 0.51 (95% CI 0.45 to 0.57), omentum 0.61 (95% CI 0.55 to 0.67), bowel 0.54 (95% CI 0.44 to 0.64), stomach 0.71 (95% CI 0.65 to 0.76), and liver 0.36 (95% CI 0.31 to 0.42). The number of laparoscopic scoring cases, tumor reductive surgery cases, or faculty rank was not significantly associated with overall or sub-scale agreement. CONCLUSIONS: Surgeon radiology review did not correlate highly with actual laparoscopic scoring assessment findings in patients with advanced stage ovarian cancer. Our study highlights the limited accuracy of surgeon radiographic assessment to determine resectability.

Phase Ib/II study of weekly topotecan and daily gefitinib in patients with platinum resistant ovarian, peritoneal, or fallopian tube cancer.

INTRODUCTION: 50-70% of epithelial ovarian cancers overexpress epidermal growth factor receptor, and its expression has been correlated with poor prognosis. We conducted a phase Ib/II trial to examine the efficacy, safety, and toxicity of gefitinib, a tyrosine kinase inhibitor, combined with topotecan in women with recurrent ovarian cancer with epidermal growth factor receptor positivity. METHODS: Patients with measurable recurrent or persistent cancer after treatment with a platinum containing regimen with positive epidermal growth factor receptor expression, as determined by immunohistochemistry, were eligible for the study. Initial treatment was 250 mg/day gefitinib (oral) and 2.0 mg/m2 topotecan (intravenous) on days 1, 8, and 15, on a 28 day cycle. Dose escalations were planned for topotecan (dose levels 1-3: 2, 3, and 4 mg/m2) until the maximum tolerated dose was reached. RESULTS: 19 patients received a total of 61 cycles. Median age was 59.8 years (range 42-76 years). Histologic types in treated patients included 74% serous (n=14), 11% mixed (n=2), 11% transitional (n=2), and 5% clear cell (n=1). For phase Ib, three patients were treated at dose level 1, three at dose level 2, and three at dose level 3 for topotecan. The maximum tolerated dose was 4.0 mg/m2 (days 1, 8, and 15) for topotecan and 250 mg (daily) for gefitinib. Therefore, dose level 3 was used for phase II. Among the 19 patients, 63.2% (n=12) had progressive disease, 15.8% (n=3) had stable disease, 10.5% (n=2) had a partial response, and 10.5% (n=2) were not evaluable. The most serious adverse events of any grade attributed to the therapy were anemia (89.4%), neutropenia (68.4%), abdominal pain (84%), constipation (78.9%), and diarrhea (78.9%). CONCLUSION: Although the drug combination was relatively well tolerated, this prospective phase Ib/II clinical trial did not show sufficient clinical activity of topotecan combined with gefitinib in patients with epidermal growth factor receptor positive recurrent ovarian, fallopian tube, or peritoneal cancers.

Facilitation of Surgical Innovation: Is It Possible to Speed the Introduction of New Technology While Simultaneously Improving Patient Safety?

OBJECTIVE: To review efficiency metrics and patient safety data before and after implementation of a structured review process for surgical innovations. SUMMARY BACKGROUND DATA: Surgical innovation ranges from minor incremental improvement to radical experimentation. Although innovation paradigms have been described, these are not widely adopted or enforced in the surgical community. METHODS: A Continuous Quality Improvement Team (CQIT) of surgical quality officers and perioperative nurses was organized to perform structured reviews of proposed new surgical devices and procedures at a large quaternary cancer care center. The CQIT process was placed to precede an established Value Analysis Team business evaluation. Pre- and post-CQIT implementation metrics of approval process efficiency and patient safety data were compared. Seven novel procedures were also vetted by the CQIT. RESULTS: Forty-six product requests were evaluated after CQIT implementation. Compared with 34 products evaluated prior to CQIT establishment, the total mean evaluation time decreased from 124 to 51 days (P= 0.007). For new devices requiring intraoperative trial, the time between product proposal and trial decreased from a mean of 260 to 99 days (P= 0.014). The rate of device-related complications in the pre-CQIT group was 10% compared with 0% post-CQIT. Two devices, which administratively bypassed CQIT review, had both minor and major complications, including a mortality. Five novel procedures approved by CQIT with simulation were performed without complications. CONCLUSIONS: Using novel algorithms, the addition of a dedicated team of surgical quality officers to the surgical innovation evaluation process improved both the efficiency and the safety associated with introducing new devices and procedures into practice.

Choosing Wisely: Decreasing the incidence of perioperative blood transfusions in gynecologic oncology.

OBJECTIVE: To evaluate the efficacy and economic impact of a transfusion reduction initiative for patients undergoing gynecologic surgery. METHODS: We conducted a prospective healthcare improvement study to align transfusion practices with the American Society of Hematology's Choosing Wisely® campaign. Baseline transfusion rates were determined retrospectively for all major gynecologic surgical cases from 3/1/14 to 6/30/14. Data for the post-intervention period from 5/15/15 to 5/16/16 were captured prospectively. The primary outcome was transfusion within 72 h of surgery. Secondary outcomes included perioperative morbidity, mortality, number of units ordered per transfusion episode and cost. RESULTS: We identified 1281 surgical cases, 334 in the baseline and 947 in the post-implementation cohort. The baseline cohort was noted to have a higher median estimated blood loss (100 v. 75 mL, P < 0.01). Otherwise, there were no differences in clinical or perioperative characteristics between the two cohorts. The perioperative transfusion rate decreased from 24% to 11% (adjusted OR 0.27, 95% CI 0.16 to 0.45; P < 0.001). The perioperative laparotomy transfusion rate decreased from 48% to 23% (adjusted OR 0.21, 95% CI 0.12, 0.37; P < 0.001). The number of occurrences in which more than one unit of blood was ordered at a time decreased from 65% to 23%, P < 0.001. The incidence of surgical site infections declined in the post-intervention group, otherwise there were no differences in 30-day mortality, cardiac, venous thromboembolism or readmission rates between the groups. The projected cost savings was $161,112 over the 12-month intervention period. CONCLUSIONS: Implementation of an educational based transfusion reduction program was associated with substantial reductions in perioperative transfusions and cost without significant changes in morbidity or mortality.

The DISINFECT Initiative: Decreasing the Incidence of Surgical INFECTions in Gynecologic Oncology.

BACKGROUND: Surgical site infections (SSIs) lead to increased patient morbidity and healthcare costs. Our objective was to decrease the SSI rate following gynecologic surgery. METHODS: Adult patients undergoing abdominal surgery for gynecologic malignancy or benign disease received the following: patient education; preoperative antibacterial soap; appropriate antibiotic prophylaxis; change of gloves and use of clean instruments at surgical closure; surgical dressing for 48 h; and a post-discharge phone call. The baseline SSI rate was determined retrospectively (1 April 2014-30 June 2014), while the post-intervention SSI rate was determined prospectively (16 February 2015-15 October 2015). The main outcome was the overall SSI rate with secondary outcomes, including the rate of superficial, deep, incisional and organ space infection, as well as the cost effectiveness of the bundle. RESULTS: A total of 232 baseline and 555 post-intervention patients were included in the study. No differences were observed between the baseline and post-intervention groups with regard to median body mass index (BMI), surgical approach, receipt of preoperative chemotherapy and/or radiation therapy, and cases including bowel surgery. Overall, the SSI rate decreased significantly from baseline [12.5 %] to post-intervention [7.4 %] (odds ratio [OR] 0.56, 90 % confidence interval [CI] 0.37-0.85; p = 0.01). A 40 % decrease was noted in the rate of superficial and deep infections (9.5 vs. 5.9 %; OR 0.60, 90 % CI 0.38-0.97; p = 0.04) and SSIs after open surgery (21.4 vs. 13.2 %; OR 0.56, 90 % CI 0.34-0.92; p = 0.03). The estimated cost of the intervention was $19.26/case and the net total amount saved during the post-intervention period was $65,625 month. CONCLUSIONS: This bundled intervention led to a significant decrease in the overall SSI rate and was cost effective. The largest decreases in SSIs were in incisional infections and following open surgery.

Sensitivity and negative predictive value for sentinel lymph node biopsy in women with early-stage cervical cancer.

OBJECTIVE: The role of sentinel lymph node (SLN) biopsy alone for staging of early-stage cervical cancer remains controversial. We aimed to determine the validity of this technique in women with early-stage cervical cancer. METHODS: We retrospectively reviewed women with early-stage cervical cancer who underwent SLN mapping followed by complete pelvic lymphadenectomy as part of initial surgical management from August 1997 through October 2015. All modes of surgical approach were included. Lymphatic mapping was performed using blue dye, technetium-99m sulfur colloid (Tc-99), and/or indocyanine green (ICG). We determined SLN detection rates, sensitivity and negative predictive value. RESULTS: One hundred eighty-eight patients were included, and 35 (19%) had lymph node metastases. At least one SLN was identified in 170 patients (90%), and bilateral SLNs were identified in 117 patients (62%). The majority of SLNs (83%) were found in the pelvis. There was no difference in detection rates between mapping agents, surgical approach, patients with and without prior conization or between patients with tumors <2cm and ≥2cm. The detection rate for bilateral SLNs was significantly lower in women with body mass index (BMI)>30kg/m2 than in women with lower BMI (p=0.03). Metastatic disease in sentinel nodes was detected by H&E staining in 78% of cases and required ultrastaging/immunohistochemistry in 22% of cases. Only one patient had a false-negative result, yielding a sensitivity of 96.4% (95% CI 79.8%-99.8%) and negative predictive value of 99.3% (95% CI 95.6%-100%). The false-negative rate was 3.6%. CONCLUSIONS: In these women with early-stage cervical cancer, SLN biopsy had very high sensitivity and negative predictive value. We believe it is time to change the standard of care for women with early-stage cervical cancer to SLN biopsy only.

A prospective validation study of sentinel lymph node mapping for high-risk endometrial cancer.

OBJECTIVE: Sentinel lymph node (SLN) mapping continues to evolve in the surgical staging of endometrial cancer (EC). The purpose of this trial was to identify the sensitivity, false negative rate (FNR) and FN predictive value (FNPV) of SLN compared to complete pelvic and para-aortic lymphadenectomy (LAD) in women with high-risk EC. METHODS: Women with high-risk EC (grade 3, serous, clear cell, carcinosarcoma) were enrolled in this prospective surgical trial. All patients underwent preoperative PET/CT and intraoperative SLN biopsy followed by LAD. Patients with peritoneal disease on imaging or at the time of surgery were excluded. Patients were evaluable if SLN was attempted and complete LAD was performed. RESULTS: 123 patients were enrolled between 4/13 and 5/16; 101 were evaluable. At least 1 SLN was identified in 89% (90); bilateral detection 58%, unilateral pelvic 40%, para-aortic only 2%. Indocyanine green was used in 61%, blue dye in 28%, and blue dye and technetium in 11%. Twenty-three pts. (23%) had ≥1 positive node. In 20/23, ≥1 SLN was identified and in 19/20 the SLN was positive. Only 1 patient had bilateral negative SLN and positive non-SLNs on final pathology. Overall, sensitivity of SLN was 95% (19/20), FNR was 5% (1/20) and FNPV was 1.4% (1/71). If side-specific LAD was performed when a SLN was not detected, the FNR decreased to 4.3% (1/23). CONCLUSION: This prospective trial demonstrated that SLN biopsy plus side-specific LAD, when SLN is not detected, is a reasonable alternative to a complete LAD in high-risk endometrial cancer.

Fighting cancer together: Development and implementation of shared medical appointments to standardize and improve chemotherapy education.

OBJECTIVE: Shared medical appointments offer a novel approach to improve efficiency and quality of care consistent with the goals of the Institute of Medicine. Our objective was to develop and implement a shared medical appointment for gynecologic cancer patients initiating chemotherapy. METHODS: We first assessed the level of interest in shared medical appointments among our patients and providers through qualitative interviews. Both patients and providers identified pre-chemotherapy as an optimal area to pilot shared medical appointments. We subsequently created a multidisciplinary team comprised of physicians, advanced practice providers, nurses, pharmacists, administrators, health education specialists and members of the Quality Improvement Department to establish a Shared Medical Appointment and Readiness Teaching (SMART) program for all gynecologic oncology patients initiating chemotherapy with platinum- and/or taxane-based regimens. We developed a standardized chemotherapy education presentation and provided patients with a tool kit that consisted of chemotherapy drug education, a guide to managing side effects, advance directives, and center contact information. RESULTS: From May 9, 2014 to June 26, 2015, 144 patients participated in 51 SMART visits. The majority of patients had ovarian cancer and were treated with carboplatin/paclitaxel. Surveyed patients reported being highly satisfied with the group visit and would recommend shared medical appointments to other patients. CONCLUSIONS: This model of care provides patient education within a framework of social support that empowers patients. Shared medical appointments for oncology patients initiating chemotherapy are both feasible and well accepted.

Update on sentinel lymph node biopsy for early-stage vulvar cancer.

Two prospective, multicenter clinical trials have demonstrated the feasibility and reproducibility of sentinel lymph node (SLN) biopsy as part of the standard management of early-stage vulvar carcinoma. On the basis of the results of these trials, many gynecologic oncologists have incorporated SLN biopsy for vulvar cancer into their practice. Studies have further shown that SLN biopsy is associated with better quality of life than full lymphadenectomy, is more cost-effective than full lymphadenectomy, and improved pathologic evaluation. A large observational study is currently evaluating the outcomes of patients with early-stage vulvar cancer according to the results of their SLN biopsy and the approach to their care; this study may confirm that full inguinofemoral lymphadenectomy is no longer necessary in most patients with this disease. Here, we review the published data supporting SLN biopsy as part of the standard of care for women with early-stage vulvar cancer and discuss future considerations for the management of this disease.

Perioperative blood transfusion in gynecologic oncology surgery: analysis of the National Surgical Quality Improvement Program Database.

OBJECTIVE: To use a large-scale multi-institutional dataset to quantify the prevalence of packed red blood cell transfusions and examine the associations between transfusion and perioperative outcomes in gynecologic cancer surgery. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (NSQIP) participant use file was queried for all gynecologic cancer cases between 2010 and 2012. Demographic, preoperative and intraoperative variables were compared between transfusion and non-transfusion groups using chi-squared, Fisher's exact and Wilcoxon rank-sum tests. The primary endpoint was 30-day composite morbidity. Secondary endpoints included composite surgical site infections, mortality and length of stay. RESULTS: A total of 8519 patients were analyzed, and 13.8% received a packed red blood cell transfusion. In the multivariate analysis, after adjusting for key clinical and perioperative factors, including preoperative anemia and case magnitude, transfusion was associated with higher composite morbidity (OR = 1.85, 95% CI 1.5-2.24), surgical site infections (OR 1.80, 95% CI 1.39-2.35), mortality (OR 3.38, 95% CI 1.80-6.36) and length of hospital stay (3.02 days v. 7.17 days, P < 0.001). CONCLUSIONS: Blood transfusions are associated with increased surgical wound infections, composite morbidity and mortality. Based on our analysis of the NSQIP database, transfusion practices in gynecologic cancer should be scrutinized. Examination of institutional practices and creation of transfusion guidelines for gynecologic malignancies could potentially result in better utilization of blood bank resources and clinical outcomes among patients.

Targeting those with decreased meaning and peace: a supportive care opportunity.

PURPOSE: To evaluate if an individual's level of meaning/peace (M/P) predicts various quality of life (QOL) and mental well-being measures. To identify targets that might enhance the overall spiritual well-being and QOL of ovarian cancer patients. METHODS: Multi-site analysis of women with newly diagnosed stages II-IV ovarian, primary peritoneal, or fallopian tube cancer. Patients completed the following surveys: Functional Assessment of Chronic Illness Therapy-Ovarian (FACT-O), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), Edmonton Symptom Assessment System (ESAS), Hospital Anxiety and Depression Scale (HADS), Templer's Death Anxiety Scale (DAS), Herth Hope Index (HHI), and Brief Multidimensional Measure of Religiousness/Spirituality (BMMRS). Linear regression models were created to examine the effect of M/P (FACIT-Sp) upon QOL, symptoms, and other measures of mental well-being. These models adjusted for the effect of site, race, age, stage, anaphylaxis to chemotherapy, and partner status as potential confounders. RESULTS: This study enrolled 104 patients from three separate sites. After adjusting for potential confounders, it was found that higher M/P predicted better QOL (FACT-O) (p < 0.0001). Higher M/P also predicted decreased death anxiety, depression, and anxiety (p ≤ 0.005). Finally, higher M/P predicted increased hope and coping scores (p ≤ 0.0005). CONCLUSIONS: Level of M/P is associated with several important mental and physical health states. This information may allow providers to identify patients at increased risk for mental/physical distress and may facilitate early referral to targeted psychotherapy interventions focused on improving patient QOL and decreasing anxiety and depression.

Improved compliance with venous thromboembolism pharmacologic prophylaxis for patients with gynecologic malignancies hospitalized for nonsurgical indications did not reduce venous thromboembolism incidence.

OBJECTIVE: National guidelines recommend prophylactic anticoagulation for all hospitalized patients with cancer to prevent hospital-acquired venous thromboembolism (VTE). However, adherence to these evidence-based recommended practice patterns remains low. We performed a quality improvement (QI) project to increase VTE pharmacologic prophylaxis rates among patients with gynecologic malignancies hospitalized for nonsurgical indications and evaluated the resulting effect on rates of development of VTE. MATERIALS AND METHODS: In June 2011, departmental VTE practice guidelines were implemented for patients with gynecologic malignancies who were hospitalized for nonsurgical indications. A standardized VTE prophylaxis module was added to the admission electronic order sets. Outcome measures included number of admissions receiving VTE pharmacologic prophylaxis within 24 hours of admission; and number of potentially preventable hospital-acquired VTEs diagnosed within 30 and 90 days of discharge. Outcomes were compared between a preguideline implementation cohort (n = 99), a postguideline implementation cohort (n = 127), and a sustainability cohort assessed 2 years after implementation (n = 109). Patients were excluded if upon admission they had a VTE, were considered low risk for VTE, or had a documented contraindication to pharmacologic prophylaxis. RESULTS: Administration of pharmacologic prophylaxis within 24 hours of admission increased from 20.8% to 88.2% immediately following the implementation of guidelines, but declined to 71.8% in our sustainability cohort (P < 0.001). There was no difference in VTE incidence among the 3 cohorts [n = 2 (4.2%) vs n = 3 (3.9%) vs n = 3 (4.2%), respectively; P = 1.00]. CONCLUSIONS: Our QI project improved pharmacologic VTE prophylaxis rates. A small decrease in prophylaxis during the subsequent 2 years suggests a need for continued surveillance to optimize QI initiatives. Despite increased adherence to guidelines, VTE rates did not decline in this high-risk population.

Sentinel lymph node evaluation in women with cervical cancer.

Lymph node status is the most important prognosticator of survival in women with early stage cervical cancer. Thus many patients with cervical cancer will undergo pelvic lymphadenectomy as part of the treatment. This procedure is associated with substantial morbidity. Use of the sentinel lymph node technique in women with cervical cancer has the potential to decrease this morbidity. Multiple studies have suggested that sentinel lymph node mapping in these patients is feasible, with excellent detection rates and sensitivity. This review examines the current body of literature about sentinel lymph node biopsy in women with cervical cancer.

Reporting of quality measures in gynecologic oncology programs at Prospective Payment System (PPS)-Exempt Cancer Hospitals: an early glimpse into a challenging initiative.

OBJECTIVE: The Affordable Care Act mandates the Prospective Payment System (PPS)-Exempt Cancer Hospitals Quality Reporting program. These 11 hospitals (which are paid fee-for-service rather than on a DRG system) began reporting measures (2 general safety, 2 breast, 1 colon) in 2013. Given this reporting mandate, we set out to determine whether the PPS-exempt gynecologic oncology programs could identify quality measures specific to the care of our patients. METHODS: A list of 12 quality measures specific to gynecologic oncology was created (from sources including the National Quality Forum and the SGO). Measures already in use were not included. The list was ranked by the gynecologic oncology program directors at the PPS-exempt hospitals. Descriptive statistics (including mean and SD for rankings) were utilized. RESULTS: Despite mandatory reporting of quality measures for PPS-exempt cancer hospitals, little consensus exists regarding specific gynecologic cancer measures. Documentation of debulking status, cancer survival, and offering minimally invasive surgery (for endometrial cancer) and intraperitoneal chemotherapy (for ovarian cancer) are important, but with widely variable responses (when ranked 1-12, standard deviations are 2-3). General issues regarding adherence to guidelines for the use of GCSF, documentation of functional status, and tracking of patient satisfaction scores were ranked the lowest. Three of the directors reported that their compensation is partially linked to quality outcomes. CONCLUSIONS: There is wide variability in ranking of quality measures, and may relate to provider or institutional factors. Despite the mandatory reporting in PPS-exempt cancer hospitals, work remains to define gynecologic cancer quality measures.

Venous thromboembolism (VTE) rates following the implementation of extended duration prophylaxis for patients undergoing surgery for gynecologic malignancies.

OBJECTIVE: To compare the incidence of venous thromboembolism (VTE) before and after the implementation of standardized extended duration prophylaxis guidelines in women undergoing laparotomy for gynecologic cancer. METHODS: In October 2009, departmental practice guidelines were implemented for VTE prevention. Patients undergoing laparotomy for gynecologic cancer were started on low molecular weight heparin (LMWH) within 24h of surgery and it was continued for a total of 28 days postoperatively. The incidence of VTE diagnosed within 30 and 90 days of surgery was determined and compared to a historic cohort of patients who underwent surgery prior to implementation of the guidelines. RESULTS: The incidence of VTE within 30 days of surgery decreased from 2.7% (8/300) to 0.6% (2/334) following implementation of VTE prevention guidelines (78% reduction, p=0.040). However, when the pre and post-guideline implementation groups were compared for the development of VTE within 90 days of surgery, there was no significant difference (11/300 (3.7%) vs. 10/334 (3.0%) respectively, p=0.619). The median time between surgery and VTE diagnosis was 12 days in the pre-guideline implementation group, compared with 57 days in the post-guideline implementation group (p=0.012). CONCLUSION: Patients receiving extended duration LMWH were found to have significantly lower rates of VTE within 30 days of surgery when compared with similar patients who did not receive extended duration LMWH. However, this effect was not sustained when the groups were compared for VTE diagnosis within 90 days of surgery. Additional study is needed to further reduce long-term VTE rates in this high-risk population.

Is bilateral lymphadenectomy for midline squamous carcinoma of the vulva always necessary? An analysis from Gynecologic Oncology Group (GOG) 173.

OBJECTIVE: To determine which patients with near midline lesions may safely undergo unilateral groin dissection based on clinical exam and lymphoscintigraphy (LSG) results. METHODS: Patients participating in GOG-173 underwent sentinel lymph node (SLN) localization with blue dye, and radiocolloid with optional LSG before definitive inguinal-femoral lymphadenectomy (LND). This analysis interrogates the reliability of LSG alone relative to primary tumor location in those patients who had an interpretable LSG and at least one SLN identified. Primary tumor location was categorized as lateral (>2cm from midline), midline, or lateral ambiguous (LA) if located within 2cm, but not involving the midline. RESULTS: Two-hundred-thirty-four patients met eligibility criteria. Sixty-four had lateral lesions, and underwent unilateral LND. All patients with LA (N=65) and midline (N=105) tumors underwent bilateral LND. Bilateral drainage by LSG was identified in 14/64 (22%) patients with lateral tumors, 38/65 (58%) with LA tumors and in 73/105 (70%) with midline tumors. At mapping, no SLNs were found in contralateral groins among those patients with LA and midline tumors who had unilateral-only LSGs. However, in these patients groin metastases were found in 4/32 patients with midline tumors undergoing contralateral dissection; none were found in 27 patients with LA tumors. CONCLUSION: The likelihood of detectable bilateral drainage using preoperative LSG decreases as a function of distance from midline. Patients with LA primaries and unilateral drainage on LSG may safely undergo unilateral SLN.

Patient cost associated with filling a prescription for extended-duration venous thromboembolism (VTE) prophylaxis following surgery for gynecologic cancer.

OBJECTIVE: The primary purpose of this study was to determine the average patient cost for filling a prescription for extended-duration enoxaparin prophylaxis. METHODS: Women who underwent major abdominal/pelvic surgery for histologically confirmed gynecologic malignancy were included. Patients who underwent minimally invasive surgery, had benign disease or were on treatment for existing VTE were excluded. Pharmacy resource specialists electronically submitted test prescriptions to verify enoxaparin coverage in the outpatient setting prior to hospital discharge. Patient co-pay information collected included: the number of patients requiring prescription insurance prior authorization, those qualifying for the Lovenox Patient Assistance Program® (PAP) and insurance status. RESULTS: Three hundred and sixty-four patients were discharged with extended-duration enoxaparin prophylaxis for 28 days between October 2009 and May 2011. The average patient cost to complete 28 days of enoxaparin prophylaxis was $62 (median $21, range $0-1210). Prior authorization was required for 32 patients (10%). Two patients (0.6%) qualified for the Lovenox Patient Assistance Program®. A decrease in the average patient cost from $71 to $52 (median $30 to $10) was observed after generic enoxaparin approval in July 2011. CONCLUSION: Our results show that at least 90% of patients filled their prescription of extended-duration enoxaparin prophylaxis after major abdominal surgery for cancer regardless of cost.

"Triple injection" lymphatic mapping technique to determine if parametrial nodes are the true sentinel lymph nodes in women with cervical cancer.

OBJECTIVES: Lymphatic mapping studies in women with cervical cancer typically identify sentinel nodes (SLNs) in the pelvis and not the parametrium. We added India ink as a mapping agent to determine whether this would allow us to pathologically identify sentinel parametrial nodes and to test our hypothesis that the parametrial nodes are the true SLNs in women with cervical cancer. METHODS: We performed lymphatic mapping and SLN biopsy in 20 women with early-stage cervical cancer undergoing radical hysterectomy or trachelectomy using a "triple injection" technique with blue dye, radiocolloid, and India ink. Pathologic processing of parametrium and nodal tissue was then performed to identify India ink in specimens. RESULTS: On pathology review, 15 (75%) patients had a parametrial node identified, and 9 patients (45%) had bilateral parametrial nodes identified; the median number of parametrial nodes identified was 2 (range, 0-7). India ink was seen in at least 1 parametrial node in 13 (87%) of the 15 patients with a parametrial node identified pathologically. Of the 9 patients with bilateral parametrial nodes identified pathologically, only 5 (54%) had bilateral parametrial nodes containing India ink. India ink was found in 26 (44%) of 59 SLNs and only 1 (0.3%) of 289 non-SLNs. In 5 patients, India ink was seen in a SLN on the same side of the pelvis where a parametrial node was identified but not microscopically black. CONCLUSIONS: There appears to be direct drainage of cervical lesions to pelvic nodal basins bypassing small parametrial nodes. Parametrial nodes, therefore, may not always be the SLNs in women with cervical cancer.

Phase II trial of imatinib mesylate in patients with recurrent platinum- and taxane-resistant low-grade serous carcinoma of the ovary, peritoneum, or fallopian tube.

OBJECTIVE: To evaluate the efficacy and tolerability of imatinib mesylate in patients with recurrent low-grade serous carcinoma (LGSC) of the ovary, peritoneum, or fallopian tube. METHODS: This open-label, single-institution phase II trial enrolled patients with platinum-resistant LGSC who had measurable disease, had received up to 4 platinum- and/or taxane-containing chemotherapy regimens, and had been previously screened for at least one imatinib targeted biomarker (c-kit, platelet-derived growth factor receptor [PDGFR]-ß, or bcr-abl). Imatinib (600 mg) was administered daily for one 6-week course and continued in the absence of toxicity and disease progression. RESULTS: Thirteen patients were enrolled; 12 were evaluable for toxicity, and 11 were evaluable for response. A total of 17 courses were administered (median, 1 course; range, 1-5 courses). Complete or partial responses were not observed. One patient had stable disease for 7.3 months. c-Kit, bcr-abl, or PDGFR-ß were present in 48%, 77%, and 100% of patients, respectively. No correlation between best response (stable disease) and the presence of imatinib-targeted biomarkers was observed. Adverse events included grade 3 skin rash in one patient leading to discontinuation of the drug, and grade 3 febrile neutropenia and grade 2 weight gain in two patients leading to dose reductions. The most common grade 1 or 2 toxicities were fatigue (66%), nausea/vomiting (66%), and diarrhea (41%); grade 3 toxicities included skin rash and granulocytopenia events. No grade 4 or 5 toxicities were observed. The median progression-free survival time was 1.3 months (95% CI, 1.27, 1.40 months), and the median overall survival time was 14.9 months (95% CI, 11.0, 18.9 months). CONCLUSION: Imatinib is well-tolerated but has no activity in patients with platinum- and taxane-resistant LGSC or the ovary, peritoneum, or fallopian tube.