Transfusion use and effect on progression-free, overall survival, and quality of life in upfront treatment of advanced epithelial ovarian cancer: evaluation of the European Organization for Research and Treatment EORTC-55971 Cohort.

BACKGROUND: The impact of blood transfusion on ovarian cancer survival is uncertain. OBJECTIVE: To investigate whether peri-operative blood transfusion negatively impacted progression-free survival, overall survival, and quality of life in patients with advanced ovarian cancer. METHODS: We performed an ancillary analysis of the European Organization for Research and Treatment (EORTC) 55971 phase III trial, in which patients were randomized to primary debulking surgery versus neoadjuvant chemotherapy. Patients included in the per-protocol analysis were categorized by receipt of a transfusion. RESULTS: 612 of 632 (97%) of patients had adequate data for analysis. Of those, 323 (53%) received a transfusion. The transfusion cohort was more likely to have had better Word Health Organization (WHO) performance status, serous histology, undergone primary debulking surgery, and received more aggressive surgery, with higher rates of no gross residual disease. Median overall survival was 34.0 vs 35.2 months in the no transfusion and transfusion cohorts (p=0.97). The adjusted HR for death was 1.18 (95% CI 0.94 to 1.48) in favor of the transfusion cohort. Median progression-free survival was 13.6 vs 12.6 months in the no transfusion and transfusion cohorts (p=0.96). The adjusted HR for progression was 1.14 (95% CI 0.91 to 1.43). There were no significant differences in global quality of life, fatigue, dyspnea, or physical functioning between the two cohorts at baseline or at any of the four assessment times. Grade 3 and 4 surgical site infections were more common in the transfusion cohort. CONCLUSION: Transfusion did not negatively impact progression-free survival or overall survival; however, it was associated with increased peri-operative morbidity without improvements in quality of life.

A Not So Perfect Score: Factors Associated with the Rate of Straight Line Scoring in Oncology Training Programs.

Straight line scoring (SLS), defined as trainee assessments with the same score for all evaluation items, is statistically improbable and potentially indicates inaccurate assessment. Factors contributing to higher SLS rates are unknown, and knowledge of SLS prevalence within oncologic training is lacking. SLS frequency was measured for evaluations from all Accreditation Council for Graduate Medical Education (ACGME)-accredited programs at a single cancer care institution between 2014 and 2018. SLS prevalence was estimated using hierarchical linear models (HLM) that considered characteristics of evaluator, trainee, and evaluation potentially related to SLS. Results were compared with national SLS rates. Six thousand one hundred sixty evaluations were included from 476 evaluators. Overall prevalence of SLS was 12.1% (95% CI 4.5-28.8). Residents (vs fellows) were less likely to have SLS evaluations (OR 0.5, 95% CI 0.4-0.8), though for all trainees increasing training year corresponded with increasing SLS frequency (OR 1.5, 95% CI 1.3-1.7). SLS was more common in procedural specialties compared with medical specialties (OR 2.1, 95% CI 1.1-3.8). Formative evaluations had lower SLS rates (OR 0.6, 95% CI 0.5-0.9) than summative evaluations, while milestone-based evaluations had higher rates than those that were not milestone-based (OR 1.5, 95% CI 1.03-2.2). Features of evaluators, such as subspecialty within oncology, and of trainees, such as seniority or trainee type, were related to SLS. Summative intent and milestone-based evaluations were more likely to be straight line scored. Specific evaluation scenarios at higher risk of SLS should be further examined.

Prospective phase II trial of levonorgestrel intrauterine device: nonsurgical approach for complex atypical hyperplasia and early-stage endometrial cancer.

BACKGROUND: The incidence of complex atypical hyperplasia and early-stage endometrioid endometrial cancer is increasing, in part owing to the epidemic of obesity, which is a risk factor tightly linked to the development of endometrial hyperplasia and cancer. The standard upfront treatment for complex atypical hyperplasia and early-stage endometrial cancer is hysterectomy. However, nonsurgical treatment of early-stage endometrial neoplasia may be necessary owing to medical comorbidities precluding surgery or desired future fertility. OBJECTIVE: This study aimed to evaluate the efficacy of the levonorgestrel intrauterine device to treat complex atypical hyperplasia and grade 1 endometrioid endometrial carcinoma. STUDY DESIGN: A single-institution, single-arm, phase II study of the levonorgestrel intrauterine device (52 mg levonorgestrel, Mirena) was conducted in patients with complex atypical hyperplasia or grade 1 endometrioid endometrial cancer. The primary endpoint was pathologic response rate at 12 months, including complete or partial response. Quality of life and toxicity were assessed. Molecular analyses for proliferation markers, hormone-regulated genes, and wingless-related integration site pathway activation were performed at baseline and 3 months. RESULTS: A total of 57 patients were treated (21 endometrial cancer, 36 complex atypical hyperplasia). The median age was 48.0 years, and the median body mass index was 45.5 kg/m2. Of the 47 evaluable patients, 12-month response rate was 83% (90% credible interval, 72.7-90.3)-37 were complete responders (8 endometrial cancer; 29 complex atypical hyperplasia), 2 were partial responders (2 endometrial cancer), 3 had stable disease (2 endometrial cancer; 1 complex atypical hyperplasia), and 5 had progressive disease (3 endometrial cancer; 2 complex atypical hyperplasia). After stratification for histology, the response rate was 90.6% for complex atypical hyperplasia and 66.7% for grade 1 endometrioid endometrial cancer. Notably, 4 patients (9.5%) experienced relapse after the initial response. Adverse events were mild, primarily irregular bleeding and cramping. Quality of life was not negatively affected. At 3 months, exogenous progesterone effect was present in 96.9% of responders (31 of 32) vs 25% of nonresponders (2 of 8) (P=.001). Nonresponders had higher baseline proliferation (Ki67) and lower dickkopf homolog 3 gene expression than responders (P=.023 and P=.030). Nonresponders had significantly different changes in secreted frizzled-related protein 1, frizzled class receptor 8, and retinaldehyde dehydrogenase 2 compared with responders. CONCLUSION: The levonorgestrel intrauterine device has a substantial activity in complex atypical hyperplasia and grade 1 endometrioid endometrial cancer, with a modest proportion demonstrating upfront progesterone resistance. Potential biomarkers were identified that may correlate with resistance to therapy; further exploration is warranted.

Pathologic distribution at the time of interval tumor reductive surgery informs personalized surgery for high-grade ovarian cancer.

INTRODUCTION: The surgical approach for interval debulking surgery after neoadjuvant chemotherapy has been extrapolated from primary tumor reductive surgery for high-grade ovarian cancer. The study objective was to compare pathologic distribution of malignancy at interval debulking surgery versus primary tumor reductive surgery. METHODS: Patients with a diagnosis of high-grade serous or mixed, non-mucinous, epithelial ovarian, fallopian tube or primary peritoneal cancer who underwent neoadjuvant chemotherapy or primary tumor reductive surgery and had at least 6 months of follow-up were identified through tumor registry at a single institution from January 1995 to April 2016. Pathologic involvement of organs was categorized as macroscopic, microscopic, or no tumor. Statistical analyses included Mann-Whitney and Fisher's exact tests. RESULTS: Of 918 patients identified, 366 (39.9%) patients underwent interval debulking surgery and 552 (60.1%) patients underwent primary tumor reductive surgery. Median age was 62.3 years (range 25.3-92.5). The majority of patients in the interval debulking surgery group were unstaged (261, 71.5%). In the patients who had a primary tumor reductive surgery, 406 (74.6%) had stage III disease. In both groups, the majority of patients had serous histology: 325 (90%) and 435 (78.8%) in the interval debulking and primary tumor reductive surgery groups, respectively. There was a statistically significant difference between disease distribution on the uterus between the groups; 31.4% of the patients undergoing interval debulking surgery had no evidence of uterine disease compared with 22.1% of primary tumor reductive surgery specimens (p<0.001). In the adnexa, there was macroscopic disease present in 253 (69.2%) and 482 (87.4%) of cases in the interval vs primary surgery groups, respectively (p<0.001). Within the omentum, no tumor was present in the omentum in 52 (14.2%) in the interval surgery group versus 91 (16.5%) in the primary surgery group (p<0.001). In the interval surgery group, there was no tumor involving the small and large bowel in 49 (13.4%) and 28 (7.7%) pathologic specimens, respectively. This was statistically significantly different from the small and large bowel in the primary surgery group, of which there was no tumor in 20 (3.6%, p<0.001) and 16 (2.9%, p<0.001) of cases, respectively. CONCLUSION: In patients undergoing interval debulking surgery, there was less macroscopic involvement of tumor in the uterus, adnexa and bowel compared with patients undergoing primary cytoreductive surgery.

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.

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.

How we use hospice: Hospice enrollment patterns and costs in elderly ovarian cancer patients.

OBJECTIVE: To describe disparities in patterns of hospice use and end-of-life costs among ovarian cancer patients. METHODS: Using Texas Cancer Registry-Medicare data, ovarian cancer patients deceased 2005-2012 with >12 months of continuous Medicare coverage before death were included. Descriptive statistics and multivariable logistic regressions were used to evaluate patterns of hospice use. Cost and resource utilization was obtained from Medicare claims and analyzed using a non-parametric Mann-Whitney test. RESULTS: 2331 patients were assessed: 1788 (77%) white, 359 (15%) Hispanic, 158 (7%) black and 26 (1%) other. 1756 (75%) enrolled in hospice prior to death but only 1580 (68%) died with hospice. 176 (10%) of 1756 patients unenrolled and died without hospice. 346 (20%) unenrolled from hospice multiple times. From 2008 to 2012, patients were less likely to unenroll from hospice prior to death. Black patients were more likely to unenroll from hospice prior to death (OR 2.07 [1.15-3.73]; p = 0.02) compared to white patients. The median amount paid by Medicare during the last six months of life was $38,530 for those in hospice compared to $49,942 if never enrolled in hospice (p < 0.0001) and was higher for black and Hispanic patients compared to white patients. 30% hospice unenrolled patients and 40% multiply enrolled hospice patients received at least one life extending or invasive care procedure following unenrollment from hospice. CONCLUSION: Recently, more patients remain enrolled in hospice, but black patients have a higher risk of unenrollment. Hospice enrollment was associated with lower costs as long as a patient did not unenroll from hospice.

Women's preferences for cancer risk management strategies in Lynch syndrome.

OBJECTIVE: We assessed preferences for cancer risk management strategies for Lynch syndrome (LS) in LS-affected women. METHODS: Women with LS aged ≥25 years evaluated 9 cancer risk management strategies using a visual analog scale (VAS) and modified standard gamble (SG). For the VAS, women ranked each strategy ranging from 0 (least preferred) to 100 (most preferred). VAS scores were calculated by dividing the corresponding number by 100. Scores closer to 1.0 reflected more favorable strategies. For the SG, participants were asked to specify their expected threshold of lifetime risk of endometrial or colorectal cancer, ranging from 0 to 100%, at which they would consider undertaking each strategy. Strategies included chemoprevention, cancer screening, and preventive surgery. Cancer worry and perceived cancer risk measures were collected on a subset of participants. RESULTS: Sixty-one women completed preference assessments. By VAS, annual combined screening was the most preferred, followed by annual screenings and chemoprevention with oral contraceptives. By SG, women were the most willing to endorse oral contraceptives and biannual screening strategies at the lowest threshold of lifetime risk followed by annual screening strategies. Surgical interventions were the least preferred strategies using both VAS and SG. Women with a family history of gynecologic or colorectal cancer were less likely to consider prevention or screening options compared to women without a family history. Cancer worry was higher among women with a positive family history of LS cancer. CONCLUSION: Understanding women's preferences may facilitate optimal use and adherence to cancer risk management strategies.

Exploring the effect of PAs on physician trainee learning: An interview study.

BACKGROUND: Physician assistants (PAs) often have been embedded in academic medical centers to help ensure an adequate patient care workforce while supporting compliance with work-hour restrictions for residents and fellows (also called trainees). Limited studies have explored the effect of PAs on trainee learning. This qualitative study explored, from the perspective of physician faculty and PAs, how PAs working in the clinical learning environment can enhance or hinder trainee learning. METHODS: Using purposive sampling, 12 PAs and 12 physician faculty members in one US teaching hospital were selected for semistructured interviews. Data collection and analysis were characterized by an iterative process. Data analysis was informed by principles of conventional content analysis. RESULTS: Participants identified various ways in which PAs may affect trainee learning, intrinsically linked to the roles PAs assume in the clinical learning environment: clinician, teammate, and clinical teacher. Trainee learning may be enhanced because learning time can be optimized by having PAs in the clinical learning environment. Trainees can learn about PAs and how to collaborate with them, and PAs can enculturate and provide clinical instruction to trainees. Trainee learning may be hindered if learning opportunities for trainees go to PAs, trainees feel intimidated by experienced PAs, or trainees become too dependent on PAs. CONCLUSIONS: Our findings demonstrate enhancements and hindrances to trainees' learning linked to three key roles PAs perform in the clinical learning environment. These findings can inform how PAs are integrated into teaching services. Further investigation is needed to understand how PAs can balance their professional roles to foster effective collaborative practice and learning.

Prospective assessment of patient-reported outcomes in gynecologic cancer patients before and after pelvic exenteration.

OBJECTIVE: Pelvic exenteration (PE) is a surgical procedure associated with significant morbidity offered to select women with locally advanced or recurrent gynecologic cancers. This ongoing study examines an array of patient-reported outcomes and satisfaction with PE. METHODS: Since February 2009, prospectively enrolled participants completed questionnaires evaluating body image (BIS), depression (CESD), social support (DUFSS), symptoms (MDASI), sexual function (SAQ), functional status (SF-12), quality of life (The Stoma-QOL), satisfaction with decision (SWD) and an investigator-designed survey at baseline, 6, and 12months after PE. Mann-Whitney and Wilcoxon signed-rank tests were used to evaluate the data. RESULTS: Fifty-four women enrolled. Median age was 56years (31, 85). Median BMI was 30.7kg/m2 (16.8, 54.4). The majority of patients (78%) were white. Cancer diagnoses included 41% cervix, 22% uterus, 19% vagina, 17% vulva and 2% ovary. Most surgeries were total PEs (76%). Patients were satisfied with their decision to undergo PE at 6 and 12months. One year after exenteration, 79% of women stated they would have a PE again. Sexual pleasure decreased from baseline to 12months after PE (p=0.02), while sexual discomfort remained unchanged (p=0.42). Body image worsened over time (p=0.003). Physical functioning (SF-12) declined (p=0.001), while mental functioning remained stable (p=0.46). There were no significant changes in stoma-related QOL, social support, or depression scores. CONCLUSIONS: Despite a decrease in physical functioning, persistent low body image and sexual pleasure, most women were satisfied with their decision and would undergo pelvic exenteration again. This study identifies survivorship issues that should be addressed after PE.

Does adjuvant chemotherapy dose modification have an impact on the outcome of patients diagnosed with advanced stage ovarian cancer? An NRG Oncology/Gynecologic Oncology Group study.

PURPOSE: To determine the relationship between chemotherapy dose modification (dose adjustment or treatment delay), overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC) who receive carboplatin and paclitaxel. METHODS: Women with stages III and IV EOC and PPC treated on the Gynecologic Oncology Group phase III trial, protocol 182, who completed eight cycles of carboplatin with paclitaxel were evaluated in this study. The patients were grouped per dose modification and use of granulocyte colony stimulating factor (G-CSF). The primary end point was OS; Hazard ratios (HR) for PFS and OS were calculated for patients who completed eight cycles of chemotherapy. Patients without dose modification were the referent group. All statistical analyses were performed using the R programming language and environment. RESULTS: A total of 738 patients were included in this study; 229 (31%) required dose modification, 509 did not. The two groups were well-balanced for demographic and prognostic factors. The adjusted hazard ratios (HR) for disease progression and death among dose-modified patients were: 1.43 (95% CI, 1.19-1.72, P < 0.001) and 1.26 (95% CI, 1.04-1.54, P = 0.021), respectively. Use of G-CSF was more frequent in dose-modified patients with an odds ratio (OR) of 3.63 (95% CI: 2.51-5.26, P < 0.001) compared to dose-unmodified patients. CONCLUSION: Dose-modified patients were at a higher risk of disease progression and death. The need for chemotherapy dose modification may identify patients at greater risk for adverse outcomes in advanced stage EOC and PPC.

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.

Factors influencing fertility-sparing treatment for gynecologic malignancies: A survey of Society of Gynecologic Oncology members.

OBJECTIVES: This study aims to examine practice patterns of gynecologic oncologists (GO) regarding fertility-sparing treatments (FST) for gynecology malignancies and explores attitudes toward collaboration with reproductive endocrinologists (RE). METHODS: An anonymous 23-question survey was sent to 1087 GO with a 14.0% completion rate. Descriptive statistics, Fisher's exact test, and Chi-square tests were used for data analysis. RESULTS: The majority of GOs offer FST for gynecologic malignancies. Providers seeing larger numbers of reproductive age women were more likely to consider cancer prognosis (p<0.03) and cancer stage (p<0.01) as key factors. Providers in the Midwestern US considered socioeconomic status more often when offering FST than those in the South (p<0.04). Those practicing in urban settings were more likely to feel that collaborating with a RE prior to treatment could improve treatment planning for women considering FST (p<0.02). Finally, providers in urban or suburban areas more often felt collaboration with a RE improves pregnancy outcomes in women who pursue FST (p<0.01, p<0.02) compared to rural practitioners. CONCLUSIONS: While FST offers women the chance to pursue pregnancy after cancer, there are minimal data on factors that influence whether FST is offered and if collaboration with a RE is sought in the management of these patients. The number of reproductive age women seen, geographic location, and practice setting are important variables that may influence current practice. Understanding these factors can help identify opportunities to improve oncologic and reproductive outcomes of this patient population.

Nothing left to chance? The impact of locus of control on physical and mental quality of life in terminal cancer patients.

PURPOSE: The purpose of this study is to evaluate if locus of control (LOC) predicts various quality of life (QOL) and mental well-being measures among terminally ill cancer patients at the time of palliative care consult. METHODS: Multi-site analysis of patients with advanced cancer being seen as new patients in a Palliative and Supportive Care outpatient clinic. Patients completed the following surveys: locus of control (LOC) scale, Functional Assessment of Chronic Illness Therapy-General (FACT-G), Functional Assessment of Chronic Illness Therapy-Spiritual (FACIT-Sp), Hospital Anxiety Depression Scale (HADS), and Herth Hope Index (HHI). Regression models were created to examine the effect of LOC upon QOL, symptoms, and other measures of mental well-being. These models adjusted for the effect of age, gender, race, partnership status, education, and months since diagnosis as potential confounders. RESULTS: This study enrolled 100 patients. After adjusting for site, race, and partnership status, higher levels of LOC chance predicted decreased QOL (FACT-G) (p < 0.01). Higher levels of LOC chance also correlated with increased depression and anxiety (p ≤ 0.01) and decreased meaning/peace and faith (p ≤ 0.01). Additionally, higher levels of LOC chance predicted decreased hope (HHI) (p ≤ 0.001). CONCLUSIONS: Terminally ill cancer patients with a high LOC chance may be at risk for decreased physical and mental well-being at the end of life. Efforts should be made to identify these patients and design interventions to increase their feeling of control over the situation in order to improve physical and mental well-being at the end of life.

Treatment Patterns, Outcomes, and Costs for Bowel Obstruction in Ovarian Cancer.

OBJECTIVE: The aim of this study was to assess treatment patterns, outcomes, and costs for bowel obstruction in ovarian cancer. METHODS/MATERIALS: All patients with stage II to IV ovarian cancer who were admitted for bowel obstruction greater than or equal to 6 months after cancer diagnosis from 2000 to 2011 were identified from the Surveillance, Epidemiology, and End Results registry-Medicare database. Management strategies and outcomes of bowel obstruction were compared. RESULTS: Among 1397 women with bowel obstruction, 562 (40%) underwent surgery, and 154 (11%) had a gastrostomy or jejunostomy (G/J) tube placed. Thirty-four percent of patients who underwent surgery subsequently received chemotherapy, compared with 8% of those managed with a G/J tube (odds ratio, 4.8; 95% confidence interval [CI], 2.7-8.8). Thirty-day complications were higher for patients in the surgery group compared with those in the tube group (69% vs 46%; odds ratio, 2.5; 95% CI, 1.8-3.7), as were mean adjusted 30-day total costs ($28,872 vs $18,528, P < 0.001). Median survival was greater for women who underwent surgery compared with those who had a G/J tube (5.3 vs 1.2 months; adjusted hazard ratio, 0.31; 95% CI, 0.25-0.38). The median survival of patients in whom surgical correction failed and required G/J tube placement during the same inpatient admission was 2.6 months. Women who received postintervention chemotherapy had improved survival compared with those who did not in both the surgery (17.0 vs 2.8 months, P < 0.001) and G/J tube (5.7 vs 1.0 months, P < 0.001) groups. CONCLUSIONS: In women with ovarian cancer who develop bowel obstruction, surgery may benefit a subset of patients, likely related to the ability to receive subsequent chemotherapy. Efforts to identify those who derive no benefit may reduce unnecessary laparotomy, along with its associated complications and costs. Given this population's limited survival, patient preferences should be evaluated in future studies assessing the management of bowel obstruction.

The Advance Care Planning Readiness Scale: Development and Validation of a Measure of Willingness to Discuss and Acceptance of End-of-Life Care in Gynecologic Cancer Patients.

OBJECTIVE: The objective of this article was to develop and validate a scale that assesses the readiness of gynecologic oncology patients to engage in advance care planning. METHODS: The Advance Care Planning Readiness Scale (ACPRS) was validated across 3 independent samples of gynecologic oncology patients. In step I, patients underwent cognitive interviewing to determine if the scale items were comprehensible and applicable to patients. Based on this, modifications to the scale (addition, removal, and merger of items) were completed. In step II, the revised scale was administered to a new sample of patients to assess scale reliability and validity. An exploratory factor analysis determined if the scale loaded onto unique factors. In step III, the revised scale was administered to a third sample of patients, and a confirmatory factor analysis was conducted to test the factor structure proposed in step II. Associations between ACPRS score and completion of advance directives were evaluated. RESULTS: Based on patients' responses, the original ACPRS used in step I was modified to the ACPRS used in step II. The final 8-item ACPRS is a valid, reliable (Cronbach α = 0.81) scale and has 2 primary factors. Women with medical power of attorney documents and living wills had higher ACPRS total scores than those who did not have these advance directives (P = 0.0030). Women with do-not-resuscitate (DNR) orders had higher ACPRS total scores than women without DNRs (P = 0.0176). CONCLUSIONS: The ACPRS is a valid and reliable 8-item scale that assesses the readiness of gynecologic oncology patients to discuss advance care planning issues.

Defining the impact of the use of granulocyte colony stimulating factors on the incidence of chemotherapy-induced neutropenia in patients with gynecologic malignancies.

Purpose The objectives of this study were to characterize the incidence of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) with specific chemotherapy agents commonly used in the treatment of gynecologic malignancies, as well as defining the impact of granulocyte colony stimulating factors (G-CSF) on the prevention of CIN and FN in this patient population. Methods This retrospective analysis was conducted from a database of 635 gynecologic cancer patients who received chemotherapy between 1 September 2007 and 31 August 2008. A logistic regression analysis was conducted to determine the impact of potential covariates on the overall incidence of CIN. Results Overall, 28.3% of patients experienced CIN with one or more cycles chemotherapy, and 13.1% had treatment delays or dose reduction associated with CIN. The use of G-CSF prior to administration of chemotherapy resulted in a decrease in the incidence of CIN from 29.8% to 19.6% compared to no G-CSF use. No difference was observed in number of treatment delays or dose reductions in the 46 (7.2%) of gynecologic cancer patients that received G-CSF prophylaxis. Multivariate analysis found that both age and the number of current cycles jointly may predict risk of CIN. Conclusions Patients with gynecologic malignancies appear to be at a higher risk of development of neutropenia when treated with chemotherapy. The proactive use of G-CSF did decrease the risk of CIN by over 30%. Prospective study is warranted to determine the impact of G-CSF to reduce CIN in patients with gynecologic malignancies receiving chemotherapy.

Dying well: How equal is end of life care among gynecologic oncology patients?

OBJECTIVE: To identify disparities in utilization of end of life (EoL) resources by gynecologic oncology (GO) patients. METHODS: This retrospective analysis of the medical records of GO patients treated 1/2007-12/2011 and deceased 1/2012-8/2014 evaluated patient demographics, disease characteristics, and utilization of EoL resources. Chi-square, Fisher's exact test, Mann Whitney and Kruskal-Wallis tests were used for statistical analysis. RESULTS: Of 189 patients analyzed, 113 (60%) were white, 38 (20%) Hispanic, 31 (16%) black, and seven (4%) Asian. Ninety-five (48%) had ovarian cancer, 51 (26%) uterine, 47 (23%) cervical, seven (3%) vulvar/vaginal. In the last 30days of life (DoL), 18 (10%) had multiple hospital admissions, 10 (5%) admitted to the Intensive Care Unit (ICU), 30 (16%) multiple Emergency Room (ER) visits, 45 (24%) received aggressive medical care and eight (4%) received chemotherapy in the final 14 DoL. Furthermore, 54 (29%) had no Supportive Care referral and 29 (15%) no hospice referral. Only 46 (24%) had a Medical Power of Attorney (PoA) or Living Will (LW) on file. Non-white race was associated with increased odds of dying without hospice (OR 3.07; 95%CI [1.27, 2.46], p=0.013). However, non-white patients who enrolled in hospice did so earlier than white patients (42 v. 27days before death, p=0.054). Non-white patients were also significantly less likely to have PoA/LW documentation (24% v. 76%, p=0.009) even if enrolled in hospice (12% v. 31%, p=0.007). CONCLUSIONS: Significant racial disparities in hospice enrollment and PoA/LW documentation were seen in GO patients. This warrants further study to identify barriers to use of EoL resources.

Room for improvement: An examination of advance care planning documentation among gynecologic oncology patients.

OBJECTIVES: The goals of this study were: (1) to evaluate patients' knowledge regarding advance directives and completion rates of advance directives among gynecologic oncology patients and (2) to examine the association between death anxiety, disease symptom burden, and patient initiation of advance directives. METHODS: 110 gynecologic cancer patients were surveyed regarding their knowledge and completion of advance directives. Patients also completed the MD Anderson Symptom Inventory (MDASI) scale and Templer's Death Anxiety Scale (DAS). Descriptive statistics were utilized to examine characteristics of the sample. Fisher's exact tests and 2-sample t-tests were utilized to examine associations between key variables. RESULTS: Most patients were white (76.4%) and had ovarian (46.4%) or uterine cancer (34.6%). Nearly half (47.0%) had recurrent disease. The majority of patients had heard about advance directives (75%). Only 49% had completed a living will or medical power of attorney. Older patients and those with a higher level of education were more likely to have completed an advance directive (p<0.01). Higher MDASI Interference Score (higher symptom burden) was associated with patients being less likely to have a living will or medical power of attorney (p=0.003). Higher DAS score (increased death anxiety) was associated with patients being less likely to have completed a living will or medical power of attorney (p=0.03). CONCLUSION: Most patients were familiar with advance directives, but less than half had created these documents. Young age, lower level of education, disease-related interference with daily activities, and a higher level of death anxiety were associated with decreased rates of advance directive completion, indicating these may be barriers to advance care planning documentation. Young patients, less educated patients, patients with increased disease symptom burden, and patients with increased death anxiety should be targeted for advance care planning discussions as they may be less likely to engage in advance care planning.

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.