Faculty Bibliography

OBJECTIVES/OBJECTIVE:Trainee well-being is a core component of ACGME program requirements and the SGO has recognized the high incidence of burnout among gynecologic oncologists and its negative impact. To foster a culture of wellness throughout the SGO community we sought to engage current fellows along with fellowship directors in a structured didactic program designed to teach wellness. We evaluated the feasibility of and preliminary responses to a pilot curriculum designed to teach skills that promote wellness and prevent burnout. METHODS:The SGO Wellness Taskforce developed a curriculum with topics based on established evidence as well as specialty specific stressors such as end of life discussions. Faculty leaders from 15 pilot-sites attended a full-day training course and then taught four modules over four months. Interactive modules engaged fellows through reflective writing, guided discussion, and multimedia presentations. Fellows completed the Perceived Stress Scale pre- and post-implementation and provided feedback regarding attitudes toward wellness and the individual modules. Faculty curriculum leaders completed surveys regarding their attitudes toward the curriculum as well as their trainees' reactions. RESULTS:Among 73 participating gynecologic oncology fellows, 95% (69/73) and 52/73 (71%) completed the pre-and post-surveys, respectively. Only 34/73 (49%) respondents reported that there was wellness programming at their institution prior to the initiation of the SGO curriculum. At institutions where such programming was available, 35% (12/34) reported not utilizing them. Fifty-five (80%) fellows had PSS scores greater than 12 compared to 39 (75%) post-intervention. After the curriculum, the percentage of fellows comfortable discussing wellness topics increased from 63 to 74%. Prior to the curriculum, 75% felt they could identify symptoms of burnout or psychosocial distress. This increased to 90% post-intervention. The modules were well received by fellows, and the time spent addressing wellness was widely appreciated. CONCLUSIONS:A structured curriculum to promote wellness among gynecologic oncology fellows is feasible and was associated with observed decreased reported stress among fellows at participating programs. This curriculum addresses ACGME requirements regarding trainee well-being, and showed potential for more programmatic, nationwide implementation. Fellowship culture change was not directly measured, but may have been one of the most significant positive outcomes of the wellness program. Further longitudinal studies will be necessary to understand the natural course of fellow burnout and the impact of structured wellness programming.

PATIENTS AND METHODS/METHODS:Probands with newly diagnosed cancer-associated pathogenic variants were offered facilitated cascade testing whereby the genetics team identified and contacted ARRs by telephone to disclose the familial pathogenic variant and offer telephone counseling and mailed saliva testing. Results and guideline-based recommendations were reviewed by telephone and shared with the primary care physician. RESULTS:Thirty probands were enrolled, and 114 ARRs were identified. Twelve ARRs were excluded (lived outside of the United States, n = 5; proband did not approve of contact, n = 7). Among 102 ARRs telephoned, contact was established with 95 (93%). Among 114 identified ARRs, 66 (58%) completed genetic testing. Among those completing testing, 27 (41%) carried the familial pathogenic variant. Surveys of ARRs at the time of genetic testing and 6 months later demonstrated low levels of anxiety, depression, distress, and uncertainty and high levels of satisfaction with testing. At 6 months, 7 ARRs with pathogenic variants had undergone cancer surveillance interventions and 4 had undergone cancer risk-reducing surgery. CONCLUSION/CONCLUSIONS:Facilitated cascade testing with telephone genetic counseling and mailed saliva kits resulted in high testing uptake among ARRs. Positive genetic testing resulted in utilization of genetically targeted primary disease prevention at short-term follow-up. Facilitated cascade testing is a straightforward, low-cost, easily implemented strategy with significant potential to promote early detection for affected ARRs and reduce cancer mortality and should be evaluated in larger scale clinical trials.

PURPOSE/UNASSIGNED:Women with ovarian cancer identify patient-physician communication as an essential element in determining treatment course and believe a discussion about goals and values should precede treatment decisions. We sought to develop a patient-centered priorities assessment tool for women with ovarian cancer that could streamline communication, enhance treatment discussions, and increase patient satisfaction. MATERIALS AND METHODS/UNASSIGNED:We designed a priorities assessment tool using a validated ovarian cancer symptom index (National Comprehensive Cancer Center-Functional Assessment of Cancer Therapy Ovarian Symptom Index-18) combined with an index to assess daily quality-of-life priorities. The tool was distributed to women with ovarian cancer in small focus group settings and online, followed by a postactivity feedback form. RESULTS/UNASSIGNED:In this pilot study, 36 women completed the priorities assessment tool and 35 completed the postactivity feedback form between September 2015 and May 2016. All participants reported that the tool was easy to understand and comprehensive in scope. Twenty-nine participants (82.9%) completed the tool in 10 minutes or less. Most participants (n = 31, 86.1%) were able to stratify their priorities and identify 5 top treatment-related priorities. Participants who indicated that their goals and priorities had changed since diagnosis (n = 25, 69.4%) reported that the tool helped to identify current goals and priorities (22 [88%] of 25 participants) and would help them feel more comfortable participating in shared decision making with their medical team (21 [84%] of 25 participants). CONCLUSION/UNASSIGNED:A patient-centered priorities assessment tool was easy to complete and viewed as comprehensive and useful in a pilot cohort of women with ovarian cancer. Use of a priorities assessment tool has the potential to enhance communication, promote shared decision making, and improve patient satisfaction.

Providers who care for women at risk for hereditary gynecologic cancers must consider the impact of these conditions on reproductive and hormonal health. This document reviews potential options for cancer prevention, family building, genetic testing and management of surgical menopause in this patient population. Capsule: Women predisposed to hereditary gynecologic cancer have options for fertility preservation, preimplantation genetic testing to select embryos without pathogenic variants, pregnancy through gestational carriers after hysterectomy and hormone replacement.

Providers who care for women at risk for hereditary gynecologic cancers must consider the impact of these conditions on reproductive and hormonal health. This document reviews potential options for cancer prevention, family building, genetic testing and management of surgical menopause in this patient population.

BACKGROUND:Studies have consistently indicated that the majority of individuals meeting the US Prevention Services Task Force guidelines for genetic testing have not had genetic counseling or testing. Despite increased availability and lower costs of multiplex cancer gene panels, there remains a gap in genetics services that has not been addressed by the current care delivery models. Lower cost of DNA sequencing with online patient-initiated ordering could increase test availability, but the ideal quantity and delivery method of patient education is not known. We hypothesized that online genetic education and testing with access to board certified genetic counselors could improve access to genetic testing while maintaining test quality and clinical utility. The MAGENTA (MAking GENetic Testing Accessible) trial is a nationwide randomized study designed to compare the effectiveness of online genetic education with pre- and post-test telephone genetic counseling to three potentially more accessible alternative approaches: online genetic education with optional telephone counseling, online genetic education with required pre-test telephone genetic counseling, and online genetic education with required post-test telephone genetic counseling. METHODS:3000 women nationwide will undergo genetic testing for 19 hereditary cancer genes. This is a randomized four-arm non-inferiority study with equal randomization. The four study arms were selected to independently assess the delivery of genetic information both before and after genetic testing (pre-test and post-test) by either requiring telephone genetic counseling or providing only online education with optional telephone counseling. Patients have post-test telephone counseling when testing positive for a pathogenic inherited mutation in all four arms. Surveys measuring psychological, behavioral and cognitive state are completed online at baseline, 3 months, 12 months and 24 months post-results disclosure. The primary study outcome is cancer-risk distress at 3 months post-result disclosure. DISCUSSION/CONCLUSIONS:This trial will assess the use of a genetic service model using online access and electronic education, while evaluating the need for personal pre- and post-test genetic counseling. Data from this study may lead to increased options for delivery of genetic testing and possibly increase access to genetic testing. Identifying more individuals with inherited cancer susceptibility will allow targeted cancer prevention. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov: NCT02993068 (registered December 14, 2016).

OBJECTIVE:To compare gynecological cancer risk management between women with BRCA variants of unknown significance (VUS) to women with negative genetic testing. METHODS:Ninety-nine patients whose BRCA genetic testing yielded VUS were matched with 99 control patients with definitive negative BRCA results at a single institution. Demographics and risk management decisions were obtained through chart review. Primary outcome was the rate of risk-reducing bilateral salpingo-oophorectomy (RRBSO). Chi square tests, t-tests, and logistic regression were performed, with significance of p<0.05. RESULTS:VUS patients were more likely to be non-Caucasian (p=0.000) and of Ashkenazi-Jewish descent (p=0.000). There was no difference in gynecologic oncology referrals or recommendations to screen or undergo risk-reducing surgery for VUS vs. negative patients. Ultimately, 44 patients (22%) underwent RRBSO, with no significant difference in surgical rate based on the presence of VUS. Ashkenazi-Jewish descent was associated with a 4.5 times increased risk of RRBSO (OR=4.489; 95% CI=1.484-13.579) and family history of ovarian cancer was associated with a 2.6 times risk of RRBSO (OR=2.641; 95% CI=1.107-6.299). CONCLUSION/CONCLUSIONS:In our institution, patients with VUS were surgically managed similarly to those with negative BRCA testing. The numbers of patients with VUS are likely to increase with the implementation of multi-gene panel testing. Our findings underscore the importance of genetic counseling and individualized screening and prevention strategies in the management of genetic testing results.

Objective: Few effective treatment options exist for women with advanced or recurrent endometrial cancer (EC). To explore a modification of the standard systemic treatment for advanced or recurrent EC, we sought to determine the feasibility of completing 6 cycles of nab-paclitaxel (Nab-P) and carboplatin. Unlike paclitaxel, Nab-P does not require any steroid or other premedication, an important consideration for patients with diabetes mellitus and in the investigation of combinations with immunotherapy. We prospectively evaluated safety and efficacy of a day 1, 8-dose schedule of Nab-P in combination with carboplatin day 1 q3weeks in patients with chemotherapy naive EC.
Method(s): Patients with early-stage and high-risk, advanced primary, or recurrent EC with no prior platinum and taxane exposure were enrolled at a single institution. Patients received 6 cycles of day 1 Nab-P 100 mg/m² IV with carboplatin AUC 6 IV and day 8 Nab-P 100 mg/m² IV q21days. We evaluated percentage completion of 6 cycles with standard dose reductions, as well as toxicity per CTCAE v.4. Measurable disease was not required, and efficacy was assessed by PFS rate at 6 months.
Result(s): From 2016 to 2018, 23 subjects were enrolled; median age was 65 (43-73) years. Nineteen (82%) completed 6 cycles of the doublet therapy. Eight subjects (35%) were dose-reduced 1 level, and 5 (22%) were reduced 2 levels; only 1 subject withdrew due to toxicity. Twelve subjects (52%) had at least 1 grade 3/4 treatment-related adverse event, the most common being anemia, 6 (26%); neutropenia, 4 (17%); and diarrhea, 2 (9%). Pre-existing neuropathy was an exclusion criteria, and 13 (57%) reported at least grade 1 neuropathy with treatment. After treatment, 3 (13%) deaths occurred with 2 due to disease progression and 1 to pulmonary embolism. At 6 months after treatment initiation, 19 (83%) had no evidence of disease or its progression; 4 (17%) had progressed. Kaplan-Meier analysis revealed a 6-month PFS rate of 80.5% (95% CI 65.1%-99.7%) (Figure 1).
Conclusion(s): The Nab-P/carboplatin day 1, 8 regimen met the prespecified criteria of feasibility with acceptable toxicity and efficacy. Use of Nab-P obviates steroid premedications, ideal for immune checkpoint inhibitors that target mismatch repair deficient advanced EC. A future phase II feasibility trial combining an anti-PD-1 agent with Nab-P and carboplatin is planned. [Figure presented]
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Objective: There are limited data on the prognostic significance of the time interval between diagnosis and primary surgery (Hyst) in endometrial cancer (EC). While the ideal interval for best clinical outcomes is not well defined, data suggest worse survival for women with intervals >6 weeks. The objective of this study is to evaluate the time interval between diagnosis and Hyst at our institution's cancer center and further assess factors contributing to treatment delay.
Method(s): This is an Institutional Review Board-approved retrospective study of EC patients treated at our cancer center between January 2011 and July 2017. We identified 688 women who met study criteria. Clinical variables including age, race, insurance and socioeconomic status (SES), stage, histology, diagnosed elsewhere (outside referral), date of diagnosis, date of Hyst, and follow-up were recorded. We classified low SES if patients were from zip codes with >20% families below poverty level. A time interval >6 weeks between diagnosis and Hyst was scored as time delay. Univariate and multivariate logistic regression analyses were completed to evaluate outcomes and the impact of clinical factors on time interval between diagnosis and Hyst.
Result(s): Overall the median time interval between diagnosis and Hyst was 3.0 weeks (range <1-18 weeks). In 123 (17.9%) patients the interval was >6 weeks. On univariate analysis, the factors significantly associated with time delay were outside referral (P < 0.0001), Medicaid insurance (P = 0.0190), and low SES (P = 0.0157). On multivariate analysis, outside referral (OR = 2.575, 95% CI 1.665-3.918) and Medicaid insurance (OR = 2.317, 95% CI 1.189-4.513) remained significant factors for time delay. See Table 1.
Conclusion(s): Identifying clinical and socioeconomic barriers contributing to variation in time-sensitive treatment for EC patients is important for cancer care. Improved understanding of such factors provides insight and opportunity to seek required support that advocates for timely cancer care for all.
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