Predictors of germline genetic testing referral and completion in ovarian cancer patients at a Comprehensive Cancer Center.

OBJECTIVES: To identify predictors of referral and completion of germline genetic testing among newly diagnosed ovarian cancer patients, with a focus on geographic social deprivation, oncologist-level practices, and time between diagnosis and completion of testing. METHODS: Clinical and sociodemographic data were abstracted from medical records of patients newly diagnosed with ovarian cancer between 2014 and 2019 in the University of North Carolina Health System. Factors associated with referral for genetic counseling, completion of germline testing, and time between diagnosis and test results were identified using multivariable regression. RESULTS: 307/459 (67%) patients were referred for genetic counseling and 285/459 (62%) completed testing. The predicted probability of test completion was 0.83 (95% CI: 0.77-0.88) for patients with a referral compared to 0.27 (95% CI: 0.18-0.35) for patients without a referral. The predicted probability of referral was 0.75 (95% CI: 0.69-0.82) for patients at the 25th percentile of ZIP code-level Social Deprivation Index (SDI) and 0.67 (0.60-0.74) for patients at the 75th percentile of SDI. Referral varied by oncologist, with predicted probabilities ranging from 0.47 (95% CI: 0.32-0.62) to 0.93 (95% CI: 0.85-1.00) across oncologists. The median time between diagnosis and test results was 137 days (IQR: 55-248 days). This interval decreased by a predicted 24.46 days per year (95% CI: 37.75-11.16). CONCLUSIONS: We report relatively high germline testing and a promising trend in time from diagnosis to results, with variation by oncologist and patient factors. Automated referral, remote genetic counseling and sample collection, reduced out-of-pocket costs, and educational interventions should be explored.

An implementation science approach to the systematic study of access to gynecologic cancer care.

INTRODUCTION: Barriers to access to cancer care are profoundly threatening to patients with gynecologic malignancies. Implementation science focuses on empirical investigation of factors influencing delivery of clinical best practices, as well as interventions designed to improve delivery of evidence-based care. We outline one prominent framework for conducting implementation research and discuss its application to improving access to gynecologic cancer care. METHODS: Literature on the use of the Consolidated Framework for Implementation Research (CFIR) was reviewed. Delivery of cytoreductive surgery for advanced ovarian carcinoma was selected as an illustrative case of an evidence-based intervention (EBI) in gynecologic oncology. CFIR domains were applied to the context of cytoreductive surgical care, highlighting examples of empirically-assessable determinants of care delivery. RESULTS: CFIR domains include Innovation, Inner Setting, Outer Setting, Individuals, and Implementation Process. "Innovation" relates to characteristics of the surgical intervention itself; "Inner Setting" relates to the environment in which surgery is delivered. "Outer Setting" refers to the broader care environment influencing the Inner Setting. "Individuals" highlights attributes of persons directly involved in care delivery, and "Implementation Process" focuses on integration of the Innovation within the Inner Setting. CONCLUSIONS: Prioritization of implementation science methods in the study of access to gynecologic cancer care will help ensure that patients are able to utilize interventions with the greatest prospect of benefiting them.

Endometrial cancer survivors' perceptions of their cardiovascular disease risk (results from WF-1804CD AH-HA).

OBJECTIVE: Despite considerable burden of cardiovascular disease (CVD), data on endometrial cancer survivors' CVD perceptions are lacking. We assessed survivors' perspectives on addressing CVD risk during oncology care. METHODS: This cross-sectional analysis utilized data from an ongoing trial of an EHR heart health tool (R01CA226078 & UG1CA189824) conducted through the NCI Community Oncology Research Program (NCORP, WF-1804CD). Endometrial cancer survivors post-potentially curative treatment were recruited from community practices and completed a pre-visit baseline survey, including American Heart Association Simple 7 CVD factors. Likert-type questions assessed confidence in understanding CVD risk, CVD risk perception, and desired discussion during oncology care. Medical record abstraction ascertained data on CVD and cancer characteristics. RESULTS: Survivors (N = 55, median age = 62; 62% 0-2 years post-diagnosis) were predominately white, non-Hispanic (87%). Most agreed/strongly agreed heart disease poses a risk to their health (87%) and oncology providers should talk to patients about heart health (76%). Few survivors reported smoking (12%) but many had poor/intermediate values for blood pressure (95%), body mass index (93%), fasting glucose/A1c (60%), diet (60%), exercise (47%) and total cholesterol (53%). 16% had not seen a PCP in the last year; these survivors were more likely to report financial hardship (22% vs 0%; p = 0.02). Most reported readiness to take steps to maintain or improve heart health (84%). CONCLUSIONS: Discussions of CVD risk during routine oncology care are likely to be well received by endometrial cancer survivors. Strategies are needed to implement CVD risk assessment guidelines and to enhance communication and referrals with primary care. Clinical Trials #: NCT03935282.

A qualitative study of patients' attitudes towards telemedicine for gynecologic cancer care.

INTRODUCTION: Women with gynecologic cancers may face geographic barriers to standard-of-care consultation with a gynecologic oncologist. While telemedicine may help overcome these geographic barriers, there are no qualitative data exploring gynecologic cancer patients' attitudes towards telemedicine for cancer care. Patients with gynecologic malignancies may have preferences distinct from general oncology populations due to the sensitive nature of the diseases and anatomy involved. METHODS: Semi-structured interviews were conducted with 15 patients with gynecologic cancers to identify perceived advantages and disadvantages of telemedicine use for gynecologic cancer care. Past experience with telemedicine was elicited as were suggestions for cancer care encounters most compatible with telemedicine. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: All patients interviewed were open to the use of telemedicine. Emergent themes regarding advantages of telemedicine included convenience, cost savings, reduced travel, avoidance of infectious disease, and availability of care for those too unwell for in-person visits. Themes regarding disadvantages of telemedical care included technical difficulties, perceived need for examination or testing, and potential compromise of therapeutic relationship. Patients were particularly concerned that difficulty in establishing a therapeutic relationship would compromise initial consultations with gynecologic oncologists via telemedicine. CONCLUSION: Patients with gynecologic cancer are open to use of telemedicine for their care. Particular attention should be paid to overcoming patients' hesitancy to have initial visits with gynecologic oncologists, as these consultations have the greatest potential to improve access to high-quality gynecologic cancer care.

Routine informed consent for mismatch repair testing in endometrial cancers: Review and ethical analysis.

OBJECTIVE: To review available data regarding consent for tumor testing for mismatch repair (MMR), and to make recommendation for ethical best practices based on synthesis of contemporary data and ethical principles. METHODS: PubMed and CINAHL databases were searched through September 2021; articles reporting on consent for MMR tumor testing for patients at risk for Lynch Syndrome were abstracted. Additional articles were identified through review of references. Key data and ethical principles were extracted, summarized, and analyzed in the context of contemporary clinical practice. RESULTS: 16 articles met inclusion criteria for this review, none of which specifically related to MMR testing for endometrial cancers. All but two studies were published prior to the approval of pembrolizumab for treatment of MMR-deficient tumors. Scant available data suggest that routine consent prior to tumor testing is uncommon; however, several decision aids improved patient knowledge and satisfaction prior to deciding whether to proceed with tumor testing. Previous ethical analyses invoke clinical utility, potential germline implications, and logistical factors in making recommendations regarding consent practices. These analyses varied in their final recommendations; however, all had significant deficits in their arguments related to contemporary clinical care for patients with endometrial cancer. CONCLUSION: Current data are needed to assess the impact of potential consent strategies for tumor testing. Based on available data, and consistent with contemporary ethical best practices, we recommend that planned MMR testing of endometrial cancers be discussed routinely with patients verbally or in surgical consent documents.

Responding to patient requests for women obstetrician-gynecologists.

Patients may request care from a woman obstetrician-gynecologist for various reasons, including privacy concerns, religious or cultural reasons, and in some cases, a history of abuse. They should be given the opportunity to voice their reasons for requesting a woman obstetrician-gynecologist but should not be compelled to do so. Respect for patient autonomy is a compelling reason to consider honoring a patient's gender-based request. When a patient requests a woman obstetrician-gynecologist, efforts should be made to accommodate the request if possible. However, medical professionals and institutions are not ethically obligated to have a woman obstetrician-gynecologist on call or to make one available at all times. If it is not feasible for a woman obstetrician-gynecologist to provide care because of staffing or other system constraints or patient safety concerns, accommodation is not required, and physicians do not have an overriding responsibility to ensure that patients receive gender-concordant care. Patients have the right to decline care and may choose to seek care elsewhere if their requested healthcare provider type is not available. Institutions and medical clinics should have policies and procedures in place for managing patient requests for women obstetrician-gynecologists, and patients should be made aware of these policies preemptively. These policies and procedures should include information about whom to contact for assistance and how to document the encounter. They should also be accessible and familiar to physicians and trainees. Care should be taken to ensure that adequate educational opportunities in obstetrics and gynecology are available for all medical trainees, regardless of gender.

Ethical challenges for women's healthcare highlighted by the COVID-19 pandemic.

Healthcare policies developed during the COVID-19 pandemic to safeguard community health have the potential to disadvantage women in three areas. First, protocols for deferral of elective surgery may assign a lower priority to important reproductive outcomes. Second, policies regarding the prevention and treatment of COVID-19 may not capture the complexity of the considerations related to pregnancy. Third, policies formulated to reduce infectious exposure inadvertently may increase disparities in maternal health outcomes and rates of violence towards women. In this commentary, we outline these challenges unique to women's healthcare in a pandemic, provide preliminary recommendations and identify areas for further exploration and refinement of policy.

Does surgical treatment of atypical endometrial hyperplasia require referral to a gynecologic oncologist?

Patients with atypical endometrial hyperplasia in the United States are commonly referred to a gynecologic oncologist, given a moderate risk of concurrent carcinoma. However, selective referral of patients to nononcologic gynecologic surgeons for surgical treatment of atypical endometrial hyperplasia may offer increased access to care without compromising clinical outcomes. Nononcologic surgeons who consider providing surgical treatment for atypical endometrial hyperplasia must be able to offer minimally invasive surgery when appropriate and have sufficient surgical volume to deliver optimal clinical outcomes. Patients considering referral to a nononcologic surgeon must be thoroughly counseled regarding the risk of occult malignancy, the possibility of a second surgery for lymph node evaluation and/or oophorectomy, and the risk of morbidity that may accompany a second surgery. Available data suggest that approximately 2-6% of patients will have postoperative risk factors meriting consideration of a second surgery. Patients who are high-risk surgical candidates or who may desire nonsurgical or fertility-sparing treatment should universally be referred for consultation with a gynecologic oncologist.

Are Patients With Cancer Best Managed in a Clinical Trial?

This Viewpoint analyzes how the NCCN's boxed statement that all cancer is best managed in a clinical trial cannot be applied to all patients and calls for its removal from its clinical practice guidelines.

Survival implications of staging lymphadenectomy for non-endometrioid endometrial cancers.

PURPOSE: To determine, in patients with non-endometrioid endometrial carcinoma, 1) survival benefit associated with pelvic lymphadenectomy (LND), 2) survival benefit for para-aortic lymphadenectomy performed in addition to pelvic lymphadenectomy, and 3) association between number of lymph nodes removed and survival. METHODS: Patients with clinical stage I serous carcinoma, clear cell carcinoma, or carcinosarcoma who underwent hysterectomy from 2010 to 2013 were identified from the National Cancer Database. Hazard ratio (HR) for death was assessed using propensity score-weighted multivariable Cox regression models. Subgroup analyses assessed for differences in risk of death among histologic subtypes. RESULTS: 7250 patients met study criteria. 930 (13%) did not undergo LND; 2177 (30%) underwent pelvic LND alone; 4143 (57%) underwent pelvic+para-aortic LND. On propensity score-weighted analysis, pelvic LND was associated with decreased risk of death (HR=0.65, 95% CI: 0.59-0.71) compared to no LND. Pelvic+para-aortic LND was associated with decreased risk of death (HR=0.85, 95% CI: 0.79-0.91) compared to pelvic LND for patients with serous carcinoma. Removal of >15 nodes was independently associated with decreased HR for death (HR=0.86, 95% CI: 0.77-0.96); this association persisted when analysis was limited to patients with node-positive disease (HR=0.78, 95% CI: 0.63-0.95). CONCLUSIONS: LND is associated with survival benefit in patients with non-endometrioid endometrial cancers. Addition of para-aortic LND to pelvic LND may be most beneficial for patients with serous carcinoma. Systematic lymphadenectomy may be associated with survival benefit through detection and microscopic cytoreduction of occult disease.

Are patients willing to travel for better ovarian cancer care?

OBJECTIVE: Improved outcomes realized by patients treated at high-volume institutions have led to a call for centralization of ovarian cancer care. However, it is unknown whether centralization respects patients' preferences regarding treatment location. This study's objective was to determine how patients balance survival benefit against the burdens of travel to a distant treatment center. METHODS: Patients presenting for evaluation of adnexal masses completed two discrete choice experiments (DCEs) assessing 1) the 5-year survival benefit required to justify 50miles of additional travel, and 2) the additional distance patients would travel for a 6% 5-year survival benefit. Demographic data were collected with measures of health numeracy, social support, and comfort with travel. t-Tests were performed to test for significant differences between group means. RESULTS: 81% (50/62) of participants required a 5-year survival benefit of ≤6% to justify 50miles of additional travel (DCE#1). These participants were less likely to be employed (56% vs 83%, p=0.05) and more likely to rate their health as good to excellent (86% vs 50%, p=0.04) than those requiring >6% benefit to travel 50miles. 80% (44/55) of participants would travel ≥50miles for a set 5-year survival benefit of 6% (DCE#2). No association was identified in DCE#2 between willingness to travel and collected sociodemographic covariates. CONCLUSIONS: 1 in 5 patients with ovarian cancer may prefer not to travel to a referral center, even when aware of the survival benefits of doing so. Policymakers should consider patients' travel preferences in designing referral structures for care.

Survival implications of time to surgical treatment of endometrial cancers.

BACKGROUND: Optimal care for women with endometrial cancers often involves transfer of care from diagnosing physicians (eg, obstetrician-gynecologists) to treating physicians (eg, gynecologic oncologists.) It is critical to determine the effect of time to treatment on cancer outcomes to set best practices guidelines for referral processes. OBJECTIVE: We sought to determine the impact of time from diagnosis of endometrial cancer to surgical treatment on mortality and to characterize those patients who may be at highest risk for worsened survival related to surgical timing. STUDY DESIGN: The National Cancer Database was queried for incident endometrial cancers in adults from 2003 through 2012. Cancers were classified as low risk (grade 1 or 2 endometrioid histologies) or high risk (nonendometrioid and grade 3 endometrioid histologies) and analyzed separately. Demographic, clinicopathologic, and health system factors were collected. Unadjusted and adjusted hazard ratios for mortality were calculated by interval between diagnosis and surgery. Linear regression of patient and health care system characteristics was performed on diagnosis-to-surgery interval. RESULTS: For low-risk cancers (N = 140,078), surgery in the first and second weeks after diagnosis was independently associated with mortality risk (hazard ratio, 1.4; 95% confidence interval, 1.3-1.5; and hazard ratio, 1.1; 95% confidence interval, 1.0-1.2, respectively). The 30-day postoperative mortality was significantly higher among patients undergoing surgery in the first or second week postdiagnosis, compared to patients treated in the third or fourth week postdiagnosis (0.7% vs 0.4%; P < .001). Mortality risk was also significantly higher than baseline when time between diagnosis and surgery was >8 weeks. Independent associations with added time to surgery of at least 1 week were seen with black race (1.1 weeks; 95% confidence interval, 0.9-1.4), uninsurance (1.3 weeks; 95% confidence interval, 1.1-1.5), Medicaid insurance (1.7 weeks; 95% confidence interval, 1.5-1.9), and Charlson-Deyo comorbidity score >1 (1.0 weeks; 95% confidence interval, 0.8-1.2). For high-risk cancers (N = 68,360), surgery in the first and second weeks after diagnosis was independently associated with mortality risk (hazard ratio, 1.5; 95% confidence interval, 1.3-1.6; and hazard ratio, 1.2; 95% confidence interval, 1.1-1.2, respectively). The 30-day postoperative mortality was significantly higher among patients undergoing surgery in the first or second week postdiagnosis, compared to patients treated in the third or fourth week postdiagnosis (2.5% vs 1.0%; P < .001). Surgery after the third week postdiagnosis was not associated with a statistically significant increase in the adjusted risk of mortality. Independent associations with added time to surgery of at least 1 week were seen with uninsurance (1.4 weeks; 95% confidence interval, 0.9-1.9) and Medicaid insurance (1.4 weeks; 95% confidence interval, 1.1-1.7). CONCLUSION: Surgery in the first 2 weeks after diagnosis of endometrial cancer was associated with worsened survival associated with elevated perioperative mortality and treatment in low-volume hospitals. Delay in surgical treatment was a risk factor for mortality in low-risk cancers only and was likely associated with poor access to specialty care. We suggest that the target interval between diagnosis and treatment of endometrial cancers be ≤8 weeks; however, referral to an experienced surgeon and adequate preoperative optimization should be prioritized over expedited surgery.

Non-surgical management of ovarian cancer: Prevalence and implications.

PURPOSE: To identify prevalence, correlates and survival implications of non-surgically managed epithelial ovarian cancer (EOC). METHODS: The National Cancer Database (NCDB) was queried for EOC cases between 2003 and 2011. Type of treatment, survival data, reasons for non-surgical treatment, clinicopathologic and process-based factors were collected. Logistic regression identified independent predictors of surgical treatment; Cox proportional hazards regression modeled association between time to death and receipt of surgery. RESULTS: 172,687 of 210,667 patients (82%) received surgical treatment for EOC. 95% of patients treated non-surgically had stage III, stage IV or unknown stage disease. The reason for non-surgical treatment was unclear in 80% of cases. Black race and uninsurance were significantly associated with non-surgical treatment. Median survival time was 57.4months (95% CI: 56.8-57.9) for surgery with or without systemic treatment compared to 11.9months (95% CI: 11.6-12.2) for systemic treatment alone and 1.4months (95% CI: 1.3-1.4) for no treatment. Relative to surgical treatment, the adjusted hazard ratio for death associated with systemic treatment alone was 1.9 (p<0.001); hazard ratio for untreated patients was 4.7 (p<0.001). Among 29,921 patients older than 75 with Stage III/IV disease, 21.5% received only systemic treatment; 22.8% were entirely untreated. CONCLUSION: 18% of EOC patients in the NCDB did not receive surgical treatment. These patients experienced significantly worsened survival. Prospective investigation is needed to determine how often apparent deviation from best-practices guidelines is clinically appropriate. Non-surgically treated patients may be at risk for poor access to gynecologic oncology care and deserve further study.

Interactions with industry under the Sunshine Act: an example from gynecologic oncology.

THE PROBLEM: Clinicians may be unaware that industry payments to physicians are now publicly searchable under the Physician Payments Sunshine Act. Furthermore, the extent of industry's financial involvement in subspecialty practice has not been previously accessible. As an example, 6948 direct, research-unrelated payments totaling $1,957,004 were made to 765 gynecologic oncologists in 2014, the first full year of data available. A total of 153 companies reported at least 1 payment; however, the 10 manufacturers reporting the highest total payment amount accounted for 82% of all payments to physicians. In all, 48 gynecologic oncologists received >$10,000 from manufacturers, accounting for $1,202,228, or 61%, of total payments. A SOLUTION: Obstetrician-gynecologists, including gynecologic oncologists, should be aware of their publicly reported payments from industry and ensure reports' accuracy. Professional organizations, including the Society of Gynecologic Oncology (SGO), should strongly consider proactively developing guidelines regarding interactions with industry for their general memberships.

Geographic access to gynecologic cancer care in the United States.

BACKGROUND: Women who live distant from the closest subspecialty treatment center are at risk of failing to utilize high-quality care for gynecologic cancers. There has not yet been a comprehensive, national investigation of populations affected by geographic barriers to gynecologic cancer care. METHODS: Geographic Information Systems (GIS) were used to identify United States counties farther than 50miles from the closest gynecologic oncologist, and hospital referral regions (HRRs) that do not contain the primary professional address of at least one gynecologic oncologist. US Census data were used to analyze counties' demographic characteristics. County-level cancer incidence was estimated using the Centers for Disease Control and Prevention's State Cancer Profiles. RESULTS: Thirty-six percent (1125/3143) of counties are further than 50miles from the nearest gynecologic oncologist. A total of 14.8 million women live in low-access counties (LACs). Annually, approximately 7663 women with gynecologic cancers may experience geography-related disparities in access. Residents of LACs have lower median household income, are more likely to be White and/or Hispanic, and less likely to be Black. Forty percent (123/306) of HRRs do not contain the primary address of a gynecologic oncologist. CONCLUSIONS: Approximately 9% of the female population of the United States may experience geographic barriers to access high-quality care for gynecologic malignancies. Future investigations should assess whether residents of low-access counties utilize high-quality care less often, and whether there is a disparity in clinical outcomes. Disparities might be addressed by ensuring subspecialty care in low-access regions, and/or adjusting system structures to minimize the burdens of traveling long distances for cancer care.