Secondary databases in gynecologic cancer research.

Observational and cohort studies using large databases have made important contributions to gynecologic oncology. Knowledge of the advantages and potential limitations of commonly used databases benefits both readers and reviewers. In this review, researchers familiar with National Cancer Database (NCDB), Surveillance, Epidemiology, and End Results Program (SEER), SEER-Medicare, MarketScan, Healthcare Cost and Utilization Project (HCUP), National Surgical Quality Improvement Program (NSQIP), and Premier, describe each database, its included data, access, management, storage, highlights, and limitations. A better understanding of these commonly used datasets can help readers, reviewers, and researchers to more effectively interpret and apply study results, evaluate new research studies, and develop compelling and practice-changing research.

Association of gynecologic oncology versus medical oncology specialty with survival, utilization, and spending for treatment of gynecologic cancers.

BACKGROUND: We examined the association of gynecologic oncology (GYO) versus medical oncology (MEDONC) based care with survival, health care utilization and spending outcomes in women undergoing chemotherapy for advanced gynecologic cancers. METHODS: Women with newly diagnosed stage III-IV uterine, ovarian, and cervical cancers from 2000 to 2015 were identified in SEER-Medicare. We assessed the association of provider specialty with overall survival, emergency department utilization, admissions, and spending. Outcomes were assessed using unadjusted and Inverse Treatment Probability Weighted propensity-score applied, multi-variable cox modeling, Poisson regression, and generalized models of log-transformed data. RESULTS: We identified 7930 gynecologic cancer patients (4360 ovarian, 2934 uterine, 643 cervix). 37% were treated by GYO and 63% by MEDONC. For ovarian patients, GYO care was associated with improved OS (median OS 3.3 v. 2.9 years; HR 0.85, 95%CI 0.80, 0.91, p < .0001) and similar mean spending per month ($4015 v. $4316, mean ratio 0.97 (95% CI 0.93, 1.02), p = .19), compared to MEDONC in adjusted analyses. For uterine patients, GYO care was associated with similar OS, but decreased spending ($3573 v. $4081, mean ratio 0.87 (95% CI.81, 0.93), p < .0001), and decreased ED utilization (RR 0.76, 95% CI 0.69, 0.85, p < .0001). For cervical patients, GYO care was associated with similar OS, and similar spending. Admissions were more likely in ovarian (RR 1.23, 95%CI 1.11, 1.37, p = .0001) and cervical patients (RR 1.26, 95% CI 1.05, 1.51, p = .015) treated by GYO, in adjusted analyses. CONCLUSIONS: GYO based care was associated with improved OS and equal spending for patients with advanced stage ovarian cancer. Uterine and cervix patients had similar OS, and less or equal spending respectively, when treated by GYO compared to MEDONC.

Intensity of end-of-life care for gynecologic cancer patients by primary oncologist specialty.

OBJECTIVE: The association of primary oncologist specialty, medical oncology versus gynecologic oncology, on intensity of care at the end of life in elderly patients with gynecologic cancer is unclear. METHODS: This retrospective cohort study used Surveillance, Epidemiology and End Results-Medicare (SEER-M) data. Subjects were fee-for-service Medicare enrollees aged 65 years and older who died of a gynecologic cancer between January 2006 and December 2015. The primary outcome was a composite score for high-intensity care received in the last month of life. Secondary outcomes included invasive procedures and Medicare spending in the last month of life. Simple and multivariable linear and logistic regression analyses evaluated differences in outcomes by primary oncologist specialty. Linear regressions were repeated after creating a more similar control group through nearest-neighbor propensity score matching. RESULTS: Of 12 189 patients, 7705 (63%) had a medical primary oncologist in the last year of life. In adjusted analyses, patients with a gynecologic versus medical primary oncologist received lower rates of high-intensity end-of-life care (53.9% vs 56.6%; p=0.018). Results were similar for the propensity score-matched cohorts. However, having a gynecologic versus medical primary oncologist was associated with higher rates of invasive procedures in the last month of life (43% vs 41%; p=0.014) and higher Medicare spending ($83 859 vs $74 849; p=0.004). CONCLUSIONS: Both specialties engage in overall high levels of intense end-of-life care, with differences by specialty in aspects of aggressive care and spending at the end of life. Physician-level training could be a target for educational or quality improvement initiatives to improve end-of-life cancer care delivery.

An increase in multi-site practices: The shifting paradigm for gynecologic cancer care delivery.

OBJECTIVE: To assess whether the number of practice sites per gynecologic oncologist (GO) and geographic access to GOs has changed over time. METHODS: This is a retrospective repeated cross-sectional study using the 2015-2019 Physician Compare National File. All GOs in the 50 United States and Washington, DC, who had completed at least one year of practice were included in the study. All practice sites with complete addresses were included. Linear regression analyses estimated trends in GOs' number of practice sites and geographic dispersion of practice sites. Secondary analyses assessed temporal trends in the number of geographic areas served by at least one GO. RESULTS: Although there was no significant change in the number of GOs from 2015 to 2019 (n = 1328), there was a significant increase in the number of practice sites (881 to 1416, p = 0.03), zip codes (642 to 984, p = 0.03), HSAs (404 to 536, p = 0.04), and HRRs (218 to 230, p = 0.03) containing a GO practice. The mean number of practice sites (1.64 versus 2.13, p < 0.001) and dispersion of practice sites (0.03 versus 0.43 miles, p = 0.049) per GO increased significantly. CONCLUSIONS: Between 2015 and 2019, an increasing number of GOs have multi-site practices, and more geographic regions contain a GO practice. Improvements in geographic access to GOs may represent improved access to care for many women in the US, but its effect on patients, physicians, and geographic disparities is unknown.

A novel classification of residual disease after interval debulking surgery for advanced-stage ovarian cancer to better distinguish oncologic outcome.

BACKGROUND: Complete surgical resection affords the best prognosis at the time of interval debulking surgery. When complete surgical resection is unachievable, optimal residual disease is considered the next best alternative. Despite contradicting evidence on the survival benefit of interval debulking surgery if macroscopic residual disease remains, the current definition of "optimal" in patients undergoing interval debulking surgery is defined as largest diameter of disease measuring ≤1.0 cm, independent of the total volume of disease. OBJECTIVE: To examine the relationship between volume and anatomic distribution of residual disease and oncologic outcomes among patients with advanced-stage epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing neoadjuvant chemotherapy then interval debulking surgery. For patients who did not undergo a complete surgical resection, a surrogate for volume of residual disease was used to assess oncologic outcomes. STUDY DESIGN: Patient demographics, operative characteristics, anatomic site of residual disease, and outcome data were collected from medical records of patients with International Federation of Gynecology and Obstetrics stage IIIC and IV epithelial ovarian cancer undergoing interval debulking surgery from January 2010 to July 2015. Among patients who did not undergo complete surgical resection but had ≤1 cm of residual disease, the number of anatomic sites (single location vs multiple locations) with residual disease was used as a surrogate for volume of residual disease. The effect of residual disease volume on progression-free survival and overall survival was evaluated. RESULTS: Of 270 patients undergoing interval debulking surgery, 173 (64.1%) had complete surgical resection, 34 (12.6%) had ≤1 cm of residual disease in a single anatomic location, 47 (17.4%) had ≤1 cm of residual disease in multiple anatomic locations, and 16 (5.9%) were suboptimally debulked. Median progression-free survival for each group was 14, 12, 10, and 6 months, respectively (P<.001). Median overall survival for each group was: 58, 37, 26, and 33 months, respectively (P<.001). CONCLUSION: Following interval debulking surgery, patients with complete surgical resection have the best prognosis, followed by patients with ≤1 cm single-anatomic location disease. In contrast, despite being considered "optimally debulked," patients with ≤1 cm multiple-anatomic location disease have a survival similar to suboptimally debulked patients.

Clinical characteristics and outcomes after bowel surgery and ostomy formation at the time of debulking surgery for advanced-stage epithelial ovarian carcinoma.

OBJECTIVE: There are limited data on clinical outcomes of patients with advanced-stage epithelial ovarian cancer who require ostomy formation at the time of either primary cytoreductive surgery or interval cytoreductive surgery. The objective of this study was to evaluate patients undergoing bowel surgery and ostomy formation after primary or interval surgery. METHODS: Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC-IV epithelial ovarian cancer who underwent cytoreductive surgery between January 2010 and December 2014 were identified retrospectively. Patients with non-epithelial histology, low-grade serous histology or incomplete medical records were excluded. Demographic and clinical data were collected and analyzed. Age, stage, co-morbidity index, pre-operative CA125, pre-operative albumin, and Aletti surgical complexity score were included in a multivariable logistic regression model to assess independent associations with ostomy formation. RESULTS: A total of 554 patients were included in the study. Of these, 261 (47%) underwent primary cytoreduction and 293 (53%) underwent interval cytoreduction. Patients undergoing primary surgery were more likely to undergo bowel resection, compared with interval surgery patients (37.2% vs 14%, p<0.001). Of the 139 (25.1%) patients who underwent bowel surgery, 25 (18%) underwent ostomy formation (11 ileostomies and 14 colostomies). Rates of ostomy formation were similar between the groups (6.1% primary vs 3.1% interval, p=0.10). Patients undergoing ostomy formation were more likely to have longer mean operative time (335 vs 229 min, p<0.001) and undergo small and large bowel resections at the time of cytoreductive surgery (44% vs 14%, p<0.001). Multivariate analysis revealed that a high surgical complexity score was associated with ostomy formation. Of the patients who underwent ostomy formation, 13 (43.3%) underwent stoma reversal including 11 ileostomies and two colostomies. Median time to ostomy reversal was 7 months. CONCLUSION: Bowel surgery is more common among patients undergoing primary surgery as compared with interval surgery, but this does not result in an increased risk of ostomy formation.

Moving beyond "complete surgical resection" and "optimal": Is low-volume residual disease another option for primary debulking surgery?

OBJECTIVES: To examine the relationship between volume of residual disease and oncologic outcomes among patients with advanced-stage epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing primary debulking surgery (PDS). For patients that did not undergo a complete surgical resection (CSR), a surrogate for volume of residual disease was used to assess oncologic outcomes. METHODS: Medical records of patients with FIGO stage IIIC and IV epithelial ovarian/fallopian tube/primary peritoneal carcinoma undergoing PDS between January 2010 and November 2014 were reviewed. Patient demographics, operative characteristics, residual disease, anatomic site of residual disease and outcome data were collected. Among patients who did not undergo CSR, but had ≤1 cm of residual disease, the number of anatomic sites (single location vs. multiple locations) with residual disease was utilized as a surrogate for volume of residual disease. The effect of residual disease volume on progression-free survival (PFS) and overall survival (OS) was evaluated. RESULTS: Of 240 patients undergoing PDS, 94 (39.2%) had CSR, 41 (17.1%) had ≤1 cm of residual disease confined to a single anatomic location (≤1 cm-SL), 67 (27.9%) had ≤1 cm of residual disease in multiple anatomic locations (≤1 cm-ML) and 38 (15.8%) were sub-optimally (SO) debulked. Median PFS for CSR, ≤1 cm-SL, ≤1 cm-ML and SO-debulked were: 23, 19, 13 and 10 months, respectively (p < 0.001). Median OS for CSR, ≤1 cm-SL, ≤1 cm-ML and SO-debulked were: Not yet reached, 64, 50 and 49 months, respectively (p = 0.001). CONCLUSIONS: Following PDS, CSR and ≤ 1 cm-SL patients have the best prognosis. In contrast, despite being considered "optimally debulked", ≤1 cm-ML patients have survival similar to those SO-debulked.

Sources of Palliative Care Knowledge Among Patients With Advanced or Metastatic Gynecologic Cancer.

CONTEXT: A minority of patients with advanced or metastatic gynecologic cancer utilize palliative care and lack of knowledge may be a barrier to receiving palliative care services. OBJECTIVES: To identify sources used by patients with advanced or metastatic gynecologic cancer to learn about palliative care and evaluate for differences in knowledge about palliative care and palliative care utilization by knowledge source. METHODS: Patients with gynecologic cancer receiving treatment for advanced or metastatic gynecologic cancer at a single academic medical center were surveyed about their awareness of and knowledge about palliative care. Medical chart review was conducted. RESULTS: Of the 111 women surveyed, 70 had heard of palliative care (63%). Sixty-eight specified from where they learned of palliative care: cancer care (n = 28; 41.2%), word of mouth (n = 26; 38.2%), work (n = 6; 8.8%), self-education (n = 4; 5.9%), personal experience (n = 2; 2.9%), or do not know (n = 2; 2.9%). Knowledge about palliative care (P = 0.35) and palliative care utilization (P = 0.81) did not differ by awareness of palliative care. CONCLUSION: Most women receiving treatment for advanced gynecologic cancer have heard of palliative care from sources other than their cancer care providers. Knowledge about palliative care and source of knowledge about palliative care were not associated with palliative care utilization. Awareness of palliative care and palliative care utilization may be improved by increasing the low rate of health provider-based education and engaging cancer patients' social networks.

Personalized Cancer Medicine in the Media: Sensationalism or Realistic Reporting?

BACKGROUND: Given that media coverage can shape healthcare expectations, it is essential that we understand how the media frames "personalized medicine" (PM) in oncology, and whether information about unproven technologies is widely disseminated. METHODS: We conducted a content analysis of 396 news reports related to cancer and PM published between 1 January 1998 and 31 December 2011. Two coders independently coded all the reports using a pre-defined framework. Determination of coverage of "standard" and "non-standard" therapies and tests was made by comparing the media print/broadcast date to the date of Federal Drug Administration approval or incorporation into clinical guidelines. RESULTS: Although the term "personalized medicine" appeared in all reports, it was clearly defined only 27% of the time. Stories more frequently reported PM benefits than challenges (96% vs. 48%, p < 0.001). Commonly reported benefits included improved treatment (89%), prediction of side effects (30%), disease risk prediction (33%), and lower cost (19%). Commonly reported challenges included high cost (28%), potential for discrimination (29%), and concerns over privacy and regulation (21%). Coverage of inherited DNA testing was more common than coverage of tumor testing (79% vs. 25%, p < 0.001). Media reports of standard tests and treatments were common; however, 8% included information about non-standard technologies, such as experimental medications and gene therapy. CONCLUSION: Confusion about personalized cancer medicine may be exacerbated by media reports that fail to clearly define the term. While most media stories reported on standard tests and treatments, an emphasis on the benefits of PM may lead to unrealistic expectations for cancer genomic care.

Controlled decompression of large ovarian cystic tumors via mini-laparotomy using Dermabond Advanced™.

Large cystic ovarian tumors usually require surgical removal because of symptoms and the possibility of malignancy. The ideal surgical approach would minimize the risk of spillage of tumor contents while minimizing surgical morbidity. The present study aims to demonstrate a novel technique to drain large cystic ovarian tumors without spillage. A mini-laparotomy is performed and the tumor surface is exposed. Dermabond Advanced™ (USA Medical and Surgical Supplies 2019a) is applied to the tumor and a surgical glove (USA Medical and Surgical Supplies 2019b) is applied to the glue area. A small incision is made in the center of the portion of the glove that is adherent to the tumor. The cyst fluid is allowed to drain into the glove where it is suctioned away, collapsing the tumor. Once the tumor is sufficiently decompressed, it is exteriorized and resected with the glove still attached. The technique was initially developed in a pig model and subsequently successfully performed by mini-laparotomy on two patients with >20 cm ovarian masses. This novel technique uses inexpensive and readily available materials for draining large cystic ovarian tumors without spillage so that they can be removed via mini-laparotomy.

Trends in Place of Death Among Patients With Gynecologic Cancer in the United States.

OBJECTIVE: To describe the change over time in place of death (hospital, home, hospice) among all women in the United States who died of gynecologic malignancies and compare them with other leading causes of female cancer deaths. METHODS: This is a retrospective cross-sectional study using national death certificate data from the Mortality Multiple Cause-of-Death Public Use Record Data. All women who died from gynecologic, breast, lung, and colorectal cancers were identified according to International Classification of Diseases, 10 Revision, cause of death from 2003 to 2015. Regression analyses with ordinary least-squares linear probability modeling were used to test for differences in location of death over time, and differences in trends by cancer type, while controlling for age, race, ethnicity, marital status, and education status. RESULTS: From 2003 to 2015, 2,133,056 women died from gynecologic, lung, breast, and colorectal malignancies in the United States. A total of 359,340 died from gynecologic malignancies, including ovarian cancer (n=188,366 [52.4%]), uterine cancer (n=106,454 [29.6%]), cervical cancer (n=52,320 [14.6%]), and vulvar cancer (n=12,200 [3.4%]). Overall, 49.2% (n=176,657) of gynecologic cancer deaths occurred at home or in hospice. The relative increase from 2003 to 2015 in the rate of deaths at home or in hospice was 47.2% for gynecologic cancer deaths (40.5% in 2003 to 59.5% in 2015). In adjusted analyses, the trend in the percentage of deaths at home or in hospice increased at a rate of 1.6 percentage points per year for gynecologic cancer deaths (95% CI 1.5-1.6) vs 1.5 (95% CI 1.4-1.5, P<.001), 1.4 (95% CI 1.4-1.5, P<.001), and 1.5 (95% CI 1.4-1.5, P=.09) percentage points per year for lung, breast, and colorectal cancer deaths, respectively. CONCLUSION: Between 2003 and 2015, there was a 47.2% increase (40.5-59.5%) in the rates of gynecologic cancer deaths occurring at home or in hospice. This trend may represent an increase in advance care planning and value-based treatment decisions.

Local Access to Family Planning Services and Female High School Dropout Rates.

OBJECTIVE: To assess whether geographic access to family planning services is associated with a reduced female high school dropout rate. METHODS: We conducted a retrospective cross-sectional study. We merged the location of Planned Parenthood and Title X clinics with microdata from the 2012-2013 American Community Surveys. The association between female high school dropout rates and local clinic access was assessed using nearest-neighbor matching estimation. Models included various covariates to account for sociodemographic differences across communities and male high school dropout rates to account for unmeasured community characteristics affecting educational outcomes. RESULTS: Our sample included 284,910 16- to 22-year-old females. The presence of a Planned Parenthood clinic was associated with a decrease (4.08% compared with 4.83%; relative risk ratio 0.84, P<.001) in female high school dropout rates. This association was consistent across several model specifications. The presence of a Title X clinic was associated with a decrease (4.79% compared with 5.07%; relative risk ratio 0.94, P=.03) in female high school dropout rates, an association that did not remain significant across model specifications. CONCLUSION: Local access to Planned Parenthood is associated with lower high school dropout rates in young women.

Physicians' attitudes about multiplex tumor genomic testing.

PURPOSE: Although predictive multiplex somatic genomic tests hold the potential to transform care by identifying targetable alterations in multiple cancer genes, little is known about how physicians will use such tests in practice. PARTICIPANTS AND METHODS: Before the initiation of enterprise-wide multiplex testing at a major cancer center, we surveyed all clinically active adult cancer physicians to assess their current use of somatic testing, their attitudes about multiplex testing, and their genomic confidence. RESULTS: A total of 160 physicians participated (response rate, 61%): 57% were medical oncologists; 29%, surgeons; 14% radiation oncologists; 37%, women; and 83%, research principal investigators. Twenty-two percent of physicians reported low confidence in their genomic knowledge. Eighteen percent of physicians anticipated testing patients infrequently (≤ 10%), whereas 25% anticipate testing most patients (≥ 90%). Higher genomic confidence was associated with wanting to test a majority of patients (adjusted odds ratio [OR], 6.09; 95% CI, 2.1 to 17.5) and anticipating using actionable (adjusted OR, 2.46; 95% CI, 1.2 to 5.2) or potentially actionable (adjusted OR, 2.89; 95% CI, 1.1 to 7.9) test results to inform treatment recommendations. Forty-two percent of physicians endorsed disclosure of uncertain genomic findings to patients. CONCLUSION: Physicians at a tertiary-care National Cancer Institute-designated comprehensive cancer center varied considerably in how they planned to incorporate predictive multiplex somatic genomic tests into practice and in their attitudes about the disclosure of genomic information of uncertain significance. Given that many physicians reported low genomic confidence, evidence-based guidelines and enhanced physician genomic education efforts may be needed to ensure that genomically guided cancer care is adequately delivered.

Depression and anxiety among high-risk obstetric inpatients.

OBJECTIVE: To assess the following among women hospitalized antenatally due to high-risk pregnancies: (1) rates of depression symptoms and anxiety symptoms, (2) changes in depression symptoms and anxiety symptoms and, (3) rates of mental health treatment. METHODS: Sixty-two participants hospitalized for high-risk obstetrical complications completed the Edinburgh Postnatal Depression Scale (EPDS), Generalized Anxiety Disorder 7-item scale (GAD-7) and Short-Form 12 weekly until delivery or discharge, and once postpartum. RESULTS: Average length of total hospital stay was 8.3 ± 7.6 days for women who completed an initial admission survey (n = 62) and 16.3 ± 8.9 (n = 34), 25.4 ± 10.2 (n = 17) and 35 ± 10.9 days (n = 9) for those who completed 2, 3 and 4 surveys, respectively. EPDS was ≥ 10 in 27% (n=17) and GAD-7 was ≥ 10 in 13% (n = 8) of participants at initial survey. Mean anxiety (4.2 ± 6.5 vs. 5.2 ± 5.1, p = .011) and depression (4.4 ± 5.6 vs. 6.9 ± 4.8, p = .011) scores were lower postpartum compared to initial survey. Past mental health diagnosis predicted depression symptoms [odds ratio (OR) = 4.54; 95% confidence interval (CI) 1.91-7.17] and anxiety symptoms (OR = 5.95; 95% CI 3.04-8.86) at initial survey; however, 21% (n = 10) with no diagnostic history had EPDS ≥ 10. Five percent (n = 3) received mental health treatment during pregnancy. CONCLUSION: Hospitalized high-risk obstetrical patients may commonly experience depression symptoms and/or anxiety symptoms and not receive treatment. A history of mental health treatment or diagnosis was associated with depression symptoms or anxiety symptoms in pregnancy. Of women with an EPDS ≥ 10, > 50% did not report a past mental health diagnosis.

Attitudes of patients with cancer about personalized medicine and somatic genetic testing.

PURPOSE: Dramatic advances in genomic technology stand to revolutionize cancer care; however, little is known about patients' understanding and acceptance of personalized medicine and widespread genetic testing (GT). PATIENTS AND METHODS: We conducted a formative, semi-structured interview study with a random sample of patients with lung, colorectal, and breast cancers to assess awareness of personalized medicine and GT and attitudes about somatic GT. Willingness to undergo GT was elicited through hypothetic scenarios. RESULTS: Sixty-nine patients participated; 71% were women; 42% were black; median age was 59 years; and 42% had an education level ≥ college. We found that a majority of patients either were not aware of the term "personalized medicine" or defined it in unexpected ways. Although many patients identified relevant benefits of somatic testing (eg, informs treatment), many patients also expressed significant concerns (ie, psychological harm and discrimination). A majority of patients expressed a willingness to undergo somatic (predictive, 96%, prognostic, 93%) and germline (cancer risk without incidental information, 87%; cancer risk with incidental information, 81%; pharmacogenetic, 91%) testing; however, far fewer patients expressed a willingness to undergo full genome sequencing (62%). Reluctance was attributed to concerns over incidental findings, information overload, and the lack of a clear benefit. CONCLUSION: Many patients relayed misunderstandings about somatic testing and a reluctance to undergo full sequencing; oncologists must carefully consider how they present testing to patients so that concerns over discrimination and psychological harm do not hinder test uptake. More work is needed to identify effective ways to communicate complex genomic concepts to patients and research participants.