Differential utilization of the online patient portal for completion of health-related social needs screening during routine gynecologic cancer care.

BACKGROUND: Telehealth technologies offer efficient ways to deliver health-related social needs (HRSN) screening in cancer care, but these methods may not reach all populations. The authors examined patient characteristics associated with using an online patient portal (OPP) to complete HRSN screening as part of gynecologic cancer care. METHODS: From June 2021 to June 2023, patients in a gynecologic oncology clinic completed validated HRSN screening questions either (1) using the OPP (independently before the visit) or (2) in person (verbally administered by clinic staff). The authors examined the prevalence of HRSN according to activated OPP status and, in a restricted subgroup, used stepwise multivariate Poisson regression to identify associations between patient and visit characteristics and using the OPP. RESULTS: Of 1616 patients, 87.4% (n = 1413) had an activated OPP. Patients with inactive OPPs (vs. activated OPPs) more frequently reported two or more needs (10% vs 5%; p < .01). Of 986 patients in the restricted cohort, 52% used the OPP to complete screening. The final multivariable model indicated that patients were less likely to use the OPP if they were Black (vs. White; adjusted relative risk [aRR], 0.70; 95% confidence interval [CI], 0.59-0.83); not employed (vs. employed; aRR, 0.81; 95% CI, 0.68-0.97), or had low measures of OPP engagement (aRR, 0.80; 95% CI, 0.68-0.92). New versus established patients were 21% more likely to use the OPP (aRR, 1.21; 95% CI, 1.06-1.38). CONCLUSIONS: Differential use of the OPP suggested that over-reliance on digital technologies could limit the ability to reach those populations that have social factors already associated with cancer outcome disparities. Cancer centers should consider using multiple delivery methods for HRSN screening to maximize reach to all populations.

Healthcare utilization in women diagnosed with endometrial cancer: A survey-based study.

OBJECTIVE: Despite similar incidence, non-Hispanic Black women are twice as likely to die of endometrial cancer as non-Hispanic White women. The social determinants of health may contribute to this disparity. We studied barriers to care and social needs of endometrial cancer patients. METHODS: In a cohort of patients with endometrial cancer from the All of Us study, participants self-reported demographics and completed validated surveys (access to medical care, transportation, caregiving, finances, medication, general care, specialty care, housing insecurity). Univariate and multivariate logistic regression models evaluated demographic and access factors associated with any need. RESULTS: Of 568 participants, 77.7% identified as non-Hispanic White, 7.5% Black, and 8.8% Hispanic. 59% were > 65 years and 95.8% insured. Contributors to delays in care were paying out of pocket (9.9%), provider anxiety (7.6%), transportation (6.3%), cost of copay (6.2%), and insufficient leave from work (5.6%). To mitigate healthcare costs, 16.2% of participants inquired about lower-cost medications, 11.1% reported delaying filling prescriptions, 7.6% taking fewer prescribed medications, and 6.5% skipped doses. Regarding multivariate analysis, participants earning <$25,000 had a 7.3 (95% CI 1.7-31.7) higher adjusted odds of transportation needs and 3.6 (95% CI 1.4-9.7) higher difficulty accessing specialists. No racial/ethnic disparities were identified. CONCLUSIONS: Social needs and barriers to care are most pronounced among endometrial cancer survivors earning <$25,000. Unexpectedly, and possibly related to sample size or survey tool, race/ethnicity were not zassociated with barriers to care. Further studies on health-related social needs, optimal screening tools, and effective interventions are needed in order to achieve equity in cancer outcomes for endometrial cancer patients.

Vulvar Cancer, Version 3.2024, NCCN Clinical Practice Guidelines in Oncology.

Vulvar cancer is annually diagnosed in an estimated 6,470 individuals and the vast majority are histologically squamous cell carcinomas. Vulvar cancer accounts for 5% to 8% of gynecologic malignancies. Known risk factors for vulvar cancer include increasing age, infection with human papillomavirus, cigarette smoking, inflammatory conditions affecting the vulva, and immunodeficiency. Most vulvar neoplasias are diagnosed at early stages. Rarer histologies exist and include melanoma, extramammary Paget's disease, Bartholin gland adenocarcinoma, verrucous carcinoma, basal cell carcinoma, and sarcoma. This manuscript discusses recommendations outlined in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for treatments, surveillance, systemic therapy options, and gynecologic survivorship.

The power of hope: Views of Ovarian Cancer patients on how maintenance therapy Affects their Lives (VOCAL).

Aim: To assess maintenance preference and trade-offs for patients with advanced epithelial ovarian cancer. Methods: Patients completed a time trade-off exercise ranking five maintenance approaches. Patients' preferred approach was compared with alternatives to determine the progression-free time they would trade off to remain on their preferred approach. Results: Of 152 patients (median age 53 years, 68% White), 56% chose one of four maintenance medications, mostly to feel proactive and 44% chose active surveillance. Compared with their preferred approach, patients were willing to trade a mean progression-free time before switching of 2.3 months for once-daily oral medications, 3.2 months for twice-daily oral medications, 5.5 months for intravenous infusions every 3 weeks (iv. q3), 6.1 months for active surveillance and 7.5 months for iv. q3 and twice-daily oral. Conclusion: Findings highlight the importance of patients' awareness of all maintenance approaches and involving them in the decision-making process.

What is the article about? The VOCAL study looked at maintenance approach preferences of patients with advanced epithelial ovarian cancer. Maintenance approach refers to the methods used after a patient has completed their initial chemotherapy to prevent disease progression for as long as possible. US patients completed an online survey, ranking five different maintenance approaches: No medication (active surveillance); Once-daily oral medication (e.g. pills); Twice-daily oral medication; Medication by intravenous infusion every 3 weeks; Medication by intravenous infusion every 3 weeks and oral twice-daily. Patients were asked to assume the same time to disease progression for all five approaches and the same side effects for the four approaches involving medications (2­5). Each patient then indicated how much time to disease progression they were willing to trade off to remain on their preferred approach before switching to an alternative. What were the results? Overall, 152 patients completed the survey (median age: 53 years, 68% White). Most patients preferred a medication approach (56%, n = 85) to active surveillance (44%, n = 67). Of the 85 patients who preferred medication, 66% (n = 56) reported this was to feel proactive in preventing their cancer returning. Once-daily oral medication was the most acceptable alternative to the patients' preferred maintenance approach, given they were willing to trade the least 'disease-free' time (2.3 months) before accepting a switch. What do the results mean? Individual patient preferences vary, and healthcare professionals should work with patients to determine which approach is most appropriate for them.

Uterine Neoplasms, Version 1.2023, NCCN Clinical Practice Guidelines in Oncology.

Adenocarcinoma of the endometrium (also known as endometrial cancer, or more broadly as uterine cancer or carcinoma of the uterine corpus) is the most common malignancy of the female genital tract in the United States. It is estimated that 65,950 new uterine cancer cases will have occurred in 2022, with 12,550 deaths resulting from the disease. Endometrial carcinoma includes pure endometrioid cancer and carcinomas with high-risk endometrial histology (including uterine serous carcinoma, clear cell carcinoma, carcinosarcoma [also known as malignant mixed Müllerian tumor], and undifferentiated/dedifferentiated carcinoma). Stromal or mesenchymal sarcomas are uncommon subtypes accounting for approximately 3% of all uterine cancers. This selection from the NCCN Guidelines for Uterine Neoplasms focuses on the diagnosis, staging, and management of pure endometrioid carcinoma. The complete version of the NCCN Guidelines for Uterine Neoplasms is available online at NCCN.org.

NTRK-Fusion Sarcoma of the Uterine Cervix: Report of 2 Cases With Comparative Clinicopathologic Features.

NTRK1/2/3 rearrangements have been identified as oncogenic drivers in a variety of tumors including those in the uterine cervix, and rarely, the uterine corpus. We report 2 cases of cervical sarcoma with NTRK gene rearrangements. Case 1 was a 54-yr-old woman who presented with postmenopausal bleeding and a 5.4 cm friable mass in the cervix. Microscopic examination of the tumor revealed proliferation of epithelioid and spindle cells arranged in alternating hypercellular and hypocellular areas, with subtle fibrosarcoma-like features. Coagulative tumor cell necrosis and readily recognizable mitoses (up to 40 mitotic figures per 10 high-power fields) were identified. Case 2 was a 52-yr-old woman who presented with abnormal vaginal bleeding and a 1.3 cm cervical mass. The resected cervical tumor showed proliferation of spindled cells with fascicular and storiform growth pattern, infiltrating into the smooth muscle with entrapment of normal endocervical glands. The tumor cells displayed mild cytologic atypia and low mitotic activity (1 mitotic figure per 10 high-power fields). The mixed inflammatory infiltrate was seen throughout the lesion, mimicking morphology of inflammatory myofibroblastic tumor. Immunohistochemical staining for S100 and CD34 demonstrated variable expression in case 1 and uniformly diffuse positivity in case 2. The tumor cells in both cases were focally positive for CD10, Cyclin D1, ER, and PR, and negative for AE1/AE3, desmin, SOX10, HMB-45. RNA fusion analysis identified SPECC1L-NTRK3 gene rearrangements in case 1 and TPM3-NTRK1 in case 2; DNA-based mutational analysis also revealed CDKN2A/B homozygous deletion in case 1. Despite accumulating literature on NTRK fusion mesenchymal tumors in gynecologic pathology, these tumors are still rare and lack well-established morphologic diagnostic criteria. Diagnostic and clinical recognition of these tumors is critical given the potential patient benefit from targeted therapy.

Adult Granulosa Cell Tumor With Sarcomatous Transformation: A Case Study With Emphasis on Molecular Alterations.

Adult granulosa cells tumors (AGCTs) are typically low-grade indolent tumors. On rare occasions, they undergo high-grade/sarcomatous transformation and behave aggressively. This transformation is postulated to occur as the result of acquired genetic alterations, some of which may be eligible for targeted therapy. Here we report a rare case of AGCT with sarcomatous transformation that harbored distinct molecular alterations from those typically seen with AGCTs supporting a molecularly driven approach to these malignancies. The patient is a 56-yr-old G3P3 woman with a history of multiple recurrences of ovarian AGCT for which the first diagnosis was made at the age of 25 when she was evaluated for infertility. The ovarian tumor displayed typical features of AGCT with low-grade, bland morphology. The first extraovarian spread of tumor involving the cul-de-sac was reported at the age of 39. After that, recurrences occurred every 2 to 3 yr with involvement of multiple anatomic sites and repeated surgical resections. At the age of 55 she developed a symptomatic recurrence in the pelvis and underwent resection of an isolated lesion (specimen 1) to no gross residual disease. Within 4 wk of resection she developed significant pelvic pain and imaging showed recurrence of the mass. Therefore, in 5 mo after the initial resection she underwent repeat excision of the lesion (specimen 2) and associated bowel. The sections from specimen 1 showed a biphasic morphology: a low-grade component with morphology and immunophenotype consistent with a typical AGCT and a high-grade spindle cell component with features consistent with a high-grade sarcoma. Specimen 2 featured a pure high-grade sarcoma characterized by coagulative tumor cell necrosis, readily recognizable mitoses, highly atypical cells with vesicular nuclei and prominent nucleoli. SF-1 positivity and the presence of FOXL2 C134W mutation in the sarcomatous component support the notion of transformation of typical AGCT. While detected TERT promoter C228T mutation may play a role in this process, we further identified genetic alterations affecting PI3K/AKT/mTOR pathway, including mutations in PIK3CA , PIK3R1 , AKT1 , and NF2 , which may also contribute to tumor progression/transformation. These findings provide rationale for molecular/pathway-based targeted therapy for patients with advanced AGCT.

Modifiable risk factors associated with long-term survival in women with serous ovarian cancer: a National Cancer Database study.

OBJECTIVE: To identify patient, clinical and hospital factors associated with long-term survival (≥10 years) in women with serous ovarian cancer. METHODS: This National Cancer Database cohort study included women with stage II-IV serous ovarian cancer. Multivariate logistic regression models were used to examine the association of long-term survival with patient (race, insurance, location, household income, education, distance traveled), clinical (age, comorbidities, stage, grade, primary treatment) and hospital factors (region, institution, hospital volume ≥20). RESULTS: Of the 4640 women identified, 12% (n=561) experienced long-term survival. Median overall survival was 41 months (95% CI 39 to 42). The odds of long-term survival were lower for women with public or no insurance (adjusted OR 0.71, 95% CI 0.55 to 0.92), age ≥75 years (0.33, 0.22 to 0.50), any comorbidities (0.70, 0.54 to 0.92), higher stage (stage III: 0.31, 0.25 to 0.41; stage IV: 0.16, 0.12 to 0.22), and moderately/poorly differentiated, undifferentiated, or tumors of unknown grade (moderately/poorly differentiated: 0.30, 0.20 to 0.47; undifferentiated: 0.28, 0.17 to 0.47; unknown: 0.30, 0.18 to 0.50). The odds of long-term survival among women who were publicly insured were lower with neoadjuvant chemotherapy (0.13, 0.04 to 0.044) and higher with optimal cytoreduction (2.24, 1.49 to 3.36). Among women who were privately insured, the odds of long-term survival were higher with optimal cytoreduction (1.99, 1.46 to 2.70) and unaffected by neoadjuvant chemotherapy. CONCLUSIONS: While immutable clinical factors such as age, stage, and grade are associated with long-term survival in women with serous ovarian cancer, modifiable factors, such as insurance type, optimal cytoreductive status, and neoadjuvant chemotherapy provide an opportunity for targeted improvement in care with potential to affect long-term patient outcomes.

Combination ATR and PARP Inhibitor (CAPRI): A phase 2 study of ceralasertib plus olaparib in patients with recurrent, platinum-resistant epithelial ovarian cancer.

OBJECTIVE: Platinum-resistant, high-grade serous ovarian cancer (HGSOC) has limited treatment options. Preclinical data suggest that poly(ADP-ribose) polymerase inhibitors (PARPi) and ataxia telangiectasia and Rad3-related kinase inhibitors (ATRi) are synergistic. CAPRI (NCT03462342) is an investigator-initiated study of olaparib plus ceralasertib in recurrent HGSOC. Herein, we present results from the platinum-resistant cohort. METHODS: A Simon 2-stage design was utilized. Platinum-resistant HGSOC patients received ceralasertib 160 mg orally daily, days 1-7 and olaparib 300 mg orally twice daily, days 1-28 of a 28-day cycle until toxicity or progression. Primary endpoints were toxicity and efficacy including objective response rate (ORR) by RECIST. Secondary endpoint was progression-free survival (PFS). The null hypothesis (≤5% ORR) would be rejected if there were ≥ 1 responses in 12 patients. RESULTS: Fourteen PARPi-naïve patients were evaluable for toxicity; 12 were evaluable for response. Three had BRCA1 mutations (1 germline, 2 somatic). Adverse events possibly related to treatment were primarily grade (G) 1/2. G3 toxicities included nausea (14.3%), fatigue (7.1%), anorexia (7.1%), and anemia (7.1%). No objective responses occurred. Best response was stable disease in 9 patients and progressive disease in three. Five patients had a ≥ 20% to <30% reduction in disease burden, including 3 with BRCA1 mutations. Three of 11 patients (27%; 2 with BRCA1 mutations) evaluable by Gynecologic Cancer Intergroup criteria had >50% CA-125 decline, including 2 with CA-125 normalization. Median PFS was 4.2 months overall (90% CI:3.5-8.2) and 8.2 months (3.6 months-not determined) for patients with BRCA1 mutations. CONCLUSIONS: Olaparib plus ceralasertib is well-tolerated. No objective responses occurred, though a signal of activity was seen particularly in disease associated with BRCA1. Further evaluation of this combination should include alternate dosing strategies in genomically-selected populations.

NCCN Guidelines® Insights: Uterine Neoplasms, Version 3.2021.

The NCCN Guidelines for Uterine Neoplasms provide recommendations for diagnostic workup, clinical staging, and treatment options for patients with endometrial cancer or uterine sarcoma. These NCCN Guidelines Insights focus on the recent addition of molecular profiling information to aid in accurate diagnosis, classification, and treatment of uterine sarcomas.

Results of an early safety analysis of a study of the combination of pembrolizumab and pelvic chemoradiation in locally advanced cervical cancer.

BACKGROUND: Immune checkpoint inhibitors are being considered for locally advanced cervical cancer (LACC) together with standard-of-care pelvic chemoradiation (CRT). However, the safety of the combination and its optimal schedule are unknown. Defining the safety of the combination is a primary objective of a study examining concurrent and sequential schedules. This article presents a safety analysis that was fully accrued and met reporting requirements. METHODS: Pembrolizumab was given after CRT (arm 1) or during CRT (arm 2) according to a randomized phase 2 design. Patients who were 18 years old or older and had LACC (stages IB-IVA according to the 2009 International Federation of Gynecology and Obstetrics system) were randomized 1:1 to the treatment regimens. The CRT was identical in the 2 arms. Pembrolizumab was administered every 3 weeks for 3 doses; no maintenance was allowed. All patients receiving any treatment were evaluated for safety. Safety assessments included the incidence and severity of adverse events (AEs) and the occurrence of protocol-defined dose-limiting toxicity (DLT) through 30 days after the last pembrolizumab infusion. RESULTS: As of August 2019, 52 of the 88 planned patients had completed treatment and were evaluable for toxicity. Treatment-related grade 2 or higher toxicity was experienced by 88%; 11 had at least 1 grade 4 AE, and another 23 had at least 1 grade 3 AE. Grade 1 or higher diarrhea was reported in 34 patients (65%; 50% of these were grade 1), and there was no difference between arms (63% in arm 1 vs 68% in arm 2). Two patients experienced 3 DLTs. Most patients completed cisplatin (100% in arm 1 vs 82% in arm 2); 83% in both arms completed all pembrolizumab. CONCLUSIONS: Preliminary results support the safety and feasibility of adding pembrolizumab to pelvic CRT concurrently or sequentially. LAY SUMMARY: Pembrolizumab is a humanized antibody against programmed cell death protein 1 that is used in cancer immunotherapy. Preliminary data suggest that pembrolizumab can be safely combined with chemotherapy and pelvic radiation in the treatment of locally advanced cervical cancer. Future studies of the addition of immunotherapy to traditional chemoradiation are planned to determine the best way to deliver the treatment and whether any improvement is seen with the addition of immunotherapy to traditional therapy.

The addition of metformin to progestin therapy in the fertility-sparing treatment of women with atypical hyperplasia/endometrial intraepithelial neoplasia or endometrial cancer: Little impact on response and low live-birth rates.

OBJECTIVE: Our objectives were 1) to compare the efficacy of progestin therapy combined with metformin (Prog-Met) to Prog alone as primary fertility sparing treatment in women with atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or early-stage endometrioid carcinoma (EC), and 2) to analyze the proportion of women achieving live birth following treatment. METHODS: A retrospective cohort study of all reproductive-aged women with AH/IN or EC treated with Prog ± Met from 1999-2018 was conducted. Complete response (CR) was assessed and Kaplan-Meier analysis used to calculate time to CR. Comparison of potential response predictors was performed with multivariable Cox regression models. RESULTS: Ninety-two women met criteria; 59% (n = 54) were treated for AH/EIN and 41% (n = 38) for EC. Their median age, body mass index, and follow up time was 35 years, 37.7 kg/m2, and 28.4 months, respectively. Fifty-eight women (63%) received Prog and 34 (37%) received Prog-Met. Overall, 79% (n = 73) of subjects responded to treatment with a CR of 69% (n = 63). There was no difference in CR (p = 0.90) or time to CR (p = 0.31) between the treatment cohorts. Overall, 22% experienced a disease recurrence. On multivariable analysis, EC histology was the only covariate associated with a decreased Prog response (HR 0.48; p = 0.007). Only 17% of the cohort achieved a live-birth pregnancy, the majority of which required assisted reproductive technologies (81%) and occurred in the Prog treatment group. CONCLUSIONS: Our study does not support the use of Prog-Met therapy for treatment of AH/EIN or EC. Additionally, fewer than 20% of women achieved a live-birth pregnancy during the study period, with most requiring ART.

Adjuvant therapy for early stage, endometrial cancer with lymphovascular space invasion: Is there a role for chemotherapy?

OBJECTIVES: Lymphovascular space invasion (LVSI) is an independent risk factor for recurrence and poor survival in early-stage endometrioid endometrial cancer (EEC), but optimal adjuvant treatment is unknown. We aimed to compare the survival of women with early-stage EEC with LVSI treated postoperatively with observation (OBS), radiation (RAD, external beam and/or vaginal brachytherapy), or chemotherapy (CHEMO)+/-RAD. METHODS: This was a multi-institutional, retrospective cohort study of women with stage I or II EEC with LVSI who underwent hysterectomy+/-lymphadenectomy from 2005 to 2015 and received OBS, RAD, or CHEMO+/-RAD postoperatively. Progression-free survival and overall survival were evaluated using Kaplan-Meier estimates and Cox proportional hazards models. RESULTS: In total, 478 women were included; median age was 64 years, median follow-up was 50.3 months. After surgery, 143 (30%) underwent OBS, 232 (48.5%) received RAD, and 103(21.5%) received CHEMO+/-RAD (95% of whom received RAD). Demographics were similar among groups, but those undergoing OBS had lower stage and grade. A total of 101 (21%) women recurred. Progression-free survival (PFS) was improved in both CHEMO+/-RAD (HR = 0.18, 95% CI: 0.09-0.39) and RAD (HR = 0.31, 95% CI: 0.18-0.54) groups compared to OBS, though neither adjuvant therapy was superior to the other. However, in grade 3 tumors, the CHEMO+/-RAD group had superior PFS compared to both RAD (HR 0.25; 95% CI: 0.12-0.52) and OBS cohorts (HR = 0.10, 95% CI: 0.03-0.32). Overall survival did not differ by treatment. CONCLUSIONS: In early-stage EEC with LVSI, adjuvant therapy improved PFS compared to observation alone. In those with grade 3 EEC, adjuvant chemotherapy with or without radiation improved PFS compared to observation or radiation alone.

Basic social resource needs screening in the gynecologic oncology clinic: a quality improvement initiative.

BACKGROUND: Social determinants of health are known to contribute to disparities in health outcomes. Routine screening for basic social needs is not a part of standard care; however, the association of those needs with increased healthcare utilization and poor compliance with guideline-directed care is well established. OBJECTIVE: In this study, we aimed to assess the prevalence of basic social resource needs identified through a quality improvement initiative in a gynecologic oncology outpatient clinic. In addition, we aimed to identify clinical and demographic factors associated with having basic social resource needs. STUDY DESIGN: We performed a prospective cohort study of women presenting to a gynecologic oncology clinic at an urban academic institution who were screened for basic social resource needs as part of a quality improvement initiative from July 2017 to May 2018. The following 8 domains of resource needs were assessed: food insecurity, housing insecurity, utility needs, financial strain, transportation, childcare, household items, and difficulty reading hospital materials. Women with needs were referred to resources to address those needs. Demographic and clinical information were collected for each patient. The prevalence of needs and successful follow-up interventions were calculated. Patient factors independently associated with having at least 1 basic social resource need were identified using multivariable Poisson regression. RESULTS: A total of 752 women were screened in the study period, of whom 274 (36%) reported 1 or more basic social resource need, with a median of 1 (range, 1-7) need. Financial strain was the most commonly reported need (171 of 752, 23%), followed by transportation (119 of 752, 16%), difficulty reading hospital materials (54 of 752, 7%), housing insecurity (31 of 752, 4%), food insecurity (28 of 752, 4%), household items (22 of 752, 3%), childcare (15 of 752, 2%), and utility needs (13 of 752, 2%). On multivariable analysis, independent factors associated with having at least 1 basic social resource need were being single, divorced or widowed, nonwhite race, current smoker, nonprivate insurance, and a history of anxiety or depression. A total of 36 of 274 (13%) women who screened positive requested assistance and were referred to resources to address those needs. Of the 36 women, 25 (69%) successfully accessed a resource or felt equipped to address their needs, 9 (25%) could not be reached despite repeated attempts, and 2 (6%) declined assistance. CONCLUSION: Basic social resource needs are prevalent in women presenting to an urban academic gynecologic oncology clinic and can be identified and addressed through routine screening. To help mitigate ongoing disparities in this population, screening for and addressing basic social resource needs should be incorporated into routine comprehensive care in gynecologic oncology clinics.

Adjuvant treatment improves overall survival in women with high-intermediate risk early-stage endometrial cancer with lymphovascular space invasion.

BACKGROUND: Adjuvant therapy in early-stage endometrial cancer has not shown a clear overall survival benefit, and hence, patient selection remains crucial. OBJECTIVE: To determine whether women with high-intermediate risk, early-stage endometrial cancer with lymphovascular space invasion particularly benefit from adjuvant treatment in improving oncologic outcomes. METHODS: A multi-center retrospective study was conducted in women with stage IA, IB, and II endometrial cancer with lymphovascular space invasion who met criteria for high-intermediate risk by Gynecologic Oncology Group (GOG) 99. Patients were stratified by the type of adjuvant treatment received. Clinical and pathologic features were abstracted. Progression-free and overall survival were evaluated using multivariable analysis. RESULTS: 405 patients were included with the median age of 67 years (range 27-92, IQR 59-73). 75.0% of the patients had full staging with lymphadenectomy, and 8.6% had sentinel lymph node biopsy (total 83.6%). After surgery, 24.9% of the patients underwent observation and 75.1% received adjuvant therapy, which included external beam radiation therapy (15.1%), vaginal brachytherapy (45.4%), and combined brachytherapy + chemotherapy (19.1%). Overall, adjuvant treatment resulted in improved oncologic outcomes for both 5-year progression-free survival (77.2% vs 69.6%, HR 0.55, p=0.01) and overall survival (81.5% vs 60.2%, HR 0.42, p<0.001). After adjusting for stage, grade 2/3, and age, improved progression-free survival and overall survival were observed for the following adjuvant subgroups compared with observation: external beam radiation (overall survival HR 0.47, p=0.047, progression-free survival not significant), vaginal brachytherapy (overall survival HR 0.35, p<0.001; progression-free survival HR 0.42, p=0.003), and brachytherapy + chemotherapy (overall survival HR 0.30 p=0.002; progression-free survival HR 0.35, p=0.006). Compared with vaginal brachytherapy alone, external beam radiation or the addition of chemotherapy did not further improve progression-free survival (p=0.80, p=0.65, respectively) or overall survival (p=0.47, p=0.74, respectively). CONCLUSION: Adjuvant therapy improves both progression-free survival and overall survival in women with early-stage endometrial cancer meeting high-intermediate risk criteria with lymphovascular space invasion. External beam radiation or adding chemotherapy did not confer additional survival advantage compared with vaginal brachytherapy alone.

Minimally invasive hysterectomy surgery rates for endometrial cancer performed at National Comprehensive Cancer Network (NCCN) Centers.

OBJECTIVES: Minimally invasive surgery (MIS) is a quality measure for endometrial cancer (EC) established by the Society of Gynecologic Oncology and the American College of Surgeons. Our study objective was to assess the proportion of EC cases performed by MIS at National Comprehensive Cancer Network (NCCN) centers and evaluate perioperative outcomes. METHODS: A retrospective cohort study of women who underwent surgical treatment for EC from 2013 to 2014 was conducted at four NCCN centers. Multivariable mixed logistic regression models analyzed factors associated with failure to perform MIS and perioperative complications. RESULTS: In total 1621 patients were evaluated; 86.5% underwent MIS (robotic-assisted 72.5%, laparoscopic 20.9%, vaginal 6.6%). On multivariable analysis, factors associated with failure to undergo MIS were uterine size >12cm (Odds Ratio [OR]: 0.17, 95% CI 0.03-0.9), stage III (OR: 0.16, 95% CI 0.05-0.49) and IV disease (OR: 0.07, 95% CI 0.02-0.22). For stage I/II disease, complications occurred in 5.1% of MIS and 21.7% of laparotomy cases (p<0.01). Laparotomy was associated with increases in any complication (OR: 6.0, 95% CI 3.3-10.8), gastrointestinal (OR: 7.2, 95% CI 2.6-19.5), wound (OR: 3.7, 95% CI 1.5-9.2), respiratory (OR 37.5, 95% CI 3.9-358.0), VTE (OR 10.5, 95% CI 1.3-82.8) and 30-day readmission (OR: 2.6, 95% CI 1.4-4.9) compared to MIS. CONCLUSIONS: At NCCN-designated centers, the MIS hysterectomy rate in EC is higher than the published national average, with low perioperative complications. Previously identified disparities of age, race, and BMI were not observed. A proposed MIS hysterectomy benchmark of >80% in EC care is feasible when performed at high volume centers.

Is there evidence of a July effect among patients undergoing hysterectomy surgery?

BACKGROUND: It is hypothesized that the quality of health care decreases during trainee turnovers at the beginning of the academic year. The influx of new gynecology and surgery residents into hospitals in this setting may be associated with poorer surgical outcomes, known as the July effect. OBJECTIVE: We sought to systematically study hysterectomy outcomes in the state of Maryland during the 3-month period July through September as compared to all other months of the academic year, in order to assess for the presence of a July effect in hysterectomy surgery. STUDY DESIGN: This is a retrospective study of the Maryland Health Services Cost Review Commission Database from July 2012 through September 2015 focused on women undergoing hysterectomies for benign or malignant disease, either by obstetricians and gynecologists or gynecologic oncologists, during July through September vs October through June. Multivariable logistic regressions accounted for clustering by hospitals and adjusted for several cofactors. The primary outcome includes at least 1 of 11 major perioperative in-hospital complications; the secondary outcomes were extended postoperative length of stay (defined as >2 days) and 30-day inpatient readmission rates. RESULTS: We identified 6311 hysterectomies (78.2% benign) performed by 424 surgeons at 20 academic hospitals. Patients were primarily white (42.8%), 45-64 years old (54.4%), and had private insurance (66.3%). The unadjusted rate of in-hospital complications was 16.8%, extended length of stay was 30.3%, and 30-day readmissions was 6.6%. After adjustment, patients undergoing hysterectomies during July through September did not have more adverse outcomes relative to those undergoing surgery at other times of the year: complications (adjusted odds ratio, 0.87; 95% confidence interval, 0.75-1.01), length of stay >2 days (adjusted odds ratio, 1.03; 95% confidence interval, 0.90-1.19), and 30-day readmissions (adjusted odds ratio, 0.99; 95% confidence interval, 0.80-1.23). Sensitivity analyses assessing individual complications, hysterectomy outcomes at nonacademic hospitals, and benign vs malignant indications for hysterectomies yielded similar findings. CONCLUSION: Women in Maryland undergoing hysterectomy surgery at academic hospitals during July through September of the academic year did not experience worse outcomes relative to women having surgery in other months. Additional studies are necessary to further assess the possibility of a July effect in hysterectomy on a national basis. Institutions should continue to provide effective surgical training environments for new interns and residents transitioning to more senior roles, while maintaining optimal patient safety.

Staging Lymphadenectomy in Patients With Clear Cell Carcinoma of the Ovary.

OBJECTIVE: The purpose of this study was to assess the rate of lymph node (LN) metastasis in comprehensively staged ovarian clear cell carcinoma (OCCC) clinically confined to the ovary and determine factors associated with LN metastasis. METHODS: We identified all cases of OCCC treated at 4 institutions from January 1994 through December 2011. We included cases with disease grossly confined to the ovary that had surgical staging performed, including at least 10 LNs sampled. Clinical and pathologic data were abstracted from electronic medical records, and a deidentified data set was compiled and processed at a single institution. Factors potentially associated with LN metastasis were tested. Appropriate statistical tests were performed. RESULTS: We identified 145 eligible cases that met the criteria for this analysis. Median age was 52.9 years (range, 30-81 years), and median total LN count was 19 (range, 10-74). Seven (4.8%) of 145 comprehensively staged cases had LN metastasis; 6 of these cases (4.1%) were isolated metastasis. Cytologic washings, peritoneal, omental, and fallopian tube involvement were not associated with nodal metastasis. Cases with ovarian surface involvement and positive cytology had a 37.5% incidence of LN positivity, which was statistically meaningful when compared with all other cases (P = 0.003). CONCLUSIONS: Women who underwent comprehensive staging for clinical stage I OCCC had an LN metastasis rate of 4.8%. The subgroup of cases with both ovarian surface involvement and positive cytology had the highest incidence of LN metastasis. This may influence clinical decision making on whether to perform lymphadenectomy in patients with incidental OCCC found after salpingo-oophorectomy.