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ObjectiveTo describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials.MethodsGynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data.Results2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p

e18765 Background: An estimated 94,000 women have newly diagnosed gynecologic cancer (ovarian, uterine, cervical, and vulvovaginal) annually–with rates increasing over the last 20 years. Surgical site infections (SSIs) complicate up to 4% of all hysterectomies in the United States. Other surgical sequelae, such as operative length, estimated blood loss, wound dehiscence, and 30-day readmission, further complicate the post-surgical course of this vulnerable population. Methods: A quality improvement initiative was conducted in a large academic health system between January to June 2022 to investigate whether implementing an SSI bundle, defined as a set of 11 evidence-based practices performed collaboratively, can reduce intraoperative and postoperative complications. The study population included women who received gynecologic oncologic surgery. To evaluate trends following the implementation of an SSI prevention bundle, we studied two time periods: 1/1/22-3/31/22 and 4/1/22-6/30/22. Trends were analyzed using chi-squared and a two-sample t-test. Results: Over our six-month study period, 233 patients underwent primary gynecologic oncologic surgery. Robotic-assisted hysterectomies were the most common (27.89%, n = 65), followed by total abdominal hysterectomies (21%, n = 49), laparoscopic hysterectomies (7.72%, n = 18), and supracervical hysterectomies (3%, n = 7). An invasive, abdominal approach was needed for less than half of the surgeries for whom intraoperative and postoperative outcomes were measured (46.35%, n = 108). Following the implementation of our SSI bundle, there was a rise in estimated blood loss (134.49 to 252.67 mL), operative length (199.24 to 227.23 min), and length of stay (1.58 to 2.20 days). Yet, there was a decline in the SSI rate from 4.62% to 3.7% (p = 0.97) and 30-day all-cause readmission from 12.96% to 7.4% (p < 0.05). The overall incidence of 30-day wound dehiscence also declined over six months from 3.7% to 1.85% (p = 0.74). Upon intersectional analysis, patients with SSI were older (55.93 vs. 62, p = 0.39) and were more likely to be obese (BMI 27.04 vs. 31.06, p < 0.05). Individuals with functional status limitations, ECOG score > 2, had longer lengths of stays (4.7 vs. 1.76 days, p < 0.05), estimated blood loss (230 vs. 185.9 mL, p = 0.12), and operative length (374 vs. 205.2 min, p < 0.001). Those with a supracervical hysterectomy also had a longer length of stays (4 days, p < 0.05), blood loss (921.43 mL, p < 0.001), and operative lengths (315.14 min, p < 0.001). Conclusions: Following the implementation of an evidence-based SSI quality improvement project, cancer patients had fewer SSI, hospital readmissions, and wound dehiscence. High ECOG scores, supracervical hysterectomies, and obesity were all associated with worse postoperative outcomes. Prospective studies on postoperative surgical quality are needed to improve care for our most vulnerable patients.

OBJECTIVES: To evaluate outcomes and cost-effectiveness of targeted therapy sequencing for metastatic and recurrent cervical cancer. METHOD: Models were simulated based on phase II and III trials on bevacizumab (bev) from GOG-240, cemiplimab (cemi) from GOG 3016, pembrolizumab (pembro) from KEYNOTE-826, and tisotumab vedotin (tiso) from GOG 3023. Costs were based on IBM Micromedex RED BOOK™ and company listed costs. RESULTS: For [chemo + bev → chemo], total cost was $125,918.04, with median overall survival (mOS) of 21.8 months, and cost-effectiveness ratio (CER) of $119,835.79. For [chemo + bev → cemi], total cost was $187,562.99 with mOS of 28.5 months and CER of $162,039.16. For [chemo + bev + pembro → chemo], total cost was $319,963.78 with mOS 32.9 months and CER of $249,930.10. For [chemo + bev + pembro → tiso], total cost was $455,204.45, with mOS 36.5 months and CER of $320,072.99. CONCLUSION: The combination of immunotherapies and biologics have significantly increased overall survival, but with associated higher costs, primarily related to drug costs.

We used data from the US Cancer Statistics database to determine trends in cancer incidence, stratified by age, race, and ethnicity, among women aged 20 years or older during an 18-year study period (2001-2018). We limited analysis to cancers associated with 5 modifiable risk factors: tobacco use, excess body fat, alcohol consumption, insufficient physical activity, and human papillomavirus infection. The incidence of cancers associated with obesity have risen, particularly among women aged 20 to 49 years (vs ≥50 y) and among Hispanic women. Strategies that address obesity rates in these populations may help decrease cancer risk.

Older patients and those who require interpreters are least likely to use telehealth for gynecologic oncology care, showing disparities which continued after statewide vaccinations.

OBJECTIVE:: Endometrial cancer (EC) is increasing in incidence and mortality rates, possibly due to the rising rates of obesity in the United States. The type I/II EC classification system was first proposed by Bokhman in 1983 following 20 years of personal observations among 366 women and established obesity as a classical risk factor for low-grade EC with a good prognosis. However, more recent pooled analyses suggest that the 2 types share many etiologic risk factors, including obesity. Given the increase in mortality as a consequence of high-risk EC, the relationship between obesity and uterine cancer, as proposed by Bohkman, may be oversimplified. This study aimed to analyze the trend of type I/II EC in the United States as it relates to obesity using national statistics. STUDY DESIGN:: Data were obtained from the United States Cancer Statistics database and the Behavioral Risk Factors Surveillance System survey from 2001 to 2017. The incidence of uterine cancer, histologic type, obesity, and average annual percentage change (AAPC) were calculated using Joinpoint regression. Endometrial histology was classified according to traditional type I (endometrioid grade 1–3) and type II (serous, clear cell, carcinosarcoma) categories. RESULTS:: Over this 17-year study period, 778,891 patients were diagnosed with uterine cancer. Overall, the rate of new uterine cancer cases increased by 0.82% annually (P

ObjectivePatients with advanced epithelial ovarian cancer (EOC) alive without progression at a landmark time-point of 10 years from diagnosis are likely cured. We report the proportion of patients with Stage III EOC who were long-term disease-free survivors (LTDFS≥10 years) following either intraperitoneal (IP) or intravenous (IV) chemotherapy as well as the predictors of LTDFS.MethodsData from 3 mature NRG/GOG trials (104, 114, 172) were analyzed and included demographics, clinicopathologic details, route of administration, and survival outcomes of patients living ≥10 years assessed according to the Kaplan-Meier method. Cox regression survival analysis was performed to evaluate independent prognostic predictors of LTDFS.ResultsOf 1174 patients randomized, 10-year overall survival (OS) was 26% (95% CI, 23-28%) and LTDFS ≥10 years was 18% (95% CI, 16-20%). Patients with LTDFS ≥10 years had a median age of 54.6 years (p < 0.001). Younger age (p < 0.001) was the only independent prognostic factor for LTDFS≥10 years on multivariate Cox analysis.ConclusionsApproximately 18% of patients were LTDFS ≥10 years. They form the tail end of the survival curve and are likely cured. Our results provide a comparative benchmark to evaluate the impact of PARP inhibitors in 1st line maintenance trials on survival outcomes.

We herein present an overview of the upcoming 5th edition of the World Health Organization Classification of Haematolymphoid Tumours focussing on lymphoid neoplasms. Myeloid and histiocytic neoplasms will be presented in a separate accompanying article. Besides listing the entities of the classification, we highlight and explain changes from the revised 4th edition. These include reorganization of entities by a hierarchical system as is adopted throughout the 5th edition of the WHO classification of tumours of all organ systems, modification of nomenclature for some entities, revision of diagnostic criteria or subtypes, deletion of certain entities, and introduction of new entities, as well as inclusion of tumour-like lesions, mesenchymal lesions specific to lymph node and spleen, and germline predisposition syndromes associated with the lymphoid neoplasms.

The upcoming 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours is part of an effort to hierarchically catalogue human cancers arising in various organ systems within a single relational database. This paper summarizes the new WHO classification scheme for myeloid and histiocytic/dendritic neoplasms and provides an overview of the principles and rationale underpinning changes from the prior edition. The definition and diagnosis of disease types continues to be based on multiple clinicopathologic parameters, but with refinement of diagnostic criteria and emphasis on therapeutically and/or prognostically actionable biomarkers. While a genetic basis for defining diseases is sought where possible, the classification strives to keep practical worldwide applicability in perspective. The result is an enhanced, contemporary, evidence-based classification of myeloid and histiocytic/dendritic neoplasms, rooted in molecular biology and an organizational structure that permits future scalability as new discoveries continue to inexorably inform future editions.

ObjectiveTo assess the presentation, characteristics, and prognostic significance of symptoms in patients with high-risk early-stage epithelial ovarian cancer.MethodsA retrospective chart review was performed on all patients enrolled in a phase III clinical trial (GOG 157). All patients had surgically staged, high-risk early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II). Chi-square and Kaplan-Meier estimates and Cox proportional hazards models were used for statistical analyses.ResultsOf 419 patients evaluated for symptoms, 301 (72%) presented with one or more symptoms, and 118 (28%) were asymptomatic but had a mass found on examination. Forty percent had only one symptom, and 32% had more than one symptom. Among those with at least one symptom, the most common were abdominal and pelvic pain (31%), and increased girth or fullness (26%). Overall, 23% of patients with tumors 10 cm or smaller, 27% of patients with tumors larger than 10 cm to 15 cm, and 46% of patients with tumors larger than 15 cm had multiple symptoms (P

ObjectiveIn the Phase 3 VELIA trial (NCT02470585), veliparib added to carboplatin plus paclitaxel concomitantly and as maintenance for women with newly-diagnosed advanced ovarian cancer significantly improved progression-free survival (PFS) versus chemotherapy alone. Here we present exploratory analyses by paclitaxel dosing schedule and germline BRCA (gBRCA) status.MethodsWomen with untreated ovarian carcinoma were randomized (1:1:1) to: veliparib during chemotherapy and maintenance (veliparib-throughout), veliparib during chemotherapy followed by placebo maintenance (veliparib-combination only), or placebo during chemotherapy and maintenance (control). Chemotherapy included carboplatin plus dose-dense (DD; weekly) or every-3-week (Q3W) paclitaxel (a stratification factor at randomization), selected at the investigator's discretion pre-randomization. PFS was assessed by paclitaxel dosing schedule using a Cox proportional hazard model adjusted by treatment arm and stratification factors; safety was analyzed based on paclitaxel dosing schedule and gBRCA status.Results1132 patients were analyzed by paclitaxel schedule. Pooled treatment arms demonstrated longer median PFS with DD (n = 586) versus Q3W (n = 546) paclitaxel (ITT: 20.5 vs 15.7 months, hazard ratio [HR] 0.77; homologous recombination proficient cancer: 15.1 vs 11.8 months, HR 0.64; BRCAwt: 18.0 vs 12.9 months, HR 0.70). Comparison between arms favored veliparib-throughout versus control in both DD (PFS, 24.2 vs 18.3 months, hazard ratio 0.67) and Q3W (19.3 vs 14.6, hazard ratio 0.69) subgroups. DD paclitaxel was associated with higher incidence of Grade 3/4 neutropenia, fatigue, and anemia versus Q3W. There were no differences in toxicity between gBRCAm (n = 211) and gBRCAwt (n = 902) subgroups.ConclusionsDD paclitaxel was tolerable and associated with longer PFS in the HR proficient and gBRCAwt groups, versus Q3W. gBRCA status did not impact safety.

• The world is working with unprecedented fervor and spending billions of dollars to find a vaccine for COVID-19. • Nearly 381,500 people worldwide died from human papillomavirus-related cancers in 2018 despite a safe and effective vaccine. • With the momentum from our fight against this pandemic, we can improve vaccine implementation.

BACKGROUND: Secondary surgical cytoreduction in women with platinum-sensitive, recurrent epithelial ovarian, primary peritoneal, or fallopian-tube (ovarian) cancer is widely practiced but has not been evaluated in phase 3 investigation. METHODS: We randomly assigned patients with recurrent ovarian cancer who had received one previous therapy, had an interval during which no platinum-based chemotherapy was used (platinum-free interval) of 6 months or more, and had investigator-determined resectable disease (to no macroscopic residual disease) to undergo secondary surgical cytoreduction and then receive platinum-based chemotherapy or to receive platinum-based chemotherapy alone. Adjuvant chemotherapy (paclitaxel-carboplatin or gemcitabine-carboplatin) and use of bevacizumab were at the discretion of the investigator. The primary end point was overall survival. RESULTS: A total of 485 patients underwent randomization, 240 to secondary cytoreduction before chemotherapy and 245 to chemotherapy alone. The median follow-up was 48.1 months. Complete gross resection was achieved in 67% of the patients assigned to surgery who underwent the procedure. Platinum-based chemotherapy with bevacizumab followed by bevacizumab maintenance was administered to 84% of the patients overall and was equally distributed between the two groups. The hazard ratio for death (surgery vs. no surgery) was 1.29 (95% confidence interval [CI], 0.97 to 1.72; P = 0.08), which corresponded to a median overall survival of 50.6 months and 64.7 months, respectively. Adjustment for platinum-free interval and chemotherapy choice did not alter the effect. The hazard ratio for disease progression or death (surgery vs. no surgery) was 0.82 (95% CI, 0.66 to 1.01; median progression-free survival, 18.9 months and 16.2 months, respectively). Surgical morbidity at 30 days was 9%; 1 patient (0.4%) died from postoperative complications. Patient-reported quality of life decreased significantly after surgery but did not differ significantly between the two groups after recovery. CONCLUSIONS: In this trial involving patients with platinum-sensitive, recurrent ovarian cancer, secondary surgical cytoreduction followed by chemotherapy did not result in longer overall survival than chemotherapy alone. (Funded by the National Cancer Institute and others; GOG-0213 ClinicalTrials.gov number, NCT00565851.).

Difficulty with communication and social functioning are two outstanding core symptoms of autism spectrum disorder, and physical activity has long been suggested to improve autism spectrum disorder symptoms. In this meta-analysis of controlled trials, we examined the effects of physical activity interventions compared to controls on communication and social functioning in autistic children and adolescents. Included studies are published articles in English with autism spectrum disorder participants younger than 18 years. Literature search was conducted on MEDLINE, Embase, CINAHL, and related databases through 6 May 2020. Quality of study was assessed with the Cochrane risk-of-bias tool regarding randomization, allocation concealment, blinding, attrition, and selective reporting. We included 12 controlled trials (N = 350) with communication outcomes (k = 8) and/or social functioning outcomes (k = 11). Results show small to moderate intervention benefits on communication (standardized mean change = 0.27, 95% confidence interval (0.06, 0.48)) and social functioning (standardized mean change = 0.39, 95% confidence interval (0.15, 0.63)), but the result for social functioning may be susceptible to publication bias. Better intervention outcomes are observed in younger participants, suggesting the importance of early participation. This study shows the benefits of physical activity interventions, and they could be considered a cost-effective means for autism spectrum disorder management in the future.