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The original vision of the field of gynecologic oncology was to establish a multidisciplinary approach to the management of patients with gynecologic cancers. Fifty years later, scientific advances have markedly changed the overall practice of gynecologic oncology, but the profession continues to struggle to define its value-financial and otherwise. These issues were examined in full at the Society of Gynecologic Oncology (SGO) Future of the Profession Summit and the purpose of this document is to summarize the discussion, share the group's perceived strengths, weaknesses, opportunities, and threats (SWOT) for gynecologic oncologists, further educate members and others within the patient care team about the unique role of gynecologic oncologists, and plan future steps in the short- and long- term to preserve the subspecialty's critical mission of providing comprehensive, longitudinal care for people with gynecologic cancers. • Gynecologic oncology has made significant scientific and practice advances since its inception over 50 years ago. • Increased benign surgery and decreasing involvement with non-surgical therapies have changed the subspecialty. • The SGO convened a summit of a diverse group of members to discuss the current and future state of the profession. • Should we reassess the original vision and better define the values and roles of gynecologic oncology in cancer care? [ABSTRACT FROM AUTHOR]

Women with persistent, recurrent, and/or metastatic cervical cancer have a poor prognosis. Even with the availability of cisplatin plus paclitaxel and bevacizumab, median overall survival (OS) is only 17.0 months, with median post-progression survival of approximately seven months. We studied the therapeutic vaccine, Axalimogene filolisbac (ADXS-HPV), in women who had progressed following at least one prior line of therapy (Gynecologic Oncology Group protocol 265/ NCT01266460). Volunteers ≥18 years with advanced cervical cancer and GOG performance status score of 0 or 1 were eligible for participation in this 2-stage, phase II trial. In stage 1, women received up to three doses of ADXS-HPV (1 × 109 colony-forming units in 250 mL IV over 15 min every 28 days) and were monitored for tumor progression. In stage 2, women were treated until progression, intolerable adverse events (AEs), or voluntary withdrawal of consent. Co-primary endpoints were safety and proportion of volunteers surviving ≥12 months. An estimated, combined (stages 1 + 2) 12-month OS of 35% was calculated from historical GOG cohorts to declare ADXS-HPV sufficiently active in this platinum-pre-treated population. Secondary endpoints were OS and progression-free survival (PFS). Among 50 evaluable volunteers, the 12-month OS was 38% (n = 19). Median OS was 6.1 months (95% CI: 4.3–12.1) and median PFS was 2.8 months (95% CI: 2.6–3.0). The most common treatment-related AEs were fatigue, chills, fever, nausea, and anemia. The majority of AEs were grade 1 or 2 and resolved spontaneously or with appropriate treatment. At the dose and schedule studied, ADXS-HPV immunotherapy was tolerable and met the protocol-specified benchmark for activity required to warrant further investigation in volunteers with cervical carcinoma. • ADXS-HPV immunotherapy was tolerable and met the protocol-specified benchmark for activity. • Among 50 evaluable volunteers, the 12-month OS was 38%. • The majority of AEs were grade 1 or 2 and resolved spontaneously or with appropriate treatment. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has challenged our ability to provide timely surgical care for our patients. In response, the U.S. Surgeon General, the American College of Srugeons, and other surgical professional societies recommended postponing elective surgical procedures and proceeding cautiously with cancer procedures that may require significant hospital resources and expose vulnerable patients to the virus. These challenges have particularly distressing for women with a gynecologic cancer diagnosis and their providers. Currently, circumstances vary greatly by region and by hospital, depending on COVID-19 prevalence, case mix, hospital type, and available resources. Therefore, COVID-19-related modifications to surgical practice guidelines must be individualized. Special consideration is necessary to evaluate the appropriateness of procedural interventions, recognizing the significant resources and personnel they require. Additionally, the pandemic may occur in waves, with patient demand for surgery ebbing and flowing accordingly. Hospitals, cancer centers and providers must prepare themselves to meet this demand. The purpose of this white paper is to highlight all phases of gynecologic cancer surgical care during the COVID-19 pandemic and to illustrate when it is best to operate, to hestitate, and reintegrate surgery. Triage and prioritization of surgical cases, preoperative COVID-19 testing, peri-operative safety principles, and preparations for the post-COVID-19 peak and surgical reintegration are reviewed. [ABSTRACT FROM AUTHOR]

Cervical cancer screening guidelines currently recommend cessation of cervical cancer screening after age 65, despite 20% of new cervical cancer cases occurring in this age group. The US population is aging, research methodology that examines cervical cancer incidence and mortality rates has changed, and sexual behaviors and the rates at which women have hysterectomies have changed over time. Current guidelines do not adequately address these changes, and may be missing significant opportunities to prevent cervical cancer cases and deaths in older women. Furthermore, racial disparities in cervical cancer outcomes may be exacerbated by not addressing the preventive health needs of older women through cervical cancer screening. • Cervical cancer screening guidelines recommend screening stop after age 65 despite 20% of new cases occurring in this group • Demographics, research methods and treatment paradigms are changing and guidelines may not adequately address these changes • Racial disparities in cervical cancer may be exacerbated by not addressing the preventive health needs of older women [ABSTRACT FROM AUTHOR]

Objective The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3. Methods Eligible patients with HPV16 + CIN2/3 were enrolled in treatment cohorts evaluating pNGVL4a-CRT-E7(detox), administered by either particle-mediated epidermal delivery (PMED), intramuscular injection (IM), or cervical intralesional injection, at study weeks 0, 4, and 8. Patients were monitored for local injection site and systemic toxicity. A standard therapeutic resection was performed at week 15. The primary endpoints were safety and tolerability. Secondary endpoints included histologic regression and change in cervical HPV viral load. Exploratory endpoints included immune responses in the blood and in the target tissue. Results Thirty-two patients with HPV16 + CIN2/3 were enrolled onto the treatment phase of the study, and were vaccinated. Twenty-two of 32 patients (69%) experienced vaccine-specific related adverse events. The most frequent vaccine-related events were constitutional and local injection site in nature, and were grade 1 or less in severity. Histologic regression to CIN 1 or less occurred in 8 of 27 (30%) patients who received all vaccinations and underwent LEEP. In subject-matched comparisons, intraepithelial CD8 + T cell infiltrates increased after vaccination in subjects in the intralesional administration cohort. Conclusion pNGVL4a-CRT-E7(detox) was well-tolerated, elicited the most robust immune response when administered intralesionally, and demonstrated preliminary evidence of potential clinical efficacy. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: To examine the current approaches to cervical screening and points to consider for improving HPV vaccination acceptance and uptake in the US. Methods: An expert forum was conducted September 12–13, 2008, by the Society of Gynecologic Oncologists including 56 experts in cervical cancer and titled “Future Strategies of Cervical Cancer Prevention: What Do We Need to Do Now to Prepare?”. Results: Cervical cancer prevention has primarily relied on screening paradigms but vaccination against human papillomavirus (HPV), the cause of the disease, is a primary preventative measure that has been recommended by all cervical cancer screening stakeholders. Guidelines for vaccination are developed by national advisory groups, but successful implementation requires a supportive infrastructure and the cooperation of providers, clinicians, and patients. HPV vaccination has been available in the United States (US) since 2006 and screening practices have been updated to also include HPV genotyping. However, many clinicians fail to adhere to the guidelines for HPV testing (and HPV co-testing) as part of cervical cancer screening, and vaccination coverage has been poor among females aged 11 and 12, the group for which vaccination is recommended by all organizations. Conclusions: The data reviewed and presented in this session of the “Future Strategies of Cervical Cancer Prevention. What Do We Need to do Now to Prepare?”. The Forum suggests that the policies influencing HPV vaccination and screening need to be reassessed at multiple levels in order to achieve more effective implementation and regular use. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To review the current state of HPV typing of the vaccinated population in the United States and potential for typing of this population over the next 5years. Methods: An expert forum conducted on September 12–13, 2008, by the Society of Gynecologic Oncologists including 56 experts in cervical cancer and titled “Future strategies of cervical cancer prevention: what do we need to do now to prepare?” Results: In principle, screening with HPV DNA testing for oncogenic genotypes followed by cytologic triage has attractive features that may serve well the screening needs of a post-vaccination era in the US. Particularly in light of the recent FDA approval of a HPV genotyping test, the group focused on how typing could be used to assist clinical decisions and whether its implementation would be cost-effective. Furthermore, it was agreed upon that HPV typing should not be used to determine who should be vaccinated against HPV. There was considerable discussion regarding the potential misuse and overuse of HPV typing in low risk women among healthcare providers. Conclusions: As HPV typing technologies gain traction in the United States, its appropriate use will depend on the evolving natural history of the vaccinated cohort, continued educational efforts of healthcare providers, and most importantly, creating an integrated approach to cervical cancer prevention that will lead to a greater decrease in the incidence of cervical disease in the US while allowing for cost equipoise. On September 12–13, 2008, the Society of Gynecologic Oncologists (SGO) convened a symposium of 56 cervical cancer experts titled “Future strategies of cervical cancer prevention: what do we need to do now to prepare?” to discuss evidence-based strategies in cervical cancer prevention and control, including HPV vaccination. This paper is the second in a series of manuscripts which highlight concepts, information, obstacles and approaches discussed during the Forum''s sessions and focuses on the current state of HPV typing of the vaccinated population in the United States and typing of this population over the next 5years. [Copyright &y& Elsevier]

Abstract: Objective.: To compare the clinical behavior and outcomes of low- and high-grade endometrial stromal sarcomas (LGESS and HGESS), respectively. Methods.: Patients with endometrial stromal sarcoma from five different institutions were identified and reviewed for clinicopathologic variables, surgical management and outcomes. Statistical calculations including Chi-square, t-test and survival using the Kaplan–Meier method with the log rank test were performed. Results.: One hundred and five patients were identified with 72 having LGESS, 31 with HGESS and 2 having unclassified tumors. The mean age was 50 years for patients with LGESS and 64 years for those with HGESS (p <0.0001). In patients with LGESS, 68% (49 patients) had disease confined to the uterine corpus or cervix compared to 39% (12 patients) in HGESS (p =0.002). The median overall survival was 53 months for HGESS and had not yet been reached in LGESS with 87.8% alive at 80 months (p <0.0001). In HGESS patients with extrauterine disease, the presence of residual disease greater than 2 cm had a significant effect on median survival. Median survival was 52 months for those who underwent optimal cytoreduction versus 2 months for those with suboptimal residual disease (p =0.007). The impact of cytoreduction was not seen in LGESS patients with extrauterine disease with 82.1% alive at 78 months. Conclusions.: Low-grade and high-grade endometrial stromal sarcomas represent two distinct clinical entities and should be treated as such. Survival in patients with high-grade tumors appears to be related to amount of residual disease at the completion of initial surgery and would suggest the need for aggressive cytoreduction. The role of surgical staging and optimal adjuvant therapy remains unclear. [Copyright &y& Elsevier]

• 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. [ABSTRACT FROM AUTHOR]

: ObjectiveThe goal of this study was to determine the outcomes of stage IC endometrial carcinoma patients who are managed with and without adjuvant radiation therapy after comprehensive surgical staging.: MethodsPatients with FIGO stage IC adenocarcinoma of the endometrium diagnosed from 1988 to 1999 were identified from tumor registry databases at four institutions. A retrospective chart review identified 220 women who underwent comprehensive surgical staging including a total hysterectomy, bilateral salpingo-oophorectomy, pelvic/paraaortic lymphadenectomy, and peritoneal cytology.: ResultsOf the 220 stage IC patients, 56 (25%) patients received adjuvant brachytherapy (BT), 19 (9%) received whole-pelvis radiation (WPRT), and 24 (11%) received both WPRT and BT. One hundred twenty-one patients (55%) did not receive adjuvant radiation. There were 6 recurrences (6%) in the radiated group and 14 (12%) in the observation group (P = 0.20). Seven of fourteen recurrences in the observation group were local, and all local recurrences were salvaged with radiation therapy. Two of seven distant recurrences in this group were also salvaged with surgery and chemotherapy. The overall salvage rate for the observation group was 64%. There was a statistical difference in 5-year disease-free survival between the radiated and observation groups (93% vs 75%, P = 0.013). However, the 5-year overall survival was similar in the two groups (92% vs 90%, P = 0.717).: ConclusionAdjuvant radiation therapy improves disease-free survival in surgical stage IC patients; however, overall survival is not improved with adjuvant radiation therapy since the majority of local recurrences in conservatively managed patients can be salvaged with radiation therapy. [ABSTRACT FROM AUTHOR]

Objective. The aim of this study was to determine the outcomes of Stage I endometrial carcinoma patients who are managed without adjuvant radiation after comprehensive surgical staging.Methods. A computerized hospital database identified women diagnosed with adenocarcinoma of the endometrium from 1993 to 1998. A chart review identified 864 women as having primary surgery for adenocarcinoma of the endometrium. A total of 670 of 864 patients (78%) underwent comprehensive surgical staging with total hysterectomy, bilateral salpingo-oophorectomy, pelvic/para-aortic lymphadenectomy, and peritoneal cytology. After 57 patients with high-risk histologic subtypes were excluded, 613 patients remained for analysis.Results. A total of 321 of 325 Stage IB patients (99%) did not receive adjuvant radiation. Fifteen of 321 patients (5%) recurred; 9 recurred in the pelvis or vagina. All 9 local recurrences were salvaged with whole pelvic radiation (XRT) and brachytherapy (BT). Seventy-seven patients were diagnosed with Stage IC disease; 53 (69%) received no adjuvant therapy. Four patients (8%) recurred, of which 2 recurred in the vagina. Three of 4 patients (75%) were salvaged, 2 with XRT/BT and 1 with surgery and chemotherapy. For all Stage I patients, the 5-year disease-free survival was 93% and the 5-year overall survival was 98%.Conclusions. Surgically staged patients with endometrial carcinoma confined to the uterine corpus have a small risk of recurrence and the majority of these recurrences can be salvaged with radiation therapy. Conservative management of Stage I endometrial carcinoma patients is an effective treatment strategy. [Copyright &y& Elsevier]

The objective of this study was to determine the trends in benign surgery in GO practice across the United States. This was a retrospective cohort analysis of the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database from 2015 to 2021. Subjects were selected by filtering for cases of hysterectomy using current procedural terminology (CPT codes). Trends over time were assessed using linear regression for continuous outcomes and logistic regression for categorical outcomes. From the 2015 to 2021, the dataset contained 246,743 hysterectomies that were performed across the United States. For all gynecologic specialties, 188,534 (76%) were performed for benign indications and 59,209 (24%) were gynecologic cancer cases. The proportion of hysterectomies done by all specialists for benign indications increased with increasing year. When looking at hysterectomy cases by surgeon's subspecialty, GOs performed 35,680 (23%) of all benign cases over the entire time period. Over our study time period, the proportion of benign hysterectomies performed by GOs increased with increasing year with the proportion of benign hysterectomies done by GO in 2016 was 37.8% and reached 45.2% in 202. The proportion of hysterectomies done by all sub-specialists for cancer indications decreased with increasing year including the proportion of cancer cases performed by GOs for cancer indications. The proportion of benign hysterectomies performed by GO consistently increased every year. This study corroborates existing survey data and hypothesizes that the practice of GO is increasingly being consumed by general gynecology. • The proportion of benign hysterectomies performed by GO consistently increased every year from 2015 to 2021. • Benign hysterectomies performed in 2016 was 37.8% and increased to 45.2% in 2021. • Out of all benign hysterectomies performed during the study period, 23% were performed by GOs [ABSTRACT FROM AUTHOR]

The primary goal for many providers in the United States has been to deliver the level of protection against cervical cancer afforded by annual cervical cytology while improving screening test performance. Adoption of recent screening recommendations has been inconsistent and has created considerable consternation and confusion. This editorial addresses the perspective of U.S. patients and providers and how their preferences may run counter to current screening recommendations. [ABSTRACT FROM AUTHOR]

To assess trends and differences in patient characteristics, complications, and distributions of hysterectomy for benign indications by benign gynecologists (BG) and gynecologic oncologists (GO). This retrospective cohort study identified patients undergoing hysterectomy for benign indications using the National Surgical Quality Improvement Program data from 2014 to 2021. Exclusions were made for gynecologic or disseminated cancers, ascites, non-gynecologic surgeons, and cesarean hysterectomies. Primary outcome was major (≥Grade 3) 30-day complications, categorized into any complications, wound, cardiovascular and pulmonary, renal, infectious, andthromboembolic complications. Thirty-day readmissions, reoperations, and mortality were also analyzed. Propensity score matching was performed in a 1:1 match of GO to BG patients and was compared. Linear regressions assessed trends. Among 198,767 patients, 18% (n = 37,707) underwent hysterectomy for benign indications with GO. GO patients exhibited more risk factors for complications and differed significantly from BG patients in comorbidities and perioperative characteristics. Overall, GO patients had higher major complication rates (3.1% vs 2.2%, p < 0.001) and for several other composite complications. After matching, compared to BG, GO-performed hysterectomies had similar rates of major complications (3.0% vs 3.0%, p = 0.55) and no differences in other composite complications, except fewer reoperations (1.2 % vs 1.5%, p < 0.01) and wound complications (0.4% vs 0.5%, p = 0.02) in GO patients. Over the eight years, the percentage of GO-performed hysterectomy (β = 0.41, R2 = 0.71, p < 0.01) increased significantly whereas BG-performed surgeries decreased by the same magnitude. BG had a significant decrease in frail patients (β = −0.47, R2 = 0.90, p < 0.01), but GO did not (β = −0.36, R2 = 0.38, p = 0.10). GO are performing more hysterectomies for benign indications on higher-risk patients. However, on a matched cohort, risks of major complications were similar between GO and BG. • Gynecologic oncologists are performing more hysterectomy for benign indications. • Gynecologic oncologists' benign hysterectomies have higher risk factors and experience more major complications. • Similar complicate rates seen between gynecologic oncologist and benign gynecologist when risk factors are controlled. • Percentage of frail patients undergoing benign hysterectomies is decreasing over time. • There are implications for patient selection, resource management, and collaboration in benign surgeries by oncologists. [ABSTRACT FROM AUTHOR]

To evaluate existing distress screening to identify patients with financial hardship (FH) compared to dedicated FH screening and assess patient attitudes toward FH screening. We screened gynecologic cancer patients starting a new line of therapy. Existing screening included: (1) Moderate/severe distress defined as Distress Thermometer score ≥ 4, (2) practical concerns identified from Problem Checklist, and (3) a single question assessing trouble paying for medications. FH screening included: (1) Comprehensive Score for Financial Toxicity (COST) tool and (2) 10-item Financial Needs Checklist to guide referrals. FH was defined as COST score < 26. We calculated sensitivity (patients with moderate/severe distress + FH over total patients with FH) and specificity (patients with no/mild distress + no FH over total patients with no FH) to assess the extent distress screening could capture FH. Surveys and exit interviews assessed patient perspectives toward screening. Of 364 patients screened for distress, average age was 62 years, 25% were Black, 45% were Medicare beneficiaries, 32% had moderate/severe distress, 15% reported ≥1 practical concern, and 0 reported trouble paying for medications. Most (n = 357, 98%) patients also completed FH screening: of them, 24% screened positive for FH, 32% reported ≥1 financial need. Distress screening had 57% sensitivity and 77% specificity for FH. Based on 79 surveys and 43 exit interviews, FH screening was acceptable with feedback to improve the timing and setting of screening. Dedicated FH screening was feasible and acceptable, but sensitivity was low. Importantly, 40% of women with FH would not have been identified with distress screening alone. • In a lay navigator-driven model, 98% of patients were screened for financial hardship when added to distress screening. • Distress Thermometer had 57% sensitivity to detect financial hardship measured by Comprehensive Score for Financial Toxicity. • Distress Thermometer had 77% specificity to detect financial hardship measured by Comprehensive Score for Financial Toxicity. • 40% of patients with financial hardship would be missed if using distress screening alone. • Financial hardship screening was acceptable to surveyed patients with input provided about the optimal time and setting. [ABSTRACT FROM AUTHOR]

▪ ▪ ▪ • The report includes endometrial and ovarian cancer rating and subspecialty rankings. • Procedure and condition ratings for gyn cancer are more reflective of quality of care. • Endometrial cancer methodology can improve by including MIS. • Ovarian cancer methodology can improve by including controls for complex surgery. [ABSTRACT FROM AUTHOR]

Studies with prophylactic HPV vaccination have demonstrated impressive efficacy, immunogenicity, and safety results; however, the implementation and uptake in both low and high-income countries continues to be challenging. Since 2006, administration guidelines have undergone multiple updates regarding age, dosing schedule, and gender. Despite these changes, the basic tenet remains the same: prioritize immunization before initiation of sexual activity and subsequent exposure to HPV. The importance of immunizing males and females equally and the role for catch-up vaccination in late adolescent and adulthood has also been supported by subsequent research. Very recently, the FDA approved to expand the range of eligible patients for the nonavalent (9vHPV) vaccine to women and men from age 27 to 45 for the prevention of HPV-related cancers and diseases. Furthermore, members of the ACIP voted to recommend that individuals between ages 27 and 45 who have not yet been vaccinated discuss the option with their physician. This review will highlight the history of the vaccine, barriers to vaccination, current recommendations, and future directions for success. • The HPV vaccine has been proven to be safe and effective, supported by over a decade of research. • Vaccine recommendations have undergone key changes regarding age, dosing schedule, and gender. • Guidelines have recently expanded to include recommendations for all persons up to age 45. • Higher rates of vaccine uptake are being seen in minority and lower socioeconomic status patients. • Trials are ongoing to clarify ideal dosing schedules and the possibility of a one-dose vaccine. [ABSTRACT FROM AUTHOR]

The Lifestyle Intervention for oVarian cancer Enhanced Survival (LIVES) is a national study of a combined diet and physical activity intervention for stage II-IV ovarian cancer survival, an under-represented cancer in lifestyle behavioral intervention research. Here, we present the data on recruitment, retention, and baseline demographic, clinical and lifestyle behavior characteristics of the LIVES study participants. The LIVES study (NRG Oncology/GOG 0225) is a Phase III diet plus physical activity intervention trial testing the hypothesis that ovarian cancer survivors in the lifestyle intervention will demonstrate better progression-free survival than those in the control condition. Study interventions were delivered via centralized telephone-based health coaching. Baseline descriptive statistics were computed for demographic, clinical, and lifestyle behavior characteristics. The LIVES study exceeded its recruitment goals, enrolling 1205 ovarian cancer survivors from 195 NRG/NCORP-affiliated oncology practices across 49 states from 2012 to 2018. The mean age of enrollees was 59.6 years; the majority (69.4%) with stage III disease; 89% White, 5.5% Hispanic; 64% overweight/obese. Baseline self-reported diet showed a mean daily intake of 6.6 servings of fruit and vegetables, 62.7 fat grams, and 21.7 g of fiber. Physical activity averaged 13.0 MET-hours/week of moderate to vigorous physical activity; 50.9 h/week of sedentary time. Retention rates exceeded 88%. The LIVES study demonstrates efficiency in recruiting and retaining ovarian cancer survivors in a 24-month study of diet and physical activity intervention with a primary endpoint of progression free survival that will be reported. ClinicalTrials.gov NCT00719303. • Lifestyle factors -diet and physical activity- may improve survival for ovarian cancer survivors. • This randomized controlled trial (N=1205) ovarian cancer survivors is the first to test this hypothesis. • Rigorous design and protocols for centralized telephonic behavioral intervention delivery drive the trial's impact. [ABSTRACT FROM AUTHOR]

Abstract: Human papillomavirus (HPV) vaccines have been shown to be both highly effective and safe, and there is now considerable enthusiasm among healthcare providers to use the vaccines to reduce the burden of HPV-associated disease in women. When considering who should be vaccinated, it is important that providers understand the complex relationships between age and HPV infections. HPV infections and cervical cancer have a widespread impact on society. Cervical cancer is the cause of a significant amount of morbidity and mortality throughout the world, making it crucial to implement prophylactic HPV vaccines to prevent cervical cancer. Nationally, the target group for vaccination is pre-adolescent females who have not been sexually active or who have recently become sexually active. In the United States, the Advisory Committee on Immunization Practices recommends HPV vaccination for females aged 11 to 12 years. “Catch-up” vaccination of females aged 13 to 26 years who have not been previously vaccinated or who have missed a vaccination is also recommended, as females within this age group have the highest prevalence of HPV infection. Vaccination can still benefit females over the age of 26 years who have not been previously exposed to HPV 6, 11, 16, or 18 and those who may have new sexual partners in the future. This review discusses the various considerations that should be addressed when making recommendations of who should be vaccinated against HPV. [Copyright &y& Elsevier]

Abstract: Cervical cancer continues to cause significant morbidity and mortality worldwide, making prophylactic cervical cancer vaccines an important focus for cervical cancer prevention. The increasing accessibility of these vaccines worldwide has the potential to greatly decrease the incidence and burden of disease in the future. However, current prophylactic vaccines offer no therapeutic benefit for persons already infected with human papillomavirus HPV types targeted by vaccines or persons with precancerous lesions or cervical cancer. The protection offered by current vaccines is primarily against HPV types used to derive the vaccine, although partial cross-protection for related virus types has been observed. Herein, we describe findings from preclinical and clinical studies that employ vaccine strategies that have the potential to shape the future of vaccines against cervical cancer. Modalities include prophylactic strategies to target more oncogenic virus types by using the minor capsid antigen L2 and/or by increasing the number of types used to derive virus-like particle vaccines. Therapeutic strategies include the development of vaccines against HPV early proteins (targets for cellular immunity) for the resolution of precancerous lesions and cervical cancer. Future applications of existing virus-like particle-based vaccines are also discussed. [Copyright &y& Elsevier]

Abstract: With the introduction of cervical screening programs, the incidence and mortality of cervical cancer has been drastically reduced. Techniques such as the traditional Papanicolaou test and the newer liquid-based cytology allow for the early detection of cervical abnormalities prior to the development of invasive cervical cancer. As oncogenic human papillomavirus (HPV) infection is necessary for cervical cancer, HPV-DNA testing has also been proposed as a routine screening method for the general population. Screening limitations, such as adherence, test sensitivity and specificity, access, and cost-effectiveness are reflected in current screening guidelines. The development of prophylactic cervical cancer vaccines is a major milestone in cervical cancer prevention. These vaccines protect against the initial infection of certain oncogenic HPV types, and therefore prevent the development of cervical dysplasia, precancerous lesions, and cervical cancer. Considering routine cervical cancer vaccination in adolescent girls, screening guidelines must adapt in order to retain efficient and cost-effective prevention measures. Although the true epidemiological and economic impact of cervical cancer vaccines cannot be immediately realized, mathematical models predict various scenarios in which vaccination, in addition to cervical screening, will be cost-effective and further reduce cervical cancer disease. [Copyright &y& Elsevier]

Abstract: In the recent period following the approval of the first vaccine targeted against human papillomavirus, it is imperative that we re-evaluate the past, present, and future of cervical cancer prevention. It is clear that the subject of vaccinating young women against a sexually transmitted infection has incited a candid debate among all groups involved. Therefore, we must make the most appropriate and accurate information available to the public and medical communities. The development of vaccines targeted against oncogenic human papillomavirus (HPV) types has made it possible to eliminate approximately 70% of all invasive cervical cancers in women worldwide. However, knowledge about HPV infection and cervical cancer, as well as the need to vaccinate against oncogenic HPV infection, is still lacking among women and physicians. This deficiency could be a key reason why some parents continue to have reservations about vaccinating their daughters. In order for HPV vaccination programs to be highly successful, multiple barriers must be overcome. Review of lessons learned to date has demonstrated that continued tailored and targeted educational and awareness initiatives are required for healthcare professionals, media, patients, and parents. This article also examines the impact of the HPV vaccination awareness campaign on media and public policy dynamics. [Copyright &y& Elsevier]

Background. : More than 30% of high-grade cervical intraepithelial neoplasia (CIN 2,3) may be missed at colposcopy. Novel optical detection system (ODS) offer the potential of improving the performance of colposcopy. Our group has now completed three multicenter trails to evaluate ODS as an aid in the detection and localization of CIN 2,3 sites for cervical biopsy. In the most recent study, a single-arm internally-controlled trial comparing colposcopy with and without the benefit of ODS was evaluated. Methods. : Women referred to colposcopy with an abnormal Pap test were evaluated by colposcopy with commitment to biopsy sites. Prior to biopsy, an ODS scan was performed to identify additional biopsy sites. The ODS combines fluorescence, white light backscattered spectroscopy, and video imaging in a hyperspectral detection algorithm (MediSpectra, Inc., Lexington, MA). ODS results are displayed as a colored overlay on a cervical image depicting areas suspect for CIN 2,3 to guide additional biopsies. Distinct colposcopy-directed and incremental ODS-directed biopsies were evaluated by reference pathology for the presence of CIN 2,3. Results. : Of 227 enrolled subjects at 7 clinical sites, data from 193 were evaluable. Referral Pap distribution was 39.4% ASCUS, 47.2% LSIL, and 13.5% HSIL. Colposcopy detected 41 cases of CIN 2,3, and ODS detected an additional 9 cases, for a 22% gain (P = 0.0037). For the ASCUS/LSIL group, initial colposcopy detected 24 cases of CIN 2,3, and the ODS detected an additional 6, for a 25% gain (P = 0.0214). Conclusions. : ODS increased the detection of CIN 2,3 by 25% among women with ASCUS/LSIL cytology referred to colposcopy. These results are in agreement with a prior dual-arm randomized controlled trial evaluating ODS in an intended use setting comprising 2299 women. [Copyright &y& Elsevier]

Patients with gynecologic malignancies may have varied responses to COVID-19 infection. We aimed to describe clinical courses, treatment changes, and short-term clinical outcomes for gynecologic oncology patients with concurrent COVID-19 in the United States. The Society of Gynecologic Oncology COVID-19 and Gynecologic Cancer Registry was created to capture clinical courses of gynecologic oncology patients with COVID-19. Logistic regression models were employed to evaluate factors for an association with hospitalization and death, respectively, within 30 days of COVID-19 diagnosis. Data were available for 348 patients across 7 institutions. At COVID-19 diagnosis, 125 patients (36%) had active malignancy. Delay (n = 88) or discontinuation (n = 10) of treatment due to COVID-19 infection occurred in 28% with those on chemotherapy (53/88) or recently receiving surgery (32/88) most frequently delayed. In addition to age, performance status, diabetes, and specific COVID symptoms, both non-White race (adjusted odds ratio (aOR) = 3.93, 95% CI 2.06–7.50) and active malignancy (aOR = 2.34, 95% CI 1.30–4.20) were associated with an increased odds of hospitalization. Eight percent of hospitalized patients (8/101) died of COVID-19 complications and 5% (17/348) of the entire cohort died within 30 days after diagnosis. Gynecologic oncology patients diagnosed with COVID-19 are at risk for hospitalization, delay of anti-cancer treatments, and death. One in 20 gynecologic oncology patients with COVID-19 died within 30 days after diagnosis. Racial disparities exist in patient hospitalizations for COVID-19, a surrogate of disease severity. Additional studies are needed to determine long-term outcomes and the impact of race. • Patients with gynecologic cancer and COVID-19 are at risk for hospitalization, delay of cancer treatment, and death. • Racial disparities exist in hospitalizations of patients with gynecologic cancer and COVID-19. • Active malignancy was associated with a 5-fold increase in the odds of 30-day mortality after COVID-19 diagnosis. [ABSTRACT FROM AUTHOR]

Our objective was to obtain perspectives from ovarian cancer patients on job demands, cancer demands, and workplace or cancer resources and strategies to manage the cancer-work interface using the cancer-work management conceptual framework. We recruited ovarian cancer patients receiving systemic therapy who screened positive for financial distress using Comprehensive Score for Financial Toxicity <26. Interviews were conducted with participants about their costs of care, including employment concerns. Interviews were recorded, transcribed verbatim, and analyzed by three researchers using an inductive thematic analysis. Of 22 participants, the average age was 57 years old, 36% were Black, 68% had income <$40,000, 41% had public insurance, and 68% were being treated for recurrent disease. Job demands included decreased productivity, inability to return to work, and worry about losing a job or employer-based health insurance coverage. Cancer demands included physical and cognitive limitations due to cancer treatment and reliance on caregivers, especially for transportation. Workplace resources/strategies including having a supportive employer, modifying job responsibilities, and utilizing family medical leave. Cancer care resources/strategies included planning appointments ahead of time and utilizing resources, such as disability. Cancer care teams should consider screening patients for employment concerns; streamline care to minimize the side effects, time, and transportation demands of treatment on patients and caregivers; maximize utilization of available resources; and proactively communicate with employers to accommodate patients and caregivers who want or need to work. • Cancer teams should screen for employment concerns and develop resources for patients and caregivers who need/want to work. • Job demands include decreased productivity, inability to work, potential for job and employer-based health insurance loss. • Cancer demands include work limitations due to symptoms, reliance on working caregivers for transportation. • Workplace resources/strategies include having a supportive employer, modifying job responsibilities, family medical leave. • Cancer care resources/strategies include streamlining care to minimize work impact and providing information on disability. [ABSTRACT FROM AUTHOR]

Distress screening and management is a recommended component of oncology care. Our objective was to evaluate distress rate, sources, and compliance with psychosocial follow-up among ovarian cancer patients receiving chemotherapy. We reviewed patient distress surveys completed by ovarian cancer patients receiving chemotherapy from 10/2017–6/2019. Lay or nurse navigators conducted screening with the NCCN Distress Thermometer from 0 (none) to 10 (highest distress). A distress score ≥ 4 (moderate/severe) was considered a positive screen. A recommendation for psychosocial follow-up was automatically generated in the treatment care plan based upon a yes response to any depression-related concern, independent of distress score. Documentation of referral to a mental health professional or social worker for counseling was considered compliant with psychosocial follow-up. We performed descriptive statistics and bivariate analyses. 97/211 (46%) ovarian cancer patients screened positive for distress. Average score was 6.1 for those who screened positive and 3.3 for the entire cohort (range 0–10). Unmarried status (p < 0.01) was associated with positive screen, whereas non-white race (p = 0.26) and recurrent disease (p = 0.21) were not. Median age was older for patients with a positive distress screen (p < 0.01). Among screened patients, the most frequent sources of distress were: cognitive/physical (87%), psychosocial (62%), practical (84%), and family concerns (40%). Of 50 patients recommended to have psychosocial referral, 4 (8%) patients had documented psychiatric follow-up and 19 (38%) patients had documented psychosocial counseling by a social worker. Nearly half of ovarian cancer patients screened positive for moderate/severe distress. Cancer/treatment-related cognitive/physical symptoms were the most frequent sources. Improved methods of symptom monitoring and management during treatment and resources to address psychosocial concerns are needed to improve distress management of ovarian cancer patients. • Nearly half of ovarian cancer patients undergoing chemotherapy screening positive for moderate/severe distress. • Cancer related cognitive/physical symptoms were the most common sources of distress. • Improved methods to manage psychosocial concerns are warranted. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: Å6 is a novel peptide that interferes with single-chain urokinase plasminogen activator activity and has shown anti-angiogenic, anti-migratory, and anti-invasive properties. We evaluated clinical efficacy and safety of subcutaneously administered Å6 in women with epithelial ovarian cancer. Methods: Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer in clinical remission after first-line chemotherapy with 2 consecutive increases of CA125 values above normal but with no disease on physical examination or imaging studies were randomly assigned to receive daily subcutaneous injections of placebo, low-dose Å6 (150 mg), or high-dose Å6 (300 mg) until disease progression or end of study participation. Primary endpoints were time to clinical progression of disease and safety of Å6. Secondary endpoints were changes in serum CA125 and biomarkers of the urokinase system. Results: Data are available for 24 women (placebo, n =12; low-dose, n =8; high-dose n =4). Å6 therapy was associated with a statistically significant delay in time to clinical progression (log-rank p-value 0.01) with a median of 100 days (95% CI: 64,168) for women who received Å6 compared with 49 days (95% CI: 29,67) for women who received placebo. The treatments appeared to be well tolerated. Treatment was not associated with CA125 response (p =0.44). On-treatment values for plasma urokinase plasminogen activator receptor were statistically significantly lower in the Å6 groups compared with placebo (p =0.02). Conclusions: Å6 therapy increases time to clinical disease progression and appears to be well tolerated in this patient population. [Copyright &y& Elsevier]

Abstract: Objective. : To determine the response rate, progression-free survival and toxicity associated with weekly topotecan administered to patients with platinum-sensitive recurrent epithelial ovarian (EOC) in the third-line setting. Methods. : Patients with measurable platinum-sensitive EOC following failure of second-line chemotherapy were eligible for this phase II study. All patients were initially treated with cytoreductive surgery and platinum/paclitaxel-based chemotherapy. Continuous, weekly topotecan was administered at a starting dose of 4 mg/m2. Toxicity and efficacy were assessed at various time points after initiation of therapy. Results. : Twenty nine patients were enrolled in this prospective study. Toxicity was acceptable with grade 1/2 nausea being the most commonly experienced side effect (52%). Nine patients (31%) had grade 3/4 leukopenia; however, only 3 patients had febrile neutropenia. Thirteen patients had a treatment delay and six required dose reductions. Twenty two patients were evaluable for efficacy. The overall response rate for weekly topotecan was 13.6% [95% CI; −0.7–27.9%] with 1 complete response, and 2 partial responses. Twelve patients (54.5%), including 2 with minor responses, had stable disease for a median duration of 18 weeks. Conclusions. : Weekly topotecan at the current schedule in the third-line setting in patients with platinum-sensitive recurrent EOC has modest clinical activity. Toxicity associated with this regimen is acceptable but growth factor support, dose reductions, or schedule alterations may need to be considered in many of these patients. [Copyright &y& Elsevier]

Abstract: Objective. : Although hand-assisted laparoscopic surgery (HALS) has been utilized in abdominal surgery, limited data exist on the feasibility and safety of HALS in the evaluation of pelvic masses. Our goal was to compare HALS to conventional laparotomy for pelvic masses in gynecologic patients. Methods. : A chart review identified patients who underwent a HALS or XLAP procedure for the evaluation of a pelvic mass from January 2003 to September 2004. Results. : 70 patients were analyzed—29 cases (HALS) and 41 controls (XLAP). The groups were comparable in terms of age (48 vs. 49 years), body mass index (29.1 vs. 29.8 m2), and mass size (11.0 vs. 11.3 cm). Operative times were similar between the groups (90 vs. 72 min, P = 0.9). HALS was associated with decreased estimated blood loss (108 vs. 207 cm3, P = 0.004), shorter hospital stay (2.8 vs. 4.2 days, P = 0.03), and fewer post-operative complications (4 vs. 11, P = 0.05). Conclusions. : HALS is a safe and feasible alternative to conventional open laparotomy for the evaluation and surgical treatment of pelvic masses. In addition to similar operative times, HALS demonstrated a decreased estimated blood loss, complication rate, and length of hospital stay. [Copyright &y& Elsevier]

Objective. We wished to evaluate survival and adverse outcomes of patients with stage IB2 cervical cancer treated primarily with radical hysterectomy and lymphadenectomy.Methods. A review was performed of all patients undergoing primary radical hysterectomy for stage IB2 cervical cancer at two institutions from 1987 to 2002. Patients were stratified into low, intermediate (Gynecologic Oncology Group protocol 92 criteria), and high-risk (positive nodes, margins, or parametria) groups. Survival and progression-free interval were analyzed using the Kaplan-Meier method and multivariate analysis.Results. Seventy-two patients underwent primary type III radical hysterectomy and lymphadenectomy (72 pelvic, 58 pelvic and paraaortic). Patients were classified as low (n = 6), intermediate (n = 49), or high (n = 17) risk for recurrence. Adjuvant therapy was administered to 94%, 12%, and 0% of the high-, intermediate-, and low-risk groups, respectively. Five-year survival was 72%, while 5-year progression-free survival was 63%. Five-year overall and progression-free survival by risk group were 47% and 40% (high-risk), 80% and 66% (intermediate-risk), 100% and 100% (low-risk). Predictors of survival in multivariate analysis were Caucasian race (P = 0.001), older age (P = 0.017), inner 2/3 cervical wall invasion (P = 0.045), and absence of lymph-vascular invasion (P < 0.001). Major complications were experienced by 10/72 (13.9%) patients. Among 34 patients who received radiation therapy, two (5.9%) experienced complications attributable to radiation.Conclusions. Radical hysterectomy and lymphadenectomy followed by tailored adjuvant therapy is a reasonable alternative to primary radiotherapy for stage IB2 cervical cancer. Patients with low- and intermediate-risk factors have satisfactory results after primary surgical management. A prospective randomized trial will clarify the optimal mode of initial therapy for patients with stage IB2 disease. [Copyright &y& Elsevier]

Both incidence and mortality of uterine cancer are on the rise and mortality is higher for African American women. The aim of our study was to evaluate how Next Generation Sequencing (NGS) may facilitate identification of and intervention for treatment disparities when integrated into clinical workflows. Our cohort included 159 uterine cancer patients with recurrent/progressive and newly diagnosed advanced stage and/or high-risk histology. The most common tumor histological subtypes included EEC (n = 67), SEC (n = 34), UCS (n = 20), and mixed (n = 14). Black patients were most likely to present with aggressive histology: (SEC, 34.0%) and carcinosarcoma (UCS, 14.0%). The four most common mutations across all subtypes were TP53, PIK3CA, PTEN, and ARID1A. There was racial disparity between Black versus non-Black patients who were initiated on targeted therapy (28.2% vs. 38.2%, respectively) and clinical trial (15% vs. 22.6%, respectively). Compared to non-Black patients, Black patients had a significantly higher percentage TP53 mutations (p < 0.05) and a significantly lower percentage ARID1A mutations (p < 0.05). NGS for uterine malignancies provides actionable information for targetable mutations and/or clinical trial enrollment in most patients; further investigation is necessary to identify potentially modifiable factors contributing to current disparities that may improve targeted therapy uptake and clinical trial participation. • Next Generation Sequencing is feasible in a uterine malignancy clinical workflow; • NGS for uterine malignancies provides guidance for targetable mutations and trials; • Incorporating NGS into clinical workflows may help address treatment disparities. [ABSTRACT FROM AUTHOR]

The Sedlis criteria define risk factors for recurrence warranting post-hysterectomy radiation for early-stage cervical cancer; however, these factors were defined for squamous cell carcinoma (SCC) at an estimated recurrence risk of ≥30%. Our study evaluates and compares risk factors for recurrence for cervical SCC compared with adenocarcinoma (AC) and develops histology-specific nomograms to estimate risk of recurrence and guide adjuvant treatment. We performed an ancillary analysis of GOG 49, 92, and 141, and included stage I patients who were surgically managed and received no neoadjuvant/adjuvant therapy. Multivariable Cox proportional hazards models were used to evaluate independent risk factors for recurrence by histology and to generate prognostic histology-specific nomograms for 3-year recurrence risk. We identified 715 patients with SCC and 105 with AC; 20% with SCC and 17% with AC recurred. For SCC, lymphvascular space invasion (LVSI: HR 1.58, CI 1.12–2.22), tumor size (TS ≥4 cm: HR 2.67, CI 1.67–4.29), and depth of invasion (DOI; middle 1/3, HR 4.31, CI 1.81–10.26; deep 1/3, HR 7.05, CI 2.99–16.64) were associated with recurrence. For AC, only TS ≥4 cm, was associated with recurrence (HR 4.69, CI 1.25–17.63). For both histologies, there was an interaction effect between TS and LVSI. For those with SCC, DOI was most associated with recurrence (16% risk); for AC, TS conferred a 15% risk with negative LVSI versus a 25% risk with positive LVSI. Current treatment standards are based on the Sedlis criteria, specifically derived from data on SCC. However, risk factors for recurrence differ for squamous cell and adenocarcinoma of the cervix. Histology-specific nomograms accurately and linearly represent risk of recurrence for both SCC and AC tumors and may provide a more contemporary and tailored tool for clinicians to base adjuvant treatment recommendations to their patients with cervical cancer. • Adenocarcinoma is a distinct cervical cancer subtype and treatment should be based on data specific to this subtype. • Risk factors for recurrence differ for squamous cell carcinoma and adenocarcinoma of the cervix. • For adenocarcinoma of the cervix, tumor size is the risk factor associated with the highest risk of recurrence. • For squamous cell carcinoma, depth of invasion is the risk factor associated with the highest risk of recurrence. • Histology-specific nomograms accurately and linearly represent risk of recurrence for squamous cell and adenocarcinoma. [ABSTRACT FROM AUTHOR]

Poly(ADP-ribose) polymerase (PARP) inhibitors are expensive and their use is expanding. We aimed to evaluate cost sharing patterns between patients, payors, and financial assistance programs. We identified ovarian cancer patients prescribed a PARP inhibitor from 5/2015–9/2019 using our pharmacy database. Cost information was collected for patients who filled their prescription at our specialty pharmacy. We calculated descriptive statistics for monthly PARP inhibitor costs for patients, payors, and financial assistance programs. We used Wilcoxon rank sum tests to evaluate monthly costs based on insurance characteristics. Seventy-six patients filled 94 different PARP inhibitor prescriptions with 42 (45%) prescriptions obtained using any type of financial assistance program. We analyzed 232 prescription months for the 41 prescriptions with available cost data. This included 18 (44%) prescriptions for rucaparib, 18 (44%) for niraparib, and 5 (12%) for olaparib. The total monthly drug cost was average $12,422 and median $13,700. The monthly out-of-pocket (OOP) cost for patients was average $46 and median $0 (IQR $0–4). Payors had the highest monthly costs with average $12,019 and median $13,662 (IQR $9914-14,709). Financial assistance programs contributed average $358 and median $0 per month (IQR $0–150). Patients with public (p <0.01) or Medicare insurance (p<0.01) had higher OOP costs than without. OOP costs were generally low with 75% of patients paying <$5 per month. While limited by small sample size at a single institution, financial assistance programs appear to play a critical role to ensure access to PARP inhibitors as nearly 50% of patients utilized these programs. • Payors are responsible for the highest amount of PARP inhibitor costs. • Patient out of pocket costs for PARP inhibitors are low at our single institution. • Nearly 50% of patients utilized financial assistance programs for PARP inhibitors. [ABSTRACT FROM AUTHOR]

To evaluate total and out-of-pocket costs for poly(ADP-ribose) polymerase (PARP) inhibitors and differences based on insurance characteristics. We identified ovarian cancer patients who were prescribed niraparib, olaparib, or rucaparib from the MarketScan (2014–2017) and Surveillance, Epidemiology, and End Results (SEER)-Medicare (2014–2016) databases. Drug costs were estimated for a 30-day supply. Descriptive statistics and Wilcoxon rank sum tests were performed. 590 commercially insured beneficiaries from MarketScan and 213 SEER-Medicare beneficiaries were prescribed PARP inhibitors for a median 112 days. For commercially insured beneficiaries, median total cost was $13,342 (IQR $12,022–$14,256). Median out-of-pocket cost was $44 (IQR $0–$120) and PARP inhibitors accounted for a median 90.8% of patients' total out-of-pocket drug spending. High-deductible health plan was not associated with higher out-of-pocket costs (N = 570; median $0 vs. $45, P = 0.87). For SEER-Medicare beneficiaries, median total cost was $12,798 (IQR $11,704–$13,180). Median out-of-pocket cost was $370 (IQR $2–$1234) and PARP inhibitors accounted for a median 99.0% of patients' total out-of-pocket drug spending. Out-of-pocket costs were lower for dual-eligible patients with supplemental Medicaid prescription coverage (N = 209; median $1 vs. $911, P < 0.001). Although insurers are responsible for a large proportion of PARP inhibitor costs, out-of-pocket costs for PARP inhibitors account for a majority of patients' drug spending. SEER-Medicare beneficiaries had higher out-of-pocket costs than patients with commercial insurance, which was offset for those with supplemental Medicaid prescription coverage. • Among insured ovarian cancer patients, payers are responsible for the majority of total PARP inhibitor costs • While on PARP inhibitor, these drugs account for over 90% of patients' total out of pocket drug spending • SEER-Medicare Part D beneficiaries had higher PARP inhibitor out of pocket costs than commercially insured in MarketScan • Medicare beneficiaries had lower out of pocket costs for PARP inhibitor if dual-eligible for Medicaid supplemental coverage [ABSTRACT FROM AUTHOR]

Survivors of gynecologic cancers have an increased risk of developing second primary cancers (SPC); however it is unclear which sites have higher risks. We aimed to ascertain risk of SPC among survivors of gynecological cancer, and identify anatomic sites at risk of SPC. We queried the Surveillance, Epidemiology and End Results database (2000–2016) for confirmed cases of index gynecological (cervix uteri [cervical], corpus and uterus [endometrial], ovarian, vaginal, and vulvar) cancers. Risk of SPC was estimated using standardized incidence ratios (SIRs: observed/expected cases) and excess absolute risks (EARs: observed - expected cases) per 10,000 person-years at risk (PYR). SIRs and EARs were stratified by index anatomic site and latency interval. Among the cohort of 301,210 gynecological cancer survivors, 19,005 (6.31%) developed an SPC (SIR = 1.16; 95% CI, 1.15–1.18 and EAR = 17.2 cases per 10,000 PYR) compared with the general population. All gynecological cancer survivors (except survivors of ovarian) had a significant risk of developing SPC (SIR range 1.06–2.16), with survivors of vulvar cancer having the highest risk (SIR = 2.16; 95% CI, 2.06–2.27; EAR = 139.5 per 10,000 PYR). Risk of SPC was highest within the first 5 years post-diagnosis for survivors of cervical, vulvar and vaginal cancers. While most index gynecological cancer sites are associated with increased risk of SPC, risk is highest among survivors of vulvar cancer. These findings have the potential to inform lifelong surveillance recommendations for gynecological cancer survivors. • Quantified the risks of second primary cancer (SPC) in patients diagnosed with first primary gynecological cancers. • 1-in-15 patients diagnosed with first primary gynecological cancers developed an SPC. • Patients diagnosed with first primary vulvar cancer had the highest risk of SPC. • The risk of SPC remain high for the first five years after the initial diagnosis of first primary gynecological cancers. [ABSTRACT FROM AUTHOR]

• Patient reported outcomes measurements (PROMs) are an essential component of comprehensive, patient centered care. • Practical considerations and challenges to collecting PROMs in routine gynecologic oncology practice are discussed. • Pragmatic, disease-specific recommendations for the use of PROMs are provided for women with gynecologic malignancies. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has consumed considerable resources and has impacted the delivery of cancer care. Patients with cancer may have factors which place them at high risk for COVID 19 morbidity or mortality. Highly immunosuppressive chemotherapy regimens and possible exposure to COVID-19 during treatment may put patients at additional risk. The Society of Gynecologic Oncology convened an expert panel to address recommendations for best practices during this crisis to minimize risk to patients from deviations in cancer care and from COVID-19 morbidity. An expert panel convened to develop initial consensus guidelines regarding anti-neoplastic therapy during the COVID-19 pandemic with respect to gynecologic cancer care and clinical trials. COVID-19 poses special risks to patients who are older, have medical co-morbidities, and cancer. In addition, this pandemic will likely strain resources, making delivery of cancer care or conduct of clinical trials unpredictable. Recommendations are to limit visits and contact with health care facilities by using telemedicine when appropriate, and choosing regimens which require less frequent visits and which are less immunosuppressive. Deviations will occur in clinical trials as a result of limited resources, and it is important to understand regulatory obligations to trial sponsors as well as to the IRB to ensure that clinical trial and patient safety oversight are maintained. The ongoing crisis will strain resources needed to deliver cancer care. When alterations to the delivery of care are mandated, efforts should be taken to minimize risks and maximize safety while approximating standard practice. • The world wide COVID-19 pandemic has limited cancer care and clinical trials. • Strategies should be employed to limit contact points with health care facilities. • All care should consider the risks of cancer care balanced against the risk of COVID-19 infection. [ABSTRACT FROM AUTHOR]

• Patient reported outcomes measurements (PROMs) are an essential component of comprehensive, patient centered care. • Practical considerations and challenges to collecting PROMs in routine gynecologic oncology practice are discussed. • Pragmatic, disease-specific recommendations for the use of PROMs are provided for women with gynecologic malignancies. [ABSTRACT FROM AUTHOR]

Patients with persistent/recurrent cervical cancer following platinum-based chemotherapy have limited therapeutic options. The Gynecologic-Oncology-Group conducted a phase II trial to assess efficacy and tolerability of nivolumab, an immune checkpoint inhibitor, in persistent/recurrent cervical carcinoma. Key eligibility criteria included persistent/recurrent cervical cancer, failure of prior systemic therapy and ECOG PS 0-1. Nivolumab 3 mg/kg was given IV every 2 wk. until disease progression or intolerable toxicity. Response was assessed every 8 wk. for 6 months and every 12 wk. thereafter. The primary endpoints were objective response as assessed by RECIST 1.1. The study used a 2-stage group sequential design. PD-L1 expression was evaluated in tumor specimens by immunohistochemistry (IHC) using a combined-positive-score (CPS) cutoff of ≥1%. Of 26 enrolled patients with persistent/recurrent cervical cancer, 25 were evaluable for response/toxicity with a median age of 45. 36% had ECOG PS of 1, and 100% had received one prior systemic chemotherapy regimen. PD-L1 expression (≥1%) was identified in 77.3% of tumor samples. As of 03/05/19, all patients were off study treatment; median follow-up for survival status was 32 months (range, 2–41.5). There were 21 (84%) patients with a treatment-related adverse event (TRAE) and most were grades 1–2. Six (24%) patients had grade 3 TRAEs with 1 discontinuing nivolumab due to hepatic toxicity. No grade 5 TRAEs occurred, and 2 patients had grade 4 TRAEs. One confirmed partial response (4%; 90% CI, 0.4%–22.9%), duration of response 3.8 months. Thirty-six percent of patients had stable disease (SD) (9/25; 90% CI, 20.2%–54.4%); the median duration of SD was 5.7 months (range, 3.5–12.7). Estimated PFS and OS at 6 months were 16% and 78.4%, respectively. Single agent nivolumab exhibited low antitumor activity and an acceptable safety profile in patients with persistent/recurrent cervical cancer previously treated with platinum-based chemotherapy. • Cervical cancers are infected with Human Papillomavirus (HPV) making these tumors potentially immunogenic. • NRG-GY002 evaluated the activity of single agent nivolumab in persistent or recurrent cervical cancer patients. • Nivolumab has an acceptable safety profile but low antitumor activity in cervical cancer. • Combinations of immune check-point inhibitors may be necessary to increase clinical responses in cervical cancer. [ABSTRACT FROM AUTHOR]