Hyaluronic acid to manage radiotoxicities in gynecological cancer patients: a scoping review.

PURPOSE: This study aimed to map the use of hyaluronic acid (HA) in preventing and controlling radiotoxicity in women with gynecological cancer undergoing radiotherapy. METHODS: We conducted a scoping review of eight electronic databases: CINAHL, Cochrane CENTRAL, LILACS, PubMed, Scopus, Embase, LIVIVO, and the Web of Science Core Collection. In addition, a grey literature search was performed using Google Scholar and ProQuest Dissertations & Theses Global. A manual search was also identified additional references. The search was conducted on May 18, 2023. We included primary studies, reviews, and guidelines that discussed the use of HA to prevent and manage the toxicities resulting from gynecological radiotherapy. RESULTS: Eighteen studies were included in this scoping review, published between 2009 and 2022. There was heterogeneity in the use of HA, particularly in the method of application (moisturizing gel, vaginal ovules, spacer gel, and bladder instillations). Furthermore, the radiotoxicities varied among studies, encompassing, among others, vaginal atrophy, dryness, dyspareunia, telangiectasis, adhesions, vaginal stenosis, bleeding, hematuria, and bladder issues. Most studies addressed the potential benefits of HA in managing the signs and symptoms resulting from radiotherapy. CONCLUSION: HA has been utilized in clinical practice, in various formulations, for managing signs and symptoms in patients with gynecological cancer undergoing radiotherapy. However, further studies are necessary to thoroughly investigate the most effective method of HA application and its effectiveness in managing radiotoxicity.

Symptom burden, palliative care knowledge, and palliative care needs in advanced gynecological cancer patients in Korea.

Advanced gynecological cancer patients endure numerous symptoms resulting from both the disease itself and the treatments they undergo. This symptom burden significantly impacts the quality of life for both patients and their caregivers, as well as escalating medical costs. Palliative care presents a solution to alleviate these challenges. However, in Korea, there exists a low level of awareness regarding palliative care and consequently, a low utilization rate. Providing timely palliative care to advanced gynecological cancer patients in Korea necessitates a comprehensive understanding of their symptom burden, palliative care knowledge, and palliative care needs. However, no previous studies have addressed this critical issue. The purpose of this study is to determine the impact of advanced gynecological cancer on palliative care needs in Korea according to patient demographic and clinical characteristics, symptom burden, and palliative care knowledge. This study was a descriptive cross-sectional study of data from 115 participants with stage III or IV gynecological cancer, collected through an online questionnaire. The main variables were symptom burden (Functional Assessment of Cancer Therapy-General), palliative care knowledge (Palliative Care Knowledge Scale), and palliative care needs (Problems and Needs in Palliative Care questionnaire-short version). Multiple hierarchical regression analyses were used to determine the relationships between variables. Palliative care needs were divided into perceived problems and requests for professional support. The most common perceived problems were financial problems, psychological issues, and physical symptoms, and the most frequent requests for professional support were financial problems, psychological issues, and the need for information. The perceived problem score increased with age, not having surgical experience, and significant symptom burden. Additionally, the requests for professional support score rose in cases of ovarian cancer, not having surgical history, substantial symptom burden, and limited palliative care knowledge. Advanced gynecological cancer patients have palliative care needs that differ according to patient characteristics, symptom burden, and palliative care knowledge. Identifying factors influencing palliative care needs can aid clinicians in identifying target groups in need of palliative care and providing them with professional palliative care.

An open-label, single-arm, prospective, multi-center, tandem two-stage designed phase II study to evaluate the efficacy of fulvestrant in women with recurrent/metastatic estrogen receptor-positive gynecological malignancies (FUCHSia study).

OBJECTIVE: This study aimed to evaluate fulvestrant efficacy in women with estrogen receptor-positive low-grade gynecological cancers. The primary objective was to determine the response rate. Secondary objectives were progression-free survival, clinical benefit, duration of response, safety, tolerability, and quality of life. METHODS: FUCHSia is an open-label, single-arm, prospective, multi-center phase II study. The study population included patients with recurrent/metastatic low-grade gynecological malignancies with estrogen receptor positivity who received a maximum of two lines of previous hormonal therapy. Patients received fulvestrant (FASLODEX, AstraZeneca) via two intramuscular injections (250 mg/5 mL each) in the gluteal muscle on day 1, day 15, day 29, and then every 28 days thereafter until disease progression, withdrawal from the trial due to any unacceptable adverse event, or withdrawal of patient consent. RESULTS: A total of 15 patients (uterine sarcoma n=4; sex cord-stromal ovarian tumors n=3; endometrial carcinoma n=4; serous ovarian cancer n=4) were enrolled. Median follow-up was 48 weeks (interquartile range (IQR) 26-122) in the uterine sarcoma cohort, 63 weeks (IQR 28-77) for sex cord-stromal tumors, 19 weeks (IQR 17-21) for endometrial carcinoma, and 60 weeks (IQR 40-119) for serous ovarian cancer. One partial response according to Response Evaluation Criteria in Solid Tumors v1.1 was observed in one uterine sarcoma patient. No responses were observed in the other cohorts. However, stable disease was observed in three uterine sarcomas (median duration 12 weeks), three sex cord-stromal tumors (median duration 32 weeks), and four low-grade serous ovarian cancer patients (median duration 20 weeks), leading to a disease control rate of 100% for these tumor types. All patients with endometrial carcinoma showed progressive disease. CONCLUSION: Fulvestrant may control tumor growth in recurrent/metastatic estrogen receptor-positive low-grade gynecological malignancies of specific histology. Further studies are needed to confirm these results.

Predictors and outcomes of same day discharge after minimally invasive hysterectomy in gynecologic oncology within the National Surgical Quality Improvement Program database.

OBJECTIVE: To assess trends over time of same day discharge after minimally invasive hysterectomy in oncology, identify perioperative factors influencing same day discharge, and evaluate 30 day postoperative morbidity. METHODS: A retrospective cohort of elective minimally invasive hysterectomies performed for gynecologic oncologic indications between January 2013 and December 2021 was identified using the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database. Clinical and surgical characteristics, length of stay, and 30 day postoperative complications were captured. Clinical and surgical factors affecting same day discharge rate and impact of same day discharge on postoperative outcomes were evaluated using χ2 tests and logistic regression. RESULTS: Patients undergoing minimally invasive hysterectomy (n=32 823) had a same day discharge rate of 34.5% over the 9 year period, increasing from 15.5% in 2013 to 55.1% in 2021. The rate of patients discharged on postoperative day 1 decreased from 76.4% to 41.4% over this period. On multivariable analysis, same day discharge decreased with: age 70-79 years (odds ratio (OR) 0.80) and ≥80 years (OR 0.42); body mass index 40-49.9 kg/m2 (OR 0.89) and ≥50 kg/m2 (OR 0.67); patient comorbidities, including hypertension (OR 0.85), chronic steroid use (OR 0.74), bleeding disorder (OR 0.54), anemia (OR 0.89), and hypoalbuminemia (OR 0.76); and surgical time >90th percentile (OR 0.40) (all p<0.05). Lymphadenectomy did not impact the same day discharge rate (unadjusted OR 1.03, p=0.22). Same day discharge had no effect on 30 day postoperative composite morbidity (OR 0.91, p=0.20), and was associated with fewer readmissions (OR 0.75, p=0.005). Age 70-79 years (OR 1.07, p=0.435) and age ≥80 years (OR 1.11, p=0.504) did not increase postoperative morbidity. However, body mass index categories 40-49.9 kg/m2 (OR 1.28, 95% CI 1.08 to 1.51) and ≥50 kg/m2 (OR 1.60, 95% CI 1.27 to 2.01) were associated with greater 30 day composite morbidity. CONCLUSION: In this study, same day discharge following minimally invasive hysterectomy for oncologic indications was safe, and rates are rising among all age and body mass index categories. Quality improvement initiatives are needed at oncology centers to promote early discharge after minimally invasive gynecologic oncology surgery.

Prognostic nutritional index as a predictor of surgical complications in women with gynecological cancer.

OBJECTIVE: To analyze the association between the prognostic nutritional index and surgical morbidity in women with gynecologic cancers. METHODS: This is a retrospective cohort study of women with ovarian, endometrial, or cervical cancer who underwent surgery between January 2013 and December 2020 at a cancer center. Demographic and clinical data were extracted from electronic medical records. The prognostic nutritional index was calculated during the immediate pre-operative period. Binomial logistic regression was conducted to identify the association of the prognostic nutritional index with the outcome of surgical complications after Clavien-Dindo classification, adjusting for confounding variables. RESULTS: A total of 1000 women were included: 114 (11.4%) were diagnosed with cervical cancer, 551 (55.1%) with ovarian cancer, and 335 (33.5%) with endometrial cancer. Patients with a prognostic nutritional index >40 had a decreased possibility of surgical complications (OR=0.39, 95% CI 0.29 to 0.52); basal blood hemoglobin, volume of surgical bleeding, operative time, and length of hospital stay were also explanatory factors. The prognostic nutritional index has a significant effect on patients with endometrial and cervical cancer, but conversely is not significant in patients with ovarian cancer. CONCLUSION: The prognostic nutritional index is associated with surgical morbidity in endometrial and cervical cancers and thus can be a useful tool for predicting morbidity and guide pre-operative interventions in patients with gynecological cancers.

Molecular changes driving low-grade serous ovarian cancer and implications for treatment.

Low-grade serous ovarian cancer was previously thought to be a subtype of high-grade serous ovarian cancer, but it is now recognized as a distinct disease with unique clinical and molecular behaviors. The disease may arise de novo or develop from a serous borderline ovarian tumor. Although it is more indolent than high-grade serous ovarian cancer, most patients have advanced metastatic disease at diagnosis and recurrence is common. Recurrent low-grade serous ovarian cancer is often resistant to standard platinum-taxane chemotherapy, making it difficult to treat with the options currently available. New targeted therapies are needed, but their development is contingent on a deeper understanding of the specific biology of the disease. The known molecular drivers of low-grade tumors are strong hormone receptor expression, mutations in the mitogen-activated protein kinase (MAPK) pathway (KRAS, BRAF, and NRAS), and in genes related to the MAPK pathway (NF1/2, EIF1AX, and ERBB2). However, MAPK inhibitors have shown only modest clinical responses. Based on the discovery of CDKN2A mutations in low-grade serous ovarian cancer, cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitors are now being tested in clinical trials in combination with hormone therapy. Additional mutations seen in a smaller population of low-grade tumors include USP9X, ARID1A, and PIK3CA, but no specific therapies targeting them have been tested clinically. This review summarizes the clinical, pathologic, and molecular features of low-grade serous ovarian cancer as they are now understood and introduces potential therapeutic targets and new avenues for research.

Highlights from the 25th European Congress on Gynaecological Oncology in Barcelona: the ENYGO-IJGC Fellow Interviews.

In March 2024, 12 European Network of Young Gynae Oncologists-International Journal of Gynaecological Cancer (ENYGO-IJGC) Editorial Fellows conducted 10 interviews with senior opinion leaders on original and controversial topics in the field of gynecologic oncology presented during the 25th European Society of Gynaecological Oncology (ESGO) Congress in Barcelona, Spain. This article provides a summary and overview of the content of these discussions summarizing key points presented at the meeting. These selected interviews were chosen by consensus by the ENYGO-IJGC Editorial Fellows based on novelty and relevance to the field of gynecologic oncology.

Early non-compliance to ERAS in gynecological open surgery for malignancies, and post-operative complications: a multicenter, prospective, observational, cohort study.

BACKGROUND: Open surgical procedures for gynecological malignancies have a potential risk of post-operative complications and hence prolonged hospitalization, despite adherence to an Enhanced Recovery After Surgery (ERAS) protocol. PRIMARY OBJECTIVE: To investigate the relationship between non-compliance to an ERAS protocol in the post-operative setting and the rate of post-operative complications, in women who underwent open surgery for gynecological malignancies. STUDY HYPOTHESIS: Early non-compliance with the ERAS protocol increases the risk of post-operative complications. TRIAL DESIGN: Multicenter, prospective, observational, cohort study. MAJOR INCLUSION CRITERIA: Patients with histologically proven gynecological cancer (endometrial, uterine, tubo-ovarian, and cervical) undergoing elective open surgery and managed according to ERAS guidelines. EXCLUSION CRITERIA: Patients with post-operative recovery in an intensive care unit, undergoing anterior or total pelvic exenteration or intraperitoneal chemotherapy. Previous radiotherapy or previous non-gynecological major abdominal surgery. PRIMARY ENDPOINT: Association of non-compliance with the ERAS protocol using five selected indicators on post-operative day 2 with the rate of 30-day post-operative complications. SAMPLE SIZE: 600 patients will be enrolled in the study. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: At present, 106 patients have been recruited. Based on this, the accrual should be completed in 2025. Results should be presented at the end of 2025. TRIAL REGISTRATION: NCT05738902.

Clinicopathological characteristics of multiple-classifier endometrial cancers: a cohort study and systematic review.

BACKGROUND: Endometrial cancers with more than one molecular feature-POLE mutations (POLEmut), mismatch repair protein deficiency (MMRd), p53 abnormality (p53abn)-are called 'multiple classifiers'. OBJECTIVE: To describe our cohort of multiple classifiers and to report the results of a review on their incidence and the techniques used to identify them. METHODS: Multiple classifiers identified at the European Institute of Oncology, Milan, between April 2019 and Decmber 2022, were included. Clinicopathological, molecular characteristics, and oncologic outcomes were summarized and compared between single and multiple classifiers sharing common features. Studies on molecular classification of endometrial cancer were searched in the PubMed Database to collect data on the incidence of multiple classifiers and the techniques used for classification. RESULTS: Among 422 patients, 48 (11.4%) were multiple classifiers: 15 (3.6%) POLEmut-p53abn, 2 (0.5%) POLEmut-MMRd, 28 (6.6%) MMRd-p53abn, and 3 (0.7%) POLEmut-MMRd-p53abn. MMRd-p53abn and MMRd differed in histotype (non-endometrioid: 14.8% vs 2.0%, p=0.006), grade (high-grade: 55.6% vs 22.2%, p=0.001), and MMR proteins expression, whereas they differed from p53abn in histotype (non-endometrioid: 14.8% vs 50.0%, p=0.006). POLEmut-p53abn and POLEmut differed only in grade (high-grade: 66.7% vs 22.7%, p=0.008), while they differed from p53abn in age (56.1 vs 66.7 years, p=0.003), stage (advanced: 6.7% vs 53.4%, p=0.001), and histotype (non-endometrioid: 6.7% vs 50.0%, p=0.002). Two (7.1%) patients with MMRd-p53abn, 4 (4.0%) with MMRd, and 25 (34.3%) with p53abn had a recurrence. No recurrences were observed in POLEmut-p53abn and POLEmut. TP53 sequencing allowed the detection of additional 7 (18.9%) multiple classifiers with normal p53 immunostaining. The incidence of multiple classifiers ranged from 1.8% to 9.8% in 10 published studies including >100 patients. When only p53 immunohistochemistry was performed, the highest incidence was 3.9%. CONCLUSIONS: The characteristics of POLEmut-p53abn resembled those of POLEmut, whereas MMRd-p53abn appeared to be intermediate between MMRd and p53abn. The high proportion of multiple classifiers may be related to the methods used for molecular classification, which included both p53 immunohistochemistry and TP53 sequencing.

The impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic cancer patients: a randomized controlled trial.

BACKGROUND: Patients diagnosed with gynecological cancers often face a range of complications that can impact their quality of life and increase their anxiety. Nursing models combined with mobile phone applications have the potential to improve outcomes for these patients. This study aimed to assess the impact of a continuous care model utilizing a smartphone application on quality of life and anxiety levels among gynecologic cancer patients. METHODS: This study involved two phases: (1) mobile App development and (2) implementation of the intervention. The two-group randomized controlled trial included 70 participants with gynecological cancers referred to medical centers affiliated with Shahrekord University of Medical Sciences in 2023. The participants were randomized into control or intervention groups (n = 35 per group). Finally, 68 patients completed the trial. The intervention group received an 8-week intervention incorporating the continuous care model, whereas the control group received routine care (the standard support provided by nurses both during and after hospitalization). The participants completed the Spielberger state-trait anxiety and quality of life (QLQ-C30) questionnaires before, immediately after, and two months after the intervention. The data were analyzed via the chi-square test, independent samples t test, analysis of covariance, and repeated-measures ANOVA. RESULTS: There were no significant differences in the baseline data between the two groups. However, after the intervention, the intervention group reported a significant increase in quality of life, with mean scores rising from 68.90 ± 17.50 to 73.78 ± 16.79 immediately after the intervention and to 80.61 ± 9.90 at the two-month follow-up. In contrast, the control group showed no significant improvement. Additionally, state anxiety significantly decreased in the intervention group from 51.64 ± 14.97 to 40.20 ± 11.70 at the follow-up, and trait anxiety scores in the intervention group decreased significantly from 49.91 ± 14.96 to 39.82 ± 10.28 at the follow-up, whereas the scores of the control group worsened. CONCLUSION: The intervention improved quality of life and reduced anxiety in patients with gynecological cancers. Given the scant attention given to mobile application-based follow-up in gynecologic cancer patients in previous studies, this approach can be incorporated into routine care to support patients, and it is recommended for nurses, health care providers, and physicians. TRIAL REGISTRATION: The study was registered as a randomized controlled trial in the Clinical Trial Registration Center of Iran. Registration Date: 2024-02-14, Registration Number: IRCT20231107059977N1.

Timing of HPV vaccination as adjuvant treatment of CIN2+ recurrence in women undergoing surgical excision: a meta-analysis and meta-regression.

OBJECTIVE: The main aim was to determine the overall vaccine effectiveness (VE) against recurrent cervical intraepithelial neoplasia grade 2 or worse (CIN2+) including specific VE associated with timing of human papillomavirus (HPV) vaccination using data from published studies. DESIGN: Meta-analysis and meta-regression. DATA SOURCES: A computerised literature search was undertaken using the MEDLINE, EMBASE, International Pharmaceutical Abstracts, Derwent Drug File, ProQuest Science and Technology, Cochrane and MedRxiv databases. To be eligible, the studies, with no language restrictions, had to be published between 1 January 2001 and 25 May 2023. REVIEW METHODS: Included were studies with an unvaccinated reference group that assessed CIN2+ recurrence irrespective of the HPV genotype in women undergoing conisation provided. The present study was carried out in compliance with the Preferred Reporting Items for Systematic Review and Meta-Analyses and Meta-analysis Of Observational Studies in Epidemiology guidelines. The risk of study bias was assessed using the Newcastle-Ottawa Quality Assessment Scale. The Grading of Recommendations Assessment, Development, and Evaluation guidelines were used to assess the strength of evidence for the primary outcome. Data synthesis was conducted using meta-analysis and meta-regression. RESULTS: Out of a total of 14 322 publications, 20 studies with a total of 21 estimates were included. The overall VE against recurrent CIN2+ irrespective of the HPV genotype achieved 69.5% (95% CI: 54.7% to 79.5%). While the HPV vaccine valency, follow-up duration, type of study including its risk of bias had no effect on VE, the highest VE of 78.1% (95% CI: 68.7% to 84.7%) was reported for women receiving their first dose not earlier than the day of excision. This outcome was supported by additional analyses and a VE prediction interval ranging from 67.1% to 85.4%. CONCLUSIONS: The outcome of this meta-analysis and meta-regression convincingly showed the beneficial effect of post-excisional HPV vaccination against CIN2+ recurrence. Studies published to date have been unable to determine whether or not vaccination, completed or initiated before conisation, would be associated with more favourable results. PROSPERO REGISTRATION NUMBER: CRD42022353530.

Clinical outcomes of pelvic exenteration for gynecologic malignancies.

OBJECTIVES: The aim of this study was to analyze morbidity and survival after pelvic exenteration for gynecologic malignancies and evaluate prognostic factors influencing postoperative outcome. METHODS: We retrospectively reviewed all patients who underwent a pelvic exenteration at the departments of gynecologic oncology of three tertiary care centers in the Netherlands, the Leiden University Medical Centre, the Amsterdam University Medical Centre, and the Netherlands Cancer Institute, during a 20-year period. We determined postoperative morbidity, 2- and 5-year overall survival (OS) and 2- and 5-year progression free survival (PFS), and investigated parameters influencing these outcomes. RESULTS: A total of 90 patients were included. The most common primary tumor was cervical cancer (n = 39, 43.3%). We observed at least one complication in 83 patients (92%). Major complications were seen in 55 patients (61%). Irradiated patients had a higher risk of developing a major complication. Sixty-two (68.9%) required ≥1 readmission. Re-operation was required in 40 patients (44.4%). Median OS was 25 months and median PFS was 14 months. The 2-year OS rate was 51.1% and the 2-year PFS rate was 41.5%. Tumor size, resection margins and pelvic sidewall involvement had a negative impact on OS (HR = 2.159, HR = 2.376, and HR = 1.200, respectively). Positive resection margins and pelvic sidewall involvement resulted in decreased PFS (HR = 2.567 and HR = 3.969, respectively). CONCLUSION: Postoperative complications after pelvic exenteration for gynecologic malignancies are common, especially in irradiated patients. In this study, a 2-year OS rate of 51.1% was observed. Positive resections margins, tumor size, and pelvic sidewall involvement were related to poor survival outcomes. Adequate selection of patients who will benefit from pelvic exenteration is important.

Utilisation of hospital-based specialist palliative care in patients with gynaecological cancer: Temporal trends, predictors and association with high-intensity end-of-life care.

OBJECTIVE: To examine hospital-based specialist palliative care (SPC) utilisation among patients with gynaecological cancer, including temporal trends, predictors and associations with high-intensity end-of-life care. METHODS: We conducted a nationwide registry-based study for all patients dying from gynaecological cancer in Denmark during 2010-2016. We estimated the proportions of patients receiving SPC by year of death and used regression analyses to examine predictors of SPC utilisation. Use of high-intensity end-of-life care according to SPC utilisation was compared by regression analyses adjusting for type of gynaecological cancer, year of death, age, comorbidities, residential region, marital/cohabitation status, income level and migrant status. RESULTS: Among 4502 patients dying from gynaecological cancer, the proportion of patients receiving SPC increased from 24.2% in 2010 to 50.7% in 2016. Young age, three or more comorbidities, residence outside the Capital Region and being immigrant/descendant were associated with increased SPC utilisation, whereas income, cancer type and stage were not. SPC was associated with lower high-intensity end-of-life care utilisation. Particularly, when compared with patients not receiving SPC, patients who accessed SPC >30 days before death had 88% lower risk of intensive care unit admissions within 30 days before death (adjusted relative risk: 0.12 (95% CI: 0.06; 0.24)) and 96% lower risk of surgery within 14 days before death (adjusted relative risk: 0.04 (95% CI: 0.01; 0.31)). CONCLUSIONS: Among patients dying from gynaecological cancer, SPC utilisation increased over time and age, comorbidities, residential region and migrant status were associated with access to SPC. Furthermore, SPC was associated with lower use of high-intensity end-of-life care.

Gestational choriocarcinoma.

Gestational choriocarcinoma accounts for 5% of gestational trophoblastic neoplasms. Approximately 50%, 25%, and 25% of gestational choriocarcinoma occur after molar pregnancies, term pregnancies, and other gestational events, respectively. The FIGO scoring system categorizes patients into low (score 0 to 6) and high risk (score 7 or more) choriocarcinoma. Single-agent and multi-agent chemotherapy are used in low- and high-risk patients, respectively. Chemotherapy for localized disease has a goal of eradication of disease without surgery and is associated with favorable prognosis and fertility preservation. Most patients with gestational choriocarcinoma are cured with chemotherapy; however, some (<5.0%) will die as a result of multi-drug resistance, underscoring the need for novel approaches in this group of patients. Although there are limited data due to its rarity, the treatment response with immunotherapy is high, ranging between 50-70%. Novel combinations of immune checkpoint inhibitors with targeted therapies (including VEGFR-2 inhibitors) are under evaluation. PD-L1 inhibitors are considered a potential important opportunity for chemo-resistant patients, and to replace or de-escalate chemotherapy to avoid or minimize chemotherapy toxicity. In this review, the Rare Tumor Working Group and the European Organization for Research and Treatment of Cancer evaluated the current landscape and further perspective in the management of patients diagnosed with gestational choriocarcinoma.

Cytology compared with Hybrid Capture 2 human papilloma virus cervical cancer screening in HIV positive and HIV negative South African women.

OBJECTIVES: Cervical cancer is preventable and caused by persistent infection with oncogenic human papilloma virus (HPV) types. HPV screening is more sensitive and is the preferred screening test. HPV screening data are mainly from developed settings, and the purpose of this study was to investigate the performance of HPV screening in previously unscreened HIV positive and negative women. METHODS: In this cross sectional multicenter study, liquid based cytology and HPV testing were performed on women attending different clinics. Patients with positive screening tests had colposcopy and biopsy or large loop excision of the transformation zone. Some women with normal screening had colposcopy and biopsy. Data of women with histology results, and data of HIV positive and negative women were analyzed for comparison. For women without histology results, data were imputed using a statistical model. RESULTS: In 903 women with known HIV status, 683 (75.6%) had negative cytology, 202 women (22.4%) had abnormal cytology, and in 18 patients (2.0%) the results were uncertain. Mean age was 41.4 years (range 25-65). HPV tests were negative in 621 women (68.8%). In HIV positive women, 54.5% tested negative compared with 79.7% HIV negative women (p<0.0001). HPV screening had higher sensitivity (60.9%), but lower specificity (82.4%), compared with cytology (48.6% and 86.7%) for detection of cervical intraepithelial neoplasia (CIN) 2+ in all women. For detection of CIN 3+, HPV screening had higher sensitivity (70.4%) compared with cytology (62.9%), and specificity (75.5%) was lower compared with cytology at a threshold of atypical squamous cells of undetermined significance (ASCUS+) (82.4%). CONCLUSION: HPV screening was more sensitive than cytology in HIV positive and HIV negative women, but specificity was lower. Although HPV screening should be the preferred screening test, cytology is a suitable screening test in HIV positive women in low resource settings. TRIAL REGISTRATION NUMBER: NCT02956031.

Endometrial carcinosarcoma.

Endometrial carcinosarcoma is a rare and aggressive high-grade endometrial carcinoma with secondary sarcomatous trans-differentiation (conversion theory). The clinical presentation and diagnostic work-up roughly align with those of the more common endometrioid counterpart, although endometrial carcinosarcoma is more frequently diagnosed at an advanced stage. Endometrial carcinosarcoma is not a single entity but encompasses different histological subtypes, depending on the type of carcinomatous and sarcomatous elements. The majority of endometrial carcinosarcomas are characterized by p53 abnormalities. The proportion of POLE and microsatellite instablity-high (MSI-H) is directly related to the epithelial component, being approximately 25% and 3% in endometrioid and non-endometrioid components.The management of non-metastatic disease is based on a multimodal approach with optimal surgery followed by (concomitant or sequential) chemotherapy and radiotherapy, even for early stages. Palliative chemotherapy is recommended in the metastatic or recurrent setting, with carboplatin/paclitaxel doublet being the first-line regimen. Although the introduction of immunotherapy plus/minus a tyrosine kinase inhibitor shifted the paradigm of treatment of patients with recurrent endometrial cancer, patients with endometrial carcinosarcoma were excluded from most studies evaluating single-agent immunotherapy or the combination. However, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved the use of pembrolizumab and lenvatinib in endometrial cancer (all histotypes) after progression on chemotherapy and single-agent immunotherapy in MSI-H cancers. In the era of precision medicine, emerging knowledge on molecular endometrial carcinosarcoma is opening new promising therapeutic options for more personalized treatment. The present review outlines state-of-the-art knowledge and future directions for patients with endometrial carcinosarcoma.

Healthcare associated infections in gynecologic oncology: clinical and economic impact.

OBJECTIVE: The purpose of this study was to assess the rate and type of infections in gynecological cancer patients. We also performed an economic analysis to provide an overview of costs related to healthcare associated infections. METHODS: We retrospectively collected data from culture samples at the site of infection from patients undergoing surgery or chemotherapy, admitted to the Gynecologic Oncology Unit, Fondazione Policlinico Agostino Gemelli IRCCS, from January 2017 to December 2018. We performed univariate and multivariate analyses to calculate potential risk factors for prolonged length of hospitalization. The average cost per patient was calculated, including the cost of hospital stay, operating room, medications, and diagnostic and invasive procedures. RESULTS: Among 5682 patients, 322 (5.6%) gynecological cancer patients with healthcare associated infections were identified. A total of 249 patients (77.3%) had undergone surgery in the previous 30 days and 73 (22.7%) patients were receiving chemotherapy. In the whole population, the most common healthcare associated infections were urinary infections (58%) and surgical wound infections (42.1%). In addition, 14.5% of patients had central venous catheter infections and 21.7% had blood stream infections. Median length of stay was 20 days (range 1-100). Among surgical patients, advanced age (odds ratio (OR) 1.233, 95% confidence interval (CI) 1.001 to 1.519, p=0.049), bowel resection (OR 2.659, 95% CI 1.493 to 4.735, p=0.001), surgical site infection (OR 10.447, 95% CI 1.143 to 95.5, p=0.038), and central venous catheter infection (OR 9.856, 95% CI 1.139 to 85.319, p=0.038) were independently associated with an increased risk of prolonged hospital stay (>20 days). The overall direct cost of healthcare associated infections was $6 273 852 per year. CONCLUSIONS: The infection rate in our population was 5.6%. The most common healthcare associated infections were urinary and surgical wound infections. Among surgical patients, advanced age, bowel resection, surgical site, and central venous catheter infection were associated with an increased length of hospitalization. Healthcare associated infections cause an increase in the length of stay after surgery and hospital costs.

Predicting resectable disease in relapsed epithelial ovarian cancer by using whole-body diffusion-weighted MRI.

OBJECTIVE: To determine the diagnostic value of whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) to predict resectable disease at the time of secondary cytoreductive surgery for relapsed epithelial ovarian cancer with a platinum-free interval of at least 6 months. METHODS: A retrospective cohort study between January 2012 and December 2021 in a tertiary referral hospital. Inclusion criteria were: (a) first recurrence of epithelial ovarian cancer; (b) platinum-free interval of ≥6 months; (c) intent to perform secondary cytoreductive surgery with complete macroscopic resection; and (d) WB-DWI/MRI was performed.Diagnostic tests of WB-DWI/MRI for predicting complete resection during secondary cytoreductive surgery are calculated as well as the progression-free and overall survival of the patients with a WB-DWI/MRI scan that showed resectable disease or not. RESULTS: In total, 238 patients could be identified, of whom 123 (51.7%) underwent secondary cytoreductive surgery. WB-DWI/MRI predicted resectable disease with a sensitivity of 93.6% (95% confidence interval [CI] 87.3% to 96.9%), specificity of 93.0% (95% CI 87.3% to 96.3%), and an accuracy of 93.3% (95% CI 89.3% to 96.1%). The positive predictive value was 91.9% (95% CI 85.3% to 95.7%).Prediction of resectable disease by WB-DWI/MRI correlated with improved progression-free survival (median 19 months vs 9 months; hazard ratio [HR] for progression 0.36; 95% CI 0.26 to 0.50) and overall survival (median 75 months vs 28 months; HR for death 0.33; 95% CI 0.23 to 0.47). CONCLUSION: WB-DWI/MRI accurately predicts resectable disease in patients with a platinum-free interval of ≥6 months at the time of secondary cytoreductive surgery and could be of complementary value to the currently used models.

Prognostic significance of delayed complete metabolic response on PET/CT after primary chemoradiation treatment of cervical cancer.

OBJECTIVE: To investigate the prognostic significance of near-complete metabolic response on initial follow-up PET/CT after primary chemoradiation treatment of cervical cancer. METHODS: Survival data were retrospectively compared between patients who had complete metabolic response on first follow-up PET/CT, 3 months after chemoradiation (group 1) with those who had near-complete metabolic response on first PET/CT and later showed complete metabolic response at subsequent PET/CT, 6 months or more after treatment (group 2). RESULTS: Of the 108 patients included in the final analysis, 74 (68.5%) showed complete metabolic response on initial PET/CT, 3 months after treatment, and 34 patients (31.5%) showed complete metabolic response on subsequent PET/CT, 6 months after treatment. Tumor characteristics were comparable between groups. Group 1 had higher percent of stage 1 (12% vs 0%) and lower percent of stage 4 disease (3% vs 14%) than those of group 2. Group 2 patients had significantly fewer cases of recurrences and deaths than group 1 patients (6% vs 26%, p=0.018; 0% vs 20%, p=0.003, respectively), with comparable 3-year survival rates (group 1, 90% vs group 2, 100%, p=0.31). Twelve patients had progressive disease on first follow-up PET/CT; these patients had significantly worse overall survival compared with all other patients (log-rank test, p<0.001). Younger age and delayed complete metabolic response were associated with lower chance of recurrence and death on univariate analysis. On multivariate analysis, delayed complete metabolic response remained significantly associated with no recurrence HR=0.14 (95% CI 0.25 to 0.84), p=0.031. CONCLUSIONS: Survival outcome of patients with cervical cancer who show residual 18F-fluorodeoxyglucose uptake on initial PET/CT after treatment, but reach complete metabolic response on follow-up PET/CT, is not inferior compared with survival of patients who show complete metabolic response on initial PET/CT 3 months after treatment. Watchful waiting with follow-up PET/CT seems a safe option for these patients.

Black and hispanic women have less support during cancer evaluation and treatment: results from a prospective patient reported outcomes program in gynecologic malignancy.

OBJECTIVE: Race remains a significant predictor of poor outcomes in women with gynecologic cancer and minority patients consistently report worse quality of life during cancer treatment. Disparities between patients in strength of social and emotional supports may contribute to these outcomes. This study's objective was to describe the racial differences in patient reported outcomes of women being evaluated or treated for a gynecologic malignancy at a large tertiary cancer hospital. METHODS: In this prospective cohort study, all patients presenting for care at a tertiary care gynecologic oncology clinic between January 2018 and September 2019 were evaluated for inclusion. All patients were administered validated patient reported outcome measure questionnaires at serial visits. Demographic data was gathered including self-reported race. Patients were characterized as White, Black, Asian, Hispanic/Latino, or Other. Patient reported outcomes were compared between respondents of different races using linear and logistic regression. RESULTS: Between January 2018 to September 2019, 2022 patients with a known race completed questionnaires. Of these patients, 86.7% were White, 4.3% Black, and 4.9% Hispanic/Latino and 58.7% had a known cancer diagnosis. Non-White patients were significantly less likely to complete questionnaires (p<0.001). Non-White patients reported significantly lower levels of emotional support on all questions (Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support: Q1 p<0.001, Q2 p<0.001, Q3 p=0.013, Q4 p=0.002), and lower overall emotional (p=0.005) and instrumental (p=0.005) support scores when compared with White patients. Hispanic/Latino patients reported the lowest levels of emotional and instrumental support and more cognitive (p=0.043) and financial (p=0.040) difficulties associated with treatment. Black women reported having less support with chores while sick (p=0.014) and being less likely to have someone to talk to (p=0.013). CONCLUSIONS: Significant differences exist in patient reported outcomes between women of different racial backgrounds. Hispanic/Latino and Black women have less support during gynecologic cancer evaluation and treatment as compared with White women.