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ObjectiveThe aim of this study was to examine the survival effect of adjuvant therapy in stage II–III endometrial cancer based on peritoneal cytology results.MethodsThe National Cancer Institute’s Surveillance, Epidemiology, and End Results Program was retrospectively queried to examine 7467 women with stage II–III endometrial cancer who underwent hysterectomy, and with available peritoneal cytology results, from 2010 to 2016. A Cox proportional hazard regression model was fitted to assess the association between adjuvant therapy and all-cause mortality stratified by peritoneal cytology results.ResultsMalignant peritoneal cytology was reported in 1662 (22.3%) women and was associated with non-endometrioid histology, higher tumor stage, and nodal metastasis (p < 0.05). In a propensity score-weighted model, malignant peritoneal cytology was associated with increased all-cause mortality compared with negative peritoneal cytology (hazard ratio 1.35, 95% confidence interval 1.23–1.48). Adjuvant therapy types varied based on histology and peritoneal cytology results. In non-endometrioid histology, the combination of chemotherapy and whole pelvic radiotherapy (WPRT) was associated with improved overall survival compared with chemotherapy or WPRT alone irrespective of the peritoneal cytology results (p < 0.05). The combination of chemotherapy and WPRT was also associated with improved overall survival in women with endometrioid histology and malignant peritoneal cytology (p = 0.026). Women with endometrioid histology and negative peritoneal cytology represented the most common subpopulation (46.5%), and overall survival was similar regardless of which of the three adjuvant therapy modalities was used (p = 0.319).ConclusionsMalignant peritoneal cytology is prevalent and prognostic in stage II–III endometrial cancer. This study found that the surgeon’s choice and benefit of adjuvant therapy for women with stage II–III endometrial cancer differed depending on the status of peritoneal cytology.

In this nationwide cross-sectional study of 4,055,462 hospital admissions with a diagnosis of coronavirus disease 2019 (COVID-19) from April 2020 to December 2021 identified in the Agency of Healthcare Research and Quality’s Healthcare Cost and Utilization Project National Inpatient Sample in the United States, a total of 489,390 (12.1%) patients experienced endotracheal intubation and mechanical ventilation, with the highest peak in August 2021 (48,735 endotracheal intubations and mechanical ventilation), followed by January 2021 (47,100 endotracheal intubations and mechanical ventilation) and December 2021 (43,835 endotracheal intubations and mechanical ventilation). During the 3-month long large surge from November 2020 to January 2021, a total of 104,750 endotracheal intubations and mechanical ventilation occurred among 1,069,874 COVID-19 admissions. Shock (adjusted-odds ratio 24.21, 95% confidence interval 23.93–24.49) and respiratory failure (adjusted-odds ratio 14.09, 95% confidence interval 13.80–14.38) were the two strongest factors associated with endotracheal intubation and mechanical ventilation. A total of 266,585 (6.6%) patients received non-invasive respiratory support alone without endotracheal intubation and mechanical ventilation during the study period with the highest peak in August 2021 (30,725 cases), followed by January 2021 (28,035 cases), and December 2021 (26,200 cases). The utilization of non-invasive respiratory support without endotracheal intubation and mechanical ventilation increased by nearly three-fold during the 21-month study period (adjusted-odds ratio for the fourth year-quarter of 2021 compared to the second year-quarter of 2020 2.94, 95% confidence interval 2.88–3.00). A total of 515,800 (12.7%) deaths occurred during COVID-19 hospitalization, with highest in the peak of multi-month lasting largest surge (January 2021, 56,775 deaths), followed by August 2021 (47,535 deaths) and December 2021 (46,880 deaths). Among those who deceased following endotracheal intubation and mechanical ventilation, the median time from admission to death was 14 days (interquartile range 7–21). COVID-19 admissions, respiratory intervention approach, and COVID-19 case fatality differed across the nine U.S. census divisions during the study period. In conclusion, these statistics may be useful to inform the national-level preparedness of global pandemic from respiratory illness in the future, possibly exceeding 48,000 endotracheal intubations and mechanical ventilation across the country in a month and 100,000 endotracheal intubations and mechanical ventilation in three months when encountering long-lasting surge with one-million admissions.

PurposeThis study was designed to examine the association between malignant peritoneal cytology and survival of women with uterine sarcoma.MethodsThis retrospective, observational study queried the National Cancer Institute’s Surveillance, Epidemiology, and End Result Program. Uterine sarcoma cases diagnosed from 2010 to 2016 with known peritoneal cytology results were examined. Propensity score inverse probability of treatment weighting was fitted to balance the measured covariates. Overall survival (OS) was compared between malignant and negative cytology cases.ResultsA total of 1481 uterine sarcomas were examined. Malignant peritoneal cytology was seen in 146 (9.9%) cases. Women who had T3 disease and distant metastases had the highest incidence of malignant peritoneal cytology (43.1%). In multivariable analysis, higher T stage, nodal involvement, distant metastasis, poorer tumor differentiation, and rhabdomyosarcoma/endometrial stromal sarcoma were significantly associated with an increased risk of malignant peritoneal cytology (all, P < 0.05). In the weighted model, malignant peritoneal cytology was associated with a nearly twofold increased risk of all-cause mortality compared with negative peritoneal cytology (3-year OS rate 34.7% versus 60.2%; hazard ratio 2.26; 95% confidence interval 1.88–2.71; P < 0.001). The absolute difference in the 3-year survival rate was particularly large in leiomyosarcoma (3-year OS rate 2.8% versus 51.9%; hazard ratio 2.64; 95% confidence interval 1.94–3.59; P < 0.001). Malignant peritoneal cytology was also associated with an increased all-cause mortality risk in early and advanced stages (both, P < 0.05).ConclusionsOur study suggests that malignant peritoneal cytology may be a prognostic factor for increased mortality in uterine sarcoma, particularly in uterine leiomyosarcoma.

Background A high percentage of epithelial ovarian cancers (EOC) express the estrogen receptor (ER), which is an ideal target for endocrine therapy. Letrozole is a proven, potent aromatase inhibitor, extensively tested and used in the treatment of ER positive breast cancer. In addition, it seems a potent drug for patients with heavily pre-treated OC as demonstrated in several distinctive settings. However, it has never been evaluated prospectively in a maintenance setting for ovarian cancer after standard of care. The here proposed trial aims to define a population of EOC patients, who would benefit from the effectiveness of the generic agent letrozole, with little expected toxicity and thus beneficial impact on overall quality of life (QoL). Methods In this international multicenter randomized, placebo-controlled phase III trial at clinical centers in Switzerland, Germany and Austria, we plan to include 540 patients with primary, newly diagnosed FIGO Stage II to IV and histologically confirmed low- or high-grade serous or endometrioid epithelial ovarian/fallopian tube/peritoneal cancer. Patients are randomized in a 1:1 ratio into two groups: receiving blinded study treatment (letrozole or placebo tablets). When assuming a HR of 0.7, a median PFS of 18 months in the control arm and a median PFS of 25.7 months in the treatment arm, a two-sided alpha level of 5%, 3.5 years recruitment and 1.5 years observation time, we expect 330 events to have occurred within these 5 years in the total cohort yielding a power of 90%. Follow-up data for the whole cohort will be collected for up to 10 years and for the low-grade cancer for up to 12 years. Discussion The here proposed randomized phase III trial aims to identify patients with EOC in the maintenance setting, who benefit from the effectiveness of the letrozole, by proving its efficacy whilst maintaining a high standard of QoL due to the limited toxicity expected in comparison to the current alternative drugs on the market for this treatment phase. Trial registration This trial is registered at clinicaltrials.gov under the identifier NCT04111978 . Registered 02 October 2019.

Purpose of ReviewTo review and discuss the present evidence of surgery- and radiation-based treatment strategies for stage IIB cervical cancer.Recent FindingsRecently, two randomized controlled trials compared the efficacy of neoadjuvant chemotherapy followed by radical hysterectomy (NACT + RH) with that of concurrent chemoradiotherapy (CCRT) for stage IB3–IIB cervical cancer. When these studies were combined (N = 1259), NACT + RH was associated with a shorter disease-free survival [hazard ratio (HR) 1.36, 95% confidence interval (CI) 1.13–1.64], but with a similar overall survival (HR 1.11, 95% CI 0.90–1.36) when compared with the findings for CCRT. Stage-specific analysis for stage IIB cervical cancer demonstrated that disease-free survival was significantly worse with NACT + RH than with CCRT (HR 1.90, 95% CI 1.25–2.89); however, no significant difference was observed for stage IB3–IIA cervical cancer.SummaryBased on the results of recent level I evidence, the standard treatment for stage IIB cervical cancer remains CCRT.

ObjectiveThe International Federation of Gynecology and Obstetrics (FIGO) revised the vulvar cancer staging schema in 2021. Previous stage IIIA–B diseases were reclassified based on nodal size (≤5 mm for stage IIIA compared with >5 mm for stage IIIB), and previous stage IVA1 disease based on non-osseous organ extension was reclassified to stage IIIA whereas osseous extension remained as stage IVA. This study sought to validate the 2021 FIGO vulvar cancer staging schema.MethodsThis retrospective cohort study examined 889 women with stage III–IV vulvar cancer from 2010 to 2015 in the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program. Stage shift and overall survival were assessed by comparing the 2021 and 2009 FIGO staging schemas.ResultsStage shift occurred in 229 (25.8%) patients (upstaged 17.7% and downstaged 8.1%). When comparing the new and previous staging schemas, 5 year overall survival rates were 45.6% versus 48.9% for stage IIIA, 47.0% versus 44.2% for stage IIIB, and 13.9% versus 25.1% (interval change −11.2%) for stage IVA diseases. According to the revised staging schema, 5 year overall survival rates were similar for stage IVA and IVB diseases (13.9% vs 14.5%) and for stage IIIA and IIIB disease (45.6% vs 47.0%). For new stage IIIA disease, 5 year overall survival rates differed significantly based on the staging factors (nodal involvement vs non-nodal organ involvement, 48.9% vs 38.7%, difference 10.2%, p=0.038).ConclusionThe 2021 FIGO staging schema results in one in four cases of advanced vulvar cancer being reclassified. Survival rates of patients with new stage IVA disease worsened significantly whereas those of patients with new stage IIIA disease were heterogenous based on the staging factors. The discriminatory ability of the revised 2021 FIGO staging schema for 5 year overall survival rate between patients with stage IIIA and IIIB tumors and those with IVA and IVB tumors is limited in this study population.

ObjectiveTo examine trends and outcomes related to adjuvant systemic chemotherapy alone for high risk, early stage cervical cancer.MethodsThis retrospective observational study queried the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program from 2000 to 2016. Surgically treated women with American Joint Commission on Cancer stages T1–2 cervical cancer who had high risk factors (nodal metastasis and/or parametrial invasion) and received additional therapy were examined. Propensity score inverse probability of treatment weighting was used to assess the survival estimates for systemic chemotherapy versus external beam radiotherapy with chemotherapy.ResultsAmong 2462 patients with high risk factors, 185 (7.5%) received systemic chemotherapy without external beam radiotherapy, of which the utilization significantly increased over time in multivariable analysis (adjusted odds ratio per 1 year increment 1.06, 95% confidence interval (CI) 1.02 to 1.09). In weighted models, adjuvant chemotherapy and combination therapy (external beam radiotherapy and chemotherapy) had comparable overall survival among patients aged <40 years (hazard ratio (HR) 0.73, 95% CI 0.41 to 1.33), in adenocarcinoma or adenosquamous histologies (HR 0.90, 95% CI 0.62 to 1.32), and in those with nodal metastasis alone without parametrial tumor invasion (HR 1.17, 95% CI 0.84 to 1.62). In contrast, systemic chemotherapy alone was associated with increased all cause mortality compared with combination therapy in patients aged ≥40 years (HR 1.57, 95% CI 1.19 to 2.06), with squamous histology (HR 1.63, 95% CI 1.19 to 2.22), and with parametrial invasion alone (HR 1.87, 95% CI 1.09 to 3.20) or parametrial invasion with nodal metastasis (HR 1.64, 95% CI 1.06 to 2.52).ConclusionUtilization of adjuvant systemic chemotherapy alone for high risk, early stage cervical cancer is increasing in the United States in the recent years. Our study suggests that survival effects of adjuvant systemic chemotherapy may vary based on patient and tumor factors. External beam radiotherapy with chemotherapy remains the standard for high risk, early stage cervical cancer, and use of adjuvant systemic chemotherapy without external beam radiotherapy should be considered with caution.

ObjectiveSentinel lymph node (SLN) biopsy has been incorporated into surgical care for many malignancies; however, the utility has not been examined in ovarian cancer. This study examined population-level trends, characteristics, and outcomes related to SLN biopsy in early stage ovarian cancer.MethodsThis is a retrospective cohort study querying the National Cancer Institute's Surveillance, Epidemiology, and End Result Program from 2003–2018. The study population consisted of 11,512 women with stage I ovarian cancer who had adnexectomy-based surgical staging including lymph node evaluation. Exposure allocation was based on SLN biopsy use. Main outcomes measured were (i) trends and characteristics associated with SLN biopsy use, assessed by multivariable logistic regression model, and (ii) overall survival assessed with inverse provability of treatment weighting propensity score.ResultsSLN biopsy was performed in less than 1% of study population. In a multivariable analysis, recent surgery (2011–2018 versus 2003–2010, odds ratio [OR] 1.64, 95% confidence interval [CI] 1.03–2.59), smaller tumor size (< 10 versus ≥ 10 cm, OR 3.07, 95% CI 1.20–7.84), and East registry area (OR 2.74, 95% CI 1.73–4.36) remained independent characteristics for SLN biopsy use. In a propensity score weighted model, 5-year overall survival rate was 90.5% for the SLN biopsy-incorporated group and 88.6% for the lymphadenectomy group (hazard ratio 0.96, 95% CI 0.53–1.73).ConclusionSLN biopsy was rarely performed for early ovarian cancer surgery during the study period with insufficient evidence to interpret the survival effect. SLN biopsy in early ovarian cancer appears to be in early development phase, warranting further study and careful evaluation to assess feasibility and oncologic outcome.

Background. This randomized, open trial compared regimens including 2 doses (2D) of human papillomavirus (HPV) 16/18 AS04-adjuvanted vaccine in girls aged 9-14 years with one including 3 doses (3D) in women aged 15-25 years. Methods. Girls aged 9-14 years were randomized to receive 2D at months 0 and 6 (M0,6; (n = 550) or months 0 and 12 (M0,12; n = 415), and women aged 15-25 years received 3D at months 0,1, and 6 (n = 482). End points included noninferiority of HPV-16/18 antibodies by enzyme-linked immunosorbent assay for 2D (M0,6) versus 3D (primary), 2D (MO, 12) versus 3D, and 2D (M0,6) versus 2D (M0,12); neutralizing antibodies; cell-mediated immunity; reactogenicity; and safety. Limits of noninferiority were predefined as < 5% difference in seroconversion rate and <2-fold difference in geometric mean antibody titer ratio. Results. One month after the last dose, both 2D regimens in girls aged 9-14 years were noninferior to 3D in women aged 15-25 years and 2D (M0,12) was noninferior to 2D (M0,6). Geometric mean antibody titer ratios (3D/2D) for HPV-16 and HPV-18 were 1.09 (95% confidence interval, .97-1.22) and 0.85 (76-.95) for 2D (M0,6) versus 3D and 0.89 (.79-1.01) and 0.75 (.67-.85) for 2D (M0,12) versus 3D. The safety profile was clinically acceptable in all groups. Conclusions. The 2D regimens for the HPV-16/18 AS04-adjuvanted vaccine in girls aged 9-14 years (M0,6 or M0,12) elicited HPV-16/18 immune responses that were noninferior to 3D in women aged 15-25 years. Clinical Trials Registration. NCT01381571.