Advanced/recurrent endometrial cancer is associated with poor long-term outcomes. Clinical studies of novel regimens are ongoing, but given that data on overall survival (OS) take a long time to mature, surrogate end points are often used to support clinical-research interpretation. The aim of this study was to explore the correlation between progression-free survival (PFS)/time to progression (TTP) and OS across multiple time points in the first-line treatment of advanced/recurrent endometrial cancer.
Abstract Background and objectives In atrial fibrillation (AF), assessment of thromboembolic and bleeding risks are recommended to prescribe anticoagulation for stroke prevention. However, AF also increases mortality, and predictors of death are less characterized than predictors for stroke. We investigated the predictive power for mortality of the CHA2DS2-VASc, the HAS-BLED score and their combination. Methods Individual patient data were analyzed from the PREvention oF thromboembolic events-European Registry in Atrial Fibrillation (PREFER AF), a prospective real-world registry with a 12-month follow-up, with a total of 7243 patients enrolled from 461 hospitals and 7 European countries (Austria, France, Germany, Italy, Spain, Switzerland, and United Kingdom). Logistic regression was used to analyze the relationship of the CHA2DS2-VASc and HAS-BLED scores, and their combinations with outcome events, including mortality, at one year. The predictive ability of the scores was analyzed by comparing c-statistics. Results The study sample consisted of 5,209 AF patients with complete information on both scores. Mean age was 71.8±10.46 years; 3145 subjects (60.4%) were male. Events rate of stroke/SEE and major bleeding at one-year were 2.3% (122 patients) and 2.9% (149 patients), respectively. At one year, 3.1% of patients died (160 out of 5,209). Both scores had broadly similar c-statistics; for CHA2DS2-VASc: 0.637, 0.656 and 0.616 for models predicting mortality, SSE and major bleeding, respectively; for HAS-BLED: 0.620, 0.647, and 0.627, respectively. When including the individual components of both scores separately, c-statistics increased to 0.715, 0.694 and 0.636 with CHA2DS2-VASc, and to 0.681, 0.697 and 0.680 with HAS-BLED. The predictive power with both scores combined, removing overlapping components, was higher, with a c-statistic of 0.74, 0.73 and 0.70 for mortality (Table), SSE and major bleeding, respectively. Conclusion Both the CHA2DS2-VASc and the HAS-BLED score predict mortality similarly in AF, and a combination of the score components increases prediction significantly. Such combination may thus be clinically useful. Funding Acknowledgement Type of funding source: None
Pulmonary embolism (PE) is associated with a substantial economic burden. However evidence from patients in Europe is scarce. The aim of this study was to report the impacts of PE on healthcare resource utilization (HCRU) and return to work using the PREFER in VTE registry.The PREFER in VTE registry was a prospective, observational, multicenter study in seven European countries, aiming to provide data concerning treatment patterns, HCRU, mortality, quality of life and work-loss. Patients with a first-time or recurrent PE were included and followed up at 1, 3, 6 and 12 months. Treatment patterns, re-hospitalization rates, length of hospital stays (LOS), and ambulatory/office visits, as well as proportion of patients returning to work, were assessed. Subgroups by country and with/without active cancer were examined separately. Zero-inflated negative binomial and Cox regression were applied to investigate the relationship between baseline characteristics and LOS and return to work, respectively.Amongst 1399 patients with PE, 53.2% were male and the average age was 62.3 ± 17.1 years old. Overall, patients were treated with combinations of heparin, vitamin K antagonists (VKA) and the non-VKA oral anticoagulants (NOACs) (50.0% treated with the combination of heparin with VKA). Patients with active cancer were primarily treated with heparin (84.9%). NOACs were used more frequently in DACH (Germany, Austria and Switzerland) and France (55.2% and 32.6%) compared to Italy and Spain (4.5% and 6.1%). The VTE-related re-hospitalization rate within 12 months and the average LOS varied substantially between countries, from 26.2% in UK to 12.3% in France, and from 12.9 days in Italy to 3.9 days in France. PE patients were often co-managed by general practitioners in France and DACH (>84%), and less frequently in other countries (<47%). The regression results confirmed the country variation of HCRU. Of the employed patients (n = 385), 60% returned to work at 1 month but 27.8% had not after one year. PE patients with DVT were more likely to return to work. Active cancer was a significant predictor for not returning to work, as well as smoking history.Medical treatment of PE differed between patients with active cancer and patients without active cancer. VTE-related resource utilization differed markedly between countries. While the reported 'not return to work' was high for patients with PE, this may at least in part reflect the presence of co-morbidities such as cancer.
