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http://clinicaltrials.gov/ct2/show/NCT00455819.

3996 Poster Board III-932 Background NT-proBNP is emerging to be of great importance in risk assessment of patients with acute pulmonary embolism (PE), by identifying both high and low-risk patients. The aim of the present management study was to investigate the safety of out of hospital treatment of patients with acute PE based on a NT-proBNP < 500 pg/ml. Methods Hemodynamically stable outpatients with objectively diagnosed acute PE and a NT-proBNP level < 500 pg/ml, were considered eligible for participation in this multicenter prospective study. Patients were discharged immediately from the emergency room or within the first 24 hours of admission. The primary objective was the 10-days mortality rate. Secondary objectives were the incidence of re-admission to hospital due to PE or its treatment, the patient's satisfaction during the first ten days of treatment and the incidence of serious adverse events in a 3-month follow-up period. Results Approximately 40 percent of all patients presenting at the emergency room with acute PE fulfilled the inclusion criteria. In total, 152 patients (mean age 53.4 ± 14.3 years; 51% female) with PE were treated as outpatients. No deaths, major bleedings or recurrent venous thromboembolism occurred during the first 10 days or in a follow-up period of 3 months. Seven patients required readmission. Three patients were admitted because of complaints of their PE: two patients with anxiety and pain and one patient with dyspnoea and low oxygen saturation. There were no signs of progression of PE in these 3 patients. Four patients were re-admitted because of an illness unrelated to PE. According to the PSQ18 and anxiety score, patients were satisfied with their out of hospital treatment; they had no progression of anxiety during the first ten days of treatment. Conclusion Out of hospital treatment is safe in a group of low risk patients with non-massive PE, based on NT-proBNP levels < 500 pg/ml. Approximately 40 percent of PE-patients can be treated in an outpatient setting. Patients consider out of hospital treatment as comfortable and have no increase in anxiety scores. Disclosures: No relevant conflicts of interest to declare.

Objective:The aim of this study was to assess the real-world effectiveness and tolerability of palbociclib combined with endocrine therapy for the treatment of hormone receptor positive (HR-positive), human epidermal growth factor receptor 2 negative (HER2-negative), advanced/metastatic breast cancer that progressed on previous endocrine therapy, and to compare these results with the outcomes of the PALOMA-3 clinical trial.Methods:This study was a retrospective observational cohort study including all patients who started with palbociclib in the St. Antonius Hospital between September 1, 2016 and April 1, 2018 for the treatment of HR-positive, HER2-negative advanced/metastatic breast cancer that progressed on previous endocrine therapy. Individual patient data were collected from electronic medical records. Primary study outcomes were progression-free survival (PFS) and the number of permanent treatment discontinuations before disease progression due to adverse events (AEs). Secondary outcomes were the frequency of all (serious) AEs and the frequency of and reasons for dose reductions, -interruptions and cycle delays.Results:A total of 46 patients were studied with a median follow-up of 13.0 months. Overall, the median PFS in real-world clinical practice was 10.0 months (95% confidence interval (CI) 4.9-15.1), compared with 9.5 months in PALOMA-3 (95% CI 9.2-11.0). Two patients discontinued treatment because of AEs. Neutropenia was the most frequent grade 3-4 AE, but with no febrile neutropenia events. Most AEs were managed with palbociclib dose modifications. Regarding these modifications, more cycle delays, less dose reductions, and less dose interruptions occurred in clinical practice compared with PALOMA-3 (59 vs 36%, 22 vs 34%, and 9 vs 54%, respectively). Patients who did not meet the PALOMA-3 study eligibility criteria (n = 16) showed a lower median PFS of 5.5 months (95% CI 4.7-6.4).Conclusions:The effectiveness and tolerability of palbociclib in real-world clinical practice corresponded well with the results obtained in the PALOMA-3 clinical trial. Despite the differences in dose modifications, this study suggests that there is no efficacy-effectiveness gap in this patient population.

Risk stratification of patients with PE has gained interest in terms of the identification of patients in whom treatment on an outpatient base can be considered. Previous studies are of limited value due to their focus on adverse clinical events within several months after diagnosis of PE. We developed a prognostic model, based on easily accessible, clinical, and laboratory parameters, to predict adverse events during the first 10 days after the diagnosis of acute PE. We have analyzed the data of 210 outpatients with confirmed PE. Collected data included medical history, pulse rate, blood pressure, NT-proBNP, and D-dimer concentrations. The primary outcome was the occurrence of adverse clinical events in a 10 day follow-up period. Our final prognostic model to predict short-term adverse events consists of NT-proBNP levels, D-dimer concentrations, pulse rate, and the occurrence of active malignancy; the total score ranges from 0 to 37 points. Patients with a low score (no active malignancy, pulse rate <90 bpm, NT-proBNP <500 pg/ml, and D-dimer <3,000 lg/l FEU) have a 10-day adverse event risk <1.5%. This risk increases to over 30% in patients with a maximum score, based on high pulse rate, D-dimer concentrations, and NT-proBNP levels. Our prognostic model, once prospectively validated in an independent sample of patients, can be used in the early risk stratification of PE to estimate the risk of adverse events and to differentiate between candidates for in-or out-hospital treatment. Am. J. Hematol. 86:646-649, 2011. V

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To enable outpatient treatment of a selected group of patients with pulmonary embolism (PE), insight in the determinants of adverse clinical outcome is warranted. We have identified risk factors for serious adverse events (SAE) within the first 10 days of acute PE. We have retrospectively analysed data of 440 consecutive patients with acute PE. Collected data included age, gender, medical history, blood pressure, pulse rate and D-dimer concentration. The variables associated with SAE in the first 10 days in univariate analysis (p<0.15) have been included in a multivariate logistic regression model (backward conditional, p out >0.10). In 440 patients with acute PE, 20 SAEs occurred in a 10-day follow-up period. Pulse rate > or = 100 beats per minute (bpm) (OR, 6.85; 95%CI 1.43-32.81) and D-dimer concentration > or = 3,000 microg/ml (OR, 5.51; 95%CI 0.68-44.64) were significantly related to the SAEs. All SAEs were predicted by a pulse rate > or = 100 bpm and/or a D-dimer concentration > or = 3,000 microg/ml. Older age, gender, history of venous thromboembolism (VTE), heart failure, chronic obstructive pulmonary disease, cancer or a systolic blood pressure < 90 mm Hg had no significant influence on short term SAEs. Pulse rate and D-dimer concentration can be used to identify patients with acute PE, who are at risk for adverse clinical outcome during the first 10 days of hospitalisation. Outpatient treatment of PE-patients with a pulse rate > or = 100 bpm and/or a D-dimer concentration > or = 3,000 microg/ml has to be discouraged.