Comparing two simultaneously acquired studies, the use of 16 instead of 8 frames has minor and predictable influence on functional data. Furthermore, there are no differences in the detection of stress-induced functional changes. The advantage of 16 over 8 frames in the daily clinical practice appears questionable.
Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). As untailored thromboprophylaxis is associated with hemorrhagic complications, the definition of a risk-assessment model (RAM) in this population is needed. INDICATE was a prospective observational study enrolling hospitalized cancer patients, with the primary objective of assessing the Negative Predictive Value (NPV) for TEs during hospitalization and within 45 days from discharge of low-grade Khorana Score (KS = 0). Secondary objectives were to assess KS Positive Predictive Value (PPV), the impact of TEs on survival and the development of a new RAM. Assuming 7% of TEs in KS = 0 patients as unsatisfactory percentage and 3% of as satisfactory, 149 patients were needed to detect the favorable NPV with one-sided α = 0.10 and power = 0.80. Stepwise logistic regression was adopted to identify variables included in a new RAM. Among 535 enrolled patients, 153 (28.6%) had a KS = 0. The primary study objective was met: 29 (5.4%) TEs were diagnosed, with 7 (4.6%) cases in the KS = 0 group (NPV = 95.4%, 95% CI 90.8–98.1%; one-sided p = 0.084). However, the PPV was low (5.7%, 95% CI 1.9–12.8%); a new RAM based on albumin (OR 0.34, p = 0.003), log(LDH) (OR 1.89, p = 0.023) and presence of vascular compression (OR 5.32, p < 0.001) was developed and internally validated. Also, TEs were associated with poorer OS (median, 5.7 vs 24.8 months, p < 0.001). INDICATE showed that the KS has a good NPV but poor PPV for TEs in hospitalized cancer patients. A new RAM was developed, and deserves further assessment in external cohorts.
Background: Advanced triple-negative breast cancer (aTNBC) has a poor prognosis; thus, there is a need to identify novel biomarkers to guide future research and improve clinical outcomes. Objectives: We tested the prognostic ability of an emerging, complete blood count (CBC)-based inflammatory biomarker, the pan-immune-inflammation value (PIV), in patients with aTNBC treated with first-line, platinum-based chemotherapy. Design: This was a retrospective, monocentric, observational study. Methods: We included consecutive aTNBC patients treated with platinum-based, first-line chemotherapy at our Institution, and for whom baseline (C1) CBC data were available. We collected CBC data early on-treatment, when available. PIV was calculated as: (neutrophil count × platelet count × monocyte count)/lymphocyte count. Patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (aBC) were included in a control, non-TNBC cohort. Results: A total of 78 aTNBC patients were included. When evaluated as a continuous variable, PIV-C1 was associated with worse overall survival (OS; p < 0.001) and progression-free survival (PFS; p < 0.001). On the other hand, when PIV-C1 was assessed on the basis of its quantile distribution, patients with ‘high PIV-C1’ experienced worse OS [adjusted hazard ratio (HR): 4.46, 95% confidence interval (CI): 2.22–8.99; adjusted p < 0.001] and PFS (adjusted HR: 2.03, 95% CI: 1.08–3.80; adjusted p = 0.027) when compared to patients with ‘low PIV-C1’. Higher PIV-C1 was also associated with primary resistance to chemotherapy. Similarly, a higher PIV calculated from CBC at C2D1 (PIV-C2) was associated with worse survival outcomes. We also created a PIV-based score combining information about both PIV-C1 and PIV-C2 and allowing the stratification of patients at low, intermediate, and high risk of death. No association was observed between PIV-C1 and clinical outcomes of HR+/HER2− aBC patients. Conclusion: PIV has a promising prognostic discrimination ability in aTNBC patients treated with first-line, platinum-based chemotherapy. Both baseline and early on-treatment PIV are associated with clinical outcomes and may be exploited for creating PIV-based risk classifiers if further validated.
e24108 Background: Hospitalized cancer patients are at increased risk for Thromboembolic Events (TEs). Given the hemorrhagic risk associated with untailored thromboprophylaxis, the identification of patients at low TE risk who might not receive it during in-hospital stay would be clinically useful. Methods: The INDICATE study was a monocentric, observational study enrolling patients with active solid malignancy hospitalized for at least two nights for treatment administration, diagnostic procedures or acute medical illness (excluding TEs). The primary objective was to assess the Negative Predictive Value (NPV) of low-grade Khorana Score (e.g. KS = 0), evaluated at the time of patients’ in-hospital admission, for TEs prediction during and after (next 45 days) hospitalization. The primary analysis was conducted on patients with KS = 0. However, all-grade KS patients were enrolled for secondary outcomes analysis. Assuming a 7% of TEs as the unsatisfactory percentage and a 3% as the satisfactory percentage, expecting about 5% of collected data as incomplete, all consecutive patients who fulfil the inclusion criteria irrespective of the KS were enrolled, until a total of 149 patients with KS = 0 were included to detect the favorable NPV with one-sided alpha equal to 0.10 and power equal to 0.80. Results: Between November 2016 and May 2019, a total of 535 patients were enrolled. Among these, 153 (28.6%) had a KS = 0. The primary study endpoint was met: 29 (5.4%) patients received a diagnosis of TEs during or after hospitalization, with 7 (4.6%) cases in the KS = 0 group. However, patients with higher KS values did not show increasing TE incidence. Among the other evaluated risk assessment models, the ONKOTEV scoreshowed the best predictive potential, with significantly higher values in patients with TEs (p < 0.001).Of note, TEs were associated with poorer overall survival (median, 6.7 vs 24.8 months, log rank p < 0.001). Conclusions: The INDICATE study showed that hospitalized cancer patients with KS = 0 at admission have a low risk of TEs, and could thus be spared from routine thromboprophylaxis. Further studies are needed to better define a RAM in this population.
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