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Background: Heart involvement is the most important prognostic determinant in AL amyloidosis patients. Echocardiography is a cornerstone for the diagnosis and provides important prognostic information., Methods and Results: We studied 754 patients with AL amyloidosis who underwent echocardiographic assessment at the Mayo Clinic, including a Doppler-derived measurement of stroke volume (SV) within 30 days of their diagnosis to explore the prognostic role of echocardiographic variables in the context of a well-established soluble cardiac biomarker staging system. Reproducibility of SV, myocardial contraction fraction, and left ventricular strain was assessed in a separate, yet comparable, study cohort of 150 patients from the Pavia Amyloidosis Center. The echocardiographic measures most predictive for overall survival were SV index <33 mL/min, myocardial contraction fraction <34%, and cardiac index <2.4 L/min/m 2 with respective hazard ratios (95% confidence intervals) of 2.95 (2.37-3.66), 2.36 (1.96-2.85), and 2.32 (1.91-2.80). For the subset that had left ventricular strain performed, the prognostic cut point was -14% (hazard ratios, 2.70; 95% confidence intervals, 1.84-3.96). Each parameter was independent of systolic blood pressure, Mayo staging system (NT-proBNP [N-terminal pro-B-type natriuretic peptide] and troponin), and ejection fraction on multivariable analysis. Simple predictive models for survival, including biomarker staging along with SV index or left ventricular strain, were generated., Conclusions: SV index prognostic performance was similar to left ventricular strain in predicting survival in AL amyloidosis, independently of biomarker staging. Because SV index is routinely calculated and widely available, it could serve as the preferred echocardiographic measure to predict outcomes in AL amyloidosis patients., (© 2018 American Heart Association, Inc.)

Objectives: We sought to determine the speed at which patients were accrued into published phase III oncology trials across geographic locations and to identify the factors that may influence this process., Materials and Methods: We searched OVID-Medline and identified all phase III oncology therapeutic trials published in 2006 to 2010. The speed of accrual for each trial was calculated by dividing the number of patients enrolled by the number of months the trial was open (patients/mo)., Results: Five hundred forty-six trials were included in our study. Most of the trials were for adults (96%), late-stage cancers (78%), sponsored by either cooperative groups or academic centers (66%), and had negative results (58%). The most common trial locations were multinational (45%), United States (16%), Italy (7%), Germany (6%), Japan (6%), and France (5%). Compared with trials conducted in a single country, multinational trials accrued significantly more patients per trial, completed enrollment faster, and were published sooner (all P≤0.01). Multivariate analyses showed that multinational (P=0.001), breast cancer (P=0.001), industry sponsored (P=0.001), and equivalency trials (P=0.039) accrued significantly faster than other types of trials. Placebo-controlled and non-placebo-controlled trials accrued at similar speeds. We found no difference in speed of accrual between the United States and Europe., Conclusions: Speed of accrual for phase III oncology trials is fastest among multinational trials and independently influenced by the type of trial sponsor, cancer investigated, and study outcome, but not by placebo use. Trials conducted in single countries seem to accrue at similar speeds.