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BACKGROUNDGemcitabine has broad activity in a variety of solid tumors including biliary tract carcinomas. The authors evaluated 6‐month survival, response, and toxicity associated with a combination of gemcitabine, 5‐fluorouracil (5‐FU), and leucovorin (LV) in patients with unresectable or metastatic biliary tract or gallbladder adenocarcinoma (ACA).METHODSA 4‐week course included 1000 mg/m2 gemcitabine by intravenous infusion over 30 minutes on Days 1, 8, and 15, 25 mg/m2 LV by intravenous push, and 600 mg/m2 5‐FU by intravenous push after LV.RESULTSForty‐two patients were enrolled in 6 months, 35 of whom had metastatic disease. Patients with biliary tract ACA included 24 with hepatic disease (19 patients had intrahepatic disease and 5 patients had extrahepatic disease) and 4 with disease in the ampulla of Vater. All patients were evaluable and received a median of 4 courses of treatment (range, 1–21 courses). Commonly occurring severe toxicity (NCI CTC Grade 3 or worse) included: dyspnea (four patients), nausea (four patients), fatigue (seven patients), thrombocytopenia (six patients), emesis (four patients), and diarrhea (four patients). Five partial responses (9.5%) occurred, 3 of which were sustained for ≥ 8 weeks. No treatment‐related deaths occurred. Thirty‐two patients had disease progression and 38 died after a median follow‐up of 20 months (range, 1.4–24 months). The median time to disease progression was 4.6 months (95% confidence interval [95% CI], 2.4–6.6%). The median survival period was 9.7 months (95% CI, 7–12%).CONCLUSIONSThis combination regimen was manageable in patients with advanced biliary tract and gallbladder ACA. Of 42 patients, 24 (57%) survived ≥ 6 months, satisfying the primary end point of the trial. The length of survival suggested that gemcitabine, 5‐FU, and LV had benefit equivalent to gemcitabine alone. Cancer 2005. © 2004 American Cancer Society.

Summary. Acquired factor X (FX) deficiency is rare, but has been reported in diverse disease states, including systemic amyloidosis and respiratory infections. FX deficiency associated with lupus anticoagulant (LA) and a bleeding diathesis has not been previously reported. We report two patients both of whom presented with a severe bleeding diathesis after a preceding respiratory infection due to isolated FX deficiency associated with a LA. The FX deficiency and LA were transient. We conclude that patients with LA may rarely present with severe acquired FX deficiency. This may be another mechanism whereby patients with antiphospholipid antibodies present with bleeding complications.

BACKGROUND Compared with a pulmonary artery catheter (PAC), transthoracic echocardiography (TTE) has been shown to have good agreement in cardiac output (CO) measurement in nonsurgical populations. Our hypothesis is that the feasibility and accuracy of CO measured by TTE (CO-TTE), relative to CO measured by PAC thermodilution (CO-PAC), is different in surgical intensive care unit patients (SP) and nonsurgical patients (NSP). METHODS Surgical patients with PAC for hemodynamic monitoring and NSP undergoing right heart catheterization were prospectively enrolled. Cardiac output was measured by CO-PAC and CO-TTE. Pearson coefficients were used to assess correlation. Bland-Altman analysis was used to determine agreement. RESULTS Over 18 months, 84 patients were enrolled (51 SP, 33 NSP). Cardiac output TTE could be measured in 65% (33/51) of SP versus 79% (26/33) of NSP; p = 0.17. Inability to measure the left ventricular outflow tract diameter was the primary reason for failure in both groups; 94% (17/18) in SP versus 86% (6/7) NSP; p = 0.47. Velocity time integral could be measured in all patients. In both groups, correlation between PAC and TTE measurement was strong; SP (r = 0.76; p < 0.0001), NSP (r = 0.86; p < 0.0001). Bland-Altman analysis demonstrated bias of −0.1 L/min, limits of agreement of −2.5 and +2.3 L/min, percentage error (PE) of 40% for SP, and bias of +0.4 L/min, limits of agreement of −1.8 and +2.5 L/min, and PE of 40% for NSP. CONCLUSION There was strong correlation and moderate agreement between TTE and PAC in both SP and NSP. In both patient populations, inability to measure the left ventricular outflow tract diameter was a limiting factor. LEVEL OF EVIDENCE Diagnostic tests or criteria, level III.

FIG 1. (A) Axial postcontrast portal venous magnetic resonance image showing that heterogeneous enhancement of the liver is more prominent in the right lobe. Note also melanoma metastases in the spleen (arrow) and ascites (*). (B) Trichrome stain of the liver biopsy highlights perisinusoidal and portal fibrosis.