SCOT: a comparison of cost-effectiveness from a large randomised phase III trial of two durations of adjuvant Oxaliplatin combination chemotherapy for colorectal cancer.

BACKGROUND: The Short Course Oncology Therapy (SCOT) study is an international, multicentre, non-inferiority randomised controlled trial assessing the efficacy, toxicity, and cost-effectiveness of 3 months (3 M) versus the usually given 6 months (6 M) of adjuvant chemotherapy in colorectal cancer. METHODS: In total, 6088 patients with fully resected high-risk stage II or stage III colorectal cancer were randomised and followed up for 3-8 years. The within-trial cost-effectiveness analysis from a UK health-care perspective is presented using the resource use data, quality of life (EQ-5D-3L), time on treatment (ToT), disease-free survival after treatment (DFS) and overall survival (OS) data. Quality-adjusted partitioned survival analysis and Kaplan-Meier Sample Average Estimator estimated QALYs and costs. Probabilistic sensitivity and subgroup analysis was undertaken. RESULTS: The 3 M arm is less costly (-£4881; 95% CI: -£6269; -£3492) and entails (non-significant) QALY gains (0.08; 95% CI: -0.086; 0.230) due to a better significant quality of life. The net monetary benefit was significantly higher in 3 M under a wide range of monetary values of a QALY. The subgroup analysis found similar results for patients in the CAPOX regimen. However, for the FOLFOX regimen, 3 M had lower QALYs than 6 M (not statistically significant). CONCLUSIONS: Overall, 3 M dominates 6 M with no significant detrimental impact on QALYs. The results provide the economic case that a 3 M treatment strategy should be considered a new standard of care.

Reproducibility of quantitative assessment of altered hepatic hemodynamics with dynamic contrast-enhanced ultrasound.

OBJECTIVES: The aim of this clinical study was to evaluate the reproducibility of quantitative assessment of altered hepatic hemodynamics with dynamic contrast-enhanced ultrasound. METHODS: Fifteen patients with colorectal liver metastases and 5 volunteers were studied. The hepatic artery proper and the portal vein were imaged simultaneously with dynamic contrast-enhanced ultrasound. The examination was repeated with 2 different contrast bolus volumes (1.2 and 2.4 mL), and time-intensity curves were formed from dynamic contrast-enhanced ultrasound image loops. The rise time, peak intensity, and wash-in slope were derived from hepatic artery and portal vein time-intensity curves. Inter-reader, intra-reader, and inter-scan agreement was assessed by 2 independent readers. Quantitative (intraclass correlation coefficients and coefficients of variation [CVs]) and qualitative (Landis and Koch classification) analyses were performed. RESULTS: Intra-reader and inter-reader agreement was "almost perfect" for the hepatic artery (CV, 10%-15% and 8%-9%, respectively), portal vein (CV, 5%-8% and 6%-12%), and hepatic artery/portal vein ratio (CV, 8%-14% and 10%-15%) measurements of 3 all studied parameters. In contrast, inter-scan agreement was only "slight" to "moderate" (CV, 25%-27%) and "fair" to "moderate" (CV, 19%-24%) for rise time and peak intensity measurements in the hepatic artery and portal vein, respectively. CONCLUSIONS: Quantitative assessment of altered hepatic hemodynamics with dynamic contrast-enhanced ultrasound is reproducible provided that measurements in the hepatic artery are normalized by those in the portal vein.

Assessment of global liver blood flow with quantitative dynamic contrast-enhanced ultrasound.

OBJECTIVES: This study assessed the potential of quantitative analysis of contrast bolus kinetics to reflect global liver blood flow. METHODS: A dynamic contrast-enhanced ultrasound flow phantom was developed. A peristaltic pump established constant volume flow ranging between 16.5 and 49.5 mL/min (2-mm tube) and 85.5 and 256.5 mL/min (5-mm tube). After bolus injection of 2 doses of a contrast agent, a region of interest was drawn over the cross section of the tube used for a particular acquisition; the rise time, peak intensity, and wash-in slope were derived from time-intensity curves. Twenty healthy volunteers and 25 patients with biopsy-proven colorectal liver metastases were scanned with dynamic contrast-enhanced ultrasound. The rise time, peak intensity, and wash-in slope were derived from hepatic artery and portal vein time-intensity curves. Hepatic artery/portal vein ratios of the parameters were also calculated. RESULTS: In the in vitro experiment, the rise time decreased while the peak intensity and wash-in slope increased with increasing volume flow for both tube diameters and contrast bolus volumes. In the clinical study, the rise time was lowered in the hepatic artery but elevated in the portal vein, and the peak intensity and wash-in slope were elevated in the hepatic artery but lowered in the portal vein in patients with colorectal liver metastases compared with healthy volunteers, although not in a statistically significant manner. This finding was consistent with an increase in hepatic artery blood flow, a decrease in portal vein blood flow, or both in patients with colorectal liver metastases compared with healthy volunteers. Only the 3 hepatic artery/portal vein ratios of the parameters achieved statistical significance in differentiating healthy volunteers from patients with colorectal liver metastases (P < .05). CONCLUSIONS: Surrogate measurements of liver blood flow may be derived from quantitative analysis of dynamic contrast-enhanced ultrasound studies. They may have potential for quick and easy assessment of altered hepatic hemodynamics.