3) There were no significant changes in the FACT-Hep between bas

3). There were no significant changes in the FACT-Hep between baseline and 1 month. More detailed analysis of the HRQL data will be reported elsewhere. Figure 6 Subjective HRQL status reported on the PBF after 1 month of treatment. *P<0.05. DISCUSSION The main antagonist FTY720 finding of this study was that octreotide LAR was well tolerated in patients with advanced HCC �C a population with cirrhosis and chronic liver disease. Although there were few objective tumour responses (one patient with AFP response plus partial response on imaging, one patient with AFP response plus stable disease on imaging), 16 patients (25%) had stable disease or better for at least 3 months. Forty per cent had only 1�C3 injections of octreotide LAR. It takes about 3 months for steady-state levels to be built up, so these patients were technically underdosed.

The median survival, 8 months, was within the range of published series (CLIP Group, 1998; Kouroumalis et al, 1998; Chow et al, 2002; Dimitroulopoulos et al, 2002; Samonakis et al, 2002; Yuen et al, 2002). Receptor expression was identified by octreotide scintigraphy in 34 of 61 patients (56%). There was no clear relationship between scan positivity and survival. Approximately 25% of patients reported improvements in some aspects of HRQL while on octreotide. Unresectable HCC commonly occurs in patients with advanced chronic liver disease and is difficult to treat. Comorbidities and poor performance status limit the use of cytotoxic chemotherapy, so identifying less toxic approaches is important.

The small randomised trial reported by Kouroumalis in 1999 showed an implausibly large effect of octreotide on survival (Kouroumalis et al, 1998). It is impossible to tell from this trial whether this effect on survival was real, and if so, whether it was due to anticancer effects or other effects such as reduction in portal pressure. Subsequent studies with long-acting octreotide analogues have shown less benefit (Raderer et al, 2000; Samonakis et al, 2002) or no benefit (Yuen et al, 2002). In a recent study, patients selected for treatment on the basis of scan positivity were treated with octreotide and, when compared with a control population in a nonrandomised manner, had better outcomes in terms of survival and quality of life (Dimitroulopoulos et al, 2002). Nonetheless, this question will remain open until a definitive confirmatory randomised trial is performed.

Safety is important for people with comorbidities. AV-951 There is limited information available about the elimination kinetics of octreotide in cirrhosis. Jenkins et al (1998) have demonstrated prolonged half-life and reduced clearance in patients with cirrhosis and suggested that dosage regimens should be modified in such patients to avoid accumulation of the analogue in the blood, which may result in undesirable side effects or toxicity.

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