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Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
Date:5/27/2009

and nervous systems. While these NET are often slow-growing, when the tumor is inoperable patients with advanced NET have limited treatment options(2).

The safety findings observed in the PROMID study were consistent with those seen in previous studies of Sandostatin LAR in patients with NET. The most frequently observed serious adverse events affected the gastrointestinal tract, hematopoietic system and other general symptoms such as fatigue and fever(1).

Afinitor in patients with advanced liver cancer

Phase I data (abstract #4587) demonstrated that 61% of patients with advanced hepatocellular carcinoma (HCC) who received daily treatment with Afinitor(R) (everolimus) tablets had tumors that stabilized or reduced in size(3).

There are currently a limited number of treatment options for patients with advanced HCC, the stage when most are diagnosed(4)(5). Everolimus shows potential to help address this unmet medical need(3).

The trial, conducted in Taiwan by Dr Li-Tzong Chen from the National Health Research Institute, included 36 advanced HCC patients who progressed after various systemic therapies or who were no longer candidates for local therapies, including surgery, percutaneous ablation or transcatheter arterial chemoembolization. Of the 31 patients evaluable in the trial, 16 received everolimus (known as RAD001 in this study) daily. The study objective was to define the maximum tolerated dose and pharmacokinetics of everolimus(3).

The Grade 3 and 4 adverse events reported in the study included elevated bilirubin, drop in platelets count, diarrhea, bleeding, cardiac ischemia, elevated liver function tests and infection. Reactivation of Hepatitis B virus was observed in four patients as well as reactivation of Hepatitis C virus in one patient(3).

Based on these data, a global Phase III clinical trial to study the daily everolimus regimen in patien
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SOURCE Novartis Pharmaceuticals Corporation
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