A Large Open Label, Non-Comparative, Phase III Study Of The Multi-Targeted Kinase Inhibitor Sorafenib In European Patients

Main Category: Urology / Nephrology
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 06 Apr 2008 - 0:00 PDT

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UroToday.com - Dr. Verzoni presented a trial to collect safety and efficacy data on sorafenib from a large and broad study population reflecting clinical practice. This nonrandomized, open-label study included male and female patients, aged ≥18, with an ECOG PS 0 2 and a life expectancy >2 months. Patients had to be unsuitable for or have failed prior cytokine therapy. Controlled, asymptomatic brain metastases were allowed. Patients received continuous therapy with sorafenib 400 mg twice daily until disease progression, intolerable toxicity, or withdrawal of consent. Dose increases were not permitted. Recruitment was planned to continue until regulatory approval of sorafenib for advanced RCC. Study assessments were conducted at baseline and then monthly. Adverse events were graded according to NCI CTCAE v 3.0 criteria. Tumor assessment and radiological evaluation were conducted within 28 days prior to the start of sorafenib therapy, and then according to local standards of care, but at least every 3 months.

A total of 1155 patients were recruited in 11 European countries. Seventy-five percent of patients were male. Median age at enrollment was 62 years. At baseline, ECOG PS = 0 in 40% of patients, 1 in 45%, and 2 in 15%; 73% of patients had tumor lesions in the lungs, 41% in lymph nodes, 36% in bone, 28% in the liver and 23% in the kidneys. Eleven percent of patients had not had the primary tumor resected. Twenty-eight percent of patients had no prior therapy and were included because they were unsuitable for cytokine treatment. Tumor histology included pure clear cell (75%), papillary (10%) and chromophobe (3%) subtypes. Sarcomatoid features were noted in tumor samples from 5% of the patients. Most frequent Grade ≥3 drug-related adverse events were hand-foot-skin reaction [12%], fatigue [8%], diarrhea [5%], rash/desquamation [5%] and hypertension [4%]. The rates of Grade ≥3 drug-related adverse events were similar across sub-populations evaluated. The median progression-free survival was 6.8 months, and the median duration of treatment 6.9 months.

This EU-ARCCS study successfully provided treatment to a large number of patients with RCC across Europe prior to regulatory approval. EU-ARCCS confirmed the safety findings of the TARGET study in a real life setting and in clinically relevant patient sub-populations. The efficacy of sorafenib appears to be comparable with that observed in randomized controlled clinical trials.

Presented by: E. Verzoni, MD, et al, at the European Association of Urology - 23rd Annual EAU Congress - March 26 - 29, 2008 - Milan, Italy

Reported by UroToday.com Contributing Editor, Christopher P. Evans, MD

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