New data was presented at the 2011 European Multidisciplinary Cancer Congress last month in Stockholm, with results from the PREDICT (patient characteristics in renal cell carcinoma and daily practice treatment with sorafenib).
The study showed that treatment with Nexavar (sorafenib) tablets was associated with safety and tolerability in patients with advanced renal cell carcinoma (RCC), regardless of baseline clinical characteristics and/or prior cancer treatment of the study population. The study was designed to gain further insight into the treatment of RCC with Nexavar under standard practice settings, Bayer said.
The study showed that treatment with Nexavar was generally well-tolerated. Ninety-one percent of patients were initiated at a full dose (400mg twice daily) of therapy and of these patients, 83 per cent were able to tolerate the full dose without requiring a dose reduction. The median duration of treatment with Nexavar was 7.3 months, with 23 per cent of patients treated 12 months or longer.
The most common drug-related adverse events (AEs) were hand-foot skin reaction (20 per cent), diarrhoea (17 per cent), rash (nine per cent), alopecia (six per cent), hypertension (four per cent) and fatigue (three per cent). Serious drug-related AEs were documented in less than five per cent of patients.
“The data from PREDICT reinforce the value of Nexavar in the treatment of RCC,” said Dr Mark Gelder, Vice President, Head, Global Medical Affairs, Oncology, Bayer HealthCare Pharmaceuticals. “Despite its role as an established therapy in the RCC patient population, as well the hepatocellular carcinoma (HCC) patient population, Bayer is committed to exploring the full potential of this compound in both clinical and real-world settings, and as a potential treatment option for various tumour types.”
To gain insights into the treatment of RCC patients with Nexavar under standard practice settings, investigators enrolled a total of 2,855 patients (2,599 patients evaluable for safety and 2,311 for efficacy) in a large prospective, open-label, non-interventional, non-controlled study, and monitored safety and patient outcomes. Patient characteristics and tumour status were assessed at baseline and during routine follow-up therapy for up to 12 months. The study took place in 592 sites in 18 countries in Europe, Asia-Pacific and Latin America.
