Side Effects Of Sunitinib In Kidney Cancer Are Expensive
The costs of managing side effects in patients with metastatic renal cell cancer (mRCC) treated with sunitinib (Sutent) are two to three times greater than if they were treated with the combination of Avastin and interferon (IFN), a combination which provides comparable patient efficacy to sunitinib.
Avastin + IFN has already been shown to significantly prolong the time patients with mRCC live without their disease getting worse (progression-free survival; PFS). The Avastin-based therapy patient benefit is comparable in terms of PFS to sunitinib, but the treatment regimens have very different side effect profiles. The study conducted in Germany, France and the UK suggests that the increased cost of managing the side effects seen with sunitinib is mainly due to the higher incidence of low blood cell counts, diarrhea and nausea/vomiting seen with sunitinib.
"Side effects are a very important consideration for both doctors and patients when making treatment decisions particularly with new treatments providing longer periods of time without advancement of disease," said Professor Gerald Mickisch, from the Center of Operative Urology, Academic Hospital Bremen in Germany, and author of the study. "Given the cost of managing side effects, tolerability is also an important consideration for healthcare payers."
Earlier results from the Avastin in Renal (AVOREN) study also showed that reducing the dose of IFN did not appear to affect the efficacy of the Avastin and IFN combination which may lead to lower cumulative toxicity than other available treatments for patients with advanced RCC. In contrast, data presented at ASCO 2007 suggest that the dose of sunitinib needs to be maintained long-term in order to maintain efficacy.
Further data from patient sub-group analysis of AVOREN are also being presented at ASCO this year which will show that Avastin is effective at improving the time patients live without their disease advancing across a wide range of patient types.
Avastin was approved in Europe in December 2007 for use in combination with IFN in the first-line treatment of patients with advanced renal cell cancer.
About the AVOREN Study
The AVOREN study is a randomised, controlled, double-blind, phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.
The results of the AVOREN trial showed that by adding Avastin to IFN:
- Progression free survival (PFS) was almost doubled from a median of 5.4 to 10.2 months
- Tumour response was significantly increased from 12.8% with IFN alone to 31.4% when Avastin was added
- Dose-reduction of IFN did not appear to affect the efficacy of the combination with Avastin (based on PFS event free rates over time, as shown by a sub-group analysis)
The study also showed a trend towards improved overall survival; however, full survival data are expected during the second half of 2008. No new or unexpected adverse events were observed.