Friday, May 30, 2008

Side Effects of Sunitinib in Kidney Cancer Are 2 to 3 Times More Expensive to Manage Than Those of Avastin Plus Interferon

- Tolerability is an Increasingly Important Factor When Selecting Treatment
Options for Patients
- ABSTRACT No: 5110 (Poster 6H)

BASEL, Switzerland, May 30 /PRNewswire/ -- Data presented at the
largest oncology meeting in the world, the American Society of Clinical
Oncology (ASCO), shows that the costs of managing side effects in patients
with metastatic renal cell cancer (mRCC) treated with sunitinib (Sutent(R))
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.

Additional information




- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs

- Avastin: http://www.avastin-info.com

To access video clips about Avastin in broadcast standard, free of
charge, please go to: http://www.thenewsmarket.com .





See Also

Via: Healthcare

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