Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Clinical trial phase III

Bevacizumab and temozolomide

http://www.news-medical.net/news/201211 ... astoma.asp

Some comments:
- their positive results are based on progression-free survival; PFS -is up by 36 percent The interim results for overall survival (OS), the other co-primary endpoint, did not reach statistical significance (HR=0.89; p=0.2135). Final data on OS are expected in 2013. Try to find it - may be OS is down - the chances are that PFS was increased but OS was decreased?
- glioblastoma is a very aggressive and a fast growing tumor. Lets say - If people gain PFS for 6 months versus they are usually dead from their disease in less than that - i.e. if the PFS is longer than the life expectancy, the gain in PFS translates into increase of the OS (overall survival). ASPS is a slow growing cancer and the dynamic is different, people can end up by loosing their time after the resistance develops and the cancers speeds up.

Dear ASPS Community Friends,
FYI for those who may be researching this drug, the correct spelling is Temodar instead of Temador.
With special caring thoughts and continued Hope,
Bonni

Thank you Bonni
Should continue correctly spelled from here on out
Debbie

temozolomide = Temodar in North America

Results of phase III randomised AVAglio and RTOG 0825 studies
Date: 24 Feb 2014

http://www.esmo.org/Oncology-News/Bevac ... ioblastoma

from the above link-


Difference in patient-reported outcomes

Both, the AVAglio and the RTOG 0825, trials included patient-reported outcomes, such as QoL and results of neurocognitive testing, in their study design as secondary endpoints. However, the results diverge in their outcomes. Whereas the AVAglio trial showed improvement in or prolonged maintenance of QoL and PS, the RTOG 0825 trial showed a worsening of QoL and a decline in cognitive function. According to Dr Mehta, the cognitive decline observed in the RTOG 0825 study may have stemmed from unrecognised progression of the tumour, masked by the use of bevacizumab, or neurotoxicity related to the bevacizumab.In the accompanying article, Dr Fine wrote that subtle differences in data acquisition, analytic methods, and extent of surgical resection could have influenced the data, but the true reason for the difference observed between studies remains unanswered. He advocates that the investigators should share raw data from their trials with each other and with independent investigators to try to resolve the question of the true effects of bevacizumab on patient-reported outcomes

N Engl J Med. 2014 Feb 20;370(8):709-22. doi: 10.1056/NEJMoa1308345.
"Bevacizumab plus radiotherapy-temozolomide for newly diagnosed glioblastoma"


http://www.ncbi.nlm.nih.gov/pubmed/24552318



CONCLUSIONS:

The addition of bevacizumab to radiotherapy-temozolomide did not improve survival in patients with glioblastoma. Improved progression-free survival and maintenance of baseline quality of life and performance status were observed with bevacizumab; however, the rate of adverse events was higher with bevacizumab than with placebo. (Funded by F. Hoffmann-La Roche; ClinicalTrials.gov number, NCT00943826.).