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AlaskaAngel · 02-13-2006, 08:51 AM

http://www.localnewsleader.com/olber...news&id=142027

The Phase III AVANT trial is designed to see how patients fare when given either conventional chemotherapy drugs or an Avastin-based combination. ...

...The temporary suspension of the study was called for by the trial‘s safety monitoring board following four sudden deaths in one of the three study arms, which involved patients taking Avastin plus the chemotherapy treatment XELOX, comprising Roche‘s Xeloda and oxaliplatin.

Three of the deaths involved younger patients, adding to safety worries.

Excluding deaths due to recurrent colon cancer, the overall death rate in the trial -- which has recruited around 2,000 patients since December 2004 -- was 0.6 percent, or four cases, in the first arm of the study involving patients given chemotherapy known as FOLFOX-4.

The death rate was 0.4 percent, or three cases, in the FOLFOX-4 plus Avastin arm but was 1 percent, or seven cases, in the XELOX plus Avastin arm. The study‘s principal investigator, Professor Aimery de Gramont, said the decision to halt recruitment was necessary, because the threshold for concern was particularly low in patients who have had surgery. But he said he remained hopeful that Avastin would yet show benefits in the post-surgery setting, just as it has done among colon cancer patients with metastatic disease, in which tumors have spread around the body.

02-13-2006, 08:51 AM	#3
AlaskaAngel Senior Member Join Date: Sep 2005 Location: Alaska Posts: 2,018	http://www.localnewsleader.com/olber...news&id=142027 The Phase III AVANT trial is designed to see how patients fare when given either conventional chemotherapy drugs or an Avastin-based combination. ... ...The temporary suspension of the study was called for by the trial‘s safety monitoring board following four sudden deaths in one of the three study arms, which involved patients taking Avastin plus the chemotherapy treatment XELOX, comprising Roche‘s Xeloda and oxaliplatin. Three of the deaths involved younger patients, adding to safety worries. Excluding deaths due to recurrent colon cancer, the overall death rate in the trial -- which has recruited around 2,000 patients since December 2004 -- was 0.6 percent, or four cases, in the first arm of the study involving patients given chemotherapy known as FOLFOX-4. The death rate was 0.4 percent, or three cases, in the FOLFOX-4 plus Avastin arm but was 1 percent, or seven cases, in the XELOX plus Avastin arm. The study‘s principal investigator, Professor Aimery de Gramont, said the decision to halt recruitment was necessary, because the threshold for concern was particularly low in patients who have had surgery. But he said he remained hopeful that Avastin would yet show benefits in the post-surgery setting, just as it has done among colon cancer patients with metastatic disease, in which tumors have spread around the body.