* Risk of drug-related death is still low
* Some data from cancers for which drug not approved-Roche
By Julie Steenhuysen
CHICAGO, Feb 1 People who took Roche's
ROG.VX popular cancer drug Avastin in combination with
chemotherapy had a 46 percent higher risk of dying from
drug-related side effects than people who got chemotherapy
alone, researchers said on Tuesday.
But they said the overall rate of deaths caused by Avastin
when used with chemotherapy was still low at 2.5 percent, and
that the benefits need to be weighed against the risks.
Roche's Genentech unit said the analysis, published in the
Journal of the American Medical Association, includes data on
cancers in which the drug is not approved and should not be
Dr. Shenhong Wu of Stony Brook University School of
Medicine in New York and colleagues pooled data from 16
previously published trials of patients with different types of
cancer and found the rate of deaths was 1.5 times higher among
people who took Avastin, or bevacizumab, plus chemotherapy
compared with those who got chemotherapy alone.
"We discovered the use of bevacizumab in combination with
other chemotherapy or biological therapy increased the risk of
treatment-related mortality by 46 percent," Wu said in a
Avastin, the world's best-selling cancer medicine with
annual sales of $6 billion, has been approved for fighting
several different cancers, including certain types of lung
cancer, advanced colorectal and kidney cancers.
It had been approved to treat breast cancer, but it failed
to help breast cancer patients live longer in four clinical
trials, and U.S. regulators in December rescinded its approval
in breast cancer. [ID: nLDE6BF1T7]
Avastin blocks vascular endothelial growth factor, or VEGF,
which is needed to form blood vessels to feed tumors but also
needed for normal blood vessel growth.
HEMORRHAGING, BLOOD CLOTS
Many of the side effects involved bleeding, including
hemorrhages, low white blood cell count, holes in the stomach
and intestines and blood clots in the lungs.
The team said the overall rate of deaths caused by the drug
was 2.5 percent, but the risks varied significantly depending
on which chemotherapy drug was used.
Because the absolute risk of treatment-related death
appears low, the team said use of Avastin should be considered
in the context of its overall survival benefits.
Roche said the data used in the analysis is not new and
included data on cancers for which the drug is not approved,
including squamous cell, non-small cell lung, prostate and
"Avastin does have serious risks within cancer care which
are clearly outlined on its label," Charlotte Arnold, a
spokeswoman for Roche's Genentech unit, said in a telephone
She said in the indications in which it is approved, the
risk-benefit profile is considered favorable.
Dr. Roman Perez-Soler of Montefiore-Einstein Center for
Cancer Care in New York who has seen the study but was not
involved with the analysis said all cancer drugs have
potentially fatal side effects, including chemotherapy.
"We have to put everything in perspective," Perez-Soler
said in a telephone interview.
He said the overall increased risk of taking Avastin should
be weighed by the chance that it could extend the lives of
gravely ill cancer patients.
"I think we should know that it may happen and be careful
in selecting the patients in which we give the drug,"
Perez-Soler said. "That is the positive aspect of the
(Editing by Maggie Fox and Jackie Frank)