[back] Roche  Chemotherapy  Heart disease & drugs

Roche U.S. cancer drug trial enrollment suspended
Fri Sep 25, 2009 5:07pm ED
 * Chemo combination trial for early-stage breast cancer

* Six patients suffer congestive heart failure, no deaths ** No further
information was available for the sixth case.

* Trial participants can still take drug once informed

ZURICH/BOSTON, Sept 25 (Reuters) - Swiss drugmaker Roche Holding AG
(ROG.VX) said enrollment into a late-stage U.S. trial of Avastin in breast
cancer patients had been suspended after six patients suffered congestive
heart failure (CHF).

Roche, the world's largest maker of cancer drugs, said on Friday current
participants in the trial with early stage breast cancer could continue
taking the drug, in combination with chemotherapy, once informed of the
cases of CHF.

This is a condition in which the heart does not pump blood efficiently,
leading to shortness of breath, fluid accumulation, fatigue and other

There had been no deaths due to cardiac toxicity and the rate of CHF in
the trial was consistent with that previously reported for Avastin, Roche
said, adding 3,439 of the planned 4,950 patients had already entered the

Avastin, which cuts off blood supply to tumours, is already a blockbuster
and a key drug for Roche, with global sales of 5.2 billion Swiss francs
($5.02 billion) in 2008 as a treatment for colon, lung and breast cancers.

Ed Lang, a spokesman for Genentech, which developed Avastin and was later
acquired by Roche, said that on a scale of one to five, with five
representing death, the patients had grade three and four CHF.

The hearts of five patients returned to their previous condition once the
patients had stopped taking the drug, Lang said. No further information
was available for the sixth case.

(Reporting by Jason Rhodes and Toni Clarke)

Bevacizumab (trade name Avastin, Genentech/Roche) is a humanized
monoclonal antibody that recognises and blocks vascular endothelial growth
factor (VEGF).[1] VEGF is a chemical signal that stimulates the growth of
new blood vessels (angiogenesis).

Blood vessels grow uncontrollably in cancer, retinal proliferation of
diabetes in the eye, and other diseases. Bevacizumab can block VEGF from
creating new blood vessels. Bevacizumab was the first clinically available
angiogenesis inhibitor in the United States.

Bevacizumab is currently approved by the U.S. Food and Drug Administration
(FDA) for cancers that are metastatic (have spread to other parts of the
body). It received its first approval in 2004 was for combination use with
standard chemotherapy for metastatic colon cancer and non-small cell lung
cancer.[2] In 2008, it was approved by the FDA for use in metastatic
breast cancer, a decision that generated some controversy as it went
against the recommendation of its advisory panel,[3] who objected because
it only slowed tumor growth but failed to extend survival.

Clinical studies are underway in non-metastatic breast cancer, renal cell
carcinoma, glioblastoma multiforme, ovarian cancer, castrate-resistant
(formally called hormone refractory) prostate cancer, non-metastatic
unresectable liver cancer and metastatic or unresectable locally advanced
pancreatic cancer. A study released in April 2009 found that bevacizumab
is not effective at preventing recurrences of non-metastatic colon cancer
following surgery.[4] In May 2009, it received FDA approval for treatment
of reccurring Glioblastoma Multiforme, while treatment for initial growth
is still in phase III clinical trial. [5]