Theresa Catharina de Góes Campos

  De: PR Newswire Brasil
Assunto: Largest Ever Data Set Shows Consistent Benefits With Avastin When Used in Combination With Different Chemotherapy Treatments
05 de junho de 2006 06:30 HORALOCAL

Largest Ever Data Set Shows Consistent Benefits With Avastin
When Used in Combination With Different Chemotherapy Treatments

Real world practice confirms Avastin's efficacy and safety in
advanced colorectal cancer

BASEL, Switzerland, June 5
/PRNewswire/ -- New data from 4,000 patients show that Avastin
(bevacizumab rhuMAb-VEGF) enables patients with advanced colorectal
cancer (CRC) to live longer without progression of their disease.(1)
The results also confirm that Avastin is well tolerated.(2) The data,
taken from two early access programmes using Avastin in combination
with a wide range of chemotherapies, support findings of previous
pivotal trials, which demonstrated superior overall survival for
Avastin when added to chemotherapy.
These data, which represent
the largest data set on Avastin available to date, were presented
today at the 2006 American Society of Clinical Oncology (ASCO) Annual
Meeting in Atlanta, Georgia.
The BEAT study, conducted in 41
countries across the world, and the BRiTE registry, its US
counterpart, are investigating the use of Avastin in advanced CRC in
combination with standard chemotherapies including oxaliplatin,
irinotecan or 5-FU and/or Xeloda (capecitabine). Outstanding
progression-free survival (length of time without the cancer growing)
is seen in BRiTE with a median at 10.2 months, independent of the
chemotherapy used.(1) This real life experience compares favourably
with the data previously seen in pivotal studies of Avastin in CRC in
which the addition of Avastin to standard chemotherapies improved
survival as well as progression free survival, compared to
chemotherapy alone.
"In multiple large, well controlled studies,
Avastin has consistently demonstrated significant survival benefits
in colorectal cancer," said Dr. Mark Kozloff, Clinical Associate,
Department of Hematology/Oncology, University of Chicago. "These new
data are very important as they confirm that the results shown in
earlier randomized trials hold true in the real world setting.
Moreover, they demonstrate that Avastin can be used in combination
with a wide range of chemotherapy treatments. This is a real advance
as it widens treatment options for physicians and patients and
bolsters their hope of overcoming the disease."
The BEAT and
BRiTE studies also evaluate the safety of Avastin with different
chemotherapies in a broad patient population. Results from the
studies show that Avastin's safety profile/tolerability is consistent
with the safety observations from other studies.
In 2002,
colorectal cancer was the third most commonly reported cancer with
approximately one million new cases worldwide. It is estimated that
over 50 percent of people diagnosed with colorectal cancer will die
of the
disease (3). In the European Union colorectal cancer is the
second most common cause of death from any cancer in both men and
women (4).
Avastin is the first and only anti-angiogenic agent to
have demonstrated improved survival in the three major causes of
cancer death: colorectal cancer, NSCLC and breast cancer. In Europe,
Avastin was approved in early 2005 for the first-line treatment of
patients with metastatic carcinoma of the colon or rectum in
combination with intravenous 5-fluorouracil/folinic acid or
intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received
approval by the US Food and Drug Administration (FDA) and was
launched in the US in February 2004. In addition, filing occurred in
the US on April 10, 2006, for use of Avastin in previously untreated
advanced non-squamous, non-small cell lung cancer and in Japan on
April 21, 2006 for use of Avastin in patients with advanced or
recurrent colorectal cancer.

About BEAT and BRiTE
BEAT and
BRiTE are two phase IV, open label, multi-centre studies of patients
with advanced CRC receiving Avastin in addition to first-line

- BEAT is a phase IV trial which has enrolled 1927
patients from 41 countries worldwide. Patients are receiving Avastin
with chemotherapy; the most common regimens are FOLFOX, CAPOX,
FOLFIRI and Xeloda (capecitabine). Efficacy data from the BEAT trial
are continuing to be evaluated. Safety data have shown that Avastin
related serious adverse events were reported in 9 percent of
patients. Gastrointestinal perforation occurred in 1.2 percent and
bleeding in 1.3 percent.

- BRiTE is a large, community based
observational registry which has enrolled 1968 patients across the
US. Patients are receiving Avastin with chemotherapy, the most common
regimens are FOLFOX, FOLFIRI and IFL. Current efficacy data from the
BRiTE study show a median progression free survival of 10.2 months.
Safety data have reported that serious adverse events were seen in 12
percent of patients. Postoperative bleeding/wound healing
complications in 1.2 percent, gastrointestinal perforation occurred
in 1.7 percent, bleeding in 1.9 percent and arterial thromboembolic
events in 2.1 percent.

About Avastin
Avastin is the first
treatment that inhibits angiogenesis - the growth of a network of
blood vessels that supply nutrients and oxygen to cancerous tissues.
Avastin targets a naturally occurring protein called VEGF (Vascular
Endothelial Growth Factor), a key mediator of angiogenesis, thus
choking off the blood supply that is essential for the growth of the
tumour and its spread throughout the body (metastasis).
Roche and
Genentech are pursuing a comprehensive clinical programme
investigating the use of Avastin in various tumour types (including
colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal
cell carcinoma and others) and different settings (advanced and
adjuvant ie post-operation). The total development programme is
expected to include over 25,000 patients worldwide.


(1) Kozloff M, et al. Efficacy of bevacizumab plus
chemotherapy as
first-line treatment of patients with metastatic
colorectal cancer: Updated results from a large observational
registry in the US (BRITE). Presented at ASCO 2006, abstract 3537

(2) Berry S, et al. Preliminary safety of bevacizumab with first-line
Folfox, Capox, Folfiri and Capecitabine for metastatic colorectal
cancer - First B E A Trial. Presented at ASCO 2006, abstract 3534

(3) Parkin D et al. Global Cancer Statistics 2002. Cancer J Clin
55: 74-108

(4) Boyle P. Cancer incidence and mortality in
Europe, 2004. Annals of Oncology 2005; 16(3): 481-488;

For further information please
contact: Media Enquiries - Onsite at ASCO - Christine Hill, Roche,
Mobile: +41(0)79-78-88-245; Nina Schwab-Hautzinger, Roche, Mobile:
+41(0)79-59-34-307; Sarah Winkless, Resolute Communications, Mobile:
+44(0)77-7175-7695; Tara Breen, Resolute Communications, Telephone:
+44(0)20-7357-8187, Email: .

About Roche
Headquartered in Basel, Switzerland, Roche is one of
the world's leading research-focused healthcare groups in the fields
of pharmaceuticals and diagnostics. As a supplier of innovative
products and services for the early detection, prevention, diagnosis
and treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries and
has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
Additional information about the Roche Group is available on the
Internet (
All trademarks used or mentioned
in this release are protected by law.

Additional information

- Roche in Oncology:

- Roche Health Kiosk, Cancer:


CONTACT: Media Enquiries, Onsite at ASCO, Christine
Hill, Mobile,
+41-0-79-78-88-245, or Nina Schwab-Hautzinger, Mobile,
+41-0-79-59-34-307, both of Roche; or Sarah Winkless, Mobile,
+44-0-77-7175-7695, or Tara Breen, +44-0-20-7357-8187, or, both of Resolute
Web site:


TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469


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