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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
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
chemotherapy.
- 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.
References:
(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
2005;
55: 74-108
(4) Boyle P. Cancer incidence and mortality in
Europe, 2004. Annals of Oncology 2005; 16(3):
481-488;
doi:10.1093/annonc/mdi098
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:
tara.breen@resolutecommunications.com .
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 (http://www.roche.com).
All trademarks used or mentioned
in this release are protected by law.
Additional information
- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Roche Health Kiosk, Cancer:
http://www.health-kiosk.ch/start_krebs
SOURCE Roche
06/05/2006
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
tara.breen@resolutecommunications.com, both of
Resolute
Communications
Web site: http://www.roche.com
BNED: NG
FONTE: PR NEWSWIRE LATIN AMERICA
CORAL GABLES - MIAMI-US
CONTATOS: USA-MARY D'LEON
BRASIL-NÉLIA GARCIA
TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461
FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469
E-MAILS: nelia_garcia@prnewswire.com.br
mary_dleon@prnewswire.com
PALAVRA-CHAVE: RJ
PALAVRA-CHAVE/RAMO DE ATIVIDADE: SAÚDE
PALAVRA-CHAVE/EMPRESA: ROCHE
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