Avastin Achieves Impressive Rate of Curative Surgery in Patients With Advanced Colorectal Cancer
Largest Series of Patients With Successful Surgery Reported in
Large, Prospective Clinical Trial
BARCELONA, Spain, Sept. 24 /CNW/ - New data from the large
international First BEAT trial unveiled today at the European
Cancer Conference (ECCO) demonstrate that a high number of patients
treated with Avastin plus standard chemotherapy for their
colorectal cancer underwent complete surgical removal of their
metastatic lesions. Complete removal of metastatic lesions was
achieved in almost 80% of patients who were previously considered
inoperable. This outcome with Avastin is higher than has been
previously seen in trials with other biologics/chemotherapy
combinations.
The First BEAT trial included 1,965
patients with advanced colorectal
cancer with primarily inoperable metastatic disease. Patients
received Avastin
in combination with the commonly used fluoropyrimidine based
chemotherapy
regimens (i) as first line treatment and were assessed for their
suitability
for potentially curative surgery during the course of the
treatment.
"The complete resection of metastatic
lesions is the only option for cure
in patients with metastatic colorectal cancer. Therefore these
results
represent a major step forward for the patient," said Dr Mondher
Mahjoubi,
Global Head Medical Affairs Oncology, Roche. "The high rates of
successful,
curative surgery achieved with Avastin plus standard chemotherapy
are
impressive, especially because First BEAT is a trial looking at a
general,
real life patient population".
First BEAT results presented at ECCO
demonstrated that 215 (11.5%) of all
patients included in the current data analysis (1,914) became
eligible for and
underwent surgery with curative intent during the course of
treatment.
Successful, complete removal of the metastatic lesions (R0
resection) was
achieved in 170 patients, an impressive success rate of 79%. The
best outcomes
as expected were achieved in the subgroup of patients with
metastatic disease
confined to the liver only (n=704). In this subgroup, 102 (14.5%)
patients
underwent surgical removal of their liver metastases in curative
intent with
successful complete (R0) resection achieved in 81 patients.
No increase in wound-healing complications
or bleeding incidents was
observed compared with historical controls underlining the
favourable safety
profile of Avastin in this setting.
Colorectal cancer is the third most common
cancer with approximately one
million new cases worldwide every year. It is estimated that over
50% of
people diagnosed with colorectal cancer will die of the
disease(1).
About First BEAT
First BEAT is an international phase IV
trial which has enrolled 1965,
community based patients from 41 countries worldwide. Patients
diagnosed with
unresectable metastatic disease received Avastin in combination
with standard
first line chemotherapy; the most common regimens were FOLFOX,
XELOX, FOLFIRI
and Xeloda (capecitabine). The dose of Avastin used was equivalent
to 2.5
mg/kg/week (5 mg/kg every 2 weeks with 5-FU-based regimens and 7.5
mg/kg every
3 weeks with capecitabine-based regimens).
First BEAT completed recruitment in
February 2006. The primary endpoint
was safety. General efficacy and surgery with curative intent were
preplanned
secondary endpoints and data were collected in a prospective
fashion. Efficacy
data from the BEAT trial are continuing to be evaluated with
further data
presentations expected at upcoming oncology conferences.
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
- Avastin: http://www.avastin-info.com
References
(1). Boyle P, Langman JS. ABC of
colorectal cancer. Epidemiology.
BMJ 2000;
321:805-8
(i) The chemotherapy regimens selected
were at the treating physician's
discretion. The
most commonly used were FOLFOX, XELOX, FOLFIRI and
Xeloda
(capecitabine) which is a reflection of current clinical
practice.
>>
-30-
/For further information: Roche, Christine Mage-Hill,
+41-79-788-8245
(mobile on-site at ECCO); Galliard Healthcare, Dominic
Elliston,
+44-0207-663-2266 (direct)/
Posted: September 2007
