Avastin Achieves Impressive Rate of Curative Surgery in Patients with Advanced Colorectal Cancer

Avastin Achieves Impressive Rate of Curative Surgery in Patients with Advanced Colorectal Cancer

September 24, 2007

- Largest Series of Patients with Successful Surgery
Reported in Large, Prospective Clinical Trial
- Abstract no: 3020, Being Presented at ECCO in Room
115-116, Starting at 12:15 on Monday 24th September 2007
- For non-US Media Only

    BARCELONA, Spain, Sept. 24 /Xinhua-PRNewswire/ -- 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 these patients, all of whom had been
considered inoperable prior to the start of treatment. 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. 

    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     

    References 

    (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.  

    1. Boyle P, Langman JS. ABC of colorectal cancer.
Epidemiology. BMJ 2000; 321:805-8  


    For more information, please contact:

     Christine Mage-Hill, 
     F.Hoffmann-La Roche
     Mobile:  [phone] (on-site at ECCO)
     Email:   [e-mail]

     Dominic Elliston, 
     Galliard Healthcare
     Tel:     [phone]
     Email:   [e-mail]

     Website:  http://www.health-kiosk.ch/start_krebs