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Avastin Achieves Impressive Rate of Curative Surgery in Patients with Advanced Colorectal Cancer
Date:9/23/2007

- 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

BARCELONA, Spain, Sept. 24 /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


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