2007-09-24

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


Barcelona, Spain (ots/PRNewswire) -

- Largest Series of Patients With Successful Surgery Reported inLarge, 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

New data from the large international First BEAT trial unveiledtoday at the European Cancer Conference (ECCO) demonstrate that ahigh number of patients treated with Avastin plus standardchemotherapy for their colorectal cancer underwent complete surgicalremoval of their metastatic lesions. Complete removal of metastaticlesions was achieved in almost 80% of these patients, all of whom hadbeen considered inoperable prior to the start of treatment. Thisoutcome with Avastin is higher than has been previously seen intrials with other biologics/chemotherapy combinations.

The First BEAT trial included 1,965 patients with advancedcolorectal cancer with primarily inoperable metastatic disease.Patients received Avastin in combination with the commonly usedfluoropyrimidine based chemotherapy regimens(i) as first linetreatment and were assessed for their suitability for potentiallycurative surgery during the course of the treatment.

"The complete resection of metastatic lesions is the only optionfor cure in patients with metastatic colorectal cancer. Thereforethese results represent a major step forward for the patient," saidDr Mondher Mahjoubi, Global Head Medical Affairs Oncology, Roche."The high rates of successful, curative surgery achieved with Avastinplus standard chemotherapy are impressive, especially because FirstBEAT 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) becameeligible for and underwent surgery with curative intent during thecourse of treatment. Successful, complete removal of the metastaticlesions (R0 resection) was achieved in 170 patients, an impressivesuccess rate of 79%. The best outcomes as expected were achieved inthe subgroup of patients with metastatic disease confined to theliver only (n=704). In this subgroup, 102 (14.5%) patients underwentsurgical removal of their liver metastases in curative intent withsuccessful complete (R0) resection achieved in 81 patients.

No increase in wound-healing complications or bleeding incidentswas observed compared with historical controls underlining thefavourable safety profile of Avastin in this setting.

Colorectal cancer is the third most common cancer withapproximately one million new cases worldwide every year. It isestimated that over 50% of people diagnosed with colorectal cancerwill die of the disease(1).

About First BEAT

First BEAT is an international phase IV trial which has enrolled1965, community based patients from 41 countries worldwide. Patientsdiagnosed with unresectable metastatic disease received Avastin incombination with standard first line chemotherapy; the most commonregimens were FOLFOX, XELOX, FOLFIRI and Xeloda (capecitabine). Thedose of Avastin used was equivalent to 2.5 mg/kg/week (5 mg/kg every2 weeks with 5-FU-based regimens and 7.5 mg/kg every 3 weeks withcapecitabine-based regimens).

First BEAT completed recruitment in February 2006. The primaryendpoint was safety,. General efficacy and surgery with curativeintent were preplanned secondary endpoints and data were collected ina prospective fashion. Efficacy data from the BEAT trial arecontinuing to be evaluated with further data presentations expectedat 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 treatingphysician's discretion. The most commonly used were FOLFOX, XELOX,FOLFIRI and Xeloda (capecitabine) which is a reflection of currentclinical practice.

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

ots Originaltext: Roche PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

Contact:For more information please contact: Christine Mage-Hill, F.Hoffmann-La Roche, Mobile: +41-79-788-8245 (on-site at ECCO), christine.mage-hill@roche.com; Dominic Elliston, Galliard Healthcare,Direct: +44-207-663-2266, delliston@galliardhealthcare.com

Roche Pharmaceuticals

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

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