New data from the First BEAT trial suggest that the majority of patients with metastatic colorectal cancer who receive bevacizumab and standard chemotherapy can have complete resection of their metastatic lesions, according to a presentation at the European Cancer Conference.

Complete removal of metastatic lesions was achieved in almost 80 percent of these patients, all of whom had been considered inoperable prior to the start of treatment. This outcome is higher than has been previously seen in trials with other combinations of biologic agents plus chemotherapy.

The First BEAT trial included 1,965 patients with advanced colorectal cancer with primarily inoperable metastatic disease. Patients received bevacizumab in combination with commonly used fluoropyrimidine-based chemotherapy regimens as first-line treatment and were assessed for suitability for potentially curative surgery during the course of 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 Pharmaceuticals. "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".

Specifically, 215 (11.5 percent) 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 metastatic lesions (R0 resection) was achieved in 170 patients, an impressive success rate of 79 percent.

The best outcomes were achieved in the subgroup of patients with metastatic disease confined to the liver only (704 patients). In this subgroup, 102 (14.5 percent) patients underwent surgical removal of 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 favorable safety profile of bevacizumab in this setting.

First BEAT is an international phase IV trial that has enrolled 1,965 community-based patients from 41 countries worldwide. Patients diagnosed with unresectable metastatic disease received bevacizumab in combination with standard first-line chemotherapy; the most common regimens were FOLFOX, XELOX, FOLFIRI and Xeloda (capecitabine). The dose of bevacizumab was equivalent to 2.5 mg/kg/week (5 mg/kg every two weeks with 5-FU-based regimens and 7.5 mg/kg every three 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; 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.