Phase III Trial Shows Efficacy of XELOX Plus Avastin in CRC

BASEL, Switzerland—Roche has reported that a large international phase III study (NO16966) enrolling 2,035 patients with previously untreated metastatic colorectal cancer (CRC), met both primary endpoints:

• The chemotherapy combination of oral capecitabine (Xeloda) plus oxaliplatin (Eloxatin), known as XELOX, was as effective as IV bolus and infusional fluorouracil/leucovorin plus oxaliplatin (FOLFOX) in terms of progression-free survival (PFS).

• The addition of bevacizumab (Avastin) to either chemotherapy regimen (FOLFOX or XELOX) significantly improved PFS vs chemotherapy alone.

New Treatment Option

"This is the first time we have significant data showing that oral Xeloda in combination with oxaliplatin is as effective as FOLFOX," Lars E. Birgerson, vice president for medical affairs at Roche, said in a press release. "This study demonstrates that oral Xeloda plus oxaliplatin (XELOX) provides a new treatment option for colorectal cancer patients. These data again show the benefits of adding Avastin to chemotherapy. In this trial, Avastin combined with XELOX and FOLFOX improved the chance of delaying disease progression by 20% in patients with advanced colorectal cancer."

Roche noted that some variability in subgroup analyses for efficacy was seen and that "no new safety signals related to Avastin were observed in the trial." The study results will be submitted for presentation at a future major medical meeting.