This phase I/II trial assessed the efficacy of mFOLFOX6 with either BIBF 1120, an oral anti-angiogenesis agent, or with bevacizumab(Drug information on bevacizumab), an anti-angiogenesis antibody, in chemotherapy-naïve patients with metastatic colorectal cancer (mCRC). Patients were randomized 2:1 to the BIBF 1120 and bevacizumab arms, respectively.
BIBF 1120 is an oral triple inhibitor of angiogenesis that had previously shown a favorable safety profile in mCRC patients, including reversible liver enzymes, mild hypertension, and mild gastrointestinal events.
Median progression-free survival was 10.6 months for both trial arms. 61.2% of patients in the BIBF 1120 arm compared with 53.7% of patients in the bevacizumab arm responded to the treatment. The median duration of response was 8.0 months, compared with 10.5 months in the BIBF 1120 and bevacizumab arms, respectively. The trial results were presented by Dr. Eric Van Cutsem from the University Hospital in Leuven, Belgium.
Slightly more hypertension and GI perforations were seen in the bevacizumab arm, compared with the BIBF 1120 arm (27% vs 18% and 12% vs 5%, respectively).
The overall survival and quality of life results are still being assessed for this trial. Dr. Cutsem concluded that the two treatment arms had similar tolerance and efficacy, but the BIBF 1120 arm had a lower frequency of serious side effects. Dr.Michel Ducreux of the Institut Gustave Roussy in Paris, France, the discussant for the trial data, noted that the study had "ambitious goals," as "angiogenesis is a very complex problem". He noted that this was the "first time that when you add a tyrosine kinase inhibitor to chemo, you are able to do it with without added toxicity." On the slight disparity in the number of GI perforations he stated that "for me, it's probably a piece of chance or lack of chance for bevacizumab." He pointed out that the numbers are very small and that the results favor antibodies over TKIs in colorectal cancer at this point.