DR GROTHEY: In the registry or the observation cohort study BRiTE, and later ARIES, we had actually 2 studies like that in the US, and in BRiTE we kind of followed 2,000 patients who all received first-line chemotherapy plus bevacizumab. And, upon progression, physicians decided whether to continue bevacizumab beyond progression or not.
And the patient who had bevacizumab beyond progression had a long overall survival, about 32 months median, compared to patients who did not have bevacizumab beyond progression, which was about 20 months. So there was this 12-month difference in survival, which was striking.
Now, as always, whenever we presented the data of the BRiTE study, it was always flanked with a caveat, limitations of the analysis, nonrandomized, cannot set a standard of care, et cetera, et cetera. And I always felt the data were hypothesis generating for such a prospective clinical trial. And, in the end, the observation cohort study served the purpose. I mean, we have a treatment principle that is now validated prospectively in a Phase III setting.
And, I mean, you can argue about the magnitude of difference of 1.4 months median or a 19% reduction of death events on the study per hazard ratio. But actually, the more intriguing part is that it validates a treatment principle. It puts in question our ideas about resistance.
What is resistance to a VEGF inhibitor? How does this translate to other diseases? I mean, it opens the door to a lot of potential clinical trials, translational studies, et cetera, which we have just scratched the surface of.