Ian W. Flinn, MD, PhD
The BRIGHT study compared the safety and efficacy of bendamustine plus rituximab (BR) versus R-CHOP or R-CVP in patients with indolent non-Hodgkin lymphoma (iNHL) and mantle cell lymphoma (MCL).
, lead author Ian W. Flinn, MD, PhD, director, Blood Cancer Research Program, principal investigator, Sarah Cannon Research Institute, discussed the 5-year update of the BRIGHT study.
OncLive: Please provide an overview of this follow-up analysis.
The BRIGHT trial is a randomized phase III trial in patients with previously untreated low-grade lymphoma and MCL. It was a study that starting in 2009 and it is a randomized trial comparing BR to R-CHOP or R-CVP. The basic design of the study was once patients were deemed eligible, their treating physician chose a standard chemotherapy for R-CHOP or R-CVP. And then they were randomized…to receive that standard chemotherapy or BR.
What has been observed 5 years later?
Our study was initially designed to be a noninferiority trial so, the primary endpoint of the trial was complete remission rate, which was judged by an independent review committee. In 2014, we published that it was noninferior; the complete remission rate was 31% with BR versus 25% for the standard chemotherapy. That clearly met the noninferiority endpoint of the trial. During this year's ASCO, we updated those results for the event-free survival and the time to event analysis such as OS and PFS and duration of response.
There were some unexpected results—it looked like there was increase in second malignancies in patients treated with BR. When we dove down into that in more detail, we found that a lot of these second malignancies were actually skin cancer, such as squamous cell carcinoma of the skin and basal cell carcinoma of the skin. So, when you excluded those, it was really just progression of the underlying disease. We found that while that it is no longer statistically significant, there was still, numerically, an increase in the number of malignancies that we need to understand.
What does this update mean for the treatment landscape?
I think that BR in the last 5 years has become the standard frontline therapy for many patients in the United States. It is interesting to talk to people around the world, as they do not always necessarily share our perspective. There are regional variations of whether BR, R-CHOP, or R-CVP is used, but in the United States, I think it'll remain BR.
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