Excerpt
Median progression-free survival time improved by 20 months with bendamustinerituximab, and the complete response rate improved by approximately one third.
These promising results, from a Phase III trial by the German Study Group Indolent Lymphomas (StiL), suggest that bendamustine-rituximab has the potential to become a new standard first-line treatment option for patients with these lymphomas, the researchers said.
Mathias J. Rummel, MD, PhD, Head of the Department of Hematology at University Hospital in Giessen, Germany, presented final results of the multicenter, randomized Phase III study, noting that the results built on the promising Phase II results of bendamustine-rituximab in relapsed/ refractory indolent or mantle cell lymphomas, published in the Journal of Clinical Oncology in 2005.
Overall response rates in the Phase III trial were similar, with a median observation time of 32 months: 93.8% for bendamustinerituximab vs 93.5% for CHOP-R.
In the primary endpoint of progressionfree survival, bendamustine-rituximab was superior to CHOP-R, with median progression- free survivals of 54.9 vs. 34.8 months, respectively.
“The complete response rate was significantly higher with in the bendamustine- rituximab group, 40.1%, compared with 30.8% for CHOP-R,” Dr. Rummel reported.
Bendamustine-rituximab was also superior to CHOP-R in event-free survival—54 months for bendamustine-rituximab vs 31 months for CHOP-R.
In time to next treatment, the median had not yet been reached in the bendamustinerituximab group, and was 40.7 months for CHOP-R.
Overall survival did not differ between the two groups at this point of time. Dr. Rummel said there would probably not be an increase in overall survival soon, because of the very indolent nature of the disease. As of the time of his report at the meeting, he said, 67 patients had died—34 in the bendamustine-rituximab group and 33 in the CHOP-R group.