Audio Journal of Oncology
SAN DIEGO—The first-line treatment of choice for older patients with chronic lymphocytic leukemia (CLL) should now be single agent ibrutinib according to conclusions drawn from the Alliance North American Intergroup Study A041202 reported at the 2018 Annual Meeting of the American Society of Hematology (ASH).
“Unless there is a good reason why patients should be on bendamustine plus rituximab (meaning that they are inappropriate for ibrutinib) ibrutinib is the most reasonable choice for front line therapy,” said lead study author Jennifer A. Woyach MD, an associate professor at the Ohio State University Comprehensive Cancer Center of Ohio State University in Columbus, OH.
Woyach told a press briefing that when they randomized patients “one to one to one” between three options for treatment: bendamustine plus rituximab, ibrutinib given as a single agent daily until disease progression, or ibrutinib given in combination with rituximab, there was a clear superiority for the ibrutinib-containing regimens.
“Progression-free survival was longer in the two ibrutinib-containing arms than in the bendamustine plus rituximab arm. And there was no difference in the progression-free survival between the two ibrutinib-containing arms.”
Woyach said they had conducted the trial to try to define the most optimal therapy for older patients with CLL. “We know that those patients are under-represented in many of our clinical trials,” she said. “So it’s hard to know whether much of our therapy can be extrapolated to this older patient group.”
Since ibrutinib had already been compared in earlier studies to chlorambucil in the phase three setting (leading to its FDA approval) it had never been compared to a chemo-immuntherapy regimen used in the CLL, she said. “So we tried to pick the most effective immunochemotherapy regimen for older patients—which is bendamustine plus rituximab—so that there would really be an effective comparator.”
In Woyach’s data there was no difference in progression free survival between patients treated with ibrutinib alone and those who received ibrutinib plus rituximab. “So ibrutinib alone would be the standard,” she said.
When she was asked about her choice of bendamustine plus rituximab as the comparator treatment she said there had been two reasons. Of the two chemo-immunotherapy regimens used in older patients (bendamustine plus rituximab and chlorambucil plus obinutuzumab) at the time the study was designed only the bendamustine regimen had been FDA approved, she said. “[But] regardless of that bendamistine plus rituximab does have superior progression free survival when you look at comparing across studies,” said Woyach.
Her interpretation of the study results? “For most patients this tells us that ibrutinib is the most effective drug for front-line CLL,” she said.