16 Min.
AUDIO JOURNAL OF ONCOLOGY—Ibrutinib Enables Transplant-Free Therapy for Mantle Cell Lymphoma Audio Journal of Oncology Podcast
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Ibrutinib Enables Transplant-Free Therapy for Mantle Cell Lymphoma
NEW ORLEANS, USA—Many patients eligible for autologous stem cell transplantation for their mantle cell lymphoma (under current best practice recommendations) could be treated as effectively—and potentially with less toxicity—with the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib, according to findings from Munich, Germany.
The Randomized Triangle Trial, conducted by the European Mantle Cell Lymphoma Network, reported positive findings about a transplant-free approach to the American Society of Hematology 2022 Annual Meeting.
https://ashpublications.org/blood/article/140/Supplement%201/1/490022/Efficacy-and-Safety-of-Ibrutinib-Combined-with
Audio Journal of Oncology correspondent Peter Goodwin talked with study leader Martin Dreyling MD PhD, Professor of Medicine at LMU (Ludwig Maximilian University) Hospital in Munich, Germany about their findings that strongly suggest standard chemotherapy plus ibrutinib (with or without autologous stem cell transplantation) should be the new first-line standard of care for patients with mantle cell lymphoma.
Toxicity
But the German team also noted that the high efficacy of chemotherapy brought high toxicity rates. So, they compared the standard induction (with a cytarabine-containing regimen plus autologous transplant and rituximab maintenance) with two experimental arms, said Dreyling. “One was a simple add-on design—which means ibrutinib [was] added to [standard] induction and maintenance. And the third arm was even more interesting: substituting for autologous transplant.”
“The add-on design resulted in a significant improvement of progression free survival—around 15 per cent after three years: in my opinion highly clinically relevant,” he said. Also, the study found that a group of difficult-to-treat patients—those whose tumors had p53 gene alterations—had specifically benefited from the addition of ibrutinib.
Patients who took the targeted drug ibrutinib had rates of failure-free survival (FFS) and overall survival (OS) that were similar to the current standard of care—whether or not they received a stem cell transplant in addition to ibrutinib. Those treated with ibrutinib who did not have ASCT had significantly lower rates of toxicity. And in the arm in which ibrutinib was added to transplantation, the toxicity was no higher than among patients treated with standard of care, the study found.
“We are moving away from intensive chemotherapy to [a] targeted approach. The new standard of care in younger patients is still a combination of chemo plus ibrutinib. The future, I hope, will be skipping chemotherapy [altogether] and moving to a purely targeted approach—hopefully leading to better outcomes, but definitely better tolerability of our treatment regimens,” Dreyling told OT.
Study details
The trial enrolled 870 adult patients up to 65 (median age 57 years) treated for MCL in 13 European countries and Israel. All patients were eligible for ASCT. 288 of them (group A) were assigned to receive standard care (high-dose cytarabine-containing immunochemotherapy followed by ASCT and rituximab maintenance). 292 patients (group A + I) were treated with the same standard care plus ibrutinib, and 290 patients received ibrutinib without having a transplant (group I).
Transplant not superior
After a median follow-up of 31 months, group A failed to show superiority over group I in terms of FFS (three-year FFS was 72 per cent compared with 86 per cent in group I (p=0.9979, hazard ratio: 1.77). In group A+I, the FFS was superior to group A: 88 per cent compared with 72 per cent in group A (p=0.0008, hazard ratio: 0.52). OS was 86 per cent in group A, 91 per cent in group A+I, and 92 per cent in group I.
Toxicities
The study found no substantial differences in the incidence of grade three to five adverse events (AEs) during induction wi
Ibrutinib Enables Transplant-Free Therapy for Mantle Cell Lymphoma
NEW ORLEANS, USA—Many patients eligible for autologous stem cell transplantation for their mantle cell lymphoma (under current best practice recommendations) could be treated as effectively—and potentially with less toxicity—with the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib, according to findings from Munich, Germany.
The Randomized Triangle Trial, conducted by the European Mantle Cell Lymphoma Network, reported positive findings about a transplant-free approach to the American Society of Hematology 2022 Annual Meeting.
https://ashpublications.org/blood/article/140/Supplement%201/1/490022/Efficacy-and-Safety-of-Ibrutinib-Combined-with
Audio Journal of Oncology correspondent Peter Goodwin talked with study leader Martin Dreyling MD PhD, Professor of Medicine at LMU (Ludwig Maximilian University) Hospital in Munich, Germany about their findings that strongly suggest standard chemotherapy plus ibrutinib (with or without autologous stem cell transplantation) should be the new first-line standard of care for patients with mantle cell lymphoma.
Toxicity
But the German team also noted that the high efficacy of chemotherapy brought high toxicity rates. So, they compared the standard induction (with a cytarabine-containing regimen plus autologous transplant and rituximab maintenance) with two experimental arms, said Dreyling. “One was a simple add-on design—which means ibrutinib [was] added to [standard] induction and maintenance. And the third arm was even more interesting: substituting for autologous transplant.”
“The add-on design resulted in a significant improvement of progression free survival—around 15 per cent after three years: in my opinion highly clinically relevant,” he said. Also, the study found that a group of difficult-to-treat patients—those whose tumors had p53 gene alterations—had specifically benefited from the addition of ibrutinib.
Patients who took the targeted drug ibrutinib had rates of failure-free survival (FFS) and overall survival (OS) that were similar to the current standard of care—whether or not they received a stem cell transplant in addition to ibrutinib. Those treated with ibrutinib who did not have ASCT had significantly lower rates of toxicity. And in the arm in which ibrutinib was added to transplantation, the toxicity was no higher than among patients treated with standard of care, the study found.
“We are moving away from intensive chemotherapy to [a] targeted approach. The new standard of care in younger patients is still a combination of chemo plus ibrutinib. The future, I hope, will be skipping chemotherapy [altogether] and moving to a purely targeted approach—hopefully leading to better outcomes, but definitely better tolerability of our treatment regimens,” Dreyling told OT.
Study details
The trial enrolled 870 adult patients up to 65 (median age 57 years) treated for MCL in 13 European countries and Israel. All patients were eligible for ASCT. 288 of them (group A) were assigned to receive standard care (high-dose cytarabine-containing immunochemotherapy followed by ASCT and rituximab maintenance). 292 patients (group A + I) were treated with the same standard care plus ibrutinib, and 290 patients received ibrutinib without having a transplant (group I).
Transplant not superior
After a median follow-up of 31 months, group A failed to show superiority over group I in terms of FFS (three-year FFS was 72 per cent compared with 86 per cent in group I (p=0.9979, hazard ratio: 1.77). In group A+I, the FFS was superior to group A: 88 per cent compared with 72 per cent in group A (p=0.0008, hazard ratio: 0.52). OS was 86 per cent in group A, 91 per cent in group A+I, and 92 per cent in group I.
Toxicities
The study found no substantial differences in the incidence of grade three to five adverse events (AEs) during induction wi
16 Min.