Patients with mantle cell lymphoma may be able to forego chemotherapy in favor of induction treatment with a two-drug regimen, according to new research presented at the American Society of Hematology (ASH) annual meeting (Dec. 9-12).
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Mantle cell lymphoma is a relatively uncommon type of B-cell non-Hodgkin’s lymphoma that mostly affects men aged 60 years and older. Initial treatment approaches generally include chemotherapy followed by the monoclonal antibody rituximab. However, aggressive induction chemotherapy can lead to significant toxicity. Recent research has shown an combination of ibrutinib and rituximab to lead to durable responses and limited toxicity in patients with relapsed and refractory mantle cell lymphoma.
Researchers from the University of Texas MD Anderson Cancer Center conducted a study to determine whether the ibrutinib with rituximab combination was similarly effective without induction chemotherapy in newly diagnosed patients with mantle cell lymphoma. The study was comprised of 50 patients treated with ibrutinib (560 mg/day) and weekly rituximab (375 mg/m2, intravenously) for 4 weeks in the first cycle and then on the first day of cycles 3-12. After patients demonstrated partial or complete remission, they received chemo-immunotherapy alternating every 28 days with rituximab and high-dose methotrexate-Ara C (cytarabine).
Results of the study showed the induction therapy demonstrated high efficacy. A total of 36 of the 50 patients responded to treatment with the ibrutinib and rituximab combination alone. Of these patients, 28% demonstrated a partial response and 72% demonstrated a complete response. Patients who achieved complete remission after the combination therapy (N = 19) received an average of 4 additional cycles of chemo-immunotherapy. All of these patients achieved a complete and sustained response.
Researchers found common grade 1-2 non-hematological adverse events that occurred with the ibrutinib and rituximab treatment including fatigue, diarrhea, and dizziness among others. The most common grade 1-2 hematological adverse event was anemia. Researchers have deemed the two-drug combination to be associated with a better safety profile than chemo-immunotherapy.
As further research is conducted to assess the validity of the two-drug regimen in treating mantle cell lymphoma, researchers anticipate that “this unprecedented efficacy and safety [of treatment with ibrutinib-rituximab] may provide a window of opportunity for less chemo-immunotherapy.”