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First-Line Ibrutinib Plus Rituximab in Elderly Patients With Mantle Cell Lymphoma

By: Vanessa A. Carter, BS
Posted: Monday, April 25, 2022

Michael L. Wang, MD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues evaluated the efficacy and safety of combination ibrutinib and rituximab in older patients with mantle cell lymphoma. The results of this study suggest that this combination is an effective, easily administered, and chemotherapy-free option for this patient population, although baseline evaluation for cardiovascular risk and further trials are recommended. These findings were published in the Journal of Clinical Oncology.

This phase II study focused on 50 patients with mantle cell lymphoma who were 65 and older and did not have blastoid morphology or a Ki67 expression level over 50%. Participants were administered oral ibrutinib once daily and intravenous rituximab once weekly for 4 weeks in cycle 1, followed by day 1 of cycles 3 to 8. After cycle 8, rituximab was administered on day 1 every 2 months for up to 2 years, and then ibrutinib was given in continuous cycles until disease progression or unacceptable toxicity.

The median patient age was 71, and 16% of patients had high-risk simplified mantle cell lymphoma. The majority (76%) of participants had relatively low (< 30%) Ki67 levels, whereas the remainder had moderately high (≥ 30%–50%) levels. With a median follow-up of 45 months, the best overall response rate was 96%, with 71% of individuals demonstrating a complete response, 25% experiencing a partial response, and 4% had stable disease.

No deaths attributed to study therapy were reported. Notably, just over half (56%) of patients discontinued treatment due to toxicities (n = 21), disease progression (n = 4), or other reasons (n = 3). Although the median progression-free survival and overall survival were not reached, the 3-year survival rates were 87% and 94%, respectively. A total of 17 patients developed atrial fibrillation, and 11 cases were of grade 3. Of note, patients with atrial fibrillation appeared to have a higher median number of baseline cardiovascular risks than those who did not develop it.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.


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