1. Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma
- Author
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Roger M. Lyons, Yunfei Wang, Philip Y. Dien, Nicholas J. Di Bella, Robert N. Raju, Julie Boston, Kathryn S. Kolibaba, Svetislava J. Vukelja, David Barrera, Raymond Taetle, Peter J. Schlegel, Thomas E. Boyd, Lina Asmar, Kristi A. Boehm, and Ernest W. Cochran
- Subjects
Adult ,Male ,medicine.medical_specialty ,Lymphoma, B-Cell ,Immunology ,Follicular lymphoma ,Salvage therapy ,Antineoplastic Agents ,Neutropenia ,Biochemistry ,Gastroenterology ,Bortezomib ,Maintenance therapy ,Recurrence ,Internal medicine ,medicine ,Humans ,Survival analysis ,Aged ,Aged, 80 and over ,Salvage Therapy ,business.industry ,Cell Biology ,Hematology ,Middle Aged ,medicine.disease ,Boronic Acids ,Survival Analysis ,Surgery ,Treatment Outcome ,Drug Resistance, Neoplasm ,Pyrazines ,Disease Progression ,Female ,Rituximab ,business ,Progressive disease ,medicine.drug - Abstract
This study evaluated the efficacy and safety of single-agent bortezomib in indolent B-cell lymphoma that had relapsed from or was refractory to rituximab. Sixty patients enrolled: 59 were treated with bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 for up to eight 21-day cycles; responders could receive 4 additional cycles; maintenance was optional. Fifty-three evaluable patients completed more than 2 cycles. The median age was 70 years, 53% female, Ann Arbor stage III-IIIE (28%) and IV (65%); 43 patients (72%) had more than 2 prior regimens; and 6 patients went on to maintenance. Overall responses are as follows: 1 complete response (1.9%), 3 unconfirmed complete response (5.7%), 3 partial response (5.7%), 34 stable disease (64.2%), and 12 progressive disease (22.6%). Median time to response = 2.2 months (range, 1.2-5.3 months); duration of response = 7.9 months (2.8-21.3 months); 1-year survival was 73% and 2-year survival was 58%; median survival = 27.7 months (range, 1.4-30.9 months); median progression-free survival = 5.1 months (range, 0.2-27.7 months), median time to progression = 5.1 months (range, 0.2-27.7 months), and median event-free survival = 1.8 months (range, 0.2-27.7 months). Treatment-related grade 3 or 4 adverse events included: thrombocytopenia (20%), fatigue (10%), neutropenia (8.5%), and neuropathy and diarrhea (6.8% each). This study demonstrates that bortezomib has modest activity against marginal zone and follicular lymphoma; it has the potential for combination with other agents in low-grade lymphomas. Maintenance therapy should be explored further.
- Published
- 2010