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Title: One Third of Patients With Mantle Cell Lymphoma Respond to Bortezomib Treatment: Presented at ASCO

"One Third of Patients With Mantle Cell Lymphoma Respond to Bortezomib Treatment: Presented at ASCO"

By Ed Susman ATLANTA, G.A. -- June 6, 2006 -- About 33% of patients with difficult-to-treat mantle cell lymphoma respond to therapy with the proteasome inhibitor bortezomib (Velcade), researchers reported here at the American Society of Clinical Oncology 2006 Annual Meeting (ASCO). In the single-agent phase 2 trial, 8% of patients treated with bortezomib achieved a complete response that maintained for an average of about 13.5 months. "These results may offer new hope for the management of mantle cell, which represents the most challenging subtype of lymphoma," said Andre Goy, MD, chief of the division of lymphoma, The Cancer Center, Hackensack University Medical Center, Hackensack, New Jersey. Mantle cell lymphoma is an aggressive, rapidly progressive subtype of non-Hodgkin's lymphoma that is not curable with standard therapy. Because there is no generally accepted treatment approach and options are limited, there is a growing need for new therapies, Dr. Goy said in an oral presentation on June 4[^th.

Dr. Goy and colleagues treated 155 patients diagnosed with relapsed or refractory mantle cell lymphoma with bortezomib 1.3 mg/m² twice per week every 21 days for up to 1 year. Patients who achieve a response received a minimum of 8 cycles. All patients received at least 4 cycles of treatment.

Results show a median duration of response of 9.2 months; median time to progression was 6.2 months; median treatment-free interval was 13.8 months, achieved in patients who had a complete response.

The most common nonhematologic adverse event was fatigue, Dr. Goy said. About 14% of these cases reached grade 3 level -- a level of fatigue that interferes with activities of daily living. About 5% of patients suffered grade 3 diarrhea, about 4% experienced grade 3 abdominal pain, and about 3% had grade 3 nausea/vomiting. About 7% of patients experienced grade 3 peripheral neuropathies.

"These results reinforce the safety and efficacy observed in multiple other phase 2 studies of bortezomib, which showed its potential to become a new standard of care for relapsed patients."

[Presentation title: Bortezomib in Relapsed or Refractory Mantle Cell Lymphoma (MCL): Results of the PINNACLE Study. Abstract 7512]

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