Bortezomib for the Treatment of Mantle Cell Lymphoma
| Autor: | Rajeshwari Sridhara, Ann T. Farrell, Richard Pazdur, Chia-Wen Ko, Ramzi Dagher, Robert C. Kane, Robert Justice |
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| Rok vydání: | 2007 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Cyclophosphamide Antineoplastic Agents Lymphoma Mantle-Cell Gastroenterology Bortezomib hemic and lymphatic diseases Internal medicine medicine Humans Prospective Studies Adverse effect Drug Approval Aged Mitoxantrone United States Food and Drug Administration business.industry medicine.disease Boronic Acids United States Discontinuation Surgery Lymphoma Oncology Pyrazines Female Mantle cell lymphoma Rituximab business medicine.drug |
| Zdroj: | Clinical Cancer Research. 13:5291-5294 |
| ISSN: | 1557-3265 1078-0432 |
| Popis: | Purpose: To describe the Food and Drug Administration review and marketing approval considerations for bortezomib (Velcade) for the treatment of patients with mantle cell lymphoma. Experimental Design: Food and Drug Administration reviewed a multicenter study of bortezomib in 155 patients with progressive mantle cell lymphoma after at least one prior therapy. Results: Seventy-seven percent were stage IV, and 75% had one or more extranodal sites of disease. Prior therapy included an anthracycline or mitoxantrone, cyclophosphamide, and rituximab. Median age was 65 years. All received bortezomib 1.3 mg/m2 i.v. on days 1, 4, 8, and 11 of each 3-week cycle. The primary end point was response. Response and progression were determined by independent review of serial computed tomography scans using International Lymphoma Workshop Response Criteria. The overall response rate was 31%, including complete response (CR) plus CR unconfirmed (CRu) plus partial response; median response duration was 9.3 months. The CR plus CRu response rate was 8% with a median duration of 15.4 months. Adverse events were similar to those observed previously for bortezomib. The most commonly reported treatment-emergent adverse events were asthenia (72%), peripheral neuropathies (55%), constipation (50%), diarrhea (47%), nausea (44%), and anorexia (39%). The most common adverse event leading to discontinuation was neuropathy. Conclusions: Bortezomib received regular approval for the treatment of patients with mantle cell lymphoma in relapse after prior therapy. |
| Databáze: | OpenAIRE |
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