Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma
| Autor: | Cong Chen, Debra L. Breneman, Justin L. Ricker, Eric C. Vonderheid, Theresa R. Pacheco, Sareeta Parker, Cesar Sanz-Rodriguez, Madeleine Duvic, Elise A. Olsen, Larisa J. Geskin, Rachel Abuav, Alexandra Gunchenko, Kathleen Boileau, Syed Rizvi |
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| Rok vydání: | 2009 |
| Předmět: |
Subset Analysis
Male Cancer Research medicine.medical_specialty Skin Neoplasms Nausea Antineoplastic Agents Hydroxamic Acids Internal medicine medicine Humans Adverse effect Vorinostat Aged Mycosis fungoides business.industry Cutaneous T-cell lymphoma Hematology General Medicine Middle Aged medicine.disease Rash Lymphoma T-Cell Cutaneous Histone Deacetylase Inhibitors Oncology Tolerability Female medicine.symptom business medicine.drug |
| Zdroj: | Clinical lymphomamyeloma. 9(6) |
| ISSN: | 1938-0712 |
| Popis: | Introduction Vorinostat, an orally active histone deacetylase inhibitor, was approved in October 2006 by the US Food and Drug Administration for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease during or after treatment with 2 systemic therapies. Patients and Methods A multicenter, open-label phase IIb trial evaluated the activity and safety of vorinostat 400 mg orally daily in patients with ≥ stage IB, persistent, progressive, or treatment-refractory mycosis fungoides or Sezary syndrome CTCL subtypes. We report the safety and tolerability of long-term vorinostat therapy in patients who experienced clinical benefit in the previous phase IIb study. Results As of December 11, 2008, 6 of 74 patients enrolled in the original study had received vorinostat for ≥ 2 years: median age, 65 years; median number of previous therapies, 2.5; median time from diagnosis to enrollment, 1.8 years. At enrollment into the continuation phase, 5 of the 6 patients had achieved an objective response, and 1 patient had prolonged stable disease. During the follow-up study, the most common drug-related grade 1–4 adverse events (AEs) were diarrhea, nausea, fatigue, and alopecia (6, 5, 4, and 3 patients, respectively). Incidence of grade 3/4 AEs was low: anorexia (n = 1), increased creatinine phosphokinase (n = 1), pulmonary embolism (n = 1), rash (n = 1), and thrombocytopenia (n = 1). Five patients have discontinued the study drug, and 1 patient is continuing therapy. Conclusion This post hoc subset analysis provides evidence for the long-term safety and clinical benefit of vorinostat in heavily pretreated patients with CTCL, regardless of previous treatment failures. |
| Databáze: | OpenAIRE |
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