Evaluation of the long-term tolerability and clinical benefit of vorinostat in patients with advanced cutaneous T-cell lymphoma

Madeleine Duvic, Elise Olsen, Debra Breneman, Theresa Pacheco, Sareeta Parker, Eric Vonderheid, Rachel Abuav, Justin Ricker, Syed Rizvi, Cong Chen, Kathleen Boileau, Alexandra Gunchenko, Cesar Sanz-Rodriguez, Larisa Geskin

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73 Scopus citations


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 Sézary 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.

Original languageEnglish (US)
Pages (from-to)412-416
Number of pages5
JournalClinical Lymphoma and Myeloma
Issue number6
StatePublished - Dec 1 2009


  • Erythroderma
  • Histone deacetylase inhibitor
  • Mycosis fungoides
  • Sézary syndrome

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Hematology


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