Phase II Multi-Institutional Trial of the Histone Deacetylase Inhibitor Romidepsin As Monotherapy for Patients With Cutaneous T-Cell Lymphoma
| Autor: | William D. Figg, Elaine S. Jaffe, Stephen Lade, Craig B. Reeder, John P. Leonard, John Wright, Maria L. Turner, Erin R. Gardner, A. Tito Fojo, Larisa J. Geskin, Robin Frye, H. Miles Prince, Maryalice Stetler-Stevenson, Mark Kirschbaum, Richard Piekarz, Steven L. Allen, Jasmine Zain, Susan E. Bates, David Joske, Seth M. Steinberg |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Oncology Cancer Research medicine.medical_specialty Metabolic Clearance Rate medicine.drug_class Population Romidepsin Depsipeptides Internal medicine Original Reports medicine Humans education Fatigue Aged Aged 80 and over Depsipeptide Mycosis fungoides education.field_of_study Antibiotics Antineoplastic Leukemia business.industry Cutaneous T-cell lymphoma Histone deacetylase inhibitor Nausea Middle Aged medicine.disease Thrombocytopenia Lymphoma T-Cell Cutaneous Surgery Lymphoma Histone Deacetylase Inhibitors Clinical trial Treatment Outcome Area Under Curve Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 27:5410-5417 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | Purpose Romidepsin (depsipeptide or FK228) is a member of a new class of antineoplastic agents active in T-cell lymphoma, the histone deacetylase inhibitors. On the basis of observed responses in a phase I trial, a phase II trial of romidepsin in patients with T-cell lymphoma was initiated. Patients and Methods The initial cohort was limited to patients with cutaneous T-cell lymphoma (CTCL), or subtypes mycosis fungoides or Sézary syndrome, who had received no more than two prior cytotoxic regimens. There were no limits on other types of therapy. Subsequently, the protocol was expanded to enroll patients who had received more than two prior cytotoxic regimens. Results Twenty-seven patients were enrolled onto the first cohort, and a total of 71 patients are included in this analysis. These patients had undergone a median of four prior treatments, and 62 patients (87%) had advanced-stage disease (stage IIB, n = 15; stage III, n= 6; or stage IV, n = 41). Toxicities included nausea, vomiting, fatigue, and transient thrombocytopenia and granulocytopenia. Pharmacokinetics were evaluated with the first administration of romidepsin. Complete responses were observed in four patients, and partial responses were observed in 20 patients for an overall response rate of 34% (95% CI, 23% to 46%). The median duration of response was 13.7 months. Conclusion The histone deacetylase inhibitor romidepsin has single-agent clinical activity with significant and durable responses in patients with CTCL. |
| Databáze: | OpenAIRE |
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