Vorinostat for treatment of cutaneous manifestations of advanced primary cutaneous T-cell lymphoma
| Autor: | Leigh Verbois, Ann T. Farrell, Robert Justice, Rajeshwari Sridhara, Bhupinder S. Mann, John R. Johnson, Sophia Abraham, David E. Morse, Richard Pazdur, Brian Booth, Josephine M. Jee, Sarah Pope, Kun He, Ravi Harapanhalli, Ramzi Dagher |
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| Rok vydání: | 2007 |
| Předmět: |
Cancer Research
medicine.medical_specialty Visual analogue scale Population Hydroxamic Acids Clinical Trials Phase II as Topic Dogs hemic and lymphatic diseases Internal medicine medicine Animals Anticarcinogenic Agents Humans education Vorinostat Neoplasm Staging Skin Response rate (survey) education.field_of_study Clinical Trials Phase I as Topic business.industry United States Food and Drug Administration Patient Selection Pruritus Cutaneous T-cell lymphoma medicine.disease Confidence interval United States Surgery Lymphoma Lymphoma T-Cell Cutaneous Clinical trial Oncology Cats business medicine.drug |
| Zdroj: | Clinical cancer research : an official journal of the American Association for Cancer Research. 13(8) |
| ISSN: | 1078-0432 |
| Popis: | Purpose: To discuss vorinostat approval for treatment of cutaneous manifestations of advanced cutaneous T-cell lymphoma (CTCL). Experimental Design: Data from 1 single-arm, open-label, multicenter pivotal trial and 11 other trials submitted to support the new drug application for vorinostat in the treatment of advanced primary CTCL were reviewed. The pivotal trial assessed responses by changes in overall skin disease score using a severity-weighted assessment tool (SWAT). Vorinostat could be considered active in CTCL if observed response rate was at least 20% and the lower bound of the corresponding 95% confidence interval (95% CI) excluded 5%. Patients reported pruritis relief using a questionnaire and a visual analogue scale. Results: The pivotal trial enrolled 74 patients with stage IB or higher CTCL. Median number of prior treatments was 3, and 61 patients (82%) had stage IIB or higher disease. The objective response rate in the skin disease assessed by change in the overall SWAT score from the baseline was 30% (95% CI, 18.5 to 42.6) in patients with stage IIB or higher disease. Median response duration (end of response defined by 50% increase in SWAT score from the nadir) was 168 days. Median time to tumor progression was 148 days for overall population and 169 days for patients with stage IIB or higher disease. Assessment of pruritis relief was considered unreliable. Conclusions: Vorinostat showed activity in CTCL, and skin responses were a clinical benefit. Vorinostat was approved for treatment of cutaneous manifestations of CTCL. A nonblinded, single-arm trial did not allow a reliable assessment of pruritis relief. |
| Databáze: | OpenAIRE |
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