Clinically meaningful reduction in pruritus in patients with cutaneous T-cell lymphoma treated with romidepsin.
Patients with cutaneous T-cell lymphoma (CTCL) frequently experience severe pruritus that can significantly impact their quality of life. Romidepsin is approved by the US Food and Drug Administration (FDA) for the treatment of patients with CTCL who have received at least one prior systemic therapy, with a reported objective response rate of 34%. In a phase 2 study of romidepsin in patients with CTCL (GPI-04-0001), clinically meaningful reduction in pruritus (CMRP) was evaluated as an indicator of clinical benefit by using a patient-assessed visual analog scale. To determine the effect of romidepsin alone, confounding pruritus treatments including steroids and antihistamines were prohibited. At baseline, 76% of patients reported moderate-to-severe pruritus; 43% of these patients experienced CMRP, including 11 who did not achieve an objective response. Median time to CMRP was 1.8 months, and median duration of CMRP was 5.6 months. Study results suggest that the clinical benefit of romidepsin may extend beyond objective responses.
Duke Scholars
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Related Subject Headings
- Treatment Outcome
- Pruritus
- Neoplasm Staging
- Middle Aged
- Male
- Lymphoma, T-Cell, Cutaneous
- Immunology
- Humans
- Female
- Depsipeptides
Citation
Published In
DOI
EISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Treatment Outcome
- Pruritus
- Neoplasm Staging
- Middle Aged
- Male
- Lymphoma, T-Cell, Cutaneous
- Immunology
- Humans
- Female
- Depsipeptides