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Phase 1 and 2 Trial of Bexarotene Gel for Skin-Directed Treatment of Patients With Cutaneous T-Cell Lymphoma
Debra Breneman, PhD;
Madeleine Duvic, MD;
Timothy Kuzel, MD;
Richard Yocum, MD;
Joseph Truglia, MD;
Victor J. Stevens, MD
Arch Dermatol. 2002;138:325-332.
Objective To evaluate the safety, dose tolerance, and efficacy of topical bexarotene
gel in patients with early-stage cutaneous T-cell lymphoma (CTCL).
Design Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene
gel.
Setting Three university-based clinics.
Participants Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL.
Interventions Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments
from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated
dose.
Main Outcome Measures Patients were followed for efficacy and safety, and treatment continued
as long as they benefited. Response ( 50% improvement) was evaluated by
the Physician's Global Assessment of cutaneous disease and by an overall severity
assessment of cutaneous disease, including signs of CTCL and area involved.
Results Most patients tolerated topical bexarotene at 1% gel twice daily for
routine use. Adverse events were generally mild to moderate in severity and
were confined to treatment sites. Treatment-limiting toxic effects were associated
with skin irritation and increased with gel exposure. Patients achieved an
overall response rate of 63% and a clinical complete response rate of 21%.
Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0
weeks), and the estimated median response duration from the start of therapy
was 99 weeks. Patients with no previous therapy for mycosis fungoides responded
at a higher rate (75%) than those who previously underwent topical therapies
(67%).
Conclusions Bexarotene gel was well tolerated, was easily self-applied, and had
a substantial response rate in treating patients with early-stage CTCL.
From the Department of Dermatology, University of Cincinnati, Cincinnati,
Ohio (Dr Breneman); the Department of Dermatology, The University of Texas
and M. D. Anderson Cancer Center, Houston (Dr Duvic); the Department of Oncology,
Northwestern University, Chicago, Ill (Dr Kuzel); and Ligand Pharmaceuticals
Inc, San Diego, Calif (Drs Yocum, Truglia, and Stevens). Drs Breneman, Duvic,
and Kuzel have received financial support from Ligand Pharmaceuticals Inc
for conducting clinical trials studying bexarotene and occasionally have received
honoraria from Ligand Pharmaceuticals Inc for speaking at medical meetings.
This study was sponsored and supported by clinical research contracts from
Ligand Pharmaceuticals Inc.
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