This Article  • Full text  • PDF  • Correction  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (52)  • Contact me when this article is cited  Related Content  • Related articles  • Similar articles in this journal  Topic Collections  • Drug Therapy  • Adverse Effects  • Hematology/ Hematologic Malignancies  • Leukemias/ Lymphomas  • Immunologic Disorders  • Alert me on articles by topic  Social Bookmarking   What's this?

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.

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED ARTICLES

Bexarotene Gel: A Food and Drug Administration–Approved Skin-Directed Therapy for Early-Stage Cutaneous T-Cell Lymphoma
Howard L. Liu and Youn H. Kim
Arch Dermatol. 2002;138(3):398-399.
EXTRACT | FULL TEXT  

Archives of Dermatology Reader's Choice: Continuing Medical Education
Arch Dermatol. 2002;138(3):421-422.
FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

How I treat mycosis fungoides and Sezary syndrome
Prince et al.
Blood 2009;114:4337-4353.
ABSTRACT | FULL TEXT  

Prognostic Factors in Primary Cutaneous Anaplastic Large Cell Lymphoma: Characterization of Clinical Subset With Worse Outcome
Woo et al.
Arch Dermatol 2009;145:667-674.
ABSTRACT | FULL TEXT  

Primary Cutaneous T-Cell Lymphomas
Rosen and Querfeld
ASH Education Book 2006;2006:323-330.
ABSTRACT | FULL TEXT  

Phase 1/2 Pilot Study of Methotrexate-Laurocapram Topical Gel for the Treatment of Patients With Early-Stage Mycosis Fungoides
Demierre et al.
Arch Dermatol 2003;139:624-628.
ABSTRACT | FULL TEXT  

Topical Nitrogen Mustard in the Management of Mycosis Fungoides: Update of the Stanford Experience
Kim et al.
Arch Dermatol 2003;139:165-173.
ABSTRACT | FULL TEXT  

Induction of Apoptosis by Bexarotene in Cutaneous T-Cell Lymphoma Cells: Relevance to Mechanism of Therapeutic Action
Zhang et al.
Clin. Cancer Res. 2002;8:1234-1240.
ABSTRACT | FULL TEXT  

Bexarotene Gel: A Food and Drug Administration-Approved Skin-Directed Therapy for Early-Stage Cutaneous T-Cell Lymphoma
Liu and Kim
Arch Dermatol 2002;138:398-399.
FULL TEXT  

Lymphoma of the Skin
Connors et al.
ASH Education Book 2002;2002:263-282.
ABSTRACT | FULL TEXT