Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: results of the phase III clinical trial - 29/08/11
, Marilyn Mehlmauer, MD b, Ann G Martin, MD c, Constance A Crowley, BS d, Richard C Yocum, MD d, Steven D Reich, MD dWorldwide Bexarotene Study Group
Abstract |
Objectives |
We sought to determine the safety and efficacy of topical bexarotene (Targretin; Ligand Pharmaceuticals, La Jolla, Calif) gel 1% in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.
Methods |
We conducted a multinational, open-label, phase III study of 50 patients with stage IA to IIA cutaneous T-cell lymphoma. The primary end point classification was the overall complete and partial response rate by the higher of 2 measures: the Physician's Global Assessment of Clinical Condition or the Composite Assessment of Index Lesion Disease Severity.
Results |
The overall response rates for the Physician's Global Assessment of Clinical Condition, Composite Assessment of Index Lesion Disease Severity, and primary end point classification were 44%, 46%, and 54%, respectively. The most common adverse events possibly related to study medication were mild to moderate irritant dermatitis, pruritus, pain (ie, primarily burning at application site), and skin disorder (eg, skin inflammation, excoriation, and new lesions). There were no serious treatment-related adverse events.
Conclusions |
Topical bexarotene gel was generally well tolerated and demonstrated substantial efficacy in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, BSA, CA, CCR, CI, CTCL, EBT, PD, PEC, PGA, PR, PUVA, QOL, TLT, UV
Plan
 | Members of the Worldwide Bexarotene Study Group include: John Aeling, MD, University of Colorado Health Sciences Center, Denver, Colo; Eduardo Lopez Bran, MD, Hospital Universitario San Carlos, Madrid, Spain; Debra Breneman, MD, University of Cincinnati, Cincinnati, Ohio; Gunter Burg, MD, University Hospital, Zurich, Switzerland; Madeleine Duvic, MD, MD Anderson Cancer Center, Houston, Tex; Rokea el-Azhary, MD, Mayo Clinic, Rochester, Minn; David Fivenson, MD, Henry Ford Hospital, Detroit, Mich; Anthony Gaspari, University of Rochester School of Medicine, Rochester, NY; Peter Heald, MD, Yale University School of Medicine, New Haven, Conn; Pascal Joly, MD, Hôtel Charles Nicolle, Rouen, France; Mohammed Kashani-Sabet, MD, University of California, San Francisco, Calif; Barbara Lecewicz-Torun, MD, Katedra i Klinika Dermatologii AM, Lublin, Poland; Nicholas Lowe, MD, private practice, Santa Monica, Calif; Ann G. Martin, MD, Washington University, St Louis, Mo; Marilyn Mehlmauer, MD, private practice, Pasadena, Calif; Larry Millikan, MD, Tulane University, New Orleans, La; Jennie Muglia, MD, Rhode Island Hospital, Providence, RI; Elise Olsen, MD, Duke University Medical Center, Durham, NC; Anna Pluzanska, MD, Klinika Chemioterapii Katedry, Lodz, Poland; H. Miles Prince, MD, Peter MacCallum Cancer Institute, East Melbourne, Australia; Daniel Sauder, MD, University of Toronto, Toronto, Ontario, Canada; Robert Turner, MD, Cross Cancer Centre, Edmonton, Alberta, Canada; Kenneth Washenik, MD, New York University Medical Center, NY, NY; Gary Wood, MD, University Hospital of Cleveland, Case Western Reserve University, Cleveland, Ohio; and John Zone, MD, University of Utah, Salt Lake City, Utah. Supported by Ligand Pharmaceuticals Inc. Disclosure: The members of the Worldwide Bexarotene Study Group were investigators contracted by Ligand Pharmaceuticals. The members have signed contracts that they do not own stock in Ligand or have family members with stock in Ligand. The investigators do not have a patent license for bexarotene. Drs Heald and Duvic are in the speaker's bureau sponsored by Ligand Pharmaceuticals. Accepted for publication February 13, 2003. |
Vol 49 - N° 5
P. 801-815 - novembre 2003 Retour au numéro
Article précédent
- CME examination : Identification No. 803-111 Instructions for Category I CME credit appear in the front advertising section. See last page of contents for page number
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