Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma Journal Article

Authors: Straus, D. J.; Duvic, M.; Kuzel, T.; Horwitz, S.; Demierre, M. F.; Myskowski, P.; Steckel, S.
Article Title: Results of a phase II trial of oral bexarotene (Targretin) combined with interferon alfa-2b (Intron-A) for patients with cutaneous T-cell lymphoma
Abstract: BACKGROUND. Bexarotene is one of the most active single agents for the treatment of recurring or refractory cutaneous T-cell lymphoma (CTCL). Interferon alfa has also been used for many years as an effective treatment for this disease. The results in recent case reports of the combination of bexarotene and interferon alfa have been promising. Based on more extensive results reported with the combination of other retinoids with interferon alfa, the present study attempted to determine the response rate, response duration, and safety of bexarotene (Targretin capsules, Ligand Pharmaceuticals, San Diego, Calif) alone and then with the addition of interferon alfa-2b (Intron-A, Schering-Plough, Kenilworth, NJ). METHODS. Patients with biopsy-proven CTCL, TNM stages IB, IIA, IIB-IV were treated with oral bexarotene 300 mg/m 2/day for at least 8 weeks. If a complete response was not seen after 8 weeks, interferon alfa-2b 3 million units (MU) subcutaneously was added, and increased to 5 MU if tolerated, 3 times a week. RESULTS. A total of 22 patients were enrolled at 5 sites, and 18 patients were assessable for response. Overall response rate for combined bexarotene and interferon alfa was 39% (95% confidence interval [CI]: 17%-64%), including 1 patient with a clinical complete response, 6 patients with partial response, 3 patients with stable disease, and 8 patients with progressive disease. Three partial responses were first noted during the bexarotene-alone phase. Adverse events were generally manageable, and only 1 patient was withdrawn from study for hypertriglyceridemia. CONCLUSIONS. The addition of interferon alfa-2b did not increase the response rate that would have been expected with bexarotene alone. © 2007 American Cancer Society.
Keywords: adult; clinical article; treatment outcome; aged; middle aged; clinical trial; neutropenia; interferon; diarrhea; drug efficacy; drug safety; hypophosphatemia; monotherapy; side effect; infection; pain; phase 2 clinical trial; skin neoplasms; antineoplastic combined chemotherapy protocols; combination chemotherapy; aspartate aminotransferase blood level; dyspnea; febrile neutropenia; lymphocytopenia; hypoalbuminemia; depression; cutaneous t cell lymphoma; thorax pain; drug mechanism; multicenter study; anticarcinogenic agents; open study; hypercholesterolemia; drug dose increase; retinol; phase ii; atorvastatin; retinoid; hypertriglyceridemia; retinoids; recombinant alpha2b interferon; denileukin diftitox; bexarotene; interferon alfa-2b; lymphoma, t-cell, cutaneous; tetrahydronaphthalenes; ctcl; rxr; fenofibrate
Journal Title: Cancer
Volume: 109
Issue: 9
ISSN: 0008-543X
Publisher: Wiley Blackwell  
Date Published: 2007-05-01
Start Page: 1799
End Page: 1803
Language: English
DOI: 10.1002/cncr.22596
PUBMED: 17366595
PROVIDER: scopus
Notes: --- - "Cited By (since 1996): 17" - "Export Date: 17 November 2011" - "CODEN: CANCA" - "Source: Scopus"
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MSK Authors
  1. Steven M Horwitz
    382 Horwitz
  2. David J Straus
    222 Straus
  3. Patricia Myskowski
    140 Myskowski