Article

Romidepsin: A New Drug for the Treatment of Cutaneous T-Cell Lymphoma

Robin Frye

Mary Myers

Karen C. Axelrod

Elizabeth A. Ness

Richard L. Piekarz

Susan E. Bates

Susan Booher

pharmaceutical preparations, lymphoma
CJON 2012, 16(2), 195-204. DOI: 10.1188/12.CJON.195-204

Patients with cutaneous T-cell lymphoma (CTCL) have a rare, disfiguring, and life-threatening subtype of non-Hodgkin lymphoma primarily localized to the skin. Their immune systems are altered and their skin is compromised. In addition, they are highly prone to infections—the most common cause of death in patients with this disease. Patients presenting with early-stage disease involvement typically are treated with topical therapies; patients with advanced-stage and recurrent disease require systemic treatment. Specialized knowledge is required by oncology healthcare providers to manage the wide array of symptoms experienced by these patients as a part of the natural course of this disease. A new drug, romidepsin, approved by the U.S. Food and Drug Administration, is indicated in the treatment of relapsed CTCL. The authors discuss use of romidepsin in the context of CTCL and the information needed to safely administer romidepsin and manage its side effects.

Jump to a section

    References

    Alibert, J. L. (1806). Description des maladies de le peau: observées a l'hôspital St. Louis et exposition des meilleurs methodes suivies pour leur traitement. Paris, France: Barrois l'ainé et fils.
    Axelrod, P. I., Lorber, B., & Vonderheid, E. C. (1992). Infections complicating mycosis fungoides and Sézary Syndrome. JAMA, 267, 1354-1358. doi:10.1001/jama.1992.03480100060031
    Booher, S., McCann, S., & Tawa, M. (2008). Cutaneous T-cell lymphoma: Mycosis fungoides/Sézary Syndrome. In P. Muehlbauer & C. McGowan (Eds.), Site-specific cancer series: Skin cancer (pp. 81-101). Pittsburgh, PA: Oncology Nursing Society.
    Cornwell, P., Arnold-Long, M., Barss, S. B., & Varnado, M. F. (2010). The use of Dakin's solution in chronic wounds. Journal of Wound Ostomy, 37, 94-104. doi:10.1097/WON.0b013e3181c78874
    Criscione, V. D., & Weinstock, M. A. (2007). Incidence of cutaneous T-cell lymphoma in the United States, 1973-2002. Archives of Dermatology, 143, 854-859. doi:10.1001/archderm.143.7.854
    DiMasi, J. A., & Grabowski, H. G. (2007). Economics of new oncology drug development. Journal of Clinical Oncology, 25, 209-216. doi:10.1200/JCO.2006.09.0803
    Duvic, M. (2001). Current treatment of cutaneous T-cell lymphoma. Retrieved from http://dermatology-s10.cdlib.org/DOJvol7num1
    Girardi, M., Heald, P., & Wilson, L. (2004). The pathogenesis of mycosis fungoides. New England Journal of Medicine, 350, 1978-1988. doi:10.1056/NEJMra032810
    Gloucester Pharmaceuticals. (2009). Istodax® (romidepsin) [Package insert]. Cambridge, MA: Author.
    Goldberg, M. T., & McGinn-Byer, M. (2007). Oncology related skin damage. In R. A. Bryant & D. P. Nix (Eds.), Acute and chronic wounds: Current management concepts (3rd ed.). St. Louis, MO: Mosby/Elsevier, Inc.
    Horwitz, S. M. (2008). Novel therapies for cutaneous T-cell lymphomas. Clinical Lymphoma and Myeloma, 8(Suppl. 5), S187-S192. doi:10.3816/CLM.2008.s.015
    Horwitz, S. M., Olsen, E. A., Duvic, M., Pierliugi, P., & Kim, Y. H. (2008). Review of the treatment of mycosis fungoides and Sézary Syndrome: A stage-based approach. Journal of the National Comprehensive Cancer Network, 6, 436-442.
    Hwang, S. T., Janik, J. E., Jaffe, E. S., & Wilson, W. H. (2008). Mycosis fungoides and Sézary Syndrome. Lancet, 37, 945-957. doi:10.1016/S0140-6736(08)60420-1
    Johnstone, R. W., & Licht, J. D. (2003). Histone deacetylase inhibitors in cancer therapy: Is transcription the primary target? Cancer Cell, 4, 13-18. doi:10.1016/S1535-6108(03)00165-X
    Keefe, D. L. (2002). The cardiotoxic potential of the 5-HT3 receptor antagonist antiemetics: Is there cause for concern? Oncologist, 7, 65-72. doi:10.1634/theoncologist.7-1-65
    Kim, Y. H., Liu, H. L., Mraz-Gernhard, S., Varghese, A., & Hoppe, R. T. (2003). Long-term outcome of 525 patients with mycosis fungoides and Sézary Syndrome: Clinical prognostic factors and risk for disease progression. Archives of Dermatology, 139, 857-866. doi:10.1001/archderm.139.7.857
    Lansigan, F., & Foss, F. M. (2010). Current and emerging treatment strategies for cutaneous T-cell lymphoma. Drugs, 70, 273-286.
    Lutzner, M., Edelson, R., Schein, P., Green, I., Kirkpatrick, C., & Ahmed, A. (1975). Cutaneous T-cell lymphomas: The Sézary Syndrome, mycosis fungoides, and related disorders. Annals of Internal Medicine, 83, 534-552.
    Marks, P. A., & Xu, W. S. (2009). Histone deacetylase inhibitors: Potential in cancer therapy. Journal of Cellular Biochemistry, 107, 600-608. doi:10.1002/jcb.22185
    Marshall, J. L., Rizvi, N., Kauh, J., Dahut, W., Figuera, M., Kang, M. H., … Hawkins, M. J. (2002). A phase I trial of depsipeptide (FR901228) in patients with advanced cancer. Journal of Experimental Therapeutics and Oncology, 2, 325-332. doi:10.1046/j.1359-4117.2002.01039.x
    Morales Suarez-Varela, M. M., Llopis Gonzalez, A., Marquina Vila, A., & Bell, J. (2000). Mycosis fungoides: Review of epidemiological observations. Dermatology, 201, 21-28. doi:10.1159/000018423
    National Cancer Institute. (2010). Mycosis fungoides and the Sezary Syndrome treatment (PDQ) [Health professional version]. Retrieved from http://www.cancer.gov/cancertopics/pdq/treatment/mycosisfungoides/HealthProfessional
    National Cancer Institute Cancer Therapy Evaluation Program. (1999). Common Toxicity Criteria [version 2.0]. Retrieved from http://www.eortc.be/services/doc/ctc/ctcv20_4-30-992.pdf
    Olsen, E., Vonderheid, E., Pimpinelli, N., Willemze, R., Kim, Y., Knobler, R., … Whittaker, S. (2007). Revisions to the staging and classification of mycosis fungoides and Sézary Syndrome: A proposal of the International Society for Cutaneous Lymphomas (ISCL) and the Cutaneous Lymphoma Task Force of the European Organisation of Research and Treatment of Cancer (EORTC). Blood, 110, 1713-1722. doi:10.1182/blood-2007-03-055749
    Piekarz, R. L., & Bates, S. E. (2009). Epigenetic modifiers: Basic understanding and clinical development. Clinical Cancer Research, 15, 3918-3926. doi:10.1158/1078-0432.CCR-08-2788
    Piekarz, R. L., Frye, A. R., Wright, J. J., Steinberg, S. M., Liewehr, D. J., Rosing, D. R., … Bates, S. E. (2006). Cardiac studies in patients treated with depsipeptide, FK228, in a phase II trial for T-cell lymphoma. Clinical Cancer Research, 12, 3762-3773. doi:10.1158/1078-0432.CCR-05-2095
    Piekarz, R. L., Frye, R., Turner, M., Wright, J. J., Allen, S. L., Kirschbaum, M. H., … Bates, S. E. (2009). Phase II multi-institutional trial of the histone deacetylase inhibitor romidepsin as monotherapy for patients with cutaneous T-cell lymphoma. Journal of Clinical Oncology, 27, 5410-5417. doi:10.1200/JCO.2008.21.6150
    Piekarz, R. L., Robey, R., Sandor, V., Bakke, S., Wilson, W. H., Dahmoush, L., … Bates, S. E. (2001). Inhibitor of histone deacetylation, depsipeptide (FR901228), in the treatment of peripheral and cutaneous T-cell lymphoma: A case report. Blood, 98, 2865-2868. doi:10.1182/blood.V98.9.2865
    Piekarz, R. L., Sackett, D. L., & Bates, S. E. (2007). Histone deacetylase inhibitors and demethylating agents: Clinical development of histone deacetylase inhibitors for cancer therapy. Cancer Journal, 13, 30-39. doi:10.1097/PPO.0b013e31803c73cc
    Richon, V. M., Garcia-Vargas, J., & Hardwick, J. S. (2009). Development of vorinostat: Current applications and future perspectives for cancer therapy. Cancer Letters, 280, 201-210. doi:10.1016/j.canlet.2009.01.002
    Sandor, V., Bakke, S., Robey, R. W., Kang, M. H., Blagosklonny, M. V., Bender, J., … Bates, S. E. (2002). Phase I trial of the histone deacetylase inhibitor, depsipeptide (FR901228, NSC630176), in patients with refractory neoplasms. Clinical Cancer Research, 8, 718-728.
    Schrump, D. S. (2009). Cytotoxicity mediated by histone deacetylase inhibitors in cancer cells: Mechanisms and potential clinical implications. Clinical Cancer Research, 15, 3947-3957. doi:10.1158/1078-0432.CCR-08-2787
    Simpson, E. (2010). Atopic dermatitis: A review of topical treatment options. Current Medical Research and Opinion, 26, 633-640.
    Title 21, United States Code of Federal Regulations (CFR), Part 312, 2010.
    Ueda, H., Manda, T., Matsumoto, S., Mukumoto, S., Nishigaki, F., Kawamura, I., & Shimomura, K. (1994). FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968. III. Antitumor activities on experimental tumors in mice. Journal of Antibiotics, 47, 315-323.
    Ueda, H., Nakajima, H., Hori, Y., Goto, T., & Okuhara, M. (1994). Action of FR901228, a novel antitumor bicyclic depsipeptide produced by Chromobacterium violaceum No. 968, on Ha-ras transformed NIH3T3 cells. Japan Society for Bioscience, Biotechnology, and Agrochemistry, 58, 1572-1583.
    Vonderheid, E. C., Bernengo, M. G., Burg, G., Duvic, M., Heald, P., Laroch, L., … Willemze, R. (2002). Update on erythrodermic cutaneous T-cell lymphoma: Report of the International Society for Cutaneous Lymphomas. Journal of the American Academy of Dermatology, 46, 95-106. doi:10.1067/mjd.2002.118538
    Whittaker, S. J., Demierre, M., Kim, E. J., Rook, A. H., Lerner, A., Duvic, M., … Kim, Y. H. (2010). Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma. Journal of Clinical Oncology, 28, 4485-4491. doi:10.1200/JCO.2010.28.9066
    Willemze, R., Jaffe, E. S., Burg, G., Cerroni, L., Berti, E., Swerdlow, S. H., … Meijer, C. J. (2005). WHO-EORTC classification for cutaneous lymphomas. Blood, 105, 3768-3785. doi:10.1182/blood-2004-09-3502