The PROVe Study: US Real-World Experience with Chlormethine/Mechlorethamine Gel in Combination with Other Therapies for Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma

Ellen J. Kim1, Joan Guitart2, Christiane Querfeld3, Michael Girardi4, Amy Musiek5, Oleg E. Akilov6, James T. Angello7, William L. Bailey7, Larisa J. Geskin8
1Department of Dermatology, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Boulevard, Philadelphia, PA, 19104, USA
2Northwestern University Feinberg School of Medicine, Chicago, IL, USA
3Division of Dermatology, City of Hope, Duarte, CA, USA
4Department of Dermatology, Yale School of Medicine, New Haven, CT, USA
5Division of Dermatology, Washington University School of Medicine, St Louis, MO, USA
6Department of Dermatology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
7Helsinn Therapeutics (U.S.) Inc., Iselin, NJ, USA
8Department of Dermatology, Columbia University, New York, NY, USA

Tóm tắt

Từ khóa


Tài liệu tham khảo

Willemze R, Jaffe ES, Burg G, Cerroni L, Berti E, Swerdlow SH, et al. WHO-EORTC classification for cutaneous lymphomas. Blood. 2005;105(10):3768–85.

Wilcox RA. Cutaneous T-cell lymphoma: 2017 update on diagnosis, risk-stratification, and management. Am J Hematol. 2017;92(10):1085–102.

Trautinger F, Eder J, Assaf C, Bagot M, Cozzio A, Dummer R, et al. European Organisation for research and treatment of cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome - update 2017. Eur J Cancer. 2017;77:57–74.

Willemze R, Hodak E, Zinzani PL, Specht L, Ladetto M, ESMO Guidelines Committee. Primary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018;29(suppl 4):iv30–40.

National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Primary cutaneous lymphomas. Version 1.2020. 2020. https://www.nccn.org/professionals/physician_gls/default_nojava.aspx. Accessed 25 Jun 2020.

Denis D, Beneton N, Laribi K, Maillard H. Management of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL): focus on chlormethine gel. Cancer Manag Res. 2019;11:2241–51.

Vonderheid EC, Tan ET, Kantor AF, Shrager L, Micaily B, Van Scott EJ. Long-term efficacy, curative potential, and carcinogenicity of topical mechlorethamine chemotherapy in cutaneous T cell lymphoma. J Am Acad Dermatol. 1989;20(3):416–28.

Ramsay DL, Meller JA, Zackheim HS. Topical treatment of early cutaneous T-cell lymphoma. Hematol Oncol Clin North Am. 1995;9(5):1031–56.

Kim YH, Martinez G, Varghese A, Hoppe RT. Topical nitrogen mustard in the management of mycosis fungoides: update of the Stanford experience. Arch Dermatol. 2003;139(2):165–73.

Valchlor [prescribing information]. Iselin, NJ: Helsinn Therapeutics (US) Inc. 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdf. Accessed 25 Jun 2020.

Lessin SR, Duvic M, Guitart J, Pandya AG, Strober BE, Olsen EA, et al. Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, multicenter trial testing the efficacy and safety of a novel mechlorethamine, 0.02%, gel in mycosis fungoides. JAMA Dermatol. 2013;149(1):25–32.

Kim YH, Duvic M, Guitart J, Lessin S. Efficacy and safety of mechlorethamine (MCH) 0.04% gel in mycosis fungoides (MF) after treatment with topical MCH 0.02%. J Clin Oncol. 2014;32(suppl 15): abstract 9093.

Ledaga [summary of product characteristics]. Dublin, Ireland: Helsinn Birex Pharmaceuticals Ltd. 2017. https://www.ema.europa.eu/en/documents/product-information/ledaga-epar-product-information_en.pdf. Accessed 25 Jun 2020.

Querfeld C, Geskin LJ, Kim EJ, Scarisbrick JJ, Quaglino P, Papadavid E, Angello JT, Ortiz-Romero PL. Lack of Systemic Absorption of Topical Mechlorethamine Gel in Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma. J Invest Dermatol. 2021. https://doi.org/10.1016/j.jid.2020.12.009

Kim EJ, Geskin L, Guitart J, Querfeld C, Girardi M, Musiek A, et al. Real-world experience with mechlorethamine gel in patients with mycosis fungoides-cutaneous lymphoma: preliminary findings from a prospective observational study. J Am Acad Dermatol. 2020;83(3):928–30.

Chren MM, Lasek RJ, Flocke SA, Zyzanski SJ. Improved discriminative and evaluative capability of a refined version of Skindex, a quality-of-life instrument for patients with skin diseases. Arch Dermatol. 1997;133(11):1433–40.

Prinsen CA, Lindeboom R, de Korte J. Interpretation of Skindex-29 scores: cutoffs for mild, moderate, and severe impairment of health-related quality of life. J Invest Dermatol. 2011;131(9):1945–7.