Maintenance and Concomitant Therapy Use with Chlormethine Gel Among Patients with Stage IA/IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma (MF-CTCL): A Real-World Evidence Study.

Autor: Querfeld C; City of Hope and Beckman Research Institute, 1500 E Duarte Rd, Duarte, CA, 91010, USA., Nelson WW; Helsinn Therapeutics (U.S.), Inc., 170 Wood Avenue South, 5th Floor, Iselin, NJ, 08830, USA., Gor D; Genesis Research, LLC., 111 River St, Suite 1120, Hoboken, NJ, 07030, USA., Pashos CL; Genesis Research, LLC., 111 River St, Suite 1120, Hoboken, NJ, 07030, USA., Doan QV; Genesis Research, LLC., 111 River St, Suite 1120, Hoboken, NJ, 07030, USA., Turini M; Helsinn Healthcare SA, Via Pian Scairolo 9, Lugano-Pazzallo, 6912, Lugano, Switzerland., Angello JT; Helsinn Therapeutics (U.S.), Inc., 170 Wood Avenue South, 5th Floor, Iselin, NJ, 08830, USA., Geskin LJ; Department of Dermatology, Columbia University, 161 Fort Washington Ave, 12th Floor, New York, NY, 10032, USA. ljg2145@cumc.columbia.edu.
Jazyk: angličtina
Zdroj: Dermatology and therapy [Dermatol Ther (Heidelb)] 2022 Dec; Vol. 12 (12), pp. 2781-2795. Date of Electronic Publication: 2022 Oct 25.
DOI: 10.1007/s13555-022-00831-w
Abstrakt: Introduction: Chlormethine (CL) gel is a skin-directed therapy approved for treatment of stage IA/IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in the USA. MF-CTCL has a chronic clinical course, requiring long-term maintenance therapy with one or more therapies. This analysis describes real-world patterns of maintenance therapy and use of concomitant therapy with CL gel among patients with stage IA/IB MF-CTCL.
Methods: In a US-based registry, MF-CTCL patients treated with CL gel were enrolled between 3/2015 and 10/2018 across 46 centers and followed for up to 2 years. Patient demographics, clinical characteristics, CL gel treatment patterns, concomitant treatments, clinical response, and adverse events (AEs) were collected from medical records. Descriptive statistics are reported.
Results: Of the 206 patients with stage IA/IB MF-CTCL, 58.7% were male, and average age was 60.7 years with 4.6 years since diagnosis. Topical steroids, phototherapy, and topical retinoids were used concomitantly with CL gel in 62.6%, 26.2%, and 6.3% of patients, respectively. Most concomitant therapies (up to 85%) were started before CL gel initiation and, in about half of the cases (up to 57%), were used concurrently for ≥ 12 months. Overall, 158 (76.7%) patients experienced partial response (PR) and 144 continued with maintenance therapy. After achieving PR, most patients (74.3%) kept the same maintenance therapy schedule, most commonly once daily. Of patients who had any skin-related AE (31.6%) or skin-related AEs associated with CL gel (28.2%), nearly half experienced CL gel treatment interruption and ~40% had a dosing reduction. The observed real-world treatment patterns were concordant with National Comprehensive Cancer Network (NCCN) guidelines.
Conclusion: The study results suggest that continuing CL gel maintenance therapy and combining treatments with CL gel are common practice in the real-world setting, with most maintained on a stable dosing schedule. Careful management of AEs may help patients maintain long-term optimal dosing with less treatment interruptions and dosing reductions.
(© 2022. The Author(s).)
Databáze: MEDLINE
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