{"doi":"10.1016/j.jid.2020.12.009","title":"Lack of Systemic Absorption of Topical Mechlorethamine Gel in Patients with Mycosis Fungoides Cutaneous T-Cell Lymphoma","abstract":"Primary cutaneous T-cell lymphomas are a heterogeneous group of lymphoproliferative disorders. The most common type is mycosis fungoides (MF), which often presents with persistent patches and plaques (Willemze et al., 2019Willemze R. Cerroni L. Kempf W. Berti E. Facchetti F. Swerdlow S.H. et al.The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas.Blood. 2019; 133: 1703-1714Crossref PubMed Scopus (277) Google Scholar). The recommended therapeutic options for patients with MF are based on international guidelines. For patients with early stage (IA–IIA) MF, skin-directed therapies are recommended as first-line treatment. Mechlorethamine is a skin-directed therapy that has been used for MF for decades (Vonderheid et al., 1989Vonderheid E.C. Tan E.T. Kantor A.F. Shrager L. Micaily B. Van Scott E.J. Long-term efficacy, curative potential, and carcinogenicity of topical mechlorethamine chemotherapy in cutaneous T cell lymphoma.J Am Acad Dermatol. 1989; 20: 416-428Abstract Full Text PDF PubMed Scopus (206) Google Scholar). Early formulations of mechlorethamine were aqueous or ointment-based. More recently, a topical mechlorethamine 0.016% w/w gel was specifically developed for treatment of MF and has been endorsed by international guidelines (National Comprehensive Cancer Network, 2020National Comprehensive Cancer NetworkNCCN clinical practice guidelines in oncology (NCCN Guidelines®). Primary cutaneous lymphomas. Version 2.2020.https://www.nccn.org/professionals/physician_gls/default_nojava.aspxDate: 2020Date accessed: August 21, 2020Google Scholar; Trautinger et al., 2017Trautinger 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: 57-74Abstract Full Text Full Text PDF PubMed Scopus (196) Google Scholar; Willemze et al., 2018Willemze R. Hodak E. Zinzani P.L. Specht L. Ladetto M. ESMO Guidelines CommitteePrimary cutaneous lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.Ann Oncol. 2018; 29: iv30-iv40Abstract Full Text Full Text PDF PubMed Scopus (64) Google Scholar). Mechlorethamine gel was approved for treatment of patients with stage IA–IB MF in the United States in 2013 on the basis of the 201 registration study (NCT00168064) and the 202 extension study (NCT00535470), in 2016 in Israel, and in 2017 in the Europe (European Medicines Agency, 2017European Medicines AgencyLedaga: summary of product characteristics.https://www.ema.europa.eu/en/documents/product-information/ledaga-epar-product-information_en.pdfDate: 2017Date accessed: August 21, 2020Google Scholar; Kim et al., 2014Kim Y.H. 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: 9093Crossref Google Scholar; Lessin et al., 2013Lessin S.R. Duvic M. Guitart J. Pandya A.G. Strober B.E. Olsen E.A. 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: 25-32Crossref PubMed Scopus (79) Google Scholar; US Food and Drug Administration, 2020US Food and Drug AdministrationValchlor (mechlorethamine) gel: prescribing information.https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202317s009lbl.pdfDate: 2020Date accessed: August 21, 2020Google Scholar). The pivotal 201 study compared 0.02% mechlorethamine gel with equal-strength compounded ointment and demonstrated that the gel met all prespecified criteria for noninferiority compared with the ointment (Lessin et al., 2013Lessin S.R. Duvic M. Guitart J. Pandya A.G. Strober B.E. Olsen E.A. et al.Topical chemotherapy in cutaneous T-cell lymphoma: positive results of a randomized, controlled, mu","journal":"Journal of Investigative Dermatology","year":2021,"id":171344,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":26,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9556,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2021-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":409106,"name":"Larisa J. Geskin","orcid":"0000-0002-0981-3513","position":1,"is_corresponding":false},{"id":705460,"name":"Ellen J. Kim","orcid":"0000-0001-9099-7614","position":2,"is_corresponding":false},{"id":291905,"name":"Julia Scarisbrick","orcid":"0000-0002-8011-4408","position":3,"is_corresponding":false},{"id":291856,"name":"Pietro Quaglino","orcid":"0000-0003-4185-9586","position":4,"is_corresponding":false},{"id":291859,"name":"Evangelia Papadavid","orcid":"0000-0002-8634-102X","position":5,"is_corresponding":false},{"id":705461,"name":"James T. Angello","orcid":"0000-0002-7714-7073","position":6,"is_corresponding":false},{"id":291879,"name":"Pablo L. Ortiz‐Romero","orcid":"0000-0003-2985-9639","position":7,"is_corresponding":false},{"id":291864,"name":"Christiane Querfeld","orcid":"0000-0001-9698-5809","position":0,"is_corresponding":true}],"reference_count":11,"raw_metadata":null,"created_at":"2026-07-18T23:46:28.747384Z","pmid":"33347924","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}