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Activity and safety of topical pimecrolimus in patients with early stage mycosis fungoides (PimTo-MF): a single-arm, multicentre, phase 2 trial.
Ortiz-Romero, Pablo L; Maroñas Jiménez, Lidia; Muniesa, Cristina; Estrach, Teresa; Servitje, Octavio; Fernández-de-Misa, Ricardo; Gallardo, Fernando; Sanmartín, Onofre; Riveiro-Falkenbach, Erica; García-Díaz, Nuria; Vega, Rosa; Lora, David; Postigo, Concepción; Jiménez, Blanca; Sánchez-Beato, Margarita; Pedro Vaqué, José; Rodríguez Peralto, José Luis; de la Cámara, Agustín Gómez; de la Cruz, Javier; Piris Pinilla, Miguel Ángel.
Afiliación
  • Ortiz-Romero PL; Department of Dermatology, Medical School, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERONC, Madrid, Spain. Electronic address: pablo.ortiz@salud.madrid.org.
  • Maroñas Jiménez L; Department of Dermatology, Medical School, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERONC, Madrid, Spain.
  • Muniesa C; Department of Dermatology, Hospital Universitari de Bellvitge, IDIBELL, Universitat de Barcelona, Barcelona, Spain.
  • Estrach T; Department of Dermatology, Hospital Clinic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain.
  • Servitje O; Department of Dermatology, Hospital Universitari de Bellvitge, IDIBELL, Universitat de Barcelona, Barcelona, Spain.
  • Fernández-de-Misa R; Department of Dermatology, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.
  • Gallardo F; Department of Dermatology, Hospital del Mar, Autonomous University of Barcelona, Barcelona, Spain.
  • Sanmartín O; Fundación Instituto Valenciano de Oncología, Valencia, Spain.
  • Riveiro-Falkenbach E; Department of Dermatology, Medical School, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERONC, Madrid, Spain.
  • García-Díaz N; Department of Molecular Biology, University of Cantabria-IDIVAL, Santander, Spain.
  • Vega R; Scientific Support Unit, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; Spanish Clinical Research Network (SCReN), Hospital 12 de Octubre, Institute i+12, Madrid, Spain.
  • Lora D; Scientific Support Unit, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERESP, Faculty of Statistical Studies, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain.
  • Postigo C; Department of Dermatology, Medical School, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERONC, Madrid, Spain.
  • Jiménez B; Lymphoma Research Group, Medical Oncology, Instituto Investigación Sanitaria Puerta de Hierro-Segovia de Arana (IDIPHISA), Madrid, Spain; CIBERONC, Madrid, Spain.
  • Sánchez-Beato M; Lymphoma Research Group, Medical Oncology, Instituto Investigación Sanitaria Puerta de Hierro-Segovia de Arana (IDIPHISA), Madrid, Spain; CIBERONC, Madrid, Spain.
  • Pedro Vaqué J; Department of Molecular Biology, University of Cantabria-IDIVAL, Santander, Spain.
  • Rodríguez Peralto JL; Department of Pathology, Medical School, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERONC, Madrid, Spain.
  • de la Cámara AG; Scientific Support Unit, Hospital 12 de Octubre, Institute i+12, Madrid, Spain; CIBERESP, Faculty of Statistical Studies, University Complutense, Hospital 12 de Octubre, Institute i+12, Madrid, Spain.
  • de la Cruz J; International R&I, SAMID, Hospital 12 de Octubre, Institute i+12, Madrid, Spain.
  • Piris Pinilla MÁ; Department of Pathology, Fundación Jiménez Díaz, Madrid, Spain.
Lancet Haematol ; 9(6): e425-e433, 2022 Jun.
Article en En | MEDLINE | ID: mdl-35654076
BACKGROUND: The calcineurin pathway is often activated in mycosis fungoides. We aimed to assess the activity and safety of topical pimecrolimus, a calcineurin inhibitor, in patients with early mycosis fungoides. METHODS: PimTo-MF was a single-arm, multicentre, phase 2 trial done at six medical centres in Spain. Patients (aged ≥18 years) had histologically confirmed early mycosis fungoides (stages IA-IIA) and an Eastern Cooperative Oncology Group performance status of 0-1. Key exclusion criteria included the use of concurrent treatments for mycosis fungoides, including sunbathing, topical or systemic corticosteroids, and other calcineurin inhibitors. Patients applied topical pimecrolimus 1% cream on their skin lesions twice daily for 16 weeks (1 g per 2% of body surface), with subsequent follow-up of 12 months. Dosage modifications were not allowed. To evaluate adherence to the treatment, patients were instructed to return all empty tubes to the hospital (as per drug accountability protocols). The primary endpoint was the overall response ratein the intention-to-treat population. PimTo-MF is registered with EudraCT, 2014-001377-14, and is complete. FINDINGS: Between March 1, 2015, and Sept 30, 2016, 39 patients were enrolled. All patients were assessable, with a median age of 51·5 years (IQR 45-62), and the population was predominantly male (24 male [62%], 15 female [38%]). Median follow-up after baseline was 5·7 years (IQR 5·7-6·2). 22 (56%) of 39 patients had an overall response (one complete response, 21 partial responses). Responses were observed across IA (14 [54%] of 26 patients) and IB (eight [73%] of 11 patients) clinical stages, but not IIA. Topical pimecrolimus was well tolerated and no patient required a dose reduction or discontinued treatment because of unacceptable drug-related toxicity. No patients were lost to follow-up or discontinued treatment. 13 (33%) of 39 patients reported adverse events; transitory mild burning or pruritus (grade 1) was the most common, seen in eight (21%) patients. In three (8%) of these patients, the burning or pruritus was considered related to treatment. No grade 4 or 5 adverse events were observed. INTERPRETATION: Pimecrolimus 1% cream seems active and safe in patients with early stage mycosis fungoides. Our findings should be taken with caution until long-term follow-up data are obtained that confirm the safety of this treatment. Further controlled clinical trials are warranted to confirm these results. FUNDING: Instituto de Salud Carlos III and the European Regional Development Fund. TRANSLATION: For the Spanish translation of the abstract see Supplementary Materials section.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Micosis Fungoide Tipo de estudio: Clinical_trials / Guideline Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Haematol Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias Cutáneas / Micosis Fungoide Tipo de estudio: Clinical_trials / Guideline Límite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Lancet Haematol Año: 2022 Tipo del documento: Article Pais de publicación: Reino Unido