Identificador para citar o enlazar este ítem: https://hdl.handle.net/20.500.13003/19025
A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors
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eISSN: 2041-1723
WOS ID: 000871124000023
Scopus EID: 2-s2.0-85140319209
PMID: 36271011
Embase PUI: L2019688670
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Martin-Broto, Javier; Redondo, Andres; Moura, David S; Valverde, Claudia; Morales, Jose Manuel; Lopez-Pousa, Antonio; Martinez-Trufero, Javier; Gutierrez, Antonio ; Diaz-Beveridge, Roberto; Luna, Pablo; Martinez-Marin, Virginia; Marcilla, David; Arribas, Ivan; Ledesma, Patricio; Lopez-Martin, Jose Antonio; Di Lernia, Davide; Zamora, Jorge; Hindi, NadiaFecha de publicación
2022-10-21Tipo de documento
research articleCitación
Martin-Broto J, Redondo A, Moura DS, Valverde C, Morales JM, Lopez-Pousa A, et al. A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors. Nat Commun. 2022 Oct;13(1):6278.Resumen
Desmoid fibromatosis (DF) are mesenchymal neoplasms, with potential aggressive course and relevant clinical impact. New systemic therapy modalities are needed in this symptomatic/progressive population. In this multicenter, phase II trial (NCT03275818), patients with symptomatic/progressing DF received three cycles of weekly nab-paclitaxel. Brief pain inventory short form (BPI-SF) was collected at baseline and in every visit. MRI was performed every 3 months. Primary composite endpoint was RECIST 1.1 overall response rate (ORR) and/or clinical response (improvement ≥ 2 points in BPI-SF). If 40% of patients achieved clinical/radiological response, further investigation would be warranted. Toxicity, progression-free survival (PFS), pattern of response and its correlation with clinical best response and BPI, variation of physical function, and analgesic consumption were secondary endpoints. The translational research reported was not a pre-specified secondary outcome. Forty eligible patients started therapy, being 35 radiologically and clinically evaluable. The study achieved its primary endpoint, as 7(20%) patients obtained RECIST partial response, whereas 31(89%) experienced pain reduction of ≥2 points in BPI-SF worst pain. Therapy was well tolerated. With a median follow-up of 30(14-44) months, median 12 and 24-months PFS rates were 91%(CI 95%, 82-100) and 84%(CI 95%, 71-97). For clinical progression, 12 and 24-months PFS rates were 85% (CI 95%, 73-97) and 74% (CI 95%, 58-90) respectively. Short course of nab-paclitaxel is active, safe and achieves quick and durable responses in progressing/symptomatic DF patients.