A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors

Javier Martin-Broto (), Andres Redondo, David S. Moura, Claudia Valverde, Jose Manuel Morales, Antonio Lopez-Pousa, Javier Martinez-Trufero, Antonio Gutierrez, Roberto Díaz-Beveridge, Pablo Luna, Virginia Martinez-Marin, David Marcilla, Iván Arribas, Patricio Ledesma, Jose Antonio Lopez-Martin, Davide Lernia, Jorge Zamora and Nadia Hindi
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Javier Martin-Broto: Universidad Autónoma de Madrid (IIS-FJD, UAM)
Andres Redondo: Hospital Universitario La Paz
David S. Moura: Universidad Autónoma de Madrid (IIS-FJD, UAM)
Claudia Valverde: Vall d’Hebron University Hospital
Jose Manuel Morales: Virgen del Rocio University Hospital
Antonio Lopez-Pousa: Sant Pau Hospital
Javier Martinez-Trufero: Miguel Servet University Hospital
Antonio Gutierrez: University Hospital Son Espases
Roberto Díaz-Beveridge: Hospital Universitari i Politècnic La Fe
Pablo Luna: Son Espases University Hospital
Virginia Martinez-Marin: Hospital Universitario La Paz
David Marcilla: Virgen del Rocio University Hospital
Patricio Ledesma: Sofpromed Investigacion Clinica SLU
Jose Antonio Lopez-Martin: 12 de Octubre University Hospital
Davide Lernia: Universidad Autónoma de Madrid (IIS-FJD, UAM)
Jorge Zamora: Universidad Autónoma de Madrid (IIS-FJD, UAM)
Nadia Hindi: Universidad Autónoma de Madrid (IIS-FJD, UAM)

Nature Communications, 2022, vol. 13, issue 1, 1-11

Abstract: Abstract 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.

Date: 2022
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DOI: 10.1038/s41467-022-33975-6

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