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

Fecha de publicación: Fecha Ahead of Print:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Martin-Broto, Javier
  • Redondo, Andres
  • Moura, David S.
  • Valverde, Claudia
  • Morales JM
  • Lopez-Pousa, Antonio
  • Martinez-Trufero, Javier
  • Diaz-Beveridge, Roberto
  • Luna, Pablo
  • Martinez-Marin, Virginia
  • Marcilla, David
  • Arribas, Ivan
  • Ledesma, Patricio
  • Lopez-Martin JA
  • Di Lernia, Davide
  • Zamora, Jorge
  • Hindi, Nadia

Abstract

In patients with progressive and symptomatic desmoid fibromatosis (DF) treatment with chemotherapy is typically prolonged, while surgery carries a high risk of relapse. Here, the authors report the results of a phase II clinical trial of short-course nab-paclitaxel in patients with progressive and symptomatic DF. 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.

© 2022. The Author(s).

Datos de la publicación

ISSN/ISSNe:
2041-1723, 2041-1723

NATURE COMMUNICATIONS  NATURE PUBLISHING GROUP

Tipo:
Article
Páginas:
6278-6278
PubMed:
36271011
Factor de Impacto:
4,846 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 1

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Keywords

  • AGGRESSIVE FIBROMATOSIS; SERIES; MANAGEMENT; METHOTREXATE; PF-03084014; RECURRENCE; PATTERNS; IMATINIB; SURGERY; HEAD

Campos de Estudio

Proyectos y Estudios Clínicos

ESTUDIO POSAUTORIZACIÓN OBSERVACIONAL EUROPEO PARA EVALUAR LA UTILIZACIÓN Y LA SEGURIDAD DEL CITRATO DE CAFEÍNA (PEYONA®) EN EL TRATAMIENTO DE NEONATOS PREMATUROS.

Investigador Principal: PILAR SÁENZ GONZÁLEZ

CHI-CAF-2011-01 . 2012

ENSAYO CLINICO, MULTICENTRICO, CONTROLADO, ALEATORIZADO, ENMASCARADO PARA COMPARAR LA SEGURIDAD Y LA EFECTIVIDAD DE SURFAXIN (LUCINANTANT) FRENTE A CUROSURF EN LA PREVENCION Y TRATAMIENTO DEL SINDROME DE DISTRES RESPIRATORIO (SDR) EN NEONATOS PREMATUROS.

Investigador Principal: JOSE MANUEL ROQUES SERRADILLA

KL4-IRDS-02

ESTUDIO DE LOS FACTORES DE RIESGO ASOCIADOS A LAS EXTUBACIONES ACCIDENTALES

Investigador Principal: MARTA AGUAR CARRASCOSA

ACCEX

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