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Phase II trial of dacomitinib, a pan-human EGFR tyrosine kinase inhibitor, in recurrent glioblastoma patients with EGFR amplification

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Sepulveda-Sanchez, JM
  • Vaz, MA
  • Balañá C
  • Gil-Gil, M
  • Gallego, O
  • Martinez-Garcia, M
  • Vicente, E
  • Quindos, M
  • Ramos, A
  • Ruano, Y
  • Perez-Segura, P
  • Sanchez-Gomez, P
  • Hernandez-Lain, A

Grupos

Abstract

Background. We conducted a multicenter, 2-stage, open-label, phase II trial to assess the efficacy and safety of dacomitinib in adult patients with recurrent glioblastoma (GB) and epidermal growth factor receptor gene (EGFR) amplification with or without variant III (EGFRvIII) deletion. Methods. Patients with first recurrence were enrolled in 2 cohorts. Cohort A included patients with EGFR gene amplification without EGFRvIII mutation. Cohort B included patients with EGFR gene amplification and EGFRvIII mutation. Dacomitinib was administered (45 mg/day) until disease progression/unacceptable adverse events (AEs). Primary endpoint was progression-free survival (PFS; RANO criteria) at 6 months (PFS6). Results. Thirty patients in Cohort A and 19 in Cohort B were enrolled. Median age was 59 years (range 39-81), 65.3% were male, and Eastern Cooperative Oncology Group Performance Status 0/1/2 were 10.2% /65.3% /24.5%, respectively. PFS6 was 10.6% (Cohort A: 13.3%; Cohort B: 5.9%) with a median PFS of 2.7 months (Cohort A: 2.7 mo; Cohort B: 2.6 mo). Four patients were progression free at 6 months and 3 patients were so at 12 months. Median overall survival was 7.4 months (Cohort A: 7.8 mo; Cohort B: 6.7 mo). The best overall response included 1 complete response and 2 partial responses (4.1%). Stable disease was observed in 12 patients (24.5%: eight in Cohort A and four in Cohort B). Diarrhea and rash were the most common AEs; 20 (40.8%) patients experienced grade 3-4 drug-related AEs. Conclusions. Dacomitinib has a limited single-agent activity in recurrent GB with EGFR amplification. The detailed molecular characterization of the 4 patients with response in this trial can be useful to select patients who could benefit from dacomitinib.

Datos de la publicación

ISSN/ISSNe:
1522-8517, 1523-5866

Neuro-Oncology  OXFORD UNIV PRESS INC

Tipo:
Article
Páginas:
1522-1531
Factor de Impacto:
4,064 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 65

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Keywords

  • dacomitinib; EGFR; glioblastoma; high-grade glioma

Campos de estudio

Proyectos asociados

ESTUDIO RETROSPECTIVO DEL MANEJO DE PACIENTES CON CANCER DE PROSTATA HORMONORESISTENTE AVANZADO. ESTUDIO ESPRO.

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Investigador Principal: JOSEP LLUIS CARBONELL ESTEVE

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