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Ibrutinib in Combination with R-GemOx in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma of Nongerminal Center B-cell-like Type: Phase II Clinical Trial of the Spanish GELTAMO Group

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Rey-Bua, Beatriz
  • Grande, Carlos
  • Sanchez Blanco, Jose J.
  • Abrisqueta, Pau
  • Ramirez Payer, Angel
  • Gine, Eva
  • Zeberio Etxetxipia, Izaskun
  • Terol, Maria J.
  • de la Cruz Vicente, Fatima
  • Andreu, Rafel
  • Ramirez, Maria J.
  • de la Fuente, Adolfo
  • Viguria, Maria C.
  • Penarrubia, Maria J.
  • Jimenez-Ubieto, Ana
  • Montes-Moreno, Santiago
  • Lopez-Guillermo, Armando
  • Caballero, Maria D.
  • Martin Garcia-Sancho, Alejandro

Abstract

Purpose: This phase II clinical trial evaluated the combination of ibrutinib with rituximab, gemcitabine, and oxaliplatin (R-GemOx) in patients with nongerminal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL).Patients and Methods: The IBDCL trial (NCT02692248) included patients with histologic diagnosis of non-GCB DLBCL with relapsed or refractory disease and non-candidates for stem-cell transplantation. Patients received an induction treatment consisting of six or eight cycles of R-GemOx at standard doses every 2 weeks, in combination with ibrutinib (560 mg daily), followed by a maintenance treatment with ibrutinib for a maximum of 2 years. The primary objective was to evaluate the overall response rate after four cycles.Results: Sixty-four patients were included, 72% of them refractory to the last regimen. The overall response rate and complete remission rate after the fourth cycle were 53% [95% confidence interval (CI), 41-65] and 34% (95% CI, 24-46), respectively. Twenty-four (37%) patients started maintenance, and 7 (11%) completed the planned 2 years. After a median follow-up of 29.7 months (range: 0.4-48.6), the estimated 2-year progression-free survival and overall survival were 18% (95% CI, 8-28) and 26% (95% CI, 14-37), respectively. The most common grade >= 3 treatment-related adverse events were thrombocytopenia (44%), neutropenia (30%), and anemia (14%). Grade >= 3 infectious and cardiovascular treatment-related adverse events were reported in 6 (9%) and 1 (2%) patient, respectively.Conclusions: Ibrutinib in combination with R-GemOx, followed by ibrutinib maintenance, demonstrated encouraging antitumor activity with durable responses and a manageable toxicity in patients with non-GCB DLBCL.

Datos de la publicación

ISSN/ISSNe:
1078-0432, 1557-3265

Clinical cancer research : an official journal of the American Association for Cancer Research  AMER ASSOC CANCER RESEARCH

Tipo:
Article
Páginas:
3704-3714
Factor de Impacto:
4,399 SCImago ℠
Cuartil:
Q1 SCImago ℠

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Keywords

  • EFFECTIVE SALVAGE REGIMEN; GENE-EXPRESSION; KAPPA-B; RITUXIMAB; BENDAMUSTINE; PATHOGENESIS; GEMCITABINE; OXALIPLATIN; CANDIDATES; MUTATIONS

Campos de estudio

Proyectos asociados

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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