1. 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.
- Author
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Rey-Búa B, Grande C, Sánchez Blanco JJ, Abrisqueta P, Gutiérrez A, Ramírez Páyer Á, Giné E, Zeberio Etxetxipia I, Terol MJ, de la Cruz Vicente F, Andreu R, Ramirez MJ, de la Fuente A, Viguria MC, Peñarrubia MJ, Jiménez-Ubieto A, Montes-Moreno S, López-Guillermo A, Caballero MD, and Martín García-Sancho A
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Adult, Aged, 80 and over, Deoxycytidine analogs & derivatives, Deoxycytidine administration & dosage, Deoxycytidine adverse effects, Gemcitabine, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology, Drug Resistance, Neoplasm, Rituximab administration & dosage, Rituximab adverse effects, Oxaliplatin administration & dosage, Oxaliplatin adverse effects, Treatment Outcome, Spain epidemiology, Pyrimidines administration & dosage, Pyrimidines adverse effects, Pyrimidines therapeutic use, Adenine analogs & derivatives, Adenine administration & dosage, Piperidines administration & dosage, Lymphoma, Large B-Cell, Diffuse drug therapy, Lymphoma, Large B-Cell, Diffuse pathology, Lymphoma, Large B-Cell, Diffuse mortality, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects
- 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., (©2024 American Association for Cancer Research.)
- Published
- 2024
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