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Single-agent ibrutinib in treatment-naïve and relapsed/refractory chronic lymphocytic leukemia: a 5-year experience.
O'Brien, Susan; Furman, Richard R; Coutre, Steven; Flinn, Ian W; Burger, Jan A; Blum, Kristie; Sharman, Jeff; Wierda, William; Jones, Jeffrey; Zhao, Weiqiang; Heerema, Nyla A; Johnson, Amy J; Luan, Ying; James, Danelle F; Chu, Alvina D; Byrd, John C.
Afiliación
  • O'Brien S; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Furman RR; Chao Family Comprehensive Cancer Center, University of California Irvine, Orange, CA.
  • Coutre S; Department of Medicine, Weill Cornell Medical College, New York, NY.
  • Flinn IW; Stanford Cancer Center, Stanford University School of Medicine, Stanford, CA.
  • Burger JA; Sarah Cannon Research Institute, Nashville, TN.
  • Blum K; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Sharman J; The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • Wierda W; Willamette Valley Cancer Institute and Research Center, Springfield, OR; and.
  • Jones J; Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
  • Zhao W; The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • Heerema NA; The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • Johnson AJ; The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • Luan Y; The Ohio State University Comprehensive Cancer Center, Columbus, OH.
  • James DF; Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
  • Chu AD; Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
  • Byrd JC; Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
Blood ; 131(17): 1910-1919, 2018 04 26.
Article en En | MEDLINE | ID: mdl-29437592
ABSTRACT
We previously reported durable responses and manageable safety of ibrutinib from a 3-year follow-up of treatment-naïve (TN) older patients (≥65 years of age) and relapsed/refractory (R/R) patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). We now report on long-term efficacy and safety with median follow-up of 5 years in this patient population with TN (N = 31) and R/R (N = 101) CLL/SLL. With the current 5-year follow-up, ibrutinib continues to yield a high overall response rate of 89%, with complete response rates increasing over time to 29% in TN patients and 10% in R/R patients. The median progression-free survival (PFS) was not reached in TN patients. The 5-year PFS rate was 92% in TN patients and 44% in R/R patients. Median PFS in R/R patients was 51 months; in those with del(11q), del(17p), and unmutated IGHV, it was 51, 26, and 43 months, respectively, demonstrating long-term efficacy of ibrutinib in some high-risk subgroups. Survival outcomes were less robust for R/R patients with del(17p) and those who received more prior therapies. The onset of grade ≥3 cytopenias, such as neutropenia and thrombocytopenia, decreased over time. Treatment--limiting adverse events were more frequent during the first year compared with subsequent periods. These results demonstrate sustained efficacy and acceptable tolerability of ibrutinib over an extended time, providing the longest experience for Bruton tyrosine kinase inhibitor treatment in patients with CLL/SLL. These trials were registered at www.clinicaltrials.gov as #NCT01105247 and #NCT01109069.
Asunto(s)

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirazoles / Pirimidinas / Leucemia Linfocítica Crónica de Células B Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2018 Tipo del documento: Article

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Pirazoles / Pirimidinas / Leucemia Linfocítica Crónica de Células B Tipo de estudio: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Blood Año: 2018 Tipo del documento: Article