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Ibrutinib-Rituximab or Chemoimmunotherapy for Chronic Lymphocytic Leukemia.
Shanafelt, Tait D; Wang, Xin V; Kay, Neil E; Hanson, Curtis A; O'Brien, Susan; Barrientos, Jacqueline; Jelinek, Diane F; Braggio, Esteban; Leis, Jose F; Zhang, Cong C; Coutre, Steven E; Barr, Paul M; Cashen, Amanda F; Mato, Anthony R; Singh, Avina K; Mullane, Michael P; Little, Richard F; Erba, Harry; Stone, Richard M; Litzow, Mark; Tallman, Martin.
Afiliação
  • Shanafelt TD; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Wang XV; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Kay NE; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Hanson CA; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • O'Brien S; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Barrientos J; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Jelinek DF; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Braggio E; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Leis JF; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Zhang CC; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Coutre SE; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Barr PM; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Cashen AF; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Mato AR; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Singh AK; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Mullane MP; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Little RF; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Erba H; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Stone RM; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Litzow M; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
  • Tallman M; From Stanford University, Stanford (T.D.S., S.E.C.), the University of California, Irvine, Medical Center, Orange (S.O.), and Kaiser Permanente National Cancer Institute Community Oncology Research Program (NCORP)-Permanente Medical Group, Oakland (C.C.Z.) - all in California; Dana-Farber Cancer Ins
N Engl J Med ; 381(5): 432-443, 2019 08 01.
Article em En | MEDLINE | ID: mdl-31365801
ABSTRACT

BACKGROUND:

Data regarding the efficacy of treatment with ibrutinib-rituximab, as compared with standard chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab, in patients with previously untreated chronic lymphocytic leukemia (CLL) have been limited.

METHODS:

In a phase 3 trial, we randomly assigned (in a 21 ratio) patients 70 years of age or younger with previously untreated CLL to receive either ibrutinib and rituximab for six cycles (after a single cycle of ibrutinib alone), followed by ibrutinib until disease progression, or six cycles of chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab. The primary end point was progression-free survival, and overall survival was a secondary end point. We report the results of a planned interim analysis.

RESULTS:

A total of 529 patients underwent randomization (354 patients to the ibrutinib-rituximab group, and 175 to the chemoimmunotherapy group). At a median follow-up of 33.6 months, the results of the analysis of progression-free survival favored ibrutinib-rituximab over chemoimmunotherapy (89.4% vs. 72.9% at 3 years; hazard ratio for progression or death, 0.35; 95% confidence interval [CI], 0.22 to 0.56; P<0.001), and the results met the protocol-defined efficacy threshold for the interim analysis. The results of the analysis of overall survival also favored ibrutinib-rituximab over chemoimmunotherapy (98.8% vs. 91.5% at 3 years; hazard ratio for death, 0.17; 95% CI, 0.05 to 0.54; P<0.001). In a subgroup analysis involving patients without immunoglobulin heavy-chain variable region (IGHV) mutation, ibrutinib-rituximab resulted in better progression-free survival than chemoimmunotherapy (90.7% vs. 62.5% at 3 years; hazard ratio for progression or death, 0.26; 95% CI, 0.14 to 0.50). The 3-year progression-free survival among patients with IGHV mutation was 87.7% in the ibrutinib-rituximab group and 88.0% in the chemoimmunotherapy group (hazard ratio for progression or death, 0.44; 95% CI, 0.14 to 1.36). The incidence of adverse events of grade 3 or higher (regardless of attribution) was similar in the two groups (in 282 of 352 patients [80.1%] who received ibrutinib-rituximab and in 126 of 158 [79.7%] who received chemoimmunotherapy), whereas infectious complications of grade 3 or higher were less common with ibrutinib-rituximab than with chemoimmunotherapy (in 37 patients [10.5%] vs. 32 [20.3%], P<0.001).

CONCLUSIONS:

The ibrutinib-rituximab regimen resulted in progression-free survival and overall survival that were superior to those with a standard chemoimmunotherapy regimen among patients 70 years of age or younger with previously untreated CLL. (Funded by the National Cancer Institute and Pharmacyclics; E1912 ClinicalTrials.gov number, NCT02048813.).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirazóis / Pirimidinas / Leucemia Linfocítica Crônica de Células B / Protocolos de Quimioterapia Combinada Antineoplásica / Rituximab / Imunoterapia Tipo de estudo: Clinical_trials / Guideline Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pirazóis / Pirimidinas / Leucemia Linfocítica Crônica de Células B / Protocolos de Quimioterapia Combinada Antineoplásica / Rituximab / Imunoterapia Tipo de estudo: Clinical_trials / Guideline Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: N Engl J Med Ano de publicação: 2019 Tipo de documento: Article