Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia

J. A. Burger, A. Tedeschi, P. M. Barr, T. Robak, C. Owen, P. Ghia, O. Bairey, P. Hillmen, N. L. Bartlett, J. Li, D. Simpson, S. Grosicki, S. Devereux, H. McCarthy, S. Coutre, H. Quach, G. Gaidano, Z. Maslyak, D. A. Stevens, A. JanssensF. Offner, J. Mayer, M. O'Dwyer, A. Hellmann, A. Schuh, T. Siddiqi, A. Polliack, C. S. Tam, D. Suri, M. Cheng, F. Clow, L. Styles, D. F. James, T. J. Kipps

Research output: Contribution to journalArticle

Abstract

Background Chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. METHODS We randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. RESULTS The median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P

Original languageEnglish
Pages (from-to)2425-2437
Number of pages13
JournalNew England Journal of Medicine
Volume373
Issue number25
DOIs
Publication statusPublished - Dec 17 2015

ASJC Scopus subject areas

  • Medicine(all)

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    Burger, J. A., Tedeschi, A., Barr, P. M., Robak, T., Owen, C., Ghia, P., Bairey, O., Hillmen, P., Bartlett, N. L., Li, J., Simpson, D., Grosicki, S., Devereux, S., McCarthy, H., Coutre, S., Quach, H., Gaidano, G., Maslyak, Z., Stevens, D. A., ... Kipps, T. J. (2015). Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia. New England Journal of Medicine, 373(25), 2425-2437. https://doi.org/10.1056/NEJMoa1509388