Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study

Jorge E. Cortes, Qian Jiang, Jianxiang Wang, Jianyu Weng, Huanling Zhu, Xiaoli Liu, Andreas Hochhaus, Dong Wook Kim, Jerald Radich, Michael Savona, Patricia Martin-Regueira, Oumar Sy, Renuka Gurnani, Giuseppe Saglio

Research output: Contribution to journalArticle

Abstract

Early molecular response is associated with improved probability of deep molecular response and superior survival in patients with CML-CP. However, ~1 in 3 patients on first-line imatinib do not achieve this threshold. The phase 2b DASCERN trial (NCT01593254) assessed the outcome of early switch to dasatinib in patients with suboptimal response to first-line imatinib. Adult patients with CML-CP were randomized (2:1) to receive 100 mg dasatinib (n = 174) or continue imatinib at ≥400 mg (n = 86). The primary endpoint was the rate of major molecular response (MMR) at 12 months, which was 29% (dasatinib) and 13% (imatinib; P = 0.005). After ≥2 years of follow-up, 45 patients (52%) randomized to continue imatinib had crossed over to dasatinib. Considering treatment crossover, the 2-year cumulative MMR rate was 64% with dasatinib and 41% with imatinib (66% and 67%, respectively by intent-to-treat). Adverse events were consistent with the established safety profiles of both drugs. The results of this first prospective study support early monitoring of patients treated with first-line imatinib, and suggest that switching to dasatinib in cases of suboptimal response may offer clinical benefit. Further follow-up is needed to assess the long-term clinical benefit of early switching.

Original languageEnglish (US)
Pages (from-to)2064-2073
Number of pages10
JournalLeukemia
Volume34
Issue number8
DOIs
StatePublished - Aug 1 2020

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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    Cortes, J. E., Jiang, Q., Wang, J., Weng, J., Zhu, H., Liu, X., Hochhaus, A., Kim, D. W., Radich, J., Savona, M., Martin-Regueira, P., Sy, O., Gurnani, R., & Saglio, G. (2020). Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia, 34(8), 2064-2073. https://doi.org/10.1038/s41375-020-0805-1