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Leuk Res. 2018 Jul;70:100-105. doi: 10.1016/j.leukres.2018.06.002. Epub 2018 Jun 7.

Comparative analyses of nilotinib versus high-dose imatinib versus sustained standard-dose imatinib in patients with chronic phase chronic myeloid leukemia following suboptimal molecular response to first-line imatinib.

Author information

1
Leukemia Research Institute, The Catholic University of Korea, Seoul, Republic of Korea; Department of Hematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
2
Leukemia Research Institute, The Catholic University of Korea, Seoul, Republic of Korea.
3
BMT Program, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.
4
Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea.
5
Department of Oncology/Hematology, Kyungpook National University Hospital, Daegu, Republic of Korea.
6
Department of Hematology/Oncology, Ajou University School of Medicine, Suwon, Republic of Korea.
7
Department of Internal Medicine, Dong-A University College of Medicine, Busan, Republic of Korea.
8
Department of Internal Medicine, Hallym University College of Medicine, Anyang, Republic of Korea.
9
Department of Internal Medicine, Kangbuk Samsung Hospital, Seoul, Republic of Korea.
10
Leukemia Research Institute, The Catholic University of Korea, Seoul, Republic of Korea; Department of Hematology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: dwkim@catholic.ac.kr.

Abstract

The aim of this study was to investigate the efficacy of nilotinib (NIL) versus high-dose imatinib (IM) versus sustained standard-dose IM for patients with chronic myeloid leukemia (CML) with suboptimal molecular response to first-line IM therapy. Patients with CML who achieved complete cytogenetic response (CCyR) but not major molecular response (MMR) after 18-24 months on first-line IM therapy were enrolled and divided into three treatment cohorts: NIL 800 mg/day (Cohort 1, n = 28) and IM 800 mg/day (Cohort 2, n = 28) in the RE-NICE study, and sustained IM 400 mg/day (Cohort 3, n = 52) in clinical practice. The primary efficacy variable of cumulative rate of MMR by 12 months was not different among the three cohorts. However, the cumulative incidence of MMR by 36 months was significantly higher in Cohort 1 than Cohort 3 (83.1% vs. 57.1%, P = 0.021), but there were no significant differences in Cohort 1 vs. 2 (P = 0.195) and Cohort 2 vs. 3 (P = 0.297). Different profile for adverse events was observed between NIL and high-dose IM therapy. In conclusion, our data suggested that switching to NIL may provide more effective long-term response than sustaining standard-dose IM for patients with suboptimal molecular response to first-line IM.

KEYWORDS:

Chronic myeloid leukemia; Imatinib; Nilotinib; Suboptimal response

PMID:
29908417
DOI:
10.1016/j.leukres.2018.06.002
[Indexed for MEDLINE]

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