International Journal of Hematology

, Volume 106, Issue 2, pp 229–239 | Cite as

Analysis of adverse events associated with dasatinib and nilotinib treatments in chronic-phase chronic myeloid leukemia patients outside clinical trials

  • Koung Jin Suh
  • Ji Yun Lee
  • Dong-Yeop Shin
  • Youngil Koh
  • Soo-Mee Bang
  • Sung-Soo Yoon
  • Seonyang Park
  • Inho Kim
  • Jeong-Ok Lee
Original Article


We analyzed adverse events (AEs) in 201 chronic phase CML patients treated with nilotinib (n = 120) or dasatinib (n = 81) as first- or second-line therapy. The dasatinib group had significantly higher grade 3–4 AEs compared to the nilotinib group (22 vs. 54%, p < 0.001), and had more frequent dose reduction, interruption, and discontinuation (p < 0.001, p = 0.004, and p = 0.006, respectively). Of 59 patients who discontinued treatment, 47 (80%) discontinued treatment due to AEs; 50% of the AEs causing drug discontinuation were of grade 2 severity. Compared to the second-line setting, discontinuation occurred more rapidly in the first-line setting (2.9 vs. 15.6 months, p = 0.015). Pleural effusion occurred in 35% (28/81) of the patients with dasatinib and led to dasatinib discontinuation in 14 patients (grade 2 of 79%). Pulmonary artery hypertension occurred in one patient with dasatinib. Stroke, acute coronary syndrome, and peripheral artery occlusive disease occurred in 5% (6/120) of the patients treated with nilotinib. The dasatinib group had shorter event-free survival than nilotinib group (first-line, p = 0.051; second-line, p = 0.025). In the clinical practice setting, nilotinib or dasatinib use was more frequently interrupted than recommended by guidelines in association with less severe AEs. We believe this phenomenon is attributable to the availability of other TKIs.


Nilotinib Dasatinib Toxicity Pleural effusion Discontinuation 


Compliance with ethical standards

Sources of funding

This study was supported by a grant from the Seoul National University Bundang Hospital Research Fund (Grant No. 11-2011-035).

Role of the funding source

The funding source had no involvement in the study design; the collection, analysis, and interpretation of the data; writing of the report; or the decision to submit the article for publication.

Conflict of interest

The authors declare that they have no conflicts of interest.

Supplementary material

12185_2017_2225_MOESM1_ESM.docx (52 kb)
Supplementary material 1 (DOCX 51 kb)


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Copyright information

© The Japanese Society of Hematology 2017

Authors and Affiliations

  1. 1.Department of Internal MedicineSeoul National University Bundang HospitalSeongnam-SiKorea
  2. 2.Department of Internal Medicine, Seoul National University HospitalSeoul National University College of MedicineSeoulKorea
  3. 3.Department of Internal MedicineInje University Haeundae Paik HospitalBusanKorea
  4. 4.Cancer Research InstituteSeoul National University College of MedicineSeoulKorea

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