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Tyrosine kinase inhibitor interruptions, discontinuations and switching in patients with chronic-phase chronic myeloid leukemia in routine clinical practice : SIMPLICITY

Hehlmann, Ruediger (author)
Heidelberg Univ, Weinheim, Germany;ELN Fdn, Weinheim, Germany
Cortes, Jorge E. (author)
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
Zyczynski, Teresa (author)
Bristol Myers Squibb Co, Princeton, NJ USA
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Gambacorti-Passerini, Carlo (author)
Univ Milano Bicocca, San Gerardo Hosp, Monza, Italy
Goldberg, Stuart L. (author)
Hackensack Univ Med Ctr, John Theurer Canc Ctr, Hackensack, NJ USA
Mauro, Michael J. (author)
Mem Sloan Kettering Canc Ctr, 1275 York Ave, New York, NY 10021 USA
Michallet, Mauricette (author)
Ctr Hosp Lyon Sud, Pierre Benite, France
Simonsson, Bengt (author)
Uppsala universitet,Hematologi
Williams, Loretta A. (author)
Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
Gajavelli, Srikanth (author)
Bristol Myers Squibb Co, Princeton, NJ USA
DeGutis, Irene (author)
Bristol Myers Squibb Co, Princeton, NJ USA
Sen, Ginny P. (author)
ICON Clin Res LLC, San Francisco, CA USA
Paquette, Ron L. (author)
UCLA Med Ctr, Los Angeles, CA USA
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 (creator_code:org_t)
2018-10-31
2019
English.
In: American Journal of Hematology. - : WILEY. - 0361-8609 .- 1096-8652. ; 94:1, s. 46-54
  • Journal article (peer-reviewed)
Abstract Subject headings
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  • SIMPLICITY (NCT01244750) is an observational study exploring tyrosine kinase inhibitor (TKI) use and management patterns in patients with chronic phase-chronic myeloid leukemia in the US and Europe in routine clinical practice. Herein we describe interruptions, discontinuations and switching of TKI therapy during the initial 2 years of treatment among 1121 patients prospectively enrolled between October 1, 2010 and March 7, 2017. Patient characteristics were broadly similar between the imatinib (n = 370), dasatinib (n = 376), and nilotinib (n = 375) cohorts. Treatment interruptions occurred in 16.4% (year 1) and 4.0% (year 2) of patients, mainly attributed to hematologic intolerances. Treatment discontinuations occurred in 21.8% (year 1) and 10.2% (year 2) of patients, with the highest rate within the first 3 months for intolerance. Switching of TKI was seen in 17.8% (year 1) and 9.5% (year 2) of patients. Significant associations were found between TKI switching and female gender (year 1), age >= 65 years at diagnosis (year 2) and treatment with imatinib (year 2). Intolerance was the most common reason given for patients discontinuing and for switching TKI therapy; however resistance was also cited. Lack of response monitoring in routine clinical practice may have resulted in lower identification of resistance in this dataset. Data from SIMPLICITY suggest that, in routine clinical practice, intolerance and resistance to TKIs influence decisions to change treatment. Changes in TKI therapy are frequent, with nearly a third of patients discontinuing their first-line TKI.

Subject headings

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Hematologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Hematology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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