TREATMENT-FREE REMISSION IN REAL-WORLD CHRONIC MYELOID LEUKEMIA PATIENTS: INSIGHTS FROM GERMAN CLINICAL HEMATOLOGY PRACTICES
Author(s): ,
Jolanta Dengler
Affiliations:
Onkologische Schwerpunktpraxis,Heilbronn,Germany
,
Hans Tesch
Affiliations:
Center for Hematology and Oncology Bethanien,Frankfurt am Main,Germany
,
Kathleen Jentsch-Ullrich
Affiliations:
Gemeinschaftspraxis für Hämatologie und Onkologie,Magdeburg,Germany
,
Anke Gerhardt
Affiliations:
MVZ für Blut- und Krebserkrankungen,Potsdam,Germany
,
Clemens Schulte
Affiliations:
Gemeinschaftspraxis für Hämatologie und Onkologie,Dortmund,Germany
,
Jörg Lipke
Affiliations:
Gemeinschaftspraxis für Hämatologie und Onkologie,Dortmund,Germany
,
Gunnar Löwe
Affiliations:
Novartis Pharma GmbH,Nürnberg,Germany
,
Isabel Holder
Affiliations:
Novartis Pharma GmbH,Nürnberg,Germany
Alexander Kiani
Affiliations:
Klinik für Onkologie und Hämatologie,Klinikum Bayreuth,Bayreuth,Germany
EHA Library. Kiani A. Jun 14, 2019; 266218; PF418
Alexander Kiani
Alexander Kiani
Contributions
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Abstract

Abstract: PF418

Type: Poster Presentation

Presentation during EHA24: On Friday, June 14, 2019 from 17:30 - 19:00

Location: Poster area

Background
Recent trials show that about 40–60% of patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) who have achieved stable deep molecular response (DMR) can discontinue tyrosine kinase inhibitor (TKI) therapy without relapsing (treatment free remission, TFR). TFR strategies are now increasingly being integrated into routine clinical practice, but “real world” information about discontinuation policies and patient outcome is scarce.

Aims
To evaluate treatment characteristics and outcome of pts with CML-CP in DMR and/or after an attempt of TFR in clinical practice in Germany.

Methods
Data from CML-CP pts were retrospectively collected from german hematologists by means of a questionnaire. Patients were eligible if they had either had achieved DMR of at least MR4 (BCR-ABL1IS ≤0.01%) or had discontinued TKI therapy prior to the time-point of data collection. Data on molecular monitoring as well as on discontinuation characteristics and TFR were assessed.

Results
1503 pts from 31 hematology practices in Germany were screened for the study, out of which 771 pts were included in the analysis. In total, 268 pts discontinued TKI treatment. The number of pts with TKI discontinuation was highly variable among practices, ranging from 0 to 36. Mean time from TKI initiation to discontinuation was 7.3 years (yrs).

At the time of entering TFR, most pts (91.0%) had achieved DMR: 101 pts (37.8%) were in MR5 (BCR-ABL1IS ≤0.001%), 116 pts (43.5%) in MR4.5 (BCR-ABL1IS ≤0.032%), and 26 pts (9.7%) in MR4. The mean time between achieving MR4 and entering TFR was 3.7 yrs. 13 pts discontinued TKI while they were in major molecular remission (BCR-ABL1IS ≤0.1%, MMR), and the molecular status of 11 pts was reported as unknown.

Molecular monitoring of BCR-ABL during the first 6 months after TKI discontinuation was heterogenous among practices: 17 of the hematologists (60.7%) reported mean monitoring intervals of 4 to <6 weeks, while monitoring intervals of 6 to 8 weeks and >8 weeks were employed by 6 (21.4%) and 5 (17.9%) of the hematologists, respectively.

144/264 (54.6%) of the pts remained in MR4 after TKI discontinuation. In 106 pts, treatment with a TKI was re-initiated, in most of the cases (70 pts) because of the loss of MMR. In 71.3% of the pts, the same TKI was used for re-treatment, while for the others an alternative TKI was chosen.

At the time-point of data collection, 703 of the 771 pts included in the analysis (91.2%) were reported to be in MR4 or better, 46 pts were in MMR. In 9 pts BCR-ABL1IS was >0.1 to 1%, in 7 pts >1-10%, and in 2 pts >10%.

 

Conclusion
These clinical data from a German real-life population show that TKI discontinuation has become part of daily clinical practice. Outcomes appear to be comparable to those reported in clinical trials, although monitoring of TFR is rather variable.

Session topic: 8. Chronic myeloid leukemia - Clinical

Keyword(s): Clinical data, Clinical outcome, Treatment-free remission, Tyrosine kinase inhibitor

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