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Chronic myeloid leukemia patients in Tunisia: epidemiology and outcome in the imatinib era (a multicentric experience)

Annals of Hematology volume 97, pages 597–604 (2018)Cite this article

Abstract

Data are limited in developing countries regarding the clinicopathologic features and response to therapy of chronic myeloid leukemia (CML) in the era of imatinib (IM). The objective of this study is to report on the clinicoepidemiologic features of CML in Tunisia, to evaluate the long-term outcome of patients in chronic (CP) or accelerated phase (AP) treated with IM 400 mg daily as frontline therapy, and to determine imatinib’s efficacy and safety. From October 2002 to December 2014, 410 CML patients were treated with IM in six Tunisian departments of hematology. Response (hematologic, cytogenetic, and molecular responses) and outcome—overall survival (OS), event-free survival (EFS), and progression-free survival (PFS)—were evaluated. The following prognostic factors were analyzed for their impact on the European leukemia net (ELN) response, OS, EFS, and PFS at 5 years: age, sex, leukocyte count, Sokal score, European Treatment and Outcome Study (EUTOS) score, CML phase, time to starting IM, and impact of adverse events. The median age was 45 years (3–85 years). Two hundred ten (51.2%) patients were male. Splenomegaly was present in 322 of the 410 (79%). Additional cytogenetic abnormalities were encountered in 25 (6.3%) patients. At diagnosis, 379 (92.4%) patients were in CP, 31 (7.6%) were in AP. The Sokal risk was low in 87 (22.5%), intermediate in 138 (35.7%), and high in 164 patients (41.9%). The EUTOS risk was low in 217 (74%), and high in 77 (26%) patients. The rates of cumulative complete cytogenetic response (CCyR), major molecular response (MMR), and molecular response 4/5 log (MR4.5) in CP/AP-CML patients were 72, 68.4, and 46.4%, respectively. The median time to reach CCyR, MMR, and MR4.5 was 6 months (3–51), 18 months (3–72), and 24 months (3–100), respectively. According to the ELN criteria, optimal, suboptimal response, and failure were noted in 206 (51.8%), 61 (15.3%), and 125 (31.4%) patients, respectively. Five-year event-free survival (EFS), progression-free survival (PFS), and overall survival (OS) were 81, 90, and 90%, respectively. By multivariate analysis, AP, high EUTOS risk, and baseline WBC ≥ 150G/l remained independent predictive factors of non-optimal response to IM. The adverse events (AE) of IM were moderate and tolerable. With the caveats that the monitoring of the disease was not optimal, response rates were similar to those reported in previous studies. It is clear to us that improvements should be made in treatment of AP-CML and high Sokal risk group of CP-CML. The frontline use of second-generation tyrosine kinase inhibitor (TKI) is expected to improve the results of the first-line treatment of these high-risk Tunisian patients, but cost and accessibility of this therapy remain the problems in developing countries.

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Authors and Affiliations

  1. Hematology Department, Aziza Othmana University Hospital, Tunis, Tunisia

    Raihane Ben Lakhal

  2. Hematology Department, Military Hospital Tunis, Tunis, Tunisia

    Hela Ghedira & Fehmi M’Sadek

  3. Hematology Department, Hedi Chaker Hospital, Sfax, Tunisia

    Hatem Bellaaj & Moez Elloumi

  4. Hematology Department, Farhat Hached Hospital, Sousse, Tunisia

    Yosra Ben Youssef & Abderrahmane Khélif

  5. Biology, Institut Pasteur, Tunis, Tunisia

    Samia Menif

  6. Hematology Department, La Rabta Hospital, Tunis, Tunisia

    Zeineb Manai & Neila Ben Romdhane

  7. Hematology Department, Fattouma Bourguiba Hospital, Monastir, Tunisia

    Manel Bedoui & Mohamed Adnène Laatiri

  8. Centre national de greffe de moelle osseuse, Tunis, Tunisia

    Amel Lakhal & Tarek Ben Othmen

  9. Department of Haematology, Aziza Othmana University Hospital, Tunis, Tunisia

    Balkis Meddeb

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  1. Raihane Ben Lakhal
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  2. Hela Ghedira
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Correspondence to Raihane Ben Lakhal.

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Ben Lakhal, R., Ghedira, H., Bellaaj, H. et al. Chronic myeloid leukemia patients in Tunisia: epidemiology and outcome in the imatinib era (a multicentric experience). Ann Hematol 97, 597–604 (2018). https://doi.org/10.1007/s00277-017-3224-2

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  • DOI: https://doi.org/10.1007/s00277-017-3224-2

Keywords

  • Tunisia
  • Clinical practice
  • CML
  • Imatinib
  • Management
  • Survey