Adherence to the standard dose of imatinib, rather than dose adjustment based on its plasma concentration, is critical to achieve a deep molecular response in patients with chronic myeloid leukemia

Yoshida, Chikashi; Komeno, Takuya; Hori, Mitsuo; Kimura, Toshihide; Fujii, Masami; Okoshi, Yasushi; Suzukawa, Kazumi; Hasegawa, Yoshinori; Mukai, Harumi Y.; Ito, Takayoshi; Shimizu, Seiichi; Kamoshita, Masaharu; Kudo, Daisuke; Shinagawa, Atsushi; Chikatsu, Norio; Monma, Yuriko; Watanabe, Norimichi; Kojima, Hiroshi

doi:10.1007/s12185-011-0838-3

Cited by 26 publications

(26 citation statements)

References 18 publications

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“…Eight publications came from Europe, 14,15,18,19,21,24,25,30 5 from the US, 20,23,[31][32][33] 5 from Asia 22,26,28,29,35 and one from Australia.…”

Section: Literature Searchmentioning

confidence: 99%

“…14,15,22,24,25,35 In the prospective Adherence Assessment with Glivec: Indicators and Outcomes (ADAGIO) study, Noens and colleagues 14 showed that, on average, patients with suboptimal response had significantly higher mean percentages of imatinib not taken than did those with optimal response: 23% versus 7% using pill count ( Figure 5A). …”

Section: The Consequences Of Non-adherencementioning

confidence: 99%

“…27 If a diagnosis code was used, it was based on ICD9 for CML patients. In 8 (42%) studies, patients were in CML-CP, 15,18,21,22,24,26,28,35 and in a further 2 studies patients could be in any of the 3 CML phases. 14,32 The disease duration varied across studies, ranging from less than three months to five years.…”

Section: Patients' Characteristics and Treatmentmentioning

confidence: 99%

“…An overview of the included articles is given in Online Supplementary Table S3. 14,15, Only 19 peer review articles were analyzed and reported in the Results section.Eight publications came from Europe, 14,15,18,19,21,24,25,30 5 from the US, 20,23,[31][32][33] 5 from Asia 22,26,28,29,35 and one from Australia.27 Almost half of the included studies were retrospective (9 of 19) and mainly conducted in the US and Asia 38,41,42,45,49,52,53 while half of the European studies were prospective (4 of 8). 14,15,18,24 …”

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confidence: 99%

“…In 8 (42%) studies, patients were in CML-CP, 15,18,21,22,24,26,28,35 and in a further 2 studies patients could be in any of the 3 CML phases.…”

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confidence: 99%

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Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges

et al. 2014

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Correspondence: Lucien.Noens@uzgent.be BCR-ABL inhibitors for treating chronic myeloid leukemia in chronic phase have transformed a previously incurable malignancy into a manageable condition. However, suboptimal medication adherence has been observed with these agents affecting clinical outcomes and healthcare costs. In order to raise awareness of the problem of adherence, and before developing pragmatic strategies to enhance medication adherence, a deep understanding of the best approaches for measuring adherence in chronic myeloid leukemia patients and identifying non-adherence is required. A systematic literature review on the prevalence, measurement methods, consequences and risk factors for non-adherence to BCR-ABL inhibitors and adherence-enhancing interventions was performed and critically appraised. Of the 19 included articles, 9 were retrospective. Average adherence varied from 19% to almost 100% of the proportion of prescribed drug taken, but it was measured through various different methods and within different study groups. Suboptimal adherence was associated with a negative impact on both clinical and economic outcomes. There is a lack of supportive evidence demonstrating a difference in adherence across BCR-ABL inhibitors and even contradictory results between the 2 nd generation inhibitors. Drug-related adverse events and forgetfulness were common reasons for intentional and unintentional non-adherence, respectively, but further research is required to identify additional reasons behind non-adherence or patients at risk of non-adherence. Non-adherence in chronic myeloid leukemia patients treated with BCR-ABL inhibitors is common and associated with critical outcomes. However, this review highlights important existing gaps, reveals inconsistent definitions, and a lack of standardized methods for measuring adherence in chronic myeloid leukemia. All require further investigation. ABSTRACT © F e r r a t a S t o r t i F o u n d a t i o nAnalyses statement for systematic reviews. 16 Publication database (EMBASE, PubMed, and Cochrane Library) specific search terms consisted of both single and MeSH terms for the disease, adherence and BCR-ABL inhibitor therapy (Online Supplementary Table S1). The last search was conducted on December 20 th , 2011. Full-text references were provided for the eligible abstracts that were published after completion of the search process and the analyses. In addition, and due to the lack of existing evidence of adherence in CML, clinical and economic conference proceedings were also searched with a time limit of three years. Preliminary inclusion (or exclusion) of a specific study or conference abstract was based on review of the title and abstract by 2 independent reviewers against pre-specified criteria (Table 1). Final inclusion of the study was based on an in-depth review of the full manuscript. Multiple variables were extracted from the articles to answer study objectives (Online Supplementary Table S2). The analysis was descriptive only. Since abstracts in conference pr...

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“…Eight publications came from Europe, 14,15,18,19,21,24,25,30 5 from the US, 20,23,[31][32][33] 5 from Asia 22,26,28,29,35 and one from Australia.…”

Section: Literature Searchmentioning

confidence: 99%

Section: The Consequences Of Non-adherencementioning

confidence: 99%

Section: Patients' Characteristics and Treatmentmentioning

confidence: 99%

mentioning

confidence: 99%

“…In 8 (42%) studies, patients were in CML-CP, 15,18,21,22,24,26,28,35 and in a further 2 studies patients could be in any of the 3 CML phases.…”

mentioning

confidence: 99%

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Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges

et al. 2014

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Imatinib assay by high‐performance liquid chromatography in tandem mass spectrometry with solid‐phase extraction in human plasma

Moreno

Wojnicz

Steegman

et al. 2012

Biomedical Chromatography

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We have developed a method of liquid chromatography in tandem with mass spectrometry to monitor therapeutic levels of imatinib in plasma, a selective inhibitor of protein tyrosine kinase. After solid-phase extraction of plasma samples, imatinib and its internal standard, imatinib-D8, were eluted with Zorbax SB-C18 at 60 °C, under isocratic conditions through a mobile phase consisting of 4 mm ammonium formate, pH: 3.2 (solution A) and acetonitrile solution B. The flow rate was 0.8 mL/min with 55% solution A + 45% solution B. Imatinib was detected and quantified by mass spectrometry with electrospray ionization operating in selected-reaction monitoring mode. The calibration curve was linear in the range 10-5000 ng/mL, the lower limit of quantitation being 10 ng/mL. The method was validated according to the recommendations of the Food and Drug Administration, including tests of matrix effect (bias < 10%) and recovery efficiency (>80 and <120%). The method is precise (coefficient of variance intra-day <2% and inter-day <7%), accurate (95-108%), sensitive and specific. It is a simple method with very fast recording time (1.2 min) that is applicable to clinical practice. This will permit improvement of the pharmacological treatment of patients.

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No clinical evidence for performing trough plasma and intracellular imatinib concentrations monitoring in patients with chronic myelogenous leukaemia

Ráčil

Rázga

Klamová

et al. 2013

Hematological Oncology

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This multicentre study focused on monitoring imatinib mesylate (IMA) trough plasma (Ctrough ) and intracellular (IMA Cintrac ) concentrations in 228 chronic myelogenous leukaemia patients. The median of measured IMA Ctrough in our patient group was 905.8 ng ml (range: 27.7-4628.1 ng/ml). We found a correlation between IMA Ctrough and alpha 1-acid glycoprotein plasma concentrations (rS = 0.42; p < 0.001). All other analysed parameters revealed only weak (gender, dose of IMA per kg) or not significant (age, albumin, creatinine plasma concentration or body mass index) impact on measured IMA Ctrough. The IMA Ctrough decreased during the first 6 months and significantly increased later during treatment. The IMA Ctrough at the first month of therapy did not differ between patients with and without an optimal response at the 12th (p = 0.724) and 18th month (p = 0.135) of therapy. There were no significant differences in medians of IMA Ctrough between both groups measured during the first year of treatment. The IMA Cintrac during the first month were not different between patients with and without an optimal response at the 6th (p = 0.273) and the 12th month (p = 0.193) of therapy. Our data obtained from real life clinical practice did not find a benefit of routine and regular IMA Ctrough nor IMA Cintrac therapeutic drug monitoring in chronic myelogenous leukaemia patients or for subsequent adjustments of the IMA dose based on these results. Moreover, actual alpha 1-acid glycoprotein plasma concentration should be used for proper interpretation of IMA Ctrough results.

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Adherence to the standard dose of imatinib, rather than dose adjustment based on its plasma concentration, is critical to achieve a deep molecular response in patients with chronic myeloid leukemia

Cited by 26 publications

References 18 publications

Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges

Measurement of adherence to BCR-ABL inhibitor therapy in chronic myeloid leukemia: current situation and future challenges

Imatinib assay by high‐performance liquid chromatography in tandem mass spectrometry with solid‐phase extraction in human plasma

No clinical evidence for performing trough plasma and intracellular imatinib concentrations monitoring in patients with chronic myelogenous leukaemia

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