TY - JOUR
T1 - ‘Real-life’ study of imatinib therapy in chronic phase-chronic myeloid leukemia
T2 - A novel retrospective observational longitudinal analysis
AU - Merante, Serena
AU - Ferretti, Virginia
AU - Elena, Chiara
AU - Calvello, Celeste
AU - Rocca, Barbara
AU - Zappatore, Rita
AU - Cavigliano, Paola
AU - Orlandi, Ester
PY - 2016/6/21
Y1 - 2016/6/21
N2 - Objectives: Imatinib is a cornerstone of treatment of chronic myeloid leukemia. It remains unclear whether transient treatment discontinuation or dose changes affect outcome and this approach has not yet been approved for use outside clinical trials. Methods: We conducted a retrospective single-institution observational study to evaluate factors affecting response in ‘real-life’ clinical practice in 138 chronic myeloid leukemia patients in chronic phase treated with imatinib. We used a novel longitudinal data analytical model, with a generalized estimating equation model, to study BCR–ABL variation according to continuous standard dose, change in dose or discontinuation; BCR–ABL transcript levels were recorded. Treatment history was subdivided into time periods for which treatment was given at constant dosage (total 483 time periods). Molecular and cytogenetic complete response was observed after 154 (32%) and 358 (74%) time periods, respectively. Results: After adjusting for length of time period, no association between dose and cytogenetic complete response rate was observed. There was a significantly lower molecular complete response rate after time periods at a high imatinib dosage. Discussion: This statistical approach can identify individual patient variation in longitudinal data collected over time and suggests that changes in dose or discontinuation of therapy could be considered in patients with appropriate biological characteristics.
AB - Objectives: Imatinib is a cornerstone of treatment of chronic myeloid leukemia. It remains unclear whether transient treatment discontinuation or dose changes affect outcome and this approach has not yet been approved for use outside clinical trials. Methods: We conducted a retrospective single-institution observational study to evaluate factors affecting response in ‘real-life’ clinical practice in 138 chronic myeloid leukemia patients in chronic phase treated with imatinib. We used a novel longitudinal data analytical model, with a generalized estimating equation model, to study BCR–ABL variation according to continuous standard dose, change in dose or discontinuation; BCR–ABL transcript levels were recorded. Treatment history was subdivided into time periods for which treatment was given at constant dosage (total 483 time periods). Molecular and cytogenetic complete response was observed after 154 (32%) and 358 (74%) time periods, respectively. Results: After adjusting for length of time period, no association between dose and cytogenetic complete response rate was observed. There was a significantly lower molecular complete response rate after time periods at a high imatinib dosage. Discussion: This statistical approach can identify individual patient variation in longitudinal data collected over time and suggests that changes in dose or discontinuation of therapy could be considered in patients with appropriate biological characteristics.
KW - Chronic myeloid leukemia
KW - Imatinib
KW - Novel statistical analysis
KW - ‘Real-life’
UR - http://www.scopus.com/inward/record.url?scp=84978472471&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84978472471&partnerID=8YFLogxK
U2 - 10.1080/10245332.2016.1196866
DO - 10.1080/10245332.2016.1196866
M3 - Article
AN - SCOPUS:84978472471
SP - 0
JO - Hematology
JF - Hematology
SN - 1024-5332
ER -