Journal of Research in Pharmacy Practice

Comparative study for the efficacy, safety and quality of life in patients of chronic myeloid leukemia treated with Imatinib or Hydroxyurea

Document Type : Original Article

Authors

. Parveen Jain 1
. V. N. R. Das 2
. Alok Ranjan 3
. Rahul Chaudhary 4
. Krishna Pandey 2

1 Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, India

2 Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna, India

3 Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna, India

4 Department of Clinical Oncology, Mahavir Cancer Institute and Research Centre, Patna, India

Abstract
Objective: Chronic myeloid leukemia (CML) is a clonal hematopoietic disorder caused 
by acquired genetic defect in pluripotent stem cells characterized by acquisition of the 
philadelphia chromosome. The aim of this study was to compare the efficacy, safety and 
quality of life (QoL) in CML patients treated with imatinib or hydroxyurea.
Methods: A prospective observational study was conducted on 40 patients with 
pathologically confirmed CML in an in‑patient department of Mahavir Cancer Sansthan 
and Research Centre (tertiary care cancer hospital) in India. Patients were divided 
into two groups (group A: Imatinib consuming patients and group B: Hydroxyurea 
consuming patients). Complete blood count was done every month to assess the efficacy 
and safety/toxicity profile of these drugs. The results were analyzed 12 months after 
completion of treatment. QoL was assessed by The European Organization for Research 
and Treatment of Cancer QoL Questionnaire core 30. Hematological response was 
analyzed using kaplan‑meier survival analysis. Chi‑square test was applied to assess the 
association of two regimens with complete hematological response, hematological and 
non‑hematological toxicity. White blood cell (WBC) was noted each month in every 
patient of each group and analyzed by generalized linear mode (repeated measures) 
analysis of variance (ANOVA). Independent t‑test was used to compare changes in QoL 
between treatment groups.
Findings: At the end of treatment, significant improvement (P = 0.001) in hematological 
response was observed in the group A (95%) compared to group B (30%). WBC count 
analyzed at each month of treatment by ANOVA achieved better results for patients 
treated with imatinib (P = 0.0001). The hematological toxicity was higher in imatinib 
group while non‑hematological toxicity was higher in the hydroxyurea group; however 
only little toxicities such as nausea and constipation were statistically significant. QoL 
assessment of patients related to functional scale showed significantly better results in 
group A (P = 0.046).
Conclusion: The study showed that imatinib has better profile compared to hydroxyurea, 
with siginificant statistical differences in terms of efficacy, non‑hematological toxicity and 
QoL in CML patients. Even with such better efficacy and safety profile, pharmacoeconomic 
evaluation needs to be done to justify and support the use of imatinib for CML patients 
in India.

Keywords

Chronic myeloid leukemia
Hydroxyurea
Imatinib
quality of life
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Journal of Research in Pharmacy Practice
Volume 2, Issue 4
Autumn 2013
Pages 156-161

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