Document Type : Original Article
Authors
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
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