title: Comparative study for the efficacy, safety and quality of life in patients of chronic myeloid leukemia treated with Imatinib or Hydroxyurea.
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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, India.
authors.forename: Parveen
authors.initials: P
authors.lastname: Jain
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna, India.
authors.forename: V N R
authors.initials: VN
authors.lastname: Das
authors.affiliation: Department of Biostatistics, Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna, India.
authors.forename: Alok
authors.initials: A
authors.lastname: Ranjan
authors.affiliation: Department of Clinical Oncology, Mahavir Cancer Institute and Research Centre, Patna, India.
authors.forename: Rahul
authors.initials: R
authors.lastname: Chaudhary
authors.affiliation: Department of Clinical Medicine, Rajendra Memorial Research Institute of Medical Sciences (ICMR), Patna, India.
authors.forename: Krishna
authors.initials: K
authors.lastname: Pandey
keywords: Chronic myeloid leukemia; Hydroxyurea; Imatinib; quality of life