1. Outcomes of Chronic Myeloid Leukemia Patients With Early Molecular Response at 3 and 6 Months: A Comparative Analysis of Generic Imatinib and Glivec
- Author
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Sevil Sadri, Ahmet Emre Eskazan, Fevzi Firat Yalniz, Ugur Ozbek, Dilek Keskin, Şeniz Öngören, Mesut Ayer, Nukhet Tuzuner, Tugrul Elverdi, Muhlis Cem Ar, Selin Berk, Teoman Soysal, Isil Erdogan Ozunal, Fuat Aydinli, Yildiz Aydin, Bulent Kantarcioglu, Zafer Baslar, Osman Yokuş, Naciye Demirel, Demet Aydin, and Ayse Salihoglu
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Time Factors ,Adolescent ,Fusion Proteins, bcr-abl ,Group B ,Disease-Free Survival ,law.invention ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Randomized controlled trial ,law ,hemic and lymphatic diseases ,Internal medicine ,Leukemia, Myelogenous, Chronic, BCR-ABL Positive ,Medicine ,Drugs, Generic ,Humans ,In patient ,Protein Kinase Inhibitors ,Aged ,Retrospective Studies ,Aged, 80 and over ,Framingham Risk Score ,business.industry ,Gene Expression Regulation, Leukemic ,Myeloid leukemia ,Imatinib ,Hematology ,Middle Aged ,Surgery ,Treatment Outcome ,Oncology ,030220 oncology & carcinogenesis ,Molecular Response ,Major Molecular Response ,Imatinib Mesylate ,Female ,business ,030215 immunology ,medicine.drug - Abstract
Background The molecular response at 3 months of the original imatinib (OI) in patients with chronic myeloid leukemia has prognostic significance; however, this has never been tested for generic imatinib (GI). Patients and Methods We evaluated the BCR-ABL1 [international reporting scale ( IS )] transcript levels at 3 and 6 months to determine whether an early molecular response (EMR) had a prognostic effect on the outcome among chronic myeloid leukemia patients receiving GI. Ninety patients were divided into 2 groups, according to the imatinib they received, as OI (group A) and GI (group B). Results Two groups were equally balanced for age, gender, Sokal risk score, and optimal response. The 2 groups did not differ in achieving an EMR at 3 months, and patients with EMR at 3 months had significantly superior complete cytogenetic response and major molecular response rates compared with patients who did not achieve an EMR in both groups. The percentage of an optimal response [ BCR-ABL1 ( IS ), BCR-ABL1 ( IS ), 1%-10%] at 6 months was 93% and 95% for groups A and B, respectively ( P = .553). Patients with an optimal response (OR) at both 3 and 6 months had significantly superior event-free survival rates compared with patients without an OR in groups A and B. Conclusion The results of the present study have demonstrated most probably for the first time that an OR at 3 and 6 months in patients receiving either first-line GI and OI is clearly associated with greater response and event-free survival rates. Prospective randomized trials with larger numbers of patients and longer follow-up periods are needed to address the effect of EMR in patients receiving GI.
- Published
- 2017