Ahmet Emre Eskazan1, Sevil Sadri1, Dilek Keskin1, Mesut Ayer2, Bulent Kantarcioglu3, Naciye Demirel3, Demet Aydin3, Fuat Aydinli4, Osman Yokus4, Isil Erdogan Ozunal1, Selin Berk1, Fevzi Firat Yalniz1, Tugrul Elverdi1, Ayse Salihoglu1, Muhlis Cem Ar1, Seniz Ongoren5, Zafer Baslar1, Yildiz Aydin1, Nukhet Tuzuner6, Ugur Ozbek7, Teoman Soysal8. 1. Division of Hematology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey. 2. Department of Hematology, Haseki Training and Research Hospital, Istanbul, Turkey. 3. Department of Hematology, Okmeydani Training and Research Hospital, Istanbul, Turkey. 4. Department of Hematology, Istanbul Training and Research Hospital, Istanbul, Turkey. 5. Division of Hematology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey. Electronic address: senizongoren@hotmail.com. 6. Department of Pathology, Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey. 7. Department of Genetics, Institute of Experimental Medicine (DETAE), Istanbul University, Istanbul, Turkey. 8. Division of Hematology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine, Istanbul University, Istanbul, Turkey. Electronic address: teomansoysal@gmail.com.
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), < 1%] and a warning response [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.
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 leukemiapatients 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), < 1%] and a warning response [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.
Authors: A Hochhaus; M Baccarani; R T Silver; C Schiffer; J F Apperley; F Cervantes; R E Clark; J E Cortes; M W Deininger; F Guilhot; H Hjorth-Hansen; T P Hughes; J J W M Janssen; H M Kantarjian; D W Kim; R A Larson; J H Lipton; F X Mahon; J Mayer; F Nicolini; D Niederwieser; F Pane; J P Radich; D Rea; J Richter; G Rosti; P Rousselot; G Saglio; S Saußele; S Soverini; J L Steegmann; A Turkina; A Zaritskey; R Hehlmann Journal: Leukemia Date: 2020-03-03 Impact factor: 11.528