Efficacy and safety profile of generic imatinib in patients with newly diagnosed chronic myeloid leukemia-chronic phase:
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ORIGINAL ARTICLE
Efficacy and safety profile of generic imatinib in patients with newly diagnosed chronic myeloid leukemia-chronic phase: sharing experience of a hemato-oncology center from eastern India Abhijit Phukan 1 & Prakas Kumar Mandal 1
&
Tuphan K. Dolai 1
Received: 6 July 2020 / Accepted: 28 September 2020 # Springer-Verlag GmbH Germany, part of Springer Nature 2020
Abstract In India, CML is the commonest adult leukemia. Imatinib is the gold standard for frontline treatment of newly diagnosed CMLCP patients. The present study was conducted to assess the efficacy and safety of generic imatinib in newly diagnosed CML-CP patients. In this prospective study, 76 newly diagnosed CML-CP patients received generic imatinib. They were monitored as per the ELN2013 recommendation. Karyotyping and BCR-ABL transcript level were done at specified time points. Adverse effects, if any, were documented as per the NCI-CTCAE criteria v4.03. Statistical analysis was done using standard methods. A total of 76 patients included in the study; median age was 36 years. The most common (71%) presenting symptom was fatigue; splenomegaly was found in all patients. CHR was achieved in 97% cases. At 3 months, 64.5% patients achieved ERM. At 6 months, CCyR and MCyR had seen in 65% and 68% cases, respectively. MMR achieved at 12 months in 44% cases. Most common hematological and non-hematological toxicity were anemia and skin changes seen in 89.5% and 71% cases, respectively. With generic imatinib therapy, the results of treatment outcome and safety profile were comparable with original imatinib. The added advantage was gross reduction in cost of therapy meeting unmet needs in CML patients in countries with resource constraints. Keywords Chronic myelogenous leukemia . Newly diagnosed . Generic imatinib . Treatment outcome . Safety profile
Abbreviations CML-CP Chronic myelogenous leukemia-chronic phase ELN European LeukemiaNet N C I National Cancer Institute Common Terminology CTCAE Criteria for Adverse Events CHR Complete hematological remission ERM Early molecular response CCyR Complete cytogenetic response MCyR Major cytogenetic response MMR Major molecular response TKI Tyrosine kinase inhibitor CBC Complete blood counts PBS Peripheral blood smear BMA Bone marrow aspiration
* Prakas Kumar Mandal [email protected] 1
Department of Hematology, NRS Medical College, 138, AJC Bose Road, Kolkata 700014, India
BMB RT-PCR DMR OS PFS
Bone marrow biopsy Reverse transcriptase-polymerase chain reaction Deep molecular response Overall survival Progression-free survival
Introduction Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm (MPN) characterized by the expansion of a clone of hematopoietic cells. Reports from several European CML registries showed an annual incidence of 0.7–1.3/100,000 population, median age at diagnosis of 56–60 years, and a male/female ratio of 1.2–1.7 [1]. In India, CML is the commonest adult leukemia with annual incidence of 0.6– 2.2/100,000, and the median age at diagnosis is 38–40 years [2, 3]. Th
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