Original Research Article
Year: 2019 | Month: November | Volume: 6 | Issue: 11 | Pages: 478-486
Experience with Nilotinib in Chronic Myeloid Leukemia-A Retrospective Analysis of Clinical Outcome
Dr. Sonia K Parikh1, Dr. Asha S Anand2, Dr. Vaibhav Srivastavas3, Dr. Harsha P Panchal2, Dr. Apurva A Patel2, Dr. Nitin C Joshi4, Dr. Bhadresh M Shashtri5
1Associate Professor & Chief of Medical Oncology Unit III, 2Professor & Chief of Medical Oncology, 3Resident Doctor, Medical Oncology, 4Paediatrician, Junior Lecturer, Paediatric Oncology, 5Clinical Assistant, Clinical Trial Wing,
Department of Medical Oncology, the Gujarat Cancer and Research Institute, Ahmedabad, INDIA
Corresponding Author: Dr. Sonia K Parikh
ABSTRACT
Background: Nilotinib is a selective and potent second generation tyrosine kinase inhibitor useful in treatment of chronic myeloid leukemia (CML). There is scarcity of data on its efficacy and safety in Indian population. Purpose of the study is to determine the clinical efficacy and adverse events (AEs) of nilotinib when used as second line treatment of CML.
Methods: This retrospective analysis was conducted at a regional cancer center in western India. CML patients with either imatinib failure or intolerance and treated with nilotinib were analyzed. Clinical outcome like hematological, cytogenetic and molecular response were reported. The frequency of AEs was assessed. Overall survivals of patients were calculated.
Results: Total 48 patients were evaluated. Median age of the patient was 45 years. There were 46 (95.83%) patients in chronic and 2(4.17%) in accelerated phase at time of treatment. Median duration of imatinib therapy was 60 (range, 3-175) months. Mean white blood cell count at time of starting treatment was 60277/µl. Imatinib resistance bcr-abl mutation was detected in 15.56% of patients. Overall, non-hematological (18.75%) and hematological (12.5%) AEs were observed in31.25% of patients. Non-laboratory AEs were electrocardiogram abnormality (6.25%), skin rash (4.17%) and gastric intolerance (2.08%). Laboratory abnormalities (grade 3 or above) were thrombocytopenia (12.5%), pancytopenia (10.42%), asymptomatic transaminitis(2.08%) and renal failure (2.08%). Overall, 82.14% patients achieved CHR with nilotinib. Median duration of exposure to nilotinib was 8.5 (range, 1–72) months. We observed 2 (4.17%) deaths. Majority (95.83%) patients were alive at time of analysis. Median overall survival was 74 (range, 5-187) months.
Conclusions: Nilotinib is safe and effective second line therapy for CML in Indian patients. Although, this is a small study with relatively short follow up, the difference made by nilotinib in progressive disease (despite high dose of imatinib) and its tolerability is worth reporting.
Key words: Chronic Myeloid Leukemia, Nilotinib, Retrospective analysis
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