Abstract:
Objective: To monitor the tolerability and toxicity of nilotinib therapy in imatinib resistant or intolerant CML patients. Materials and Methods: All eligible patients were monitored by history & physical examination, electrocardiography (ECG), hematologic, electrolytes & pancreatic enzymes evaluation at baseline, after 2, 5, 9 & 13 weeks interval. Data analyzed with SPSS v.19. Toxicity was graded according to National Cancer Institutes Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTC v3).Results: We included 33 eligible patients. Seventy percent (23) were male. Median age 37 years (range 13 – 62). The indications for nilotinib were: Twenty four patients resistant to imatinib and 9 imatinib intolerant. These were generally mild to moderate in intensity. The most frequent adverse effect was myelosupression of which lower grade (1 and 2) thrombocytopenia was commonest (57%). Second most frequent complication was hepatotoxicity. Five patients (15%) had elevation of lipase enzyme out of them 2 had grade 3/4 derangement. Fatal toxicity occurred in only one patient who developed accelerated hypertension, led to massive intracranial hemorrhage and death. None of the patients in our study had serious QT interval prolongation. Treatment was interrupted in eight patients (5 due to hematologic toxicity, one due to hepatotoxicity, one due to elevated lipase and one patient with intracranial hemorrhage). Conclusion: Nilotinib is generally a well tolerated drug with hematological toxicity being the most common treatment related adverse effect. However due to serious events like intracranial hemorrhage as in our patient and risk of sudden cardiac death, it needs frequent monitoring during treatment.
Page(s):
75-78
DOI:
DOI not available
Published:
Journal: Annals of the Pakistan Institute of Medical Sciences, Volume: 8, Issue: 1, Year: 2012