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Background@#Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea. @*Methods@#An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response. @*Results@#During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients). @*Conclusion@#This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.
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PURPOSE: Cyclosporin A (CsA) is widely used as a prophylactic and therapeutic agent against a graft- versus-host disease following bone marrow transplantation. Herein, a case of cyclosporin-induced optic neuropathy, after bone marrow transplantation, is reported, which to our knowledge has never previously been reported. METHODS: A 43-year-old man, with acute myelogenous leukemia, who was treated with bone marrow transplantation one month previously, also with immunosuppressive medication, presented with decreased visual acuity and nystagmus in both eyes. He had been administerd CsA for about one month, from one day before the bone marrow transplantation. A fundus examination, visual field, electroretinography, and brain MRI were performed. RESULTS: At the first ocular examination, his visual acuity was markedly decreased in both eyes. On fundus examination, an edematous optic nerve head, with superficial peripapillary hemorrhage, was noticed in both eyes. A large central scotoma was seen in both eyes on a visual field examination. The amplitude of the b-wave in the scotopic ERG was slightly decreased in both eyes. However, there were no abnormal findings in the other examinations. Cyclosporin-induced optic neuropathy was suspected as the cause of the decreased visual acuity, so the CsA was discontinued and replaced by FK506(tacrolimus). On the second day after the discontinuation of the CsA, the optic disc edema improved, and the visual acuity of both eyes recovered almost too normal. CONCLUSIONS: It is important to monitor the neuro-ophthalmologic and neurologic signs of bone marrow transplant closely in patients taking cyclosporin.