Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: Results from the European ENEST1st study
| Autor: | Wieslaw Wiktor-Jedrzejczak, Delphine Rea, P Di Matteo, Michele Baccarani, P. le Coutre, Laimonas Griskevicius, Peter Schuld, Giuseppe Saglio, Luca Dezzani, Guenther Gastl, Giovanni Rosti, Tamás Masszi, Gert J. Ossenkoppele, Angela Pellegrino, Nicholas C.P. Cross, Andrzej Hellmann, T H Brümmendorf, Mahon Fx, Francis J. Giles, Kimmo Porkka, Ljubomir Petrov, J.L. Steegmann, Martin C. Müller, Daniel Coriu, Andreas Hochhaus |
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| Přispěvatelé: | Hematology, CCA - Clinical Therapy Development |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Male
Cancer Research bcr-abl Fusion Proteins bcr-abl myeloid leukemia nilotinib ENEST1st BCR-ABL1 0302 clinical medicine hemic and lymphatic diseases Clinical endpoint 80 and over Chronic Aged 80 and over Leukemia Myeloid leukemia Hematology Middle Aged Protein-Tyrosine Kinases Rash 3. Good health Oncology 030220 oncology & carcinogenesis Original Article Female medicine.symptom medicine.drug Adult medicine.medical_specialty Adolescent Blastic Phase 03 medical and health sciences Internal medicine Leukemia Myelogenous Chronic BCR-ABL Positive medicine Humans Adverse effect Protein Kinase Inhibitors Aged business.industry Fusion Proteins Imatinib Pyrimidines Anesthesiology and Pain Medicine Clinical trial Nilotinib Immunology BCR-ABL Positive business 030215 immunology Myelogenous |
| Zdroj: | Leukemia Leukemia, London : Nature Publishing Group, 2016, vol. 30, no 1, p. 57-64 Hochhaus, A, Rosti, G, Cross, N C P, Steegmann, J L, le Coutre, P, Ossenkoppele, G, Petrov, L, Masszi, T, Hellmann, A, Griskevicius, L, Wiktor-Jedrzejczak, W, Rea, D, Coriu, D, Brümmendorf, T H, Porkka, K, Saglio, G, Gastl, G, Müller, M C, Schuld, P, Di Matteo, P, Pellegrino, A, Dezzani, L, Mahon, F-X, Baccarani, M & Giles, F J 2016, ' Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase : results from the European ENEST1st study ', Leukemia, vol. 30, no. 1, pp. 57-64 . https://doi.org/10.1038/leu.2015.270 Leukemia : normal and malignant hemopoiesis 30(1), 57-64 (2016). doi:10.1038/leu.2015.270 Leukemia, 30(1), 57-64. Nature Publishing Group Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid |
| ISSN: | 0887-6924 1476-5551 |
| DOI: | 10.1038/leu.2015.270 |
| Popis: | The Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study included 1089 patients with newly diagnosed chronic myeloid leukemia in chronic phase. The rate of deep molecular response (MR4 (BCR-ABL1less than or equal to0.01% on the International Scale or undetectable BCR-ABL1 with greater than or equal to10?000 ABL1 transcripts)) at 18 months was evaluated as the primary end point, with molecular responses monitored by the European Treatment and Outcome Study network of standardized laboratories. This analysis was conducted after all patients had completed 24 months of study treatment (80.9% of patients) or discontinued early. In patients with typical BCR-ABL1 transcripts and less than or equal to3 months of prior imatinib therapy, 38.4% (404/1052) achieved MR4 at 18 months. Six patients (0.6%) developed accelerated or blastic phase, and 13 (1.2%) died. The safety profile of nilotinib was consistent with that of previous studies, although the frequencies of some nilotinib-associated adverse events were lower (for example, rash, 21.4%). Ischemic cardiovascular events occurred in 6.0% of patients. Routine monitoring of lipid and glucose levels was not mandated in the protocol. These results support the use of frontline nilotinib, particularly when achievement of a deep molecular response (a prerequisite for attempting treatment-free remission in clinical trials) is a treatment goal. |
| Databáze: | OpenAIRE |
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