Nilotinib first-line therapy in patients with Philadelphia chromosome-negative/BCR-ABL-positive chronic myeloid leukemia in chronic phase:ENEST1st sub-analysis
| Autor: | Maria Liz Paciello Coronel, Beatrice Vincenzi, Ljubomir Petrov, Fausto Castagnetti, Delphine Rea, Andrzej Hellmann, Francis J. Giles, Andreas Hochhaus, Valentin Garcia-Gutierrez, Maria Asuncion Echeveste Gutierrez, Franҫois-Xavier Mahon, Luca Dezzani, Philipp le Coutre, Gianantonio Rosti, Norbert Gattermann, Nicholas C.P. Cross, Jeroen Janssen |
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| Přispěvatelé: | CCA - Cancer Treatment and quality of life, Hematology, Hochhaus, Andrea, Mahon, Franois-Xavier, le Coutre, Philipp, Petrov, Ljubomir, Janssen, Jeroen J. W. M., Cross, Nicholas C. P., Rea, Delphine, Castagnetti, Fausto, Hellmann, Andrzej, Rosti, Gianantonio, Gattermann, Norbert, Coronel, Maria Liz Paciello, Gutierrez, Maria Asuncion Echeveste, Garcia-Gutierrez, Valentin, Vincenzi, Beatrice, Dezzani, Luca, Giles, Francis J. |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Male
0301 basic medicine Cancer Research Myeloid Original Article – Clinical Oncology Fusion Proteins bcr-abl Gastroenterology Antineoplastic Agent 0302 clinical medicine hemic and lymphatic diseases Philadelphia Chromosome Hematology Chronic myeloid leukemia Myeloid leukemia General Medicine Middle Aged Leukemia medicine.anatomical_structure Oncology 030220 oncology & carcinogenesis Female Human medicine.drug Adult medicine.medical_specialty Adolescent Anemia Philadelphia Chromosome Negative Protein Kinase Inhibitor Antineoplastic Agents Real-Time Polymerase Chain Reaction Philadelphia chromosome Leukemia Myeloid Chronic Atypical BCR-ABL Negative Young Adult 03 medical and health sciences Internal medicine medicine Humans Philadelphia chromosome negative/BCR-ABL positive Protein Kinase Inhibitors Aged ENEST1st business.industry Nilotinib medicine.disease Pyrimidines 030104 developmental biology Pyrimidine business Multiplex Polymerase Chain Reaction |
| Zdroj: | Hochhaus, A, Mahon, F-X, le Coutre, P, Petrov, L, Janssen, J J W M, Cross, N C P, Rea, D, Castagnetti, F, Hellmann, A, Rosti, G, Gattermann, N, Coronel, M L P, Gutierrez, M A E, Garcia-Gutierrez, V, Vincenzi, B, Dezzani, L & Giles, F J 2017, ' Nilotinib first-line therapy in patients with Philadelphia chromosome-negative/BCR-ABL-positive chronic myeloid leukemia in chronic phase : ENEST1st sub-analysis ', Journal of Cancer Research and Clinical Oncology, vol. 143, no. 7, pp. 1225-1233 . https://doi.org/10.1007/s00432-017-2359-9 Journal of Cancer Research and Clinical Oncology Journal of Cancer Research and Clinical Oncology, 143(7), 1225-1233. Springer Verlag Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid |
| ISSN: | 0171-5216 |
| DOI: | 10.1007/s00432-017-2359-9 |
| Popis: | PURPOSE: The ENEST1st sub-analysis presents data based on Philadelphia chromosome (Ph) status, i.e., Ph+ and Ph-/BCR-ABL1 + chronic myeloid leukemia.METHODS: Patients received nilotinib 300 mg twice daily, up to 24 months.RESULTS: At screening, 983 patients were identified as Ph+ and 30 patients as Ph-/BCR-ABL + based on cytogenetic and RT-PCR assessment; 76 patients had unknown karyotype (excluded from this sub-analysis). In the Ph-/BCR-ABL1 + subgroup, no additional chromosomal aberrations were reported. In the Ph+ subgroup, 952 patients had safety and molecular assessments. In the Ph-/BCR-ABL1 + subgroup, 30 patients had safety assessments and 28 were followed up for molecular assessments. At 18 months, the molecular response (MR) 4 rate [MR4; BCR-ABL1 ≤0.01% on International Scale (IS)] was similar in the Ph-/BCR-ABL1+ (39.3%) and Ph+ subgroups (38.1%). By 24 months, the cumulative rates of major molecular response (BCR-ABL1IS≤0.1%;), MR4, and MR4.5(BCR-ABL1IS≤0.0032%) were 85.7, 60.7, and 50.0%, respectively, in the Ph-/BCR-ABL1 + subgroup, and 80.3, 54.7, and 38.3%, respectively, in the Ph+ subgroup. In both Ph-/BCR-ABL1 + and Ph+ subgroups, rash (20 and 22%), pruritus (16.7 and 16.7%), nasopharyngitis (13.3 and 10.4%), fatigue (10 and 14.2%), headache (10 and 15.8%), and nausea (6.7 vs 11.4%) were frequent non-hematologic adverse events, whereas hypophosphatemia (23.3 and 6.8%), anemia (10 and 6.5%), and thrombocytopenia (3.3 and 10.2%) were the common hematologic/biochemical laboratory events.CONCLUSION: Based on similar molecular response and safety results in both subgroups, we conclude that Ph-/BCR-ABL1 + patients benefit from nilotinib in the same way as Ph+ patients. |
| Databáze: | OpenAIRE |
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