Durable treatment-free remission in patients with chronic myeloid leukemia in chronic phase following frontline nilotinib: 96-week update of the ENESTfreedom study
| Autor: | Véronique Bédoucha, Norbert Gattermann, Philipp le Coutre, Prashanth Gopalakrishna, Jerald P. Radich, Weiping Deng, Susanne Saussele, Eibhlin Conneally, Nancy Krunic, Giuseppe Saglio, Andrzej Hellmann, Bruno Martino, Francis J. Giles, Valentín García-Gutiérrez, Tamás Masszi, David M. Ross, María Teresa Gómez Casares, Jesper Stentoft, Andreas Hochhaus |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Oncology
Male Cancer Research Predictors of TFR Time Factors Original Article – Clinical Oncology Kaplan-Meier Estimate 0302 clinical medicine Treatment-free remission hemic and lymphatic diseases 80 and over Medicine Young adult Chronic Aged 80 and over Hematology Leukemia Chronic myeloid leukemia Remission Induction Myeloid leukemia General Medicine Middle Aged Protein-Tyrosine Kinases Clinical trial Treatment Outcome 030220 oncology & carcinogenesis Female medicine.drug Adult medicine.medical_specialty 03 medical and health sciences Young Adult Internal medicine Leukemia Myelogenous Chronic BCR-ABL Positive Humans In patient Frontline Adverse effect Aged business.industry Nilotinib Pyrimidines Major Molecular Response BCR-ABL Positive business 030215 immunology Myelogenous |
| Zdroj: | Journal of Cancer Research and Clinical Oncology Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid Consejería de Sanidad de la Comunidad de Madrid Ross, D M, Masszi, T, Gómez Casares, M T, Hellmann, A, Stentoft, J, Conneally, E, Garcia-Gutierrez, V, Gattermann, N, le Coutre, P D, Martino, B, Saussele, S, Giles, F J, Radich, J P, Saglio, G, Deng, W, Krunic, N, Bédoucha, V, Gopalakrishna, P & Hochhaus, A 2018, ' Durable treatment-free remission in patients with chronic myeloid leukemia in chronic phase following frontline nilotinib : 96-week update of the ENESTfreedom study ', Journal of Cancer Research and Clinical Oncology, vol. 144, no. 5, pp. 945-954 . https://doi.org/10.1007/s00432-018-2604-x |
| ISSN: | 1432-1335 0171-5216 |
| Popis: | Purpose: ENESTfreedom is evaluating treatment-free remission (TFR) following frontline nilotinib in patients with chronic myeloid leukemia (CML) in chronic phase. Following our primary analysis at 48 weeks, we here provide an updated 96-week analysis. Methods: Attempting TFR required ≥ 3 years of nilotinib, a molecular response of MR4.5 [BCR-ABL1 ≤ 0.0032% on the International Scale (BCR-ABL1IS)], and sustained deep molecular response (DMR) during a 1-year consolidation phase. Patients restarted nilotinib following loss of major molecular response (MMR; BCR-ABL1IS ≤ 0.1%). Results: Ninety-six weeks after stopping treatment (3.6-year median prior nilotinib duration), 93 of 190 patients (48.9%) remained in TFR. Of 88 patients who restarted nilotinib following loss of MMR, 87 regained MMR and 81 regained MR4.5 by the data cut-off. Ninety-six-week TFR rates were 61.3, 50.0, and 28.6% in patients with low, intermediate, and high Sokal risk scores at diagnosis, respectively. Patients consistently in MR4.5 during consolidation had higher TFR rates (50.6%) than patients with ≥ 1 assessment without MR4.5 during consolidation (35.0%). In a landmark analysis, 96-week TFR rates for patients with MR4.5, MR4 (BCR-ABL1IS ≤ 0.01%) but not MR4.5, and MMR but not MR4 at TFR week 12 were 82.6, 23.1, and 0%, respectively. There were no reports of disease progression or death due to CML; overall adverse event frequency decreased following TFR. Within the follow-up period, TFR did not adversely affect disease outcomes. Conclusions: These results demonstrate the feasibility and durability of TFR following frontline nilotinib and emphasize the importance of sustained DMR for TFR. |
| Databáze: | OpenAIRE |
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