| Autor: |
Hughes TP; South Australian Health and Medical Research Institute, University of Adelaide, Adelaide, SA, Australia. tim.hughes@sahmri.com., Clementino NCD; Hospital Das Clinicas Da UFMG, Belo Horizonte, Brazil., Fominykh M; Russian Research Institute of Hematology and Transfusiology, Saint Petersburg, Russian Federation.; Saint Petersburg State University, Saint Petersburg, Russian Federation., Lipton JH; Princess Margaret Cancer Centre, Toronto, ON, Canada., Turkina AG; National Research Center for Hematology, Moscow, Russian Federation., Moiraghi EB; Hospital General De Agudos J. M. Ramos Mejia, Buenos Aires, Argentina., Nicolini FE; Hematology Department, Centre Léon Berard, Lyon, France., Takahashi N; Department of Hematology, Nephrology and Rheumatology, Akita University Graduate School of Medicine, Akita, Japan., Sacha T; Department of Hematology, Jagiellonian University Hospital, Krakow, Poland., Kim DW; Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea., Fellague-Chebra R; Novartis Pharma SAS, Rueil-Malmaison, Paris, France., Tiwari R; Novartis Healthcare Pvt. Ltd, Hyderabad, India., Bouard C; Novartis Pharma SAS, Rueil-Malmaison, Paris, France., Mahon FX; Cancer Center of Bordeaux, Institut Bergonié, INSERM U1218, University of Bordeaux, Bordeaux, France. |
| Abstrakt: |
The ENESTop study evaluated treatment-free remission (TFR) in patients with chronic myeloid leukemia (CML) in chronic phase who had received ≥3 years of tyrosine kinase inhibitor therapy and achieved sustained deep molecular response only after switching from imatinib to nilotinib. After 1-year nilotinib consolidation, 126 patients attempted TFR. At 48 weeks (primary analysis), 57.9% (73/126) were in TFR. In the present analysis at 5 years, 42.9% (54/126) were in TFR. Since the 48-week analysis, among patients who left the TFR phase, 58% (11/19) did not have a loss of molecular response and discontinued for other reasons. Of the 59 patients who reinitiated nilotinib upon loss of major molecular response (MMR) or confirmed loss of MR 4 , 98.3% regained MMR, 94.9% regained MR 4 , and 93.2% regained MR 4.5 . Overall adverse event rates decreased over the 5 years of TFR. In patients reinitiating nilotinib, there was a cumulative increase in cardiovascular events with longer nilotinib exposure. No disease progression or CML-related deaths were reported. Overall, these results confirm the durability and safety of TFR for patients receiving second-line nilotinib. Cardiovascular risk should be carefully managed, particularly when reinitiating treatment after TFR. |
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