Nilotinib is Superior to Imatinib as First-line Therapy of Chronic Myeloid Leukemia: The ENESTnd Study

Francis J Giles; Gianantonio Rosti; Photis Beris; Richard E Clark; Philipp le Coutre; Francois-Xavier Mahon; Juan-Luis Steegmann; Peter Valent; Giuseppe Saglio


Expert Rev Hematol. 2010;3(6):665-673. 

In This Article

Five-year View

Based on the results of the French STIM study, a proportion of patients who achieve CMR on imatinib therapy remain in CMR for variable periods after cessation of imatinib therapy.[21] Nilotinib confers a much higher rate of durable CMR than imatinib and will thus allow the prospective randomized studies of therapy cessation to be carried out in large numbers of patients with CML. These studies are a very important step in the quest for cure of CML. For both the individual patient and society's fiscal health, we should continue to strive for safe therapy cessation as the ultimate reflection of successful therapy of CML and the final step in a true response to cure continuum. In order to deliver cure to all patients, we need to be able to prospectively identify any patients who have a genetic profile at diagnosis, and/or an early pattern of failure to respond to nilotinib, that will allow the optimal early intervention with non-Abl inhibition-based approaches. Interferon, which was the first biologic agent to significantly improve the prognosis of patients with CML, may still have a role in some patients in the nilotinib era – a number of large international studies will investigate this approach. Our options in terms of novel therapeutic approaches in CML are increasing and range from smoothened modulators to vaccines. A new paradox is that many of these highly targeted approaches are likely to be most effective in a minimal disease burden situation. While such approaches may be very valuable in helping to truly cure patients, it is difficult to design studies where we can incorporate them into the prevention of, or therapy of, our main residual threat to cure, which is the development of AP/BP in patients on nilotinib. While nilotinib has significantly reduced the incidence of these transformation events over that seen on imatinib therapy, we need to eliminate these transformation events in order to offer a universal cure of CML.


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