TY - JOUR
T1 - Nilotinib as front-line treatment for patients with chronic myeloid leukemia in early chronic phase
AU - Cortes, Jorge E.
AU - Jones, Dan
AU - O'Brien, Susan
AU - Jabbour, Elias
AU - Konopleva, Marina
AU - Ferrajoli, Alessandra
AU - Kadia, Tapan
AU - Borthakur, Gautam
AU - Stigliano, Denise
AU - Shan, Jianqin
AU - Kantarjian, Hagop
PY - 2010/1/20
Y1 - 2010/1/20
N2 - Purpose: Although most patients with chronic myeloid leukemia (CML) in chronic phase respond well to front-line therapy with imatinib, some patients do not achieve the desirable end point, and others may eventually lose response or are intolerant. Patients and Methods: Patients with newly diagnosed CML in chronic phase were treated with nilotinib 400 mg twice daily on an empty stomach as initial therapy. Results: Among 51 patients in chronic phase observed for at least 3 months, 50 (98%) achieved a complete cytogenetic remission (CCyR), and 39 (76%) achieved a major molecular response (MMR). Responses occurred rapidly, with 96% of patients achieving CCyR by 3 months and 98% achieving CCyR by 6 months. The projected event-free survival at 24 months is 90%, and all patients are alive after a median follow-up time of 17 months. Grade ≥ 3 neutropenia occurred in 12% of patients, and thrombocytopenia in occurred 11%. Nonhematologic toxicity was usually grade 1 to 2 and manageable. The actual median dose at 12 months was 800 mg (range, 200 to 800 mg). Conclusion: Nilotinib is an effective option for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR, with most patients reaching these responses early during their therapy.
AB - Purpose: Although most patients with chronic myeloid leukemia (CML) in chronic phase respond well to front-line therapy with imatinib, some patients do not achieve the desirable end point, and others may eventually lose response or are intolerant. Patients and Methods: Patients with newly diagnosed CML in chronic phase were treated with nilotinib 400 mg twice daily on an empty stomach as initial therapy. Results: Among 51 patients in chronic phase observed for at least 3 months, 50 (98%) achieved a complete cytogenetic remission (CCyR), and 39 (76%) achieved a major molecular response (MMR). Responses occurred rapidly, with 96% of patients achieving CCyR by 3 months and 98% achieving CCyR by 6 months. The projected event-free survival at 24 months is 90%, and all patients are alive after a median follow-up time of 17 months. Grade ≥ 3 neutropenia occurred in 12% of patients, and thrombocytopenia in occurred 11%. Nonhematologic toxicity was usually grade 1 to 2 and manageable. The actual median dose at 12 months was 800 mg (range, 200 to 800 mg). Conclusion: Nilotinib is an effective option for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR, with most patients reaching these responses early during their therapy.
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U2 - 10.1200/JCO.2009.25.4896
DO - 10.1200/JCO.2009.25.4896
M3 - Article
C2 - 20008621
AN - SCOPUS:75749090051
SN - 0732-183X
VL - 28
SP - 392
EP - 397
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -