BACKGROUND: We assessed whether the achievement of a 3-month complete cytogenetic response (CCyR) in 123 patients with chronic myeloid leukemia (CML) in the chronic phase, which was treated with second-generation tyrosine kinase inhibitors (2nd-TKI) after imatinib failure could predict for survival. PATIENTS AND METHODS: In a multivariate analysis, the lack of a 3-month CCyR to 2nd-TKI therapy was selected as the only independent factor associated with poor event-free survival (hazard ratio [HR] 4.5; P < .001) and overall survival (5.4; P = .03). RESULTS: The 3-year event-free survival and overall survival rates were 74% and 43%, respectively, for patients with 3-month CCyR, and were 98% and 79%, respectively, for patients without 3-month CCyR. In a multivariate analysis, high hemoglobin level, previous major cytogenetic response to imatinib therapy, and ≤90% Philadelphia-positive metaphases were associated with the achievement of a 3-month CCyR. CONCLUSION: The achievement of a 3-month CCyR is the only predictor of outcome in patients treated with 2nd-TKI therapy after imatinib failure. Patients with <3-month CCyR may not obtain long-term benefit and should be followed-up closely.
BACKGROUND: We assessed whether the achievement of a 3-month complete cytogenetic response (CCyR) in 123 patients with chronic myeloid leukemia (CML) in the chronic phase, which was treated with second-generation tyrosine kinase inhibitors (2nd-TKI) after imatinib failure could predict for survival. PATIENTS AND METHODS: In a multivariate analysis, the lack of a 3-month CCyR to 2nd-TKI therapy was selected as the only independent factor associated with poor event-free survival (hazard ratio [HR] 4.5; P < .001) and overall survival (5.4; P = .03). RESULTS: The 3-year event-free survival and overall survival rates were 74% and 43%, respectively, for patients with 3-month CCyR, and were 98% and 79%, respectively, for patients without 3-month CCyR. In a multivariate analysis, high hemoglobin level, previous major cytogenetic response to imatinib therapy, and ≤90% Philadelphia-positive metaphases were associated with the achievement of a 3-month CCyR. CONCLUSION: The achievement of a 3-month CCyR is the only predictor of outcome in patients treated with 2nd-TKI therapy after imatinib failure. Patients with <3-month CCyR may not obtain long-term benefit and should be followed-up closely.
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Authors: Stephen G O'Brien; François Guilhot; Richard A Larson; Insa Gathmann; Michele Baccarani; Francisco Cervantes; Jan J Cornelissen; Thomas Fischer; Andreas Hochhaus; Timothy Hughes; Klaus Lechner; Johan L Nielsen; Philippe Rousselot; Josy Reiffers; Giuseppe Saglio; John Shepherd; Bengt Simonsson; Alois Gratwohl; John M Goldman; Hagop Kantarjian; Kerry Taylor; Gregor Verhoef; Ann E Bolton; Renaud Capdeville; Brian J Druker Journal: N Engl J Med Date: 2003-03-13 Impact factor: 91.245
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