Prediction of outcomes in patients with ph+ chronic myeloid leukemia in chronic phase treated with nilotinib after imatinib resistance/intolerance
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2012-11-06Author
Jabbour, E
le Coutre, P D
Cortes, J
Giles, F
Bhalla, K N
Pinilla-Ibarz, J
Larson, R A
Gattermann, N
Ottmann, O G
Hochhaus, A
Hughes, T P
Saglio, G
Radich, J P
Kim, D-W
Martinelli, G
Reynolds, J
Woodman, R C
Baccarani, M
Kantarjian, H M
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Jabbour, E; le Coutre, P D; Cortes, J; Giles, F; Bhalla, K N; Pinilla-Ibarz, J; Larson, R A; Gattermann, N; Ottmann, O G; Hochhaus, A; Hughes, T P; Saglio, G; Radich, J P; Kim, D-W; Martinelli, G; Reynolds, J; Woodman, R C; Baccarani, M; Kantarjian, H M (2012). Prediction of outcomes in patients with ph+ chronic myeloid leukemia in chronic phase treated with nilotinib after imatinib resistance/intolerance. Leukemia 27 (4), 907-913
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Abstract
The purpose was to assess predictive factors for outcome in patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP) treated with nilotinib after imatinib failure. Imatinib-resistant and -intolerant patients with CML-CP (n = 321) were treated with nilotinib 400 mg twice daily. Of 19 baseline patient and disease characteristics and two response end points analyzed, 10 independent prognostic factors were associated with progression-free survival (PFS). In the multivariate analysis, major cytogenetic response (MCyR) within 12 months, baseline hemoglobin >= 120 g/l, baseline basophils <4%, and absence of baseline mutations with low sensitivity to nilotinib were associated with PFS. A prognostic score was created to stratify patients into five groups (best group: 0 of 3 unfavorable risk factors and MCyR by 12 months; worst group: 3 of 3 unfavorable risk factors and no MCyR by 12 months). Estimated 24-month PFS rates were 90%, 79%, 67% and 37% for patients with prognostic scores of 0, 1, 2 and 3, respectively, (no patients with score of 4). Even in the presence of poor disease characteristics, nilotinib provided significant clinical benefit in patients with imatinib-resistant or -intolerant CML. This system may yield insight on the prognosis of patients. Leukemia (2013) 27, 907-913; doi:10.1038/leu.2012.305