Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study by Neil P. Shah, François.

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Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study by Neil P. Shah, François Guilhot, Jorge E. Cortes, Charles A. Schiffer, Philipp le Coutre, Tim H. Brümmendorf, Hagop M. Kantarjian, Andreas Hochhaus, Philippe Rousselot, Hesham Mohamed, Diane Healey, Michael Cunningham, and Giuseppe Saglio Blood Volume 123(15):2317-2324 April 10, 2014 ©2014 by American Society of Hematology

CONSORT diagram for the CA180-034 study. CONSORT diagram for the CA180-034 study. One of the 167 patients treated with dasatinib 50 mg twice daily had been randomly assigned to receive 100 mg once daily. Adapted from Shah et al9 and reproduced with permission from the American Society of Clinical Oncology. (*) Reasons for discontinuation are presented in Table 1. Neil P. Shah et al. Blood 2014;123:2317-2324 ©2014 by American Society of Hematology

Kaplan-Meier analyses (all patients). Kaplan-Meier analyses (all patients). (A) PFS. (B) OS. bid, twice daily; qd, once daily. Neil P. Shah et al. Blood 2014;123:2317-2324 ©2014 by American Society of Hematology

Kaplan-Meier landmark analyses (landmark populations). Kaplan-Meier landmark analyses (landmark populations). (A) PFS according to molecular response at 3 months. For BCR-ABL ≤1% vs >1% to 10%, P = .003; for >1% to 10% vs >10%, P < .0001. Of note, 212 (90%) of the 235 patients with BCR-ABL >10% at 3 months in this analysis had CHR. (B) OS according to molecular response at 3 months. For BCR-ABL ≤1% vs >1% to 10%, P = .285; for >1% to 10% vs >10%, P < .0001. (C) PFS according to molecular response at 6 months. For BCR-ABL ≤1% vs >1% to 10%, P = .001; for >1% to 10% vs >10%, P = .017. (D) OS according to molecular response at 6 months. For BCR-ABL ≤1% vs >1% to 10%, P = .554; for >1% to 10% vs >10%, P = .001. Patients without a molecular assessment at 3 or 6 months were not included in the corresponding analyses. In addition, patients who progressed (for PFS) or died (for OS) before the landmark time point were excluded from those analyses. Neil P. Shah et al. Blood 2014;123:2317-2324 ©2014 by American Society of Hematology

PFS and OS by CHR and molecular response at 3 months (all treatment arms combined). PFS and OS by CHR and molecular response at 3 months (all treatment arms combined). Analysis excludes patients with CHR or BCR-ABL ≤10% at baseline; only those patients who had not progressed (n = 258) or had not died (n = 262) by 3 months were included in (A) and (B), respectively. Four patients who had progressed but had not died by 3 months were included in (B). P < .0001 (log-rank) for CHR plus ≤10% vs CHR plus >10% at 3 months for PFS and OS. For CHR plus >10% vs no CHR at 3 months, P < .0001 (log-rank) for PFS and P = .0001 (log-rank) for OS. Neil P. Shah et al. Blood 2014;123:2317-2324 ©2014 by American Society of Hematology