Imatinib Compared with Interferon and Low-Dose Cytarabine for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

2003 ◽  
Vol 348 (11) ◽  
pp. 994-1004 ◽  
Author(s):  
Stephen G. O'Brien ◽  
François Guilhot ◽  
Richard A. Larson ◽  
Insa Gathmann ◽  
Michele Baccarani ◽  
...  
Cancer ◽  
2004 ◽  
Vol 101 (11) ◽  
pp. 2584-2592 ◽  
Author(s):  
Kevin J. Anstrom ◽  
Shelby D. Reed ◽  
Andrew S. Allen ◽  
G. Alastair Glendenning ◽  
Kevin A. Schulman

2003 ◽  
Vol 21 (11) ◽  
pp. 2138-2146 ◽  
Author(s):  
Elizabeth A. Hahn ◽  
G. Alastair Glendenning ◽  
Mark V. Sorensen ◽  
Stacie A. Hudgens ◽  
Brian J. Druker ◽  
...  

Purpose: Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study. Patients and Methods: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy–Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over. Results: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P < .001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P < .001) differences were observed between patients who did and did not cross over in favor of imatinib. Conclusion: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC.


Cancer ◽  
2004 ◽  
Vol 101 (11) ◽  
pp. 2574-2583 ◽  
Author(s):  
Shelby D. Reed ◽  
Kevin J. Anstrom ◽  
Jennifer A. Ludmer ◽  
G. Alastair Glendenning ◽  
Kevin A. Schulman

2006 ◽  
Vol 86 (2) ◽  
pp. 117-125 ◽  
Author(s):  
W. Deenik ◽  
B. van der Holt ◽  
G. E. G. Verhoef ◽  
A. V. M. B. Schattenberg ◽  
L. F. Verdonck ◽  
...  

Leukemia ◽  
2021 ◽  
Author(s):  
Hagop M. Kantarjian ◽  
Timothy P. Hughes ◽  
Richard A. Larson ◽  
Dong-Wook Kim ◽  
Surapol Issaragrisil ◽  
...  

AbstractIn the ENESTnd study, with ≥10 years follow-up in patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase, nilotinib demonstrated higher cumulative molecular response rates, lower rates of disease progression and CML-related death, and increased eligibility for treatment-free remission (TFR). Cumulative 10-year rates of MMR and MR4.5 were higher with nilotinib (300 mg twice daily [BID], 77.7% and 61.0%, respectively; 400 mg BID, 79.7% and 61.2%, respectively) than with imatinib (400 mg once daily [QD], 62.5% and 39.2%, respectively). Cumulative rates of TFR eligibility at 10 years were higher with nilotinib (300 mg BID, 48.6%; 400 mg BID, 47.3%) vs imatinib (29.7%). Estimated 10-year overall survival rates in nilotinib and imatinib arms were 87.6%, 90.3%, and 88.3%, respectively. Overall frequency of adverse events was similar with nilotinib and imatinib. By 10 years, higher cumulative rates of cardiovascular events were reported with nilotinib (300 mg BID, 16.5%; 400 mg BID, 23.5%) vs imatinib (3.6%), including in Framingham low-risk patients. Overall efficacy and safety results support the use of nilotinib 300 mg BID as frontline therapy for optimal long-term outcomes, especially in patients aiming for TFR. The benefit-risk profile in context of individual treatment goals should be carefully assessed.


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