Clinical considerations

Expectations in CML treatment are evolving2
The value of achieving molecular milestones
In today’s treatment of CML, CCyR remains a satisfactory and acceptable response; however, increasing emphasis has been placed on achieving MMR as well as molecular responses beyond MMR2
Early molecular response may impact future outcomes4,a
It has been shown that patients with BCR-ABL1 ≤10% at 3 and 6 months may achieve better outcomes (OS, PFS, CCyR) than those with higher levels
Patients reaching MMR and responses beyond MMR may be more likely to achieve improved long-term clinical outcomes5,a
Reaching MMR, MR4, and MR4.5 are important milestones for patients, as they may minimize the risk of loss of CCyR or MMR
Evidence demonstrates the need to evaluate patients for underlying comorbidities prior to initiating treatment6
Current guidelines recommend that patient comorbidities, including cardiovascular disease (CVD), be taken into consideration when evaluating TKI therapy options for patients with CML3
The presence of comorbidities at diagnosis has been associated with decreased overall survival in CML7,a
The presence of CVD or risk factors for CVD may impact treatment of CML6
aBosutinib was not included in the study cited.
Adverse reaction profiles are a key consideration in the management of CML8
With advancements in treatment, CML is becoming a chronic condition—underscoring the importance of considering adverse reaction profiles when initiating treatment.
BCR-ABL1=breakpoint cluster region-Abelson 1; CCyR=complete cytogenetic response; MMR=major molecular response; MR=molecular response; OS=overall survival; PFS=progression-free survival; Ph+=Philadelphia chromosome–positive.
References
1.
BOSULIF Prescribing Information. New York, NY: Pfizer Inc.
2.
Cortes JE, Gambacorti-Passerini C, Deininger MW, et al. Bosutinib versus imatinib for newly diagnosed chronic myeloid leukemia: results from the randomized BFORE trial. J Clin Oncol. 2018;36(3):231-237.
3.
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Chronic Myeloid Leukemia V.1.2019. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed August 20, 2018. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content or its use or application and disclaims any responsibility for its use or application in any way.
4.
Marin D, Ibrahim AR, Lucas C, et al. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. J Clin Oncol. 2012;30(3):232-238.
5.
Falchi L, Kantarjian HM, Wang X, et al. Significance of deeper molecular responses in patients with chronic myeloid leukemia in early chronic phase treated with tyrosine kinase inhibitors. Am J Hematol. 2013;88(12):1024-1029.
6.
Moslehi JJ, Deininger M. Tyrosine kinase inhibitor–associated cardiovascular toxicity in chronic myeloid leukemia. J Clin Oncol. 2015;33(35):4210-4218.
7.
Saußele S, Krauß M-P, Hehlmann R, et al. Impact of comorbidities on overall survival in patients with chronic myeloid leukemia: results of the randomized CML Study IV. Blood. 2015;126(1):42-49.
8.
Larson RA. Is there a best TKI for chronic phase CML? Blood. 2015;126(21):2370-2375.