He said the most relevant implication from this investigation is that there is no urgent need for changes in therapy for patients who fall into the warning category. Dr Cortes said that patients with a major cytogenetic response at 3 months or complete cytogenetic response at 6 months do not need a treatment change regardless of their transcript levels.
The study demonstrated that those patients who achieved optimal response had longer event-free survival, failure-free survival, transformation-free survival, and overall survival compared to those patients who had warning and failure responses at all time points. For the past 16 years, TKIs have been the first-line therapy for patients with CML-CP. However, there are still many unanswered questions about the potential beneﬁt of treatment change or dosage change for patients who fall into the warning category.
Jerald Radich, MD, who is a molecular biologist in the Clinical Research Division at Fred Hutchinson Cancer Research Center in Seattle, WA, said this study is very important because it is a validation of findings from several other studies.
“The ELN response guidelines were crafted from several studies, demonstrating the correlation of cytogenetic and molecular response to treatment outcomes. The advantage of this study is that it is based on patients all seen sequentially at the same center,” Dr Radich told Cancer Therapy Advisor.
The study emphasized the importance of the ELN response criteria in predicting outcomes. Dr Radich noted that the National Comprehensive Cancer Network in the United States has similar response criteria. He said what is clinically relevant is that this study confirmed the ability to predict long-term success based on short-team responses (3 month and 6 month).
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“CML is a model for targeted therapy and the power of molecular monitoring of disease response,” said Dr Radich. “Many diseases in the future will use serial monitoring to predict outcome and to shape therapy. Also, for physicians who take care of CML patients, it emphasizes the need to do frequent testing.”
- Preetesh J, Hagop K, Koji S, et al. Analysis of 2013 European LeukaemiaNet (ELN) responses in chronic phase CML across four frontline TKI modalities and impact on clinical outcomes. Br J Haematol. 2016;173(11):114-126.