Dr. Shah Discusses Frontline Considerations for the Treatment of CML

Neil Shah, MD, PhD
Published: Friday, Oct 05, 2018



Neil Shah, MD, PhD, professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF) Program Leader, Hematopoietic Malignancies Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses frontline treatment considerations for patients with chronic myeloid leukemia (CML).

For many years, there have been 3 frontline options for the treatment of patients with CML. In December 2017, the FDA granted an accelerated approval to bosutinib (Bosulif) as a first-line treatment for patients with Philadelphia chromosome-positive CML. This approval was based on findings from the phase III BFORE trial, which showed that the major molecular response at 12 months was 47.2% with bosutinib (95% CI, 40.9-53.4) compared with 36.9% (95% CI, 30.8-43.0) for imatinib (Gleevec).

This was a 2-year follow-up, which Shah says provided a sense of how well tolerated bosutinib is compared with imatinib. Toxicities remain though, including gastrointestinal issues and thrombotic events. Shah says that it is too early to know if it is going to improve overall survival. Nonetheless, he says it is looking favorable in terms of response compared with imatinib.
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Neil Shah, MD, PhD, professor, Department of Medicine (Hematology/Oncology), University of California, San Francisco (UCSF) Program Leader, Hematopoietic Malignancies Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses frontline treatment considerations for patients with chronic myeloid leukemia (CML).

For many years, there have been 3 frontline options for the treatment of patients with CML. In December 2017, the FDA granted an accelerated approval to bosutinib (Bosulif) as a first-line treatment for patients with Philadelphia chromosome-positive CML. This approval was based on findings from the phase III BFORE trial, which showed that the major molecular response at 12 months was 47.2% with bosutinib (95% CI, 40.9-53.4) compared with 36.9% (95% CI, 30.8-43.0) for imatinib (Gleevec).

This was a 2-year follow-up, which Shah says provided a sense of how well tolerated bosutinib is compared with imatinib. Toxicities remain though, including gastrointestinal issues and thrombotic events. Shah says that it is too early to know if it is going to improve overall survival. Nonetheless, he says it is looking favorable in terms of response compared with imatinib.



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