Need for more precise TKI dosing in real-world CML-CP patients

Key clinical point: Considering inadequate representation of real-world patients (RWP) with chronic-phase chronic myeloid leukemia (CML-CP) in clinical trials, a “one size fits all” tyrosine kinase inhibitor (TKI) dosing regimen may not be apt.

Major finding: RWPs with 2 or more exclusion factors were more likely to achieve major molecular response at 3 months (adjusted relative risk [aRR] 1.89; P = .03) compared to those with no exclusion factors. They did achieve complete hematologic response at 1 month (aRR 0.80; P = .02), or have a higher adverse event-induced TKI dose reduction (aRR 1.53; P = .03) or shorter time to dose reduction (aRR 2.47; P = .005).

Study details: This retrospective study included 174 adult RWP with CML-CP treated with imatinib, dasatinib, nilotinib, or bosutinib for at least 30 days, with 0, 1, or 2 or more phase 3 clinical trial exclusion criterion.

Disclosures: This study was funded by the Eshelman Institute for Innovation at the University of North Carolina Eshelman School of Pharmacy. Some investigators reported receiving honoraria and research funding from or consulting for various pharmaceutical companies.

Source: Szeto AH et al. Ann Pharmacother. 2021 Sep 18. doi: 10.1177/10600280211044160.

Key clinical point: Considering inadequate representation of real-world patients (RWP) with chronic-phase chronic myeloid leukemia (CML-CP) in clinical trials, a “one size fits all” tyrosine kinase inhibitor (TKI) dosing regimen may not be apt.

Major finding: RWPs with 2 or more exclusion factors were more likely to achieve major molecular response at 3 months (adjusted relative risk [aRR] 1.89; P = .03) compared to those with no exclusion factors. They did achieve complete hematologic response at 1 month (aRR 0.80; P = .02), or have a higher adverse event-induced TKI dose reduction (aRR 1.53; P = .03) or shorter time to dose reduction (aRR 2.47; P = .005).

Study details: This retrospective study included 174 adult RWP with CML-CP treated with imatinib, dasatinib, nilotinib, or bosutinib for at least 30 days, with 0, 1, or 2 or more phase 3 clinical trial exclusion criterion.

Disclosures: This study was funded by the Eshelman Institute for Innovation at the University of North Carolina Eshelman School of Pharmacy. Some investigators reported receiving honoraria and research funding from or consulting for various pharmaceutical companies.

Source: Szeto AH et al. Ann Pharmacother. 2021 Sep 18. doi: 10.1177/10600280211044160.

Key clinical point: Considering inadequate representation of real-world patients (RWP) with chronic-phase chronic myeloid leukemia (CML-CP) in clinical trials, a “one size fits all” tyrosine kinase inhibitor (TKI) dosing regimen may not be apt.

Major finding: RWPs with 2 or more exclusion factors were more likely to achieve major molecular response at 3 months (adjusted relative risk [aRR] 1.89; P = .03) compared to those with no exclusion factors. They did achieve complete hematologic response at 1 month (aRR 0.80; P = .02), or have a higher adverse event-induced TKI dose reduction (aRR 1.53; P = .03) or shorter time to dose reduction (aRR 2.47; P = .005).

Study details: This retrospective study included 174 adult RWP with CML-CP treated with imatinib, dasatinib, nilotinib, or bosutinib for at least 30 days, with 0, 1, or 2 or more phase 3 clinical trial exclusion criterion.

Disclosures: This study was funded by the Eshelman Institute for Innovation at the University of North Carolina Eshelman School of Pharmacy. Some investigators reported receiving honoraria and research funding from or consulting for various pharmaceutical companies.

Source: Szeto AH et al. Ann Pharmacother. 2021 Sep 18. doi: 10.1177/10600280211044160.