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Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.
Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.
Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.
Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.
Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.
Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.
Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.
Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.
Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.
Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.
Key clinical point: Dasatinib dose optimization by therapeutic drug monitoring (TDM) during treatment initiation in patients with newly diagnosed chronic myeloid leukemia (CML) was feasible and led to a significant reduction in pleural effusion (PIEff) without affecting molecular responses.
Major finding: Reduced incidence of all-grade PlEff was observed in patients with high trough concentration [(C)min] who underwent dasatinib dose optimization by TDM (TDM arm; 13.2%) vs those who continued with standard dose (control arm; 42.8%) and those with low (C)min assigned to observation (observation arm; 17.4%; P = .006), with no major effect on major molecular response (P = .978) across the 3 arms.
Study details: Findings are from the phase 2 OPTIM-dasatinib study including 287 patients with newly diagnosed, previously untreated (except with hydroxycarbamide) CML. Patients were initially started on dasatinib 100 mg/day. After 7-10 days, patients with low (C)min were assigned to the observation arm (n=207) and those with high (C)min (3 nmol/L or higher) were randomly assigned to either TDM (n=38) or control (n=42) arms.
Disclosures: This study was funded by Bristol-Myers Squibb. The lead author reported research funding from Bristol-Myers Squibb, Pfizer, and Incyte.
Source: Rousselot P et al. Br J Haematol. 2021 Jun 30. doi: 10.1111/bjh.17654.