Figure 3.
Figure 3. Response. (A) Response to a 5-day treatment with TDZ as a monotherapy was monitored at the level of peripheral blood ABC. Response for patients 2 and 9 was determined by percent bone marrow blast due to a lack of circulating blasts as indicated by the asterisk. Patients 12 and 13 were excluded from this analysis because they did not complete the 5-day treatment with TDZ. Red curves indicate disease progression based on ABC prior to the start of TDZ treatment. Blue color coding indicates TDZ dose level. Insets depict percent change in blast counts at day 5 compared with day 1. “+HU” indicates concurrent use of hydroxyurea during the 5-day treatment with TDZ. (B) Absolute neutrophil counts after exposure to up to 100 mg of TDZ every 6 hours based on data from 11 patients that completed the 5-day monotherapy with TDZ. Data are expressed as cohort means and 95% CI (mean change from day 1 to day 5: −1.00, 95% CI: −2.7 to 0.7, P = .22). (C) Platelet counts after a 5-day treatment with up to 100 mg of TDZ every 6 hours. Data points include patients that did not receive platelet transfusions within the first 5 days of TDZ, or up to 4 days prior to the start of the trial. Data are expressed as cohort means and 95% CI (mean change from day 1 to day 5: −23.00, 95% CI: −45.4 to −0.54, P = .04). (D) Baseline levels of DRD2 protein expression in MNCs of patients that showed no blast response vs patients that showed blast reduction after the 5-day treatment with TDZ (difference between group means: 1.20, 95% CI: 0.56 to 1.84; P = .002). The shaded area indicates the upper and lower 99% CI for DRD2 levels in healthy primitive cells as defined in supplemental Figure 3D. (E) DRD2 protein expression in MNCs of 20 AML patient samples (16 diagnosis and 4 relapse cases) not including on-study patients. The shaded area indicates the upper and lower 99% CI for DRD2 levels in healthy primitive cells (CD34+) as defined in supplemental Figure 3D. Inset depicts a representative flow cytometry plot for DRD2 expression in AML (red histogram), overlayed on the staining control (dotted histogram).

Response. (A) Response to a 5-day treatment with TDZ as a monotherapy was monitored at the level of peripheral blood ABC. Response for patients 2 and 9 was determined by percent bone marrow blast due to a lack of circulating blasts as indicated by the asterisk. Patients 12 and 13 were excluded from this analysis because they did not complete the 5-day treatment with TDZ. Red curves indicate disease progression based on ABC prior to the start of TDZ treatment. Blue color coding indicates TDZ dose level. Insets depict percent change in blast counts at day 5 compared with day 1. “+HU” indicates concurrent use of hydroxyurea during the 5-day treatment with TDZ. (B) Absolute neutrophil counts after exposure to up to 100 mg of TDZ every 6 hours based on data from 11 patients that completed the 5-day monotherapy with TDZ. Data are expressed as cohort means and 95% CI (mean change from day 1 to day 5: −1.00, 95% CI: −2.7 to 0.7, P = .22). (C) Platelet counts after a 5-day treatment with up to 100 mg of TDZ every 6 hours. Data points include patients that did not receive platelet transfusions within the first 5 days of TDZ, or up to 4 days prior to the start of the trial. Data are expressed as cohort means and 95% CI (mean change from day 1 to day 5: −23.00, 95% CI: −45.4 to −0.54, P = .04). (D) Baseline levels of DRD2 protein expression in MNCs of patients that showed no blast response vs patients that showed blast reduction after the 5-day treatment with TDZ (difference between group means: 1.20, 95% CI: 0.56 to 1.84; P = .002). The shaded area indicates the upper and lower 99% CI for DRD2 levels in healthy primitive cells as defined in supplemental Figure 3D. (E) DRD2 protein expression in MNCs of 20 AML patient samples (16 diagnosis and 4 relapse cases) not including on-study patients. The shaded area indicates the upper and lower 99% CI for DRD2 levels in healthy primitive cells (CD34+) as defined in supplemental Figure 3D. Inset depicts a representative flow cytometry plot for DRD2 expression in AML (red histogram), overlayed on the staining control (dotted histogram).

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