Determination of a radotinib dosage regimen based on dose-response relationships for the treatment of newly diagnosed patients with chronic myeloid leukemia.

摘要: Radotinib is a second-generation BCR-ABL1 tyrosine kinase inhibitor approved for the treatment of chronic myeloid leukemia in phase (CP-CML). Here, using data from Phase 3 study conducted patients with newly diagnosed CP-CML, dose-efficacy as well dose-safety relationship analyses were performed to determine safe and effective initial dosage regimen radotinib. A significant positive association was detected between starting dose radotinib adjusted body weight (Dose/BW) probability dose-limiting toxicity (≥grade hematologic nonhematologic toxicity) (P = 0.003). In contrast, inverse discovered Dose/BW major molecular response (BCR-ABL1/ABL1 ≤ 0.1%) when controlled sex 0.033). Moreover, frequent interruptions reductions secondary toxicities occurred study, resulting nearly half (44%) receiving reduced at 12-month follow-up. conclusion, results this demonstrate need attenuation improve long-term efficacy safety Hence, authors suggest new upfront 400 mg once daily be tested CP-CML.