Clinical Pharmacokinetics of Intra-arterial Melphalan and Topotecan Combination in Patients with Retinoblastoma – Corrected Proof
Purpose: To assess the antitumor activity, toxicity, and plasma pharmacokinetics of the combination of melphalan and topotecan for superselective ophthalmic artery infusion (SSOAI) treatment of children with retinoblastoma.Design: Single-center, prospective, clinical pharmacokinetic study.Participants: Twenty-six patients (27 eyes) with intraocular retinoblastoma.Methods: Patients with an indication for SSOAI received melphalan (3–6 mg) and topotecan (0.5–1 mg; doses calculated by age and weight). Plasma samples were obtained for pharmacokinetic studies, and a population approach via nonlinear mixed effects modeling was used. Safety and efficacy were assessed and compared with historical cohorts of patients treated with melphalan single-agent SSOAI.Main Outcome Measures: Melphalan and topotecan (Read more...)