Interim analysis of a multicenter study on patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukemia: the RODEO study

Abstract

Patient-guided dose reduction, as explored in the RODEO study, offers a promising approach to alleviate the burden of tyrosine kinase inhibitor (TKI) therapy in chronic myeloid leukemia (CML). Supported by shared decision-making (SDM) and a patient decision aid, this strategy aims to reduce TKI toxicity while maintaining effectiveness. This interim analysis evaluates its effectiveness at six months, focusing on intervention failure, i.e., TKI dose re-escalation due to loss of major molecular remission (MMR) of BCR::ABL1 (>0.1%IS) or expected loss of MMR, and patient-reported health-related quality of life (HRQoL) and symptom burden. The SDM-process and decisional conflict are also evaluated. This is a prospective, single-arm, multicenter trial including 148 patients with chronic-phase CML in at least MMR. Patients and their treating hematologists were engaged in an SDM-process and selected a reduced TKI dose. BCR::ABL1 monitoring was conducted regularly; HRQoL and symptom burden was assessed using the scores of the QLQ-C30 and QLQ-CML24 questionnaires, and IL 156 item list. of the European Organisation for Research and Treatment of Cancer (EORTC). SDM and decisional conflict were evaluated via SDM-Q-9, SDM-Q-Doc, and the Decisional Conflict Scale. Of 146 patients analyzed, 2.8% experienced intervention failure at six months. Modest statistically significant improvements were seen in multiple symptom scales. SDM was well-evaluated, with low decisional conflict by patients. Patient-guided dose reduction appears safe and beneficial at six months follow-up.