CML-405: Treatment-Free Remission in Chronic Myeloid Leukemia: A Tunisian Experience

Abstract

Context: Discontinuation of tyrosine kinase inhibitor (TKI) treatment for chronic phase (CP) chronic myeloid leukemia (CML) patients with a deep molecular response (DMR) has entered standard practice. Objective: In this study, we characterize the treatment-free remission in Tunisian CML patients. Design: This retrospective study collected data for CML patients who had discontinued TKI treatment as part of daily clinical practice in Sfax, Tunisia. Setting: Department of Medical Genetics in University Hospital. Patients or Other Participants: Patients with CML who discontinued their TKI were enrolled. Interventions: Quantitative assessment of the BCR-ABL transcript was performed using the Cepheid Xpert BCR-ABL ultra-assay. Main Outcome Measures: We investigated reasons for discontinuation, duration of TKI treatment before discontinuation, molecular response (MR) status at TKI discontinuation, and treatment-free remission (TFR) duration. Molecular recurrence is defined as the loss of major molecular response (MMR). Results: A total of 17 patients who discontinued treatment were enrolled in this study. Reasons for interruption were deep molecular response (n=13), adverse events (n = 1), and pregnancy (n = 3). TFR was maintained in 10 (64.7%) patients with a median follow-up of 26 months (8–127). The minimum treatment duration before discontinuation was 86 months. Five patients with sustained DMR (38.4%) had a molecular recurrence and re-initiated TKI. Conclusions: Our study highlights that TKI discontinuation was safe and effective in CML patients who are in sustained deep molecular response with longer TKI treatment duration. A larger study is mandatory for a comprehensive analysis of molecular recurrence in CML patients.