CML-411: Treatment-Free Remission in Patients with Chronic Myeloid Leukemia (CML): A Real-World Cohort of Patients in Colombia

Abstract

Context Long-term TKI treatment is related to notable adverse events, quality-of-life impact, and significant costs to health systems. TFR has been shown to be safe in multiple clinical trials, so it has become a new goal for CML management, although information about TFR in Colombia is scarce. Objective Our aim is to show the outcomes of TFR in Colombia. Design The Colombian Association of Hematology and Oncology (ACHO)'s hematological disease registry (RENEHOC) is a multicenter study that has collected information in 14 centers with Institutional Ethics Committee approval. This report represents a sub-analysis of the patients in the registry in whom discontinuation was performed. Setting RENEHOC is a nationwide, multicenter registry on hematologic malignancies that captures information from academic and general community centers. Since 2019, it has been collecting information on CML. Patients or other participants A total of 357 CML adult patients treated in the last 20 years have been registered until now on RENEHOC. Twenty patients were considered candidates for TFR; in 14 of them, TKI have been discontinued. Interventions Treatment was according to investigator preferences. Ten patients received Imatinib as first-line and ten received second-generation TKI. Four required a second line (Nilotinib); three due to intolerance. Nine patients discontinued in a standardized TFR program, three with the intention to seek a pregnancy, one for toxicity (pleural effusion), and one for personal reasons. Main outcome measures The main outcome measured is survival without TKI re-initiation. Results The mean age was 56 yrs. (25–92), 11 were women, and 19 were in the chronic phase. On average, they received 9.3 years of TKI (3.2–14) and were in RMM for 6.9 years before TFR. At a median follow-up of 15.2 months (range 1–44.5), 12 patients remain TKI-free; the patients that re-initiated TKI regained 4.5 MMR. Five patients developed withdrawal syndrome. Conclusions The TFR is a real goal for a selected group of patients with CML. This report represents real-world data in Colombia, showing its feasibility and safety under well-controlled settings. Funding ACHO has received grants for RENEHOC project from Takeda, Abbvie, Amgen, Dr. Reddy's.