Abstract
BackgroundTyrosine kinase inhibitors (TKI) can be safely discontinued in chronic phase chronic myeloid leukemia (CP‐CML) patients who had achieved a sustained deep molecular response. Based on the results of discontinuation trials, recommendations regarding patient selection for a treatment‐free remission (TFR) attempt had been proposed. The aims of this study were to evaluate the rate of patients eligible for TKI discontinuation and molecular recurrence‐free survival (MRFS) after stop according to recommendations.MethodsOver a 10‐year period, newly diagnosed CP‐CML patients and treated with first‐line TKI in the nine French participating centers were included. Eligibility to treatment discontinuation and MRFS were analyzed and compared according to selection criteria defined by recommendations and first‐line treatments.ResultsFrom January 2006 to December 2015, 398 patients were considered. Among them, 73% and 27% of patients received imatinib or either second or third generation tyrosine kinase inhibitors as frontline treatment, respectively. Considering the selection criteria defined by recommendations, up to 55% of the patients were selected as optimal candidates for treatment discontinuation. Overall 95/398 (24%) discontinued treatment. MRFS was 51.8% [95% CI 41.41–62.19] at 2 years and 43.8% [31.45–56.15] at 5 years. Patients receiving frontline second‐generation TKI and fulfilling the eligibility criteria suggested by recommendations had the lowest probability of molecular relapse after TKI stop when compare to others.ConclusionOne third of CP‐CML patients treated with TKI frontline fulfilled the selection criteria suggested by European LeukemiaNet TFR recommendations. Meeting selection criteria and second‐generation TKI frontline were associated with the highest MRFS.
Highlights
Following the results of the first two large studies evaluating the possibility of imatinib (IMA) discontinuation in chronic phase chronic myeloid leukemia (CP-CML) patients who had achieved a sustained deep molecular response (DMR), numerous experiences of tyrosine kinase inhibitor (TKI) cessation are available.1–3 Currently, thousands CML patients have discontinued Tyrosine kinase inhibitors (TKI)
The aims of this retrospective and observational study were to evaluate the proportion of eligible patients to treatment-free remission (TFR) and to estimate the molecular recurrence-free survival (MRFS) after TKI cessation in CP- CML according to the patient selection criteria suggested in these recommendations
Based on the results of numerous clinical trials evaluating the feasibility of TKI stop, recommendations by experts in the field have been suggested and concern notably the optimal selection of the patient, the monitoring after TKI cessation and treatment resumption after molecular recurrence (MolRec) currently defined by MMR loss.[4,6,7,9]
Summary
Following the results of the first two large studies evaluating the possibility of imatinib (IMA) discontinuation in chronic phase chronic myeloid leukemia (CP-CML) patients who had achieved a sustained deep molecular response (DMR), numerous experiences of tyrosine kinase inhibitor (TKI) cessation are available.1–3 Currently, thousands CML patients have discontinued TKI. Given the recent report of infrequent progression events after TKI discontinuation, selecting patients who will be optimal candidates for TFR experience outside a clinical trial and in daily clinical practice remains a significant challenge.[4,5] Over the past 4 years several recommendations regarding the selection of the patients for a TFR program have been proposed.6–9 While CP of the disease at diagnosis and during follow-u p and typical BCR-A BL1 transcript are conditions shared by all of these recommendations, TKI type and duration, depth and duration of DMR and CML history in terms of non-optimal response or switch unrelated to TKI intolerance, support some slight differences Whether these differences have an impact on TFR eligibility and TFR rate remains to be dertermined. The aims of this retrospective and observational study were to evaluate the proportion of eligible patients to TFR and to estimate the molecular recurrence-free survival (MRFS) after TKI cessation in CP- CML according to the patient selection criteria suggested in these recommendations
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