PB1934 QUALITY OF LIFE IN CHRONIC MYELOID LEUKEMIA PATIENTS WITH DEEP MOLECULAR RESPONSE AFTER STOPPING TREATMENT BY TYROSINE KINASE INHIBITORS AT LONG‐TERM FOLLOW‐UP

Abstract

Background:It is reasonable to incorporate the quality of life (QoL) assessment into the comprehensive evaluation of treatment outcomes in chronic phase chronic myeloid leukemia (CML CP) patients (pts) with deep molecular response (DMR) who enter the treatment‐free remission (TFR) phase and stop therapy by tyrosine kinase inhibitors (TKIs).Aims:We aimed to study QoL in CML CP pts who had stable DMR at long‐term follow‐up.Methods:The CML CP pts who had received therapy by any TKI ≥ 3 years (yrs) and had maintained DMR (MR4 or deeper with BCR‐ABL ≤0.01% IS) were enrolled into the prospective multicenter study RU‐SKI which has been conducted within the clinical approbation supported by Ministry of Health of RF. TKI were resumed in a case of major molecular response (MMR, BCR‐ABL>0.1% IS) loss. The QoL questionnaires RAND SF‐36 and EORTC QLQ C30 were filled out by the pts before stopping TKI treatment (base‐line) and at different time points after TKI treatment discontinuation. QoL analysis was performed in patients who were in TFR lasting >12 months. The paired Wilcoxon test was used for the statistical analysis.Results:In total, 98 CML CP pts with DMR were enrolled in the trial. Mean age was 46 yrs; 48% were males; 13% had high Sokal risk score; 80.6% pts were with comorbidity. The TKIs before treatment cessation were the following: imatinib in 67 (78%) pts, second‐generation (2G) TKIs were used as 1st line and as 2nd line in 11 (11.2%) and in 20 (20,4%) pts respectively. Toxicity to TKI was revealed in 62/98 pts (63.2%). During TFR phase TKI withdrawal syndrome was observed in 41/98 pts (41.8%). Me TFR duration was 24 mos (range 14–42). MMR loss and TKI resuming was in 46 (47%) pts. In QoL analysis at long term follow‐up 51/98 pts were included. In the vast majority of pts (46/51) during TFR phase QoL scores improved (11.8%) or were stable (78.4%) as compared with base‐line. Physical functioning (80.7 vs 87.2) and general health (63.3 vs 69.7) significantly improved (p≤0.01); Integral QoL Index (IQoLI) increased from 0.575 to 0.633 (p < 0.05). Also significant decrease of fatigue, nausea/vomiting, shortness of breath and sleep disturbance during long‐term TFR was revealed (p < 0.05). To note, five pts who exhibited QoL worsening at long‐term follow‐up after stopping treatment (57% decrease of mean IQoLI as compared with base‐line) had toxicity to TKI, TKI withdrawal syndrome and comorbidities.Summary/Conclusion:In general, the positive QoL changes and decrease of symptom burden was revealed in the majority of CML CP pts who maintained stable MMR and were off‐treatment for more than 12 months. Toxicity to TKI, TKI withdrawal syndrome and comorbidities may be accompanied with unfavorable QoL changes in CML CP pts at long‐term follow‐up after TKI stop therapy. The results of QoL assessment may contribute to optimization of the treatment strategies of CML patients with DMR.