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Abstract Chronic myeloid leukemia (CML) is a malignant hematologic disease that arises from the pluripotent hematopoietic stem cells. According to the guidelines issued by the European LeukemiaNet (ELN), BCR-ABL transcript levels on the international scale (BCR-ABLIS) at 3 and 6 months are defined as indicators of the early efficacy of firstline TKI treatment. A BCR-ABLIS ≤10% after 3 months of TKI treatment or BCR-ABLIS <1% after 6 months of treatment indicates an optimal response to TKI therapy with no need to adjust the therapeutic strategy. The present study aimed to investigate the impact of early molecular response (EMR; BCR-ABL ≤ 10% on the International scale [BCR-ABLIS] at 3 or 6 months) on outcomes in patients with newly diagnosed chronic myeloid leukemia in chronic phase treated with Nilotinib. Results of the current study showed that (74.5%) of the studied cases were male. Baseline serum creatinine (Scr) was ≥1.4 mg/dL in (62.8%) of the studied cases. eosinophilia was present in only (12.8%).In the present study, Baseline uric acid (UA) was <6 mg/dL in (62.8%) of the studied cases. Baseline peripheral blasts were <5% in (86.2%) of the studied cases. Splenomegaly was present in only (3.2%) of the studied cases. Age at diagnosis was <55 in (87.2%) of the studied cases. The present study results showed that, Baseline total leucocytic count (TLC) was ≥100k in (83.0%). Baseline Hb was ≥10 mg/dL in (51.1%). Baseline platelet count was ≥100k in (57.4%). Treatment compliance was found in (96.8%) of the studied cases. Hematologic response was found in (97.9%) of the studied cases. In the current study, early molecular response (EMR) was not achieved in four cases out of (94) studied subjects and achieved in (90) studied cases. We noticed male predominance in study cases achieved and not achieved EMR representing 74.4% and 75.0%, respectively. There was none statistically significant difference between the two groups regarding gender. The present study results showed that, in cases not achieved EMR; the majority (75%) had Scr <1.4 mg/dL, while in cases achieved EMR (64.4%) had Scr ≥1.4 mg/dL.There was none statistically significant difference between the two groups regarding baseline Scr . The current study results showed that, in cases not achieved EMR; (25%) had eosinophilia and in cases achieved EMR (12.2%) had eosinophilia. In cases not achieved EMR; (50%) had UA ≥6 mg/dL and (50%) had UA <6 mg/dL; while in cases achieved EMR (63.3%) had baseline UA <6 mg/dL. There was none statistically significant difference between the two groups regarding baseline UA and baseline eosinophilia. Regarding baseline peripheral blasts in the present study; all cases not achieved EMR had peripheral blasts ≥5%, while in cases achieved EMR (90%) had peripheral blasts <5%. There was statistically significant difference between the two groups regarding peripheral blasts. In our study, splenomegaly was found in (50%) of cases not achieved EMR and in (1.1%) of cases achieved EMR. There was statistically significant difference between the two groups as regard splenomegaly.The present study results showed that, (75%) of cases not achieved EMR were ≥55 years age at diagnosis; while (90%) of cases achieved EMR were <55 years age at diagnosis. There was statistically significant difference between the two groups as regard age at diagnosis. In the current investigation, TLC was ≥100k in all cases not achieved EMR while (82.2%) were ≥100k in cases achieved EMR. There was none statistically significant difference between the two groups regarding TLC. Regarding baseline Hb; (50%) of cases not achieved EMR had Hb ≥10 mg/dL, while (51.1%) of cases achieved EMR had Hb ≥10 mg/dL. There was none statistically significant difference between the two groups regarding baseline Hb. The present study results showed that, (50%) of cases not achieved EMR had baseline platelets ≥100k and (57.8%) of cases achieved EMR had baseline platelets ≥100k. There was none statistically significant difference between the two groups regarding baseline platelets. In our study, (25%) of cases not achieved EMR were complaint, while all cases achieved EMR were complaint.There was statistically significant difference between the two groups as regard compliance. Results of the current study showed that hematologic response was achieved in (50%) of cases not achieved EMR and in (100%) of cases achieved EMR. There was statistically significant difference between the two groups as regard hematologic response. Results of the current study showed that the median OS was (95%CI: 128.580 – 381.420). The mean OS in cases not achieved EMR3 was (95%CI: 219.210 – 415.290); the mean OS in cases achieved EMR3 was (95%CI: 485.666 – 499.321) and the mean OS in cases achieved EMR3 was (95%CI: 469.447 – 494.077). |