Treatment outcome of 100 chronic myeloid leukemia patients using nilotinib as the 2nd line therapy

Abstract

BACKGROUND: Nilotinib is a potent and selective BCR‑ABL inhibitor approved for use in patientswith newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CML‑CP) and in patientswith CML‑CP and accelerated phase (CML‑AP) who are resistant to or intolerant of imatinib. Patientswith imatinib‑resistant CML, nilotinib treatment resulted in a significant proportion of patients achievinghematologic and cytogenetic responses in all phases of CML.OBJECTIVES: The aim of the present study was to assess the treatment outcomes in term of themolecular response rate of CML patients using Nilotinib as the second‑line therapy after failure ofimatinib therapy.PATIENTS AND METHODS: A prospective study conducted between December 2014 and December2016 in Baghdad Teaching Hospital and National Centre of hematology. A total of 100 patients,who were on nilotinib therapy as the second‑line therapy, were enrolled in this study. The molecularresponse was assessed using real‑time quantitative polymerase chain reaction (RQ‑PCR). Majormolecular response (MMR) was defined as the BCR‑ABL1 of <0.1% by RQ‑PCR.RESULTS: The median age was 39 years, 59 were female and 41 were male. Fifty‑three patientswere classified as high‑risk group, and 47 patients were as low risk. The BCR‑ABL transcription levelhad a significant reduction from baseline at 3 months (P = 0.035) and the reduction from 3 monthsto 6 months was also statistically significant (P < 0.001). Comparing the patients who achievedMMR versus NO MMR, there was a significant association between low European Treatment andOutcome Study score and achieving MMR. An estimated 24 months overall survival (OS) is 95%.CONCLUSION: This study concluded that nilotinib is an effective therapeutic option for patientswith CML‑CP‑resistant to imatinib therapy. Nilotinib treatment resulted in a high‑OS rate and waswell tolerated.