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Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients
BACKGROUND: Nilotinib (Tasigna®) is a second-generation tyrosine kinase inhibitor that shows faster and deeper molecular responses (MR) in comparison to Imatinib as initial therapy in chronic phase chronic myeloid leukemia (CML). Efficacy and safety data for nilotinib in the Asian population is scar...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388993/ https://www.ncbi.nlm.nih.gov/pubmed/30863159 http://dx.doi.org/10.2147/CMAR.S181911 |
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author | Zaidi, Uzma Kaleem, Bushra Borhany, Munira Maqsood, Sidra Fatima, Naveena Sufaida, Gul Ansari, Saqib Hussain Farzana, Tasneem Shamsi, Tahir Sultan |
author_facet | Zaidi, Uzma Kaleem, Bushra Borhany, Munira Maqsood, Sidra Fatima, Naveena Sufaida, Gul Ansari, Saqib Hussain Farzana, Tasneem Shamsi, Tahir Sultan |
author_sort | Zaidi, Uzma |
collection | PubMed |
description | BACKGROUND: Nilotinib (Tasigna®) is a second-generation tyrosine kinase inhibitor that shows faster and deeper molecular responses (MR) in comparison to Imatinib as initial therapy in chronic phase chronic myeloid leukemia (CML). Efficacy and safety data for nilotinib in the Asian population is scarce, particularly in Pakistan. We aimed to determine the MR to nilotinib and its safety profile in patients with chronic phase CML. PATIENTS AND METHODS: This observational study was conducted among 173 patients with newly diagnosed CML presenting in the chronic phase. Most patients (50.1%) had a high Sokal score at diagnosis. All patients received nilotinib 600 mg/day. The hematological and molecular responses were assessed at 3 and 6 months respectively and thereafter at 6-monthly intervals. Long-term event free survival (EFS), transformation free survival (TFS), overall survival (OS) and adverse events were observed. RESULTS: Cumulative incidence of major MR (MMR) was 86% and deep MR (DMR ie MR 4.0 and MR4.5) was 39%. Early MMR and DMR after 6 months of therapy were achieved by 74.9% and 37% of patients, respectively. Two-year EFS, TFS and OS rates for all patients were 91.9%, 92% and 92.3%, respectively. At median follow-up of 24 months, 81% and 49% of patients sustained MMR and DMR, respectively. The main adverse events were weight gain (4.6%) and abdominal pain (4%). CONCLUSION: This study showed promising results in terms of achievement of early and sustained DMR in chronic phase CML, therefore, we recommend nilotinib as frontline treatment in Pakistani population. |
format | Online Article Text |
id | pubmed-6388993 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-63889932019-03-12 Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients Zaidi, Uzma Kaleem, Bushra Borhany, Munira Maqsood, Sidra Fatima, Naveena Sufaida, Gul Ansari, Saqib Hussain Farzana, Tasneem Shamsi, Tahir Sultan Cancer Manag Res Original Research BACKGROUND: Nilotinib (Tasigna®) is a second-generation tyrosine kinase inhibitor that shows faster and deeper molecular responses (MR) in comparison to Imatinib as initial therapy in chronic phase chronic myeloid leukemia (CML). Efficacy and safety data for nilotinib in the Asian population is scarce, particularly in Pakistan. We aimed to determine the MR to nilotinib and its safety profile in patients with chronic phase CML. PATIENTS AND METHODS: This observational study was conducted among 173 patients with newly diagnosed CML presenting in the chronic phase. Most patients (50.1%) had a high Sokal score at diagnosis. All patients received nilotinib 600 mg/day. The hematological and molecular responses were assessed at 3 and 6 months respectively and thereafter at 6-monthly intervals. Long-term event free survival (EFS), transformation free survival (TFS), overall survival (OS) and adverse events were observed. RESULTS: Cumulative incidence of major MR (MMR) was 86% and deep MR (DMR ie MR 4.0 and MR4.5) was 39%. Early MMR and DMR after 6 months of therapy were achieved by 74.9% and 37% of patients, respectively. Two-year EFS, TFS and OS rates for all patients were 91.9%, 92% and 92.3%, respectively. At median follow-up of 24 months, 81% and 49% of patients sustained MMR and DMR, respectively. The main adverse events were weight gain (4.6%) and abdominal pain (4%). CONCLUSION: This study showed promising results in terms of achievement of early and sustained DMR in chronic phase CML, therefore, we recommend nilotinib as frontline treatment in Pakistani population. Dove Medical Press 2019-02-15 /pmc/articles/PMC6388993/ /pubmed/30863159 http://dx.doi.org/10.2147/CMAR.S181911 Text en © 2019 Zaidi et al. This work is published and licensed by Dove Medical Press Limited The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. |
spellingShingle | Original Research Zaidi, Uzma Kaleem, Bushra Borhany, Munira Maqsood, Sidra Fatima, Naveena Sufaida, Gul Ansari, Saqib Hussain Farzana, Tasneem Shamsi, Tahir Sultan Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title | Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title_full | Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title_fullStr | Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title_full_unstemmed | Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title_short | Early and sustained deep molecular response achieved with nilotinib in high Sokal risk chronic myeloid leukemia patients |
title_sort | early and sustained deep molecular response achieved with nilotinib in high sokal risk chronic myeloid leukemia patients |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6388993/ https://www.ncbi.nlm.nih.gov/pubmed/30863159 http://dx.doi.org/10.2147/CMAR.S181911 |
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