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Updated: Feb 6, 2026

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Experience with the Use of Nilotinib in Indian Patients

Avaronnan Manuprasad1, Prasanth Ganesan1, Trivadi S Ganesan1

  • 11Department of Medical Oncology, Cancer Institute (WIA), 36, Sardar Patel Road, Guindy, Chennai, Tamilnadu 600036 India.

Indian Journal of Hematology & Blood Transfusion : an Official Journal of Indian Society of Hematology and Blood Transfusion
|August 22, 2018
PubMed

Insights

Nilotinib shows efficacy in Indian chronic myeloid leukemia patients as a second-line therapy. However, this study observed a higher incidence of liver toxicity compared to prior reports.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Genetic and ethnic factors influence tyrosine kinase inhibitor (TKI) efficacy and toxicity.
  • Nilotinib has been available in India since 2010, but its safety and toxicity in Indian patients with chronic myeloid leukemia (CML) remain undocumented.
  • TKIs are crucial in CML treatment, necessitating understanding of drug-specific outcomes in diverse populations.

Purpose of the Study:

  • To analyze the efficacy and toxicity of nilotinib as a second-line therapy in Indian patients with chronic myeloid leukemia (CML).
  • To document the safety profile of nilotinib in a specific ethnic cohort previously underrepresented in clinical trials.
  • To compare observed toxicity, particularly liver toxicity, with existing international data.

Main Methods:

  • Retrospective analysis of 37 Indian CML patients who initiated nilotinib between 2010 and 2016 after imatinib failure or intolerance.
  • Data collection included patient demographics, reasons for switching therapy, nilotinib dosage, dose modifications, toxicities, and treatment outcomes.
  • Efficacy was assessed by response rates, including complete hematologic response (CHR) and major molecular response (MMR).

Main Results:

  • The commonest grade 3/4 toxicities were thrombocytopenia (24%), hyperbilirubinemia (18%), and leukopenia (8%).
  • Six patients (16%) discontinued nilotinib due to toxicity, and 8 (21%) stopped due to lack of efficacy.
  • After a median follow-up of 14 months, 54% of patients responded to nilotinib, with 14 achieving CHR and 7 achieving MMR.
  • A higher incidence of liver toxicity was observed compared to previous reports, potentially linked to its use as second-line therapy.

Conclusions:

  • Nilotinib demonstrates efficacy as a second-line treatment for Indian CML patients, achieving significant hematologic and molecular responses.
  • The study highlights a potentially higher incidence of liver toxicity in this Indian cohort, warranting close monitoring.
  • Further prospective studies are needed to confirm these findings and optimize nilotinib use in diverse ethnic populations.
Keywords:
Chronic myeloid leukemiaIndiaNilotinibSecond line therapyToxicity

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