Jayshree Shah on the Safety and Efficacy of Nilotinib

Jayshree Shah, RN, APN-C, MSN, BSN, BS, Nurse Practitioner, Leukemia Division, John Theurer Cancer Center, Hackensack University Medical Center, discusses the safety and efficacy of nilotinib (Tasigna), a selective BCR-ABL kinase inhibitor for patients with chronic myeloid leukemia (CML).

In a subanalysis of the ENESTnd trial, presented in an abstract at the 2012 ONS Congress, looked at the safety and efficacy of nilotinib in elderly patients with chronic phase CML. Elderly patients tend to be more difficult to treat than those diagnosed at a younger age and require more consideration when treating, in order to provide the best care and management.

The ENESTnd subset study showed similar results to the original trial, supporting the use of nilotinib in elderly patients. In the trial, when compared to imatinib, nilotinib prolonged disease-free survival, reduced the number of BCR-ABL transcripts, and induced a higher complete cytogenetic response.

A transition from imatinib to nilotinib carries several new concerns for side effect management. Imatinib is taken once daily, while nilotinib is taken twice per day with special attention needed to ensure that there are 10-12 hours between doses. Shah added that not leaving adequate time between doses could result in the development of pancreatitis, which is the most significant side effect associated with the treatment.

Symptoms that need monitoring include abdominal discomfort and QTc prolongation, which is associated with an irregular heart rhythm. Shah suggests that QT intervals be obtained by an ECG at baseline and 7 days after the initiation of therapy.

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