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Nilotinib a Second-Line Treatment for Chronic Myelogenous Leukaemia: Presented at NCCN

By Ed Susman

HOLLYWOOD, Fla. -- March 10, 2008 -- The tyrosine kinase inhibitor nilotinib (Tasinga) has been declared a second-line treatment for chronic myelogenous leukaemia.

Nilotnib, which targets the bcr-abl genetic mutation responsible for causing chronic myelogenous leukaemia, has been added to the National Comprehensive Cancer Network treatment algorithm, it was noted at a presentation given here on March 7 at the National Comprehensive Cancer Network (NCCN) 13th Annual Conference: Clinical Practice Guidelines and Quality Cancer Care.

The guideline committee inserted the use of nilotinib into the guidelines as a choice equal to treatment with dasatinib (Sprycel), haematopoietic stem-cell transplantation, or entry into a clinical trial in nearly every instance of treatment failure with imatinib (Gleevec) or intolerance to imatinib.

"We do not recommend, however, the use of nilotinib among patients who are in blast crisis," said Susan O'Brien, MD, Professor of Medicine, University of Texas, M.D. Anderson Cancer Center, Houston, Texas. Dr. O'Brien noted that there are no clinical data available to show that nilotinib is effective in treating patients in blast crises.

Dr. O'Brien suggested that if a patient with chronic myelogenous leukaemia has had no response to imatinib after 3 months, doctors should double-check their testing to make sure that the original diagnosis was not a false positive, since almost all chronic myelogenous leukaemia patients have some response to imatinib.

The NCCN guidelines give clinicians choices for treatment at the 6-month follow-up, at which time karyotypic bone-marrow cytogenetics testing should be performed. If the testing indicates a complete cytogenetic response, continuation of the same dose of imatinib is warranted. If a patient experiences a partial cytogenetic response, Dr. O'Brien said the guidelines still suggest continuing with imatinib or considering a slight dose increase. If there is minimal or no cytogenetic response, Dr. O'Brien noted that doctors should consider increasing the dose of imatinib to 600 to 800 mg a day, assuming the patient is able to tolerate this dose. If the patient cannot tolerate high-dose imatinib, the guidelines suggest the use of dasatinib or nilotinib, entry into a clinical trial, or stem-cell transplantation.

The guidelines offer the same advice at the 12-month follow-up visit.

Dr. O'Brien stated that a lack of a major cytogenetic response to imatinib by 12 months is associated with a significant decrease in survival, according to recent studies. The 5-year survival of patients achieving a complete response was 97%, while it was 93% for those achieving a partial response. Five-year survival was only 81%, however, for those achieving a major cytogenetic response.

At 18 months, if there is no complete cytogenetic response, Dr. O'Brien said that a change in therapy is required. For cases in which imatinib fails to control the progress of the disease, the guidelines suggest switching to dasatinib or nilotinib, followed by transplantation, if feasible.

In blast crisis after imatinib failure, the guidelines only suggest the use of dasatinib.

The guidelines caution that, when prescribing nilotinib, physicians should carefully check to ensure that the patient's electrolytes are in proper balance.


[Presentation title: Update: Chronic Myelogenous Leukemia Guidelines.]

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