Dasatinib and nilotinib useful alternatives for CML
Dasatinib and nilotinib could be useful alternatives to imatinib for first-line treatment of certain patients with chronic myeloid leukaemia (CML), according to two studies published in the New England Journal of Medicine.
In the first study (2010;362:2251), 846 patients with newly diagnosed Philadelphia chromosome-positive, chronic-phase CML were randomised to receive nilotinib 300mg twice a day, nilotinib 400mg twice a day or imatinib 400mg daily.
In the phase III, open-label study, rates of major molecular response at 12 months were higher for nilotinib than for imatinib (80% for nilotinib 300mg and 78% for nilotinib 400mg, vs 65% for imatinib; P<0.001 for both comparisons).
In the second study (ibid, p2260), a similar cohort of patients with CML who received dasatinib had a higher rate of complete cytogenetic response at 12 months than those who received imatinib.
Of the 519 patients randomised in the study, 77% taking dasatinib 100mg daily achieved a complete cytogenetic response, compared with 66% of patients taking imatinib 400mg daily (P=0.007).
Nick Duncan, principal pharmacist for haematology and oncology at University Hospitals Birmingham NHS Foundation Trust, commented: “Given the pre-eminence of imatinib as the standard first-line treatment for CML, it is exciting to see superior response rates being demonstrated by both of these new tyrosine kinase inhibitors. However, only with extended follow-up will we know whether these drugs can offer a survival advantage over imatinib.”
He added: “Both dasatinib and nilotinib demonstrated very similar cytogenetic and molecular response rates, so choosing between them is likely to be driven by cost and tolerability issues. It is noteworthy that a lower dose of nilotinib — 300mg twice a day — was shown to be as effective as the UK licensed dose of 400mg twice a day.”
Nonetheless, Mr Duncan said: “The potential for either dasatinib or nilotinib to be used as a first-line treatment for CML in the foreseeable future may ultimately be wishful thinking, given that the National Institute for Health and Clinical Excellence has recently published a negative appraisal consultation document on the use of these medicines for imatinib-intolerant patients.”
Citation: Clinical Pharmacist URI: 11016963
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