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First-Line Nilotinib Treatment In Newly Diagnosed CML

By: Andrew Goldstein
Posted: Thursday, January 10, 2019

First-line nilotinib treatment yielded “high rates of deep molecular responses, few progressions to accelerated/blast phase, and a high overall survival” across age groups, according to findings presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 458). Gabriele Gugliotta, MD, PhD, of the Institute of Hematology "L. and A. Seràgnoli," Bologna, Italy, and colleagues, indicated that for patients younger than age 60 with newly diagnosed chronic phase chronic myeloid leukemia (CML), “nilotinib may be a very good choice, with high efficacy and low toxicity.”

The researchers analyzed the response rates, events, and outcomes of 472 patients with chronic phase CML. They were treated with 300 mg twice daily of nilotinib (276 patients), 400 mg twice daily of nilotinib (73 patients), or a 3-month rotation of 400 mg twice daily of nilotinib and 400 mg once daily of imatinib (123 patients). The patients were also stratified by age with 98 patients between the ages of 18 and 39, 217 between the ages of 40 and 59, and 157 patients aged 60 years or older.

With major molecular response (MR3) defined as BCR-ABL ≤ 0.1% (international scale), with > 10,000 ABL copies, and MR4 defined as BCR-ABL ≤ 0.01% (international scale), with > 10,000 ABL copies, the cumulative incidences of MR3 at 12, 24, and 36 months were 75%, 88%, and 93%, respectively. The cumulative incidences of MR4 by 12, 24, and 36 months were 38%, 63%, and 76%, respectively. These rates were similar across age groups.

Events leading to permanent nilotinib discontinuation occurred in 132 patients. Arterial thrombotic events were noted in 33 patients. Fifteen patients experienced disease progression to accelerated/blast phase. Overall, 23 patients died, 11 of them after disease progression to accelerated/blast phase. The estimated 5-year overall survival was 93%. The 5-year overall survival was 91%, 97%, and 89% in patients between the ages of 18 and 39 years, 40 and 59 years, and 60 years and older, respectively.

Disclosure: The study authors’ disclosures can be found at ash.confex.com.



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