Nilotinib versus imatinib in patients (pts) with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): ENESTnd 3-year (yr) follow-up (f/u).
2012; Lippincott Williams & Wilkins; Volume: 30; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2012.30.15_suppl.6509
ISSN1527-7755
AutoresHagop M. Kantarjian, Ian W. Flinn, Stuart L. Goldberg, Udomsak Bunworasate, Maria Aparecida Zanichelli, Hirohisa Nakamae, Timothy P. Hughes, Andreas Hochhaus, Giuseppe Saglio, Richard C. Woodman, Rick E. Blakesley, Charisse Kemp, Matt Kalaycio, Richard A. Larson,
Tópico(s)Myeloproliferative Neoplasms: Diagnosis and Treatment
Resumo6509^ Background: In ENESTnd, nilotinib significantly reduced progression to AP/BC and demonstrated superior rates of MMR, MR 4 , and MR 4.5 vs imatinib with f/u of 2 yrs. Methods: 846 pts with Ph+ CML-CP were randomized to nilotinib 300 mg BID (n = 282), nilotinib 400 mg BID (n = 281), or imatinib 400 mg QD (n = 283). Here, we report 3-yr f/u data. Results: Both nilotinib doses continued to demonstrate significantly higher rates of MMR, MR 4 , and MR 4.5 vs imatinib. In a landmark analysis, pts with BCR-ABL transcript levels ≤ 10% at 3 months (mo) had a higher probability of achieving MMR by 1 and 2 yrs vs pts with transcript levels > 10%. No new progressions occurred on treatment since the 2-yr analysis; rates of progression to AP/BC including events on treatment (n = 2, 3, 12) and those occurring both on treatment and after discontinuation (n = 9, 6, 19) were significantly lower for nilotinib 300 mg BID and nilotinib 400 mg BID vs imatinib, respectively. At 3 yrs, OS considering only CML-related deaths was significantly higher for nilotinib vs imatinib. The safety profiles of nilotinib and imatinib were similar to those at 2 yrs. Conclusions: 3-yr f/u confirms the superiority of nilotinib vs imatinib and an acceptable tolerability profile for the treatment of pts with newly diagnosed Ph+ CML-CP. [Table: see text]
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