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Therapy

Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up

Leukemia volume 26, pages 2197–2203 (2012)Cite this article

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A Corrigendum to this article was published on 10 October 2012

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Abstract

Evaluating Nilotinib Efficacy and Safety in Clinical Trials Newly Diagnosed Patients compares nilotinib and imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). With a minimum follow-up of 3 years, major molecular response, molecular response of BCR-ABL⩽0.01% expressed on the international scale (BCR-ABLIS; MR4) and BCR-ABLIS⩽0.0032% (MR4.5) rates were significantly higher with nilotinib compared with imatinib, and differences in the depth of molecular response between nilotinib and imatinib have increased over time. No new progressions occurred on treatment since the 2-year analysis. Nilotinib was associated with a significantly lower probability of progression to accelerated phase/blast crisis vs imatinib (two (0.7%) progressions on nilotinib 300 mg twice daily, three (1.1%) on nilotinib 400 mg twice daily and 12 (4.2%) on imatinib). When considering progressions occurring after study treatment discontinuation, the advantage of nilotinib over imatinib in preventing progression remained significant (nine (3.2%) progressions on nilotinib 300 mg twice daily, six (2.1%) on nilotinib 400 mg twice daily and 19 (6.7%) on imatinib). Both nilotinib and imatinib were well tolerated, with minimal changes in safety over time. Nilotinib continues to demonstrate superior efficacy in all key response and outcome parameters compared with imatinib for the treatment of patients with newly diagnosed CML-CP.

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Acknowledgements

We thank Richard Woodman and Albert Hoenekopp (Novartis Pharmaceuticals) for providing ongoing medical and clinical support and Ariful Haque (Novartis Pharmaceuticals) for providing ongoing statistical analyses and invaluable collaboration. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We also thank Michael Mandola, PhD and Cornel Phillip, PhD (Articulate Science) for medical editorial assistance with this manuscript.

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Authors and Affiliations

  1. University of Chicago, Chicago, IL, USA

    R A Larson

  2. Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Germany

    A Hochhaus

  3. Royal Adelaide Hospital, SA Pathology, Adelaide, Australia

    T P Hughes

  4. Royal Liverpool University Hospital, Liverpool, UK

    R E Clark

  5. Institut Bergonié, Bordeaux, France

    G Etienne

  6. Seoul St Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea

    D-W Kim

  7. Sarah Cannon Research Institute, Nashville, TN, USA

    I W Flinn

  8. University of Tokyo, Tokyo, Japan

    M Kurokawa

  9. Hospital Jose Maria Ramos Mejia, Buenos Aires, Argentina

    B Moiraghi

  10. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

    R Yu & R E Blakesley

  11. Novartis Pharma AG, Basel, Switzerland

    N J Gallagher

  12. University of Turin, Orbassano, Italy

    G Saglio

  13. MD Anderson Cancer Center, The University of Texas, Houston, TX, USA

    H M Kantarjian

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  1. R A Larson
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Correspondence to R A Larson.

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Competing interests

RAL was a consultant for Novartis, BMS, Pfizer and Ariad, received research funding from Novartis, BMS and Ariad, and received honoraria from Novartis. AH received research funding and honoraria from BMS, Novartis, Pfizer, MSD and Ariad. TPH was a consultant for and received honoraria from Novartis, BMS and Ariad and research funding from Novartis, BMS and CSL. REC received research funding from Novartis and BMS, honoraria from Novartis, BMS and Pfizer, and was on the speakers' bureau for Novartis. GE has no relationships to disclose. D-WK was an advisor for and received research funding from Novartis, BMS and Pfizer, received honoraria from Novartis and BMS, was a consultant for Novartis and BMS, and was on the speaker's bureau for Novartis. IWF received research funding from Novartis. MK was on the speakers' bureau, an advisor, and received research funding from Novartis. BM was on the speakers' bureau for BMS and Novartis. RY and NJG are Novartis employees and stock holders. REB is a Novartis employee. GS is a consultant for Novartis, BMS and Pfizer and on the speakers' bureau for Novartis and BMS. HMK received research funding from Novartis, BMS and Pfizer and is a consultant for Novartis.

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AH and HMK designed research; RAL, AH, TPH, REC, D-WK, IWF, GS and HMK performed research; HMK contributed vital new reagents or analytical tool; AH, REC, GE, DW-K, MK, RY and HMK collected data; RAL, AH, TPH, GE, IWF, D-WK, RY, REB, NJG, GS and HMK analyzed and interpreted data; REB and HMK performed statistical analysis; and all authors drafted and approved the manuscript.

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Larson, R., Hochhaus, A., Hughes, T. et al. Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up. Leukemia 26, 2197–2203 (2012). https://doi.org/10.1038/leu.2012.134

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