Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib

Timothy P. Hughes, Jeffrey H. Lipton, Nelson Spector, Francisco Cervantes, Ricardo Pasquini, Nelma Cristina D Clementino, Pedro Enrique Dorlhiac Llacer, Anthony P. Schwarer, Francois Xavier Mahon, Delphine Rea, Susan Branford, Das Purkayastha, La Tonya Collins, Tomasz Szczudlo, Brian Leber

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52 Citations (Scopus)

Abstract

Patients in complete cytogenetic response (CCyR) with detectable BCR-ABL1 after ≥2 years on imatinib were randomized to nilotinib (400 mg twice daily, n = 104) or continued imatinib (n = 103) in the Evaluating Nilotinib Efficacy and Safety in clinical Trials-Complete Molecular Response (ENESTcmr) trial. By 1 and 2 years, confirmed undetectable BCR-ABL1 was achieved by 12.5% vs 5.8% (P = .108) and 22.1% vs 8.7% of patients in the nilotinib and imatinib arms, respectively (P = .0087). Among patients without molecular response 4.5 (BCR-ABL1 IS ≤0.0032%; MR 4.5 ) and those without major molecular response at study start, MR 4.5 by 2 years was achieved by 42.9% vs 20.8% and 29.2% vs 3.6% of patients in the nilotinib and imatinib arms, respectively. No patient in the nilotinibarm lostCCyR, vs 3 in the imatinib arm. Adverse events were morecommonin the nilotinib arm, as expected with the introduction of a new drug vs remaining on a well-tolerated drug. The safety profile of nilotinib was consistent with other reported studies. In summary, switching to nilotinib enabled more patients with chronic myeloid leukemia in chronic phase (CML-CP) to sustain lower levels of disease burden vs remaining on imatinib. This trial was registered at www. clinicaltrials.gov as #NCT00760877.

LanguageEnglish
Pages729-736
Number of pages8
JournalBlood
Volume124
Issue number5
DOIs
Publication statusPublished - 31 Jul 2014

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Hughes, T. P., Lipton, J. H., Spector, N., Cervantes, F., Pasquini, R., Clementino, N. C. D., ... Leber, B. (2014). Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. Blood, 124(5), 729-736. https://doi.org/10.1182/blood-2013-12-544015
Hughes, Timothy P. ; Lipton, Jeffrey H. ; Spector, Nelson ; Cervantes, Francisco ; Pasquini, Ricardo ; Clementino, Nelma Cristina D ; Dorlhiac Llacer, Pedro Enrique ; Schwarer, Anthony P. ; Mahon, Francois Xavier ; Rea, Delphine ; Branford, Susan ; Purkayastha, Das ; Collins, La Tonya ; Szczudlo, Tomasz ; Leber, Brian. / Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. In: Blood. 2014 ; Vol. 124, No. 5. pp. 729-736.
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abstract = "Patients in complete cytogenetic response (CCyR) with detectable BCR-ABL1 after ≥2 years on imatinib were randomized to nilotinib (400 mg twice daily, n = 104) or continued imatinib (n = 103) in the Evaluating Nilotinib Efficacy and Safety in clinical Trials-Complete Molecular Response (ENESTcmr) trial. By 1 and 2 years, confirmed undetectable BCR-ABL1 was achieved by 12.5{\%} vs 5.8{\%} (P = .108) and 22.1{\%} vs 8.7{\%} of patients in the nilotinib and imatinib arms, respectively (P = .0087). Among patients without molecular response 4.5 (BCR-ABL1 IS ≤0.0032{\%}; MR 4.5 ) and those without major molecular response at study start, MR 4.5 by 2 years was achieved by 42.9{\%} vs 20.8{\%} and 29.2{\%} vs 3.6{\%} of patients in the nilotinib and imatinib arms, respectively. No patient in the nilotinibarm lostCCyR, vs 3 in the imatinib arm. Adverse events were morecommonin the nilotinib arm, as expected with the introduction of a new drug vs remaining on a well-tolerated drug. The safety profile of nilotinib was consistent with other reported studies. In summary, switching to nilotinib enabled more patients with chronic myeloid leukemia in chronic phase (CML-CP) to sustain lower levels of disease burden vs remaining on imatinib. This trial was registered at www. clinicaltrials.gov as #NCT00760877.",
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Hughes, TP, Lipton, JH, Spector, N, Cervantes, F, Pasquini, R, Clementino, NCD, Dorlhiac Llacer, PE, Schwarer, AP, Mahon, FX, Rea, D, Branford, S, Purkayastha, D, Collins, LT, Szczudlo, T & Leber, B 2014, 'Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib', Blood, vol. 124, no. 5, pp. 729-736. https://doi.org/10.1182/blood-2013-12-544015

Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib. / Hughes, Timothy P.; Lipton, Jeffrey H.; Spector, Nelson; Cervantes, Francisco; Pasquini, Ricardo; Clementino, Nelma Cristina D; Dorlhiac Llacer, Pedro Enrique; Schwarer, Anthony P.; Mahon, Francois Xavier; Rea, Delphine; Branford, Susan; Purkayastha, Das; Collins, La Tonya; Szczudlo, Tomasz; Leber, Brian.

In: Blood, Vol. 124, No. 5, 31.07.2014, p. 729-736.

Research output: Contribution to journalArticle

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T1 - Deep molecular responses achieved in patients with CML-CP who are switched to nilotinib after long-term imatinib

AU - Hughes, Timothy P.

AU - Lipton, Jeffrey H.

AU - Spector, Nelson

AU - Cervantes, Francisco

AU - Pasquini, Ricardo

AU - Clementino, Nelma Cristina D

AU - Dorlhiac Llacer, Pedro Enrique

AU - Schwarer, Anthony P.

AU - Mahon, Francois Xavier

AU - Rea, Delphine

AU - Branford, Susan

AU - Purkayastha, Das

AU - Collins, La Tonya

AU - Szczudlo, Tomasz

AU - Leber, Brian

PY - 2014/7/31

Y1 - 2014/7/31

N2 - Patients in complete cytogenetic response (CCyR) with detectable BCR-ABL1 after ≥2 years on imatinib were randomized to nilotinib (400 mg twice daily, n = 104) or continued imatinib (n = 103) in the Evaluating Nilotinib Efficacy and Safety in clinical Trials-Complete Molecular Response (ENESTcmr) trial. By 1 and 2 years, confirmed undetectable BCR-ABL1 was achieved by 12.5% vs 5.8% (P = .108) and 22.1% vs 8.7% of patients in the nilotinib and imatinib arms, respectively (P = .0087). Among patients without molecular response 4.5 (BCR-ABL1 IS ≤0.0032%; MR 4.5 ) and those without major molecular response at study start, MR 4.5 by 2 years was achieved by 42.9% vs 20.8% and 29.2% vs 3.6% of patients in the nilotinib and imatinib arms, respectively. No patient in the nilotinibarm lostCCyR, vs 3 in the imatinib arm. Adverse events were morecommonin the nilotinib arm, as expected with the introduction of a new drug vs remaining on a well-tolerated drug. The safety profile of nilotinib was consistent with other reported studies. In summary, switching to nilotinib enabled more patients with chronic myeloid leukemia in chronic phase (CML-CP) to sustain lower levels of disease burden vs remaining on imatinib. This trial was registered at www. clinicaltrials.gov as #NCT00760877.

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