Research ExplorerPublicationsNilotinib versus imatinib for newly diagnosed chronic myeloi...

Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia

Standard

Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. / Saglio, Giuseppe; Kim, Dong-Wook; Issaragrisil, Surapol; le Coutre, Philipp; Etienne, Gabriel; Lobo, Clarisse; Pasquini, Ricardo; Clark, Richard E; Hochhaus, Andreas; Hughes, Timothy P; Gallagher, Neil; Hoenekopp, Albert; Dong, Mei; Haque, Ariful; Larson, Richard A; Kantarjian, Hagop M; ENESTnd Investigators ; Schafhausen, Philippe.

In: NEW ENGL J MED, Vol. 362, No. 24, 17.06.2010, p. 2251-9.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Saglio, G, Kim, D-W, Issaragrisil, S, le Coutre, P, Etienne, G, Lobo, C, Pasquini, R, Clark, RE, Hochhaus, A, Hughes, TP, Gallagher, N, Hoenekopp, A, Dong, M, Haque, A, Larson, RA, Kantarjian, HM, ENESTnd Investigators & Schafhausen, P 2010, 'Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia', NEW ENGL J MED, vol. 362, no. 24, pp. 2251-9. https://doi.org/10.1056/NEJMoa0912614

APA

Saglio, G., Kim, D-W., Issaragrisil, S., le Coutre, P., Etienne, G., Lobo, C., Pasquini, R., Clark, R. E., Hochhaus, A., Hughes, T. P., Gallagher, N., Hoenekopp, A., Dong, M., Haque, A., Larson, R. A., Kantarjian, H. M., ENESTnd Investigators, & Schafhausen, P. (2010). Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. NEW ENGL J MED, 362(24), 2251-9. https://doi.org/10.1056/NEJMoa0912614

Vancouver

Saglio G, Kim D-W, Issaragrisil S, le Coutre P, Etienne G, Lobo C et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. NEW ENGL J MED. 2010 Jun 17;362(24):2251-9. https://doi.org/10.1056/NEJMoa0912614

Bibtex

@article{3971e191e7f84d26885603e346f0a6de,
title = "Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia",
abstract = "BACKGROUND: Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase.METHODS: In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome-positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months.RESULTS: At 12 months, the rates of major molecular response for nilotinib (44% for the 300-mg dose and 43% for the 400-mg dose) were nearly twice that for imatinib (22%) (P<0.001 for both comparisons). The rates of complete cytogenetic response by 12 months were significantly higher for nilotinib (80% for the 300-mg dose and 78% for the 400-mg dose) than for imatinib (65%) (P<0.001 for both comparisons). Patients receiving either the 300-mg dose or the 400-mg dose of nilotinib twice daily had a significant improvement in the time to progression to the accelerated phase or blast crisis, as compared with those receiving imatinib (P=0.01 and P=0.004, respectively). No patient with progression to the accelerated phase or blast crisis had a major molecular response. Gastrointestinal and fluid-retention events were more frequent among patients receiving imatinib, whereas dermatologic events and headache were more frequent in those receiving nilotinib. Discontinuations due to aminotransferase and bilirubin elevations were low in all three study groups.CONCLUSIONS: Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive CML. (ClinicalTrials.gov number, NCT00471497.)",
keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Benzamides, Blast Crisis, Disease Progression, Female, Fusion Proteins, bcr-abl, Humans, Kaplan-Meier Estimate, Leukemia, Myeloid, Chronic-Phase, Male, Middle Aged, Piperazines, Protein Kinase Inhibitors, Pyrimidines, Young Adult",
author = "Giuseppe Saglio and Dong-Wook Kim and Surapol Issaragrisil and {le Coutre}, Philipp and Gabriel Etienne and Clarisse Lobo and Ricardo Pasquini and Clark, {Richard E} and Andreas Hochhaus and Hughes, {Timothy P} and Neil Gallagher and Albert Hoenekopp and Mei Dong and Ariful Haque and Larson, {Richard A} and Kantarjian, {Hagop M} and {ENESTnd Investigators} and Philippe Schafhausen",
note = "2010 Massachusetts Medical Society",
year = "2010",
month = jun,
day = "17",
doi = "10.1056/NEJMoa0912614",
language = "English",
volume = "362",
pages = "2251--9",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "24",

}

RIS

TY - JOUR

T1 - Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia

AU - Saglio, Giuseppe

AU - Kim, Dong-Wook

AU - Issaragrisil, Surapol

AU - le Coutre, Philipp

AU - Etienne, Gabriel

AU - Lobo, Clarisse

AU - Pasquini, Ricardo

AU - Clark, Richard E

AU - Hochhaus, Andreas

AU - Hughes, Timothy P

AU - Gallagher, Neil

AU - Hoenekopp, Albert

AU - Dong, Mei

AU - Haque, Ariful

AU - Larson, Richard A

AU - Kantarjian, Hagop M

AU - ENESTnd Investigators

AU - Schafhausen, Philippe

N1 - 2010 Massachusetts Medical Society

PY - 2010/6/17

Y1 - 2010/6/17

N2 - BACKGROUND: Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase.METHODS: In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome-positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months.RESULTS: At 12 months, the rates of major molecular response for nilotinib (44% for the 300-mg dose and 43% for the 400-mg dose) were nearly twice that for imatinib (22%) (P<0.001 for both comparisons). The rates of complete cytogenetic response by 12 months were significantly higher for nilotinib (80% for the 300-mg dose and 78% for the 400-mg dose) than for imatinib (65%) (P<0.001 for both comparisons). Patients receiving either the 300-mg dose or the 400-mg dose of nilotinib twice daily had a significant improvement in the time to progression to the accelerated phase or blast crisis, as compared with those receiving imatinib (P=0.01 and P=0.004, respectively). No patient with progression to the accelerated phase or blast crisis had a major molecular response. Gastrointestinal and fluid-retention events were more frequent among patients receiving imatinib, whereas dermatologic events and headache were more frequent in those receiving nilotinib. Discontinuations due to aminotransferase and bilirubin elevations were low in all three study groups.CONCLUSIONS: Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive CML. (ClinicalTrials.gov number, NCT00471497.)

AB - BACKGROUND: Nilotinib has been shown to be a more potent inhibitor of BCR-ABL than imatinib. We evaluated the efficacy and safety of nilotinib, as compared with imatinib, in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in the chronic phase.METHODS: In this phase 3, randomized, open-label, multicenter study, we assigned 846 patients with chronic-phase Philadelphia chromosome-positive CML in a 1:1:1 ratio to receive nilotinib (at a dose of either 300 mg or 400 mg twice daily) or imatinib (at a dose of 400 mg once daily). The primary end point was the rate of major molecular response at 12 months.RESULTS: At 12 months, the rates of major molecular response for nilotinib (44% for the 300-mg dose and 43% for the 400-mg dose) were nearly twice that for imatinib (22%) (P<0.001 for both comparisons). The rates of complete cytogenetic response by 12 months were significantly higher for nilotinib (80% for the 300-mg dose and 78% for the 400-mg dose) than for imatinib (65%) (P<0.001 for both comparisons). Patients receiving either the 300-mg dose or the 400-mg dose of nilotinib twice daily had a significant improvement in the time to progression to the accelerated phase or blast crisis, as compared with those receiving imatinib (P=0.01 and P=0.004, respectively). No patient with progression to the accelerated phase or blast crisis had a major molecular response. Gastrointestinal and fluid-retention events were more frequent among patients receiving imatinib, whereas dermatologic events and headache were more frequent in those receiving nilotinib. Discontinuations due to aminotransferase and bilirubin elevations were low in all three study groups.CONCLUSIONS: Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome-positive CML. (ClinicalTrials.gov number, NCT00471497.)

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents

KW - Benzamides

KW - Blast Crisis

KW - Disease Progression

KW - Female

KW - Fusion Proteins, bcr-abl

KW - Humans

KW - Kaplan-Meier Estimate

KW - Leukemia, Myeloid, Chronic-Phase

KW - Male

KW - Middle Aged

KW - Piperazines

KW - Protein Kinase Inhibitors

KW - Pyrimidines

KW - Young Adult

U2 - 10.1056/NEJMoa0912614

DO - 10.1056/NEJMoa0912614

M3 - SCORING: Journal article

C2 - 20525993

VL - 362

SP - 2251

EP - 2259

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 24

ER -