A  Barcellona, durante il congresso dell 'European Hematology Association , si e' discusso molto anche del ruolo del nilotib

 nella  LMC : sostituira' lo storico imatinib?

di seguito trovate un articolo pubblicato come anticipazione   nel  web   (e-pub. del 5 giugno 2010)

Nilotinib versus Imatinib for Newly Diagnosed
Chronic Myeloid Leukemia
Giuseppe Saglio, M.D., Dong-Wook Kim, M.D., Ph.D., Surapol Issaragrisil, M.D., Philipp le Coutre, M.D.,
Gabriel Etienne, M.D., Clarisse Lobo, M.D., Ricardo Pasquini, M.D., Richard E. Clark, M.D., Andreas Hochhaus, M.D.,
Timothy P. Hughes, M.D., M.B., B.S., Neil Gallagher, M.D., Ph.D., Albert Hoenekopp, M.D., Mei Dong, M.D.,
Ariful Haque, M.S., Richard A. Larson, M.D., and Hagop M. Kantarjian, M.D., for the ENESTnd Investigators*
Abstract
From the University of Turin, San Luigi
Gonzaga Hospital, Orbassano, Turin, Italy
(G.S.); Seoul St. Mary’s Hospital, Catholic
University of Korea, Seoul, South Korea
(D.-W.K.); Siriraj Hospital, Mahidol University,
Bangkok, Thailand (S.I.); Charité,
Campus Virchow, Universitätsmedizin
Berlin, Berlin (P.C.); Institut Bergonié, Bordeaux,
France (G.E.); Instituto Estadual
de Hematologia Arthur de Siqueira Cavalcanti,
Rio de Janeiro (C.L.); Universidade
Federal do Paraná, Curitiba, Paraná, Brazil
(R.P.); Royal Liverpool University Hospital,
Liverpool, United Kingdom (R.E.C.);
Universitätsklinikum Jena, Jena, Germany
(A. Hochhaus); Royal Adelaide Hospital,
Adelaide, SA, Australia (T.P.H.); Novartis
Pharma, Basel, Switzerland (N.G., A.
Hoenekopp); Novartis Pharmaceuticals,
East Hanover, NJ (M.D., A. Haque); the
University of Chicago, Chicago (R.A.L.);
and the University of Texas M.D. Anderson
Cancer Center, Houston (H.M.K.).
Address reprint requests to Dr. Saglio at
the Divisione di Medicina Interna e di
Ematologia, Ospedale San Luigi Gonzaga,
Orbassano, Turin 10043, Italy, or at
giuseppe.saglio@unito.it.
*Investigators in the Evaluating Nilotinib
Efficacy and Safety in Clinical Trials–
Newly Diagnosed Patients (ENESTnd)
study are listed in the Supplementary
Appendix, available with the full text of
this article at NEJM.org.
This article (10.1056/NEJMoa0912614) was
published on June 5, 2010, at NEJM.org.
N Engl J Med 2010.
Copyright © 2010 Massachusetts Medical Society.
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.)

AGGIORNAMENTO 17/06/2010

L'FDA americano ha approvato il nilotinib come prima indicazione  nelal

PH+CP-LMC ( Philadelphia cromosome positive  chronic phase

chronic myeloid leukemia)