Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia: a European LeukemiaNet Study

Comparison of imatinib 400 mg and 800 mg daily in the front-line treatment of high-risk, Philadelphia-positive chronic myeloid leukemia : a European LeukemiaNet Study

Imatinib mesylate (IM), 400 mg daily, is the standard treatment of Philadelphia-positive (Ph(+)) chronic myeloid leukemia (CML). Preclinical data and results of single-arm studies raised the suggestion that better results could be achieved with a higher dose. To investigate whether the systematic use of a higher dose of IM could lead to better results, 216 patients with Ph(+) CML at high risk (HR) according to the Sokal index were randomly assigned to receive IM 800 mg or 400 mg daily, as front-line therapy, for at least 1 year. The CCgR rate at 1 year was 64% and 58% for the high-dose arm and for the standard-dose arm, respectively (P = .435). No differences were detectable in the CgR at 3 and 6 months, in the molecular response rate at any time, as well as in the rate of other events. Twenty-four (94%) of 25 patients who could tolerate the full 800-mg dose achieved a CCgR, and only 4 (23%) of 17 patients who could tolerate less than 350 mg achieved a CCgR. This study does not support the extensive use of high-dose IM (800 mg daily) front-line in all CML HR patients. This trial was registered at www.clinicaltrials.gov as #NCT00514488.

Rosti, Gianantonio (author)
Castagnetti, Fausto (author)
Haznedaroglu, Ibrahim (author)
Porkka, Kimmo (author)
Abruzzese, Elisabetta (author)
Alimena, Giuliana (author)
Ehrencrona, Hans (author)
Hjorth-Hansen, Henrik (author)
Kairisto, Veli (author)
Levato, Luciano (author)
Martinelli, Giovanni (author)
Nagler, Arnon (author)
Lanng Nielsen, Johan (author)
Ozbek, Ugur (author)
Palandri, Francesca (author)
Palmieri, Fausto (author)
Pane, Fabrizio (author)
Rege-Cambrin, Giovanna (author)
Russo, Domenico (author)
Specchia, Giorgina (author)
Testoni, Nicoletta (author)
Weiss-Bjerrum, Ole (author)
Saglio, Giuseppe (author)
Simonsson, BengtUppsala universitet,Institutionen för medicinska vetenskaper,Blodsjukdomar(Swepub:uu)bengtss (author)
Uppsala universitetInstitutionen för medicinska vetenskaper (creator_code:org_t)

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