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Imatinib mesylate in the treatment of newly diagnosed or refractory/resistant c-KIT positive acute myeloid leukemia. Results of an italian multicentric phase II study.

Pier Paolo Piccaluga^*,, Michele Malagola^°, Michela Rondoni^*, Mario Arpinati^*, Stefania Paolini^*, Anna Candoni^*, Renato Fanin^#, Emanuela Messa^@, Maria Teresa Pirrotta^{^}, Francesco Lauria^{^}, Giuseppe Visani, Daniele Alberti^**, Francesca Rancati^**, Vincenza Vinaccia^**, Domenico Russo^°, Giuseppe Saglio^@, Michele Baccarani^*, Giovanni Martinelli^*

^* Institute of Hematology and Medical Oncology "L. and A. Seràgnoli", S. Orsola-Malpighi Hospital, University of Bologna, Bologna;
^° Department of Hematology, University of Brescia;
^# Department of Hematology, University of Udine;
^@ Department of Hematology,Orbassano,University of Torino;
^{^} Department of Hematology,University of Siena;
Department of Hematology, Pesaro;
^** Novartis-Pharma, Italy

Correspondence: Pier Paolo Piccaluga, MD, PhD, Institute of Hematology and Medical Oncology "L. and A. Seràgnoli", S. Orsola Malpighi Hospital, University of Bologna, Via Massarenti, 9, 40138 Bologna, Italy. Phone: international +39.051.6364043. Fax: international +39.051.6364037. E-mail: pierpaolo.piccaluga{at}unibo.it

We evaluated safety and efficacy of imatinib (600 mg) in 36 c-KIT+ acute myeloid leukemia patients not amenable to receive conventional chemotherapy. No patient achieved complete remission. One patient obtained a hematologic improvement (platelet increase with transfusion independence). Median overall survival was 3 months (0.5–44+). Non-hematologic toxicity was overall mild.

Key words: imatinib mesylate, acute myeloid leukemia, c-KIT, PDGFRB, targeted therapy.