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Long-Term Outcome of Complete Cytogenetic Responders After Imatinib 400 mg in Late Chronic Phase, Philadelphia-Positive Chronic Myeloid Leukemia: The GIMEMA Working Party on CML

Francesca Palandri, Ilaria Iacobucci, Giovanni Martinelli, Marilina Amabile, Angela Poerio, Nicoletta Testoni, Simona Soverini, Fausto Castagnetti, Antonio De Vivo, Massimo Breccia, Giorgina Specchia, Elisabetta Abruzzese, Bruno Martino, Daniela Cilloni, Giuseppe Saglio, Fabrizio Pane, Anna Marina Liberati, Gianantonio Rosti, Michele Baccarani

From the Department of Hematology/Oncology "L. and A. Seràgnoli" S. Orsola Malpighi Hospital, University of Bologna, Bologna; Department of Cellular Biotechnology and Hematology, University "La Sapienza"; University Tor Vergata, Rome; Hematology Section, University of Bari; Division of Hematology, Ospedali Riuniti, Reggio Calabria; Department of Clinical and Biological Science, University of Turin at Orbassano, Turin; CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II, Naples; and Istituto di Medicina Interna e Scienze Oncologiche, Policlinico Monteluce Perugia, Italy

Corresponding author: Francesca Palandri, MD, Institute of Hematology and Medical Oncology "L. and A. Seràgnoli," St. Orsola-Malpighi University Hospital, Via Massarenti, 9-40138 Bologna, Italy; e-mail: francesca.palandri{at}libero.it

Purpose Imatinib mesylate (IM) has rapidly become the front-line treatment of Philadelphia-positive (Ph-pos) chronic myeloid leukemia, but the number of patients who were treated and are being treated with IM second-line is still substantial.

Patients and Methods We have monitored and analyzed the cytogenetic and molecular response to IM 400 mg/d in a cohort of 277 late chronic phase (LCP) patients who were resistant or intolerant to interferon- and were observed for 48 to 79 months (median, 72 months).

Results One hundred fifty-three patients (55%) achieved a complete cytogenetic response (CCgR). Seventy-seven percent of them were still in CCgR after 5 years. The rate of response loss did not increase over time. The 6-year progression-free survival and overall survival of these 153 complete cytogenetic responders were 90% and 91%, respectively. Molecular response was less than major in 21%, major in 78%, and complete in one patient only.

Conclusion These data confirm that, in LCP the CCgR rate to IM is 50% to 60%, and show that CCgR is stable and is associated with a prolonged survival, even if leukemia continues to be molecularly detectable.

Supported by the Italian Association for Cancer Research (AIRC), by Fondazione del Monte di Bologna e Ravenna, by European LeukemiaNet funds, and by grants from the Associazione Italiana Contro le Leucemie.

F.P. and I.I contributed equally to this work.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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