Blood Journal
Leading the way in experimental and clinical research in hematology

Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia

  1. Domenico Russo1,*,
  2. Giovanni Martinelli2,
  3. Michele Malagola1,
  4. Cristina Skert1,
  5. Simona Soverini2,
  6. Ilaria Iacobucci2,
  7. Antonio De Vivo2,
  8. Nicoletta Testoni2,
  9. Fausto Castagnetti2,
  10. Gabriele Gugliotta2,
  11. Diamante Turri3,
  12. Michela Bergamaschi4,
  13. Patrizia Pregno5,
  14. Ester Pungolino6,
  15. Fabio Stagno7,
  16. Massimo Breccia8,
  17. Bruno Martino9,
  18. Tamara Intermesoli10,
  19. Carmen Fava11,
  20. Elisabetta Abruzzese12,
  21. Mario Tiribelli13,
  22. Catia Bigazzi14,
  23. Bruno Mario Cesana15,
  24. Gianantonio Rosti2, and
  25. Michele Baccarani2
  1. 1 Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, University of Brescia, Brescia, Italy;
  2. 2 Institute of Hematology "L. and A. Seragnoli", S. Orsola Malpighi Hospital, University of Bologna, Bologna, Italy;
  3. 3 Ematologia 1-TMO, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy;
  4. 4 Chair of Hematology, University of Genova, Department of Hematology, University of Genoa, Genoa, Italy;
  5. 5 Hematology 2, ASO S. Giovanni Battista, Turin, Italy;
  6. 6 Division of Hematology, Department of Oncology and Hematology, Niguarda Ca' Granda Hospital, Milan, Italy;
  7. 7 Department of Clinical and Molecular Bio-Medicine, Section of Hematology, Oncology and General Pathology, University of Catania, Ferrarotto Hospital, Catania, Italy;
  8. 8 Department of Cellular Biotechnologies and Hematology, University "La Sapienza", Rome, Italy;
  9. 9 Hematology Unit, 'Bianchi-Melacrino-Morelli' Hospital, Reggio Calabria, Italy;
  10. 10 Division of Hematology, Ospedali Riuniti, Bergamo, Italy;
  11. 11 University of Turin, San Luigi Gonzaga Hospital, Orbassano, Italy;
  12. 12 Hematology, S. Eugenio Hospital, Rome, Italy;
  13. 13 Division of Hematology and Bone Marrow Transplantation, University of Udine, Udine, Italy;
  14. 14 Hematology, Mazzoni Hospital, Ascoli Piceno, Italy;
  15. 15 Medical Statistics and Biometry Unit, Department of Biomedical Sciences and Biotechnologies, University of Brescia, Brescia, Italy
  1. * Corresponding author; email: russo{at}med.unibs.it
This article has an Erratum 123(18):2902

Key points

  • Intermittent imatinib treatment affects cytogenetic and molecular response, but not the outcome

  • No patients treated with INTERIM progressed to AP or BP

Abstract

We report a study of an alternative treatment schedule of imatinib (IM) in chronic myeloid leukemia (CML). Seventy-six Philadelphia-positive (Ph+) - BCR-ABL - positive patients aged 65 years or older, who had been treated with IM for more than two years and who were in stable complete cytogenetic response (CCgR) and in major molecular response (MMR), were enrolled in a single-arm study to test the effects of a policy of intermittent imatinib (INTERIM) therapy, one month on and one month off. With a minimum follow-up of four years, 13 patients (17%) lost CCgR and MMR, and 14 (18 %) lost MMR only. All these patients resumed continuous imatinib, and all - but one (lost to follow-up) regained CCgR and MMR. No patients progressed to accelerated or blastic phase, or developed clonal chromosomal abnormalities in Ph+ cells, or BCR-ABL mutations. In elderly Ph+ CML patients carefully selected for a stable CCgR (lasting > 2 years), the policy of intermittent imatinib treatment affected the markers of residual disease, but not the clinical outcomes (overall and progression-free survival). ClinicalTrials.gov number: NCT 00858806

  • Submitted January 28, 2013.
  • Accepted May 7, 2013.