Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia
Domenico Russo, Giovanni Martinelli, Michele Malagola, Cristina Skert, Simona Soverini, Ilaria Iacobucci, Antonio De Vivo, Nicoletta Testoni, Fausto Castagnetti, Gabriele Gugliotta, Diamante Turri, Micaela Bergamaschi, Patrizia Pregno, Ester Pungolino, Fabio Stagno, Massimo Breccia, Bruno Martino, Tamara Intermesoli, Carmen Fava, Elisabetta Abruzzese, Mario Tiribelli, Catia Bigazzi, Bruno Mario Cesana, Gianantonio Rosti, Michele Baccarani, Domenico Russo, Giovanni Martinelli, Michele Malagola, Cristina Skert, Simona Soverini, Ilaria Iacobucci, Antonio De Vivo, Nicoletta Testoni, Fausto Castagnetti, Gabriele Gugliotta, Diamante Turri, Micaela Bergamaschi, Patrizia Pregno, Ester Pungolino, Fabio Stagno, Massimo Breccia, Bruno Martino, Tamara Intermesoli, Carmen Fava, Elisabetta Abruzzese, Mario Tiribelli, Catia Bigazzi, Bruno Mario Cesana, Gianantonio Rosti, Michele Baccarani
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 2 years and who were in stable complete cytogenetic response (CCgR) and major molecular response (MMR) were enrolled in a single-arm study to test the effects of a policy of intermittent IM (INTERIM) therapy for 1 month on and 1 month off. With a minimum follow-up of 4 years, 13 patients (17%) lost CCgR and MMR and 14 (18%) lost MMR only. All these patients resumed continuous IM 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 INTERIM treatment affected the markers of residual disease, but not the clinical outcomes (overall and progression-free survival). This trial was registered at www.clinicaltrials.gov as NCT 00858806.
Trial registration: ClinicalTrials.gov NCT00858806.
Source: PubMed