A Retrospective Analysis about Frequency of Monitoring in Italian Chronic Myeloid Leukemia Patients after Discontinuation

Matteo Dragani ,Michele Cedrone,Alessandra Iurlo,Carmen Fava,Daniele Cattaneo,Francesca Lunghi,Fausto Castagnetti,Monica Crugnola,Gianantonio Rosti,Isabella Capodanno,Luigia Luciano,Giuseppe Saglio,Paola Berchialla,Giovanni Caocci,Giovanna Rege Cambrin,Antonella Gozzini,Nicola Sgherza,Marco Cerrano,Chiara Elena,Massimo Breccia,Monica Bocchia,Sara Galimberti,Irene Dogliotti,Dario Ferrero,Elisabetta Abruzzese,Valentina Giai,Luciano Levato,Marco Santoro,Federica Sorà ,Salvatore Russo

doi:10.1182/blood-2019-129335

Abstract

A Retrospective Analysis about Frequency of Monitoring in Italian Chronic Myeloid Leukemia Patients after Discontinuation

Highlights

Since the first proof of concept trial for stopping tyrosine kinase inhibitors (TKIs), the STIM1 study, successful treatment-free remission (TFR) has been obtained in many patients with chronic-phase chronic myeloid leukemia (CP-CML), both after imatinib and after second generation TKIs (2GTKIs) [1,2,3,4,5,6,7].Criteria for treatment discontinuation and for treatment resumption varied among the published studies and reported TFR rates ranged from 38% to 70% as well
All patients who had discontinued TKI treatment per clinical practice while in deep molecular remission were eligible for the study, provided a minimum follow-up after discontinuation of 2 years was available
The primary endpoint was the rate of TFR at one-year from TKI treatment discontinuation

Summary

Introduction

Since the first proof of concept trial for stopping tyrosine kinase inhibitors (TKIs), the STIM1 study, successful treatment-free remission (TFR) has been obtained in many patients with chronic-phase chronic myeloid leukemia (CP-CML), both after imatinib and after second generation TKIs (2GTKIs) [1,2,3,4,5,6,7].Criteria for treatment discontinuation and for treatment resumption varied among the published studies and reported TFR rates ranged from 38% to 70% as well. Up to 80% of molecular relapses arise within the first 6 to 12 months from treatment discontinuation [10,11]; a stringent monitoring is advised in the initial phases of TKI discontinuation to guarantee a prompt resumption of therapy according to retreatment threshold criteria. Monthly quantitative PCR (qPCR) monitoring during the first half-year has been adopted by all prospective protocols to address safety concerns, and it has been used to establish the median BCR-ABL1 doubling time, equal to 9 days (6.9–25.5), in case of imatinib discontinuation after sustained complete molecular remission (CMR) [1,4,8,12,13]

Methods

Results

Conclusion