Defining therapy goals for major molecular remission in chronic myeloid leukemia: results of the randomized CML Study IV

Leukemia
S SausseleMichael Lauseker

Abstract

Major molecular remission (MMR) is an important therapy goal in chronic myeloid leukemia (CML). So far, MMR is not a failure criterion according to ELN management recommendation leading to uncertainties when to change therapy in CML patients not reaching MMR after 12 months. At monthly landmarks, for different molecular remission status Hazard ratios (HR) were estimated for patients registered to CML study IV who were divided in a learning and a validation sample. The minimum HR for MMR was found at 2.5 years with 0.28 (compared to patients without remission). In the validation sample, a significant advantage for progression-free survival (PFS) for patients in MMR could be detected (p-value 0.007). The optimal time to predict PFS in patients with MMR could be validated in an independent sample at 2.5 years. With our model we provide a suggestion when to define lack of MMR as therapy failure and thus treatment change should be considered. The optimal response time for 1% BCR-ABL at about 12-15 months was confirmed and for deep molecular remission no specific time point was detected. Nevertheless, it was demonstrated that the earlier the MMR is achieved the higher is the chance to attain deep molecular response later.

References

Dec 8, 2006·The New England Journal of Medicine·Brian J DrukerUNKNOWN IRIS Investigators
Aug 28, 2009·Leukemia·M C MüllerA Hochhaus
Mar 23, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rüdiger HehlmannSusanne Saussele
Dec 4, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rüdiger HehlmannAndreas Hochhaus
Jun 24, 2014·Journal of Cancer Research and Clinical Oncology·Michael LausekerMartin C Müller
Apr 29, 2015·Blood·Susanne SausseleUNKNOWN Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung and the German CML Study Group
Oct 13, 2015·International Journal of Cancer. Journal International Du Cancer·Belal FirwanaAref Al-Kali
Jun 22, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Hannah BowerTherese M-L Andersson

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Citations

Nov 16, 2018·Blood·Naranie Shanmuganathan, Timothy P Hughes
Dec 7, 2018·Hematology·Naranie Shanmuganathan, Timothy P Hughes
Dec 7, 2018·Hematology·Simone Claudiani, Jane F Apperley
Jul 15, 2020·Pharmacology Research & Perspectives·Ashley M HopkinsMichael J Sorich
Aug 1, 2020·British Journal of Haematology·Graeme SmithUNKNOWN British Society for Haematology
Mar 20, 2019·HemaSphere·Tariq I MughalRichard A Van Etten
Sep 29, 2020·Expert Review of Anticancer Therapy·Fabio StagnoFrancesco Di Raimondo
Oct 7, 2020·Journal of the National Comprehensive Cancer Network : JNCCN·Michael W DeiningerHema Sundar

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