ELN 2013 response status criteria: Relevance for de novo imatinib chronic phase chronic myeloid leukemia patients?

Abstract

The response definitions proposed by the European Leukemia Net (ELN) have been recently modified. We evaluated the new criteria for de novo imatinib (400 mg/d) chronic phase chronic myeloid leukemia (CP‐CML) patients. Response status according to the 2009 and 2013 criteria were determined in 180 unselected patients. Outcome of the subgroups of patients were then compared. The 180 patients were classified as optimal responders (OR2009; n = 113, 62.7%), suboptimal responders (SOR2009; n = 47, 26.1%) and failures (FAIL2009; n = 20, 11.1%) according to the 2009 ELN criteria and optimal responders (OR2013; n = 77, 42.7%), warnings (WAR2013; n = 59, 32.7%), and failures (FAIL2013; n = 44, 24.4%) according to the 2013 ELN criteria. No difference in terms of outcome was observed between OR2009 patients who became WAR2013 when compared with OR2013 patients. When compared with FAIL2009 patients, SOR2009 patients who became WAR2013 had better EFS, FFS, PFS, and OS. No difference was observed in PFS or OS in SOR2009 patients who became FAIL2013. The 2013 ELN response status criteria have improved patients classification in terms of response status. However, in our patient population this improvement is related to a better definition of failure rather than that of optimal response for CP‐CML patients treated with IM frontline therapy. Am. J. Hematol. 90:37–41, 2015. © 2014 Wiley Periodicals, Inc.

Critical appraisal of European LeukemiaNet (ELN) 2013 recommendations for the management of chronic myeloid leukemia: is it early for a warning?

“…In this study, patients who achieved optimal responses had significantly better long-term outcomes (EFS, FFS, and transformation-free survival (TFS)) at 3, 6, or 12 months compared to cases with warning and failure. However, like in the previous two studies [7,8], the authors of this study [9] could not demonstrate a significant OS difference between patients with optimal response and warning at 3, 6, or 12 months.…”

“…A total of 55 (33%) of these patients comprise the warning responders, and the number of cases with optimal response and failure were 77 (43%) and 44 (24%), respectively. Optimal and warning responders both had significantly better event-free survival (EFS), failure-free survival (FFS), PFS, and OS rates than patients with a failure [8]. However, no significant difference between optimal and warning responders could be demonstrated with regard to the aforementioned outcomes within this patient cohort.…”

“…Recently, a number of studies have been published evaluating the outcomes of CML-CP patients with 'warning signs' according to the ELN 2013 recommendations [7][8][9][10]. These papers, in general, focused on the 'warning' patients with regard to MR and CyRs under TKIs, whereas patients with CCA/Ph+ or CCA/Ph− were not taken into consideration.…”

“…In another retrospective study conducted by Etienne et al [8], quality of response to treatment was evaluated in 180 patients with CML-CP who received upfront 400 mg/day imatinib with a median follow-up of 5.4 years, using both 2009 and 2013 ELN guidelines. A total of 55 (33%) of these patients comprise the warning responders, and the number of cases with optimal response and failure were 77 (43%) and 44 (24%), respectively.…”

Chronic myeloid leukemia: reminiscences and dreams

“…A recent French report expressed some concern in not being able to validate the current recommendations with regards to identifying optimal response, though treatment failure was confirmed for a cohort of 180 patients being treated with imatinib. 200 Our understanding of the mechanisms and treatment of patients with advanced phase disease remains limited. In addition, questions remain with regard to the initiating biological event, at least in some patients with CML in chronic phase.…”