SOHO 2020: Predicting Treatment-Free Remission With Nilotinib in Chronic-Phase CML
Posted: Monday, September 21, 2020
According to Jerald P. Radich, MD, of Fred Hutchinson Cancer Research Center, Seattle, and international colleagues, the benefits of treatment-free remission for patients with chronic-phase chronic myeloid leukemia (CML) are many: relief from treatment-related side effects, decreased risk of toxicity from long-term treatment with tyrosine kinase inhibitors, and reduced economic burden of therapy. In a recent study, these investigators attempted to identify clinical predictors of durable treatment-free remission by performing a pooled analysis of data from the ENESTfreedom and ENESTop trials. Their study findings were presented during the virtual edition of the 2020 Society of Hematologic Oncology (SOHO) Annual Meeting (Abstract CML-110).
Among the enrolled patients of the two clinical trials, 190 (88%) and 126 (77%) entered the treatment-free remission phases of the ENESTfreedom and ENESTop trials, respectively. The investigators conducted univariate and multivariate analyses on the pooled data of patients who received at least 3 years of nilotinib treatment and sustained a deep molecular response for at least 1 year. The definition of durable treatment-free remission was maintaining a deep molecular response (MR4.5) up to week 24 after cessation of nilotinib treatment.
In the ENESTfreedom trial, 84 patients (44.2%) were in treatment-free remission at 192 weeks, and 81 of them achieved MR4.5. In the ENESTop trial, 58 patients (46.0%) were in treatment-free remission at 192 weeks, and 57 of them achieved MR4.5. In the combined analysis, the investigators reported, 57% of patients remained in the treatment-free remission phase with MR4.5 at 24 weeks.
In the univariate analysis, the duration of nilotinib prior to the treatment-free remission phase entry (P = .0008) and the time since MR4.5 achievement until treatment-remission phase entry (P = .0025) were significantly associated with durable treatment-free remission at 24 weeks. In the multivariable analysis, the duration of nilotinib prior to the treatment-free remission phase entry (P = .0333) was significantly associated with durable treatment-free remission.
Disclosure: For full disclosures of the study authors, visit soho2020.com.