Feasibility of treatment free remission with generic imatinib: Results
of GIFT-in-CML-CP study
Abstract
Both innovator and generic imatinib are approved for the treatment of
Chronic Myeloid Leukemia-Chronic phase (CML-CP). Currently, there are no
studies on the feasibility of treatment free remission (TFR) with
generic imatinib. In a single center prospective Generic Imatinib Free
Trial - in -CML-CP (GIFT-in-CML-CP) study, twenty-six patients on
generic imatinib for more than 3 years and in sustained deep molecular
response (BCR ABLIS <0.01% for more than 2 years) were
included. After treatment discontinuation, patients were monitored with
complete blood count and BCR ABLIS by real time quantitative PCR monthly
for one year and three monthly thereafter. Generic imatinib was
restarted at single documented loss of major molecular response. At a
median follow-up of 20 months (range, 4-34 months), 42.3% patients
(n=11) continued to be in TFR. Estimated TFR at 1 year was 44%. All
patients restarted on generic imatinib regained major molecular
response. On multivariate analysis, attainment of complete molecular
remission (CMR) prior to TFR trial was predictive of TFR [p=0.022, HR
0.284 (0.096-0.837)]. We conclude that , generic imatinib can be
safely discontinued in CML-CP patients who are in deep molecular
remission.