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.

Background: The majority of patients with high-risk neuroblastoma (HR-NB) in low- and middle-income countries (LMIC) do not have access to autologous stem cell transplant (ASCT) and dinutuximab. Consolidation with non-myeloablative chemotherapy is not well-defined, and the outcomes are variable. We report a single-center outcome of patients with HR-NB, treated with non-myeloablative consolidation. A tabulated compilation of similar reports is included. Procedure: A retrospective chart review of patients with HR-NB was performed from January 2009 till June 2016. Patients were treated on the backbone of HR-NBL1/SIOPEN protocol. Treatment included induction with rapid-COJEC, surgery, consolidation, radiotherapy to the primary tumor, and differentiation therapy with isotretinoin. Consolidation included 4 cycles of topotecan, vincristine, and doxorubicin (TVD) instead of ASCT. Infusion of vincristine and doxorubicin were modified for ease and to enable administration in daycare. Results: Over 7-½ years, 28 patients with HR-NB were treated. Two (7%) patients had therapy-related mortality. A relapse or disease progression occurred in 11 (39%) patients at a median duration of 17 months (IQR: 5, 18). Treatment abandonment was observed in 4 (14%) patients. The 4-year event-free survival was 29.3%. The median follow up of disease-free patients is 49 months (IQR: 45, 79). Patients with relapse were not treated further. Conclusions: A 4-year EFS of 29.3% was observed when 4-cycles of TVD were administered instead of ASCT in patients with HR-NB. The study and the review will aid stakeholders in LMIC for decision-making while considering the options of treatment for HR-NB if access to ACST and dinutuximab is lacking.