Feasibility of treatment-free remission with generic imatinib: Results of generic imatinib-free trial-in-chronic myeloid leukaemia chronic phase study

dc.contributor.authorGoni, Deepaken_US
dc.contributor.authorJain, Arihanten_US
dc.contributor.authorSingh, Charanpreeten_US
dc.contributor.authorJindal, Nishanten_US
dc.contributor.authorNampoothiri, Ramen_US
dc.contributor.authorJandial, Adityaen_US
dc.contributor.authorLad, Deepeshen_US
dc.contributor.authorKhadwal, Alkaen_US
dc.contributor.authorPrakash, Gauraven_US
dc.contributor.authorNaseem, Shanoen_US
dc.contributor.authorVarma, Neelamen_US
dc.contributor.authorMalhotra, Pankajen_US
dc.date.accessioned2023-08-19T04:51:46Z
dc.date.available2023-08-19T04:51:46Z
dc.date.issued2023-01
dc.description.abstractBackground & objectives: Both innovator and generic imatinib are approved for the treatment of Chronic Myeloid Leukaemia-Chronic phase (CML-CP). Currently, there are no studies on the feasibility of treatment-free remission (TFR) with generic imatinib. This study attempted to determine the feasibility and efficacy of TFR in patients on generic Imatinib. Methods: In this single-centre prospective Generic Imatinib-Free Trial-in-CML-CP study, twenty six patients on generic imatinib for ?3 yr and in sustained deep molecular response (BCR ABLIS ?0.01% for more than two 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 (BCR ABLIS>0.1%). Results: At a median follow up of 33 months (interquartile range 18.7-35), 42.3 per cent patients (n=11) continued to be in TFR. Estimated TFR at one year was 44 per cent. All patients restarted on generic imatinib regained major molecular response. On multivariate analysis, attainment of molecularly undetectable leukaemia (>MR5) prior to TFR was predictive of TFR [P=0.022, HR 0.284 (0.096-0.837)]. Interpretation & conclusions: The study adds to the growing literature that generic imatinib is effective and can be safely discontinued in CML-CP patients who are in deep molecular remission.en_US
dc.identifier.affiliationsDepartment ofen_US
dc.identifier.affiliationsClinical Hematology and Medical Oncologyen_US
dc.identifier.affiliationsDepartment of Hematology, Postgraduate Institute of Medical Education & Research, Chandigarh, Indiaen_US
dc.identifier.citationGoni Deepak, Jain Arihant, Singh Charanpreet, Jindal Nishant, Nampoothiri Ram, Jandial Aditya, Lad Deepesh, Khadwal Alka, Prakash Gaurav, Naseem Shano, Varma Neelam, Malhotra Pankaj. Feasibility of treatment-free remission with generic imatinib: Results of generic imatinib-free trial-in-chronic myeloid leukaemia chronic phase study. Indian Journal of Medical Research. 2023 Jan; 157(1): 87-91en_US
dc.identifier.issn0971-5916
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/223516
dc.languageenen_US
dc.publisherWolters Kluwer – Medknowen_US
dc.relation.issuenumber1en_US
dc.relation.volume157en_US
dc.source.urihttps://doi.org/10.4103/ijmr.ijmr_1090_21en_US
dc.subjectChronic myeloid leukaemiaen_US
dc.subjectgeneric imatiniben_US
dc.subjecttreatment-free remissionen_US
dc.titleFeasibility of treatment-free remission with generic imatinib: Results of generic imatinib-free trial-in-chronic myeloid leukaemia chronic phase studyen_US
dc.typeJournal Articleen_US
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