Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study

Maria Gemelli; Elena Maria Elli; Chiara Elena; Alessandra Iurlo; Tamara Intermesoli; Margherita Maffioli; Ester Pungolino; Maria Cristina Carraro; Mariella D’Adda; Francesca Lunghi; Michela Anghileri; Nicola Polverelli; Marianna Rossi; Mattia Bacciocchi; Elisa Bono; Cristina Bucelli; Francesco Passamonti; Laura Antolini; Carlo Gambacorti- Passerini

doi:10.5045/br.2020.2020130

Blood Res https://doi.org/10.5045/br.2020.2020130

Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study

Maria Gemelli^1*, Elena Maria Elli^2*, Chiara Elena³, Alessandra Iurlo⁴, Tamara Intermesoli⁵, Margherita Maffioli⁶, Ester Pungolino⁷, Maria Cristina Carraro⁸, Mariella D’Adda⁹, Francesca Lunghi¹⁰, Michela Anghileri¹¹, Nicola Polverelli¹², Marianna Rossi¹³, Mattia Bacciocchi¹⁴, Elisa Bono³, Cristina Bucelli⁴, Francesco Passamonti⁶, Laura Antolini¹⁵, Carlo Gambacorti- Passerini^2,14

¹Oncology Unit, ASST - Monza San Gerardo Hospital, Monza, ²Hematology Division and Bone Marrow Unit, Ospedale San Gerardo, ASST- Monza, ³Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, ⁴Hematology Division, Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, ⁵Hematology and Bone Marrow Transplant Unit, ASST Papa Giovanni XXIII, Bergamo, ⁶Hematology Unit, Ospedale di Circolo, Varese, ⁷Division of Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milano, ⁸Hematology and Transfusional Medicine Unit, ASST Fatebenefratelli Sacco, Milan, ⁹Department of Hematology, ASST Spedali Civili di Brescia, Brescia, ¹⁰Hematology and Bone Marrow Transplantation Unit, San Raffaele Scientific Institute, IRCCS Milano, ¹¹Oncology Department, ASST Lecco, Lecco, ¹²Chair of Hematology, Unit of Blood Diseases and Stem Cell Transplantation, University of Brescia, ASST Spedali Civili di Brescia, Brescia, ¹³Department of Hematology, Cancer Center, IRCCS Humanitas Research Hospital/Humanitas University, Rozzano, ¹⁴Department of Medicine and Surgery, University of Milano-Bicocca, ¹⁵Center of Biostatistics for Clinical Epidemiology, Department of Medicine and Surgery, University of Milano- Bicocca, Monza, Italy

Correspondence to: Carlo Gambacorti-Passerini, Ph.D.
Department of Medicine and Surgery, University of Milano- Bicocca, Via Cadore 48, 20900, Monza (MB), Italy
E-mail: carlo.gambacorti@unimib.it
*These authors contributed equally to this work

Published online: August 14, 2020.

This is an Open Access article distributed unAcute myeloid leukemia, New FDA approvalsder the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract: Background: Generic formulations of imatinib mesylate have been introduced in Western Europe since 2017 to treat patients with chronic myeloid leukemia (CML). However, results on the safety and efficacy of generic formulations are contrasting. The aim of this study was to investigate the safety and efficacy of generic imatinib in CML patients treated in 12 Italian institutes.
Methods: This is an observational, retro-prospective analysis of patients with CML for whom the treatment was switched from brand to generic imatinib. We analyzed and compared the variation in quantitative PCR values before and after the switch, and the proportion of patients who maintained molecular response after changing from brand to generic imatinib. Adverse events (AEs) were also evaluated.
Results: Two hundred patients were enrolled. The median PCR value after the switch was reduced by 0.25 compared to the values before the switch. A significant difference was found between median PCR values before and after the switch in favor of generic imatinib (P<0.0001). Molecular responses remained stable in 69.0%, improved in 25.5%, and worsened in 5.5% of patients. AEs were similar in the pre- and post-switch periods; however, a significant difference was found in favor of generic imatinib for muscular cramps (P<0.0001), periorbital edema (P=0.0027), edema of the limbs (P<0.0001), fatigue (P=0.0482), and diarrhea (P=0.0028).
Conclusion: Our data indicate that generic imatinib does not have deleterious effects on CML control and present an acceptable safety profile, similar or better than brand imatinib.; Keywords: Imatinib, Generic, Chronic myeloid leukemia, Generic imatinib, BCR/ABL, Adverse events

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