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, 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

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=0.003). 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=0.0028), edema of the limbs (P<0.0001), fatigue (P=0.0482), and diarrhea (P=0.0027).

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: Adverse events; BCR/ABL; Chronic myeloid leukemia; Generic; Generic imatinib; Imatinib.

Conflict of interest statement

Authors’ Disclosures of Potential Conflicts of Interest

No potential conflicts of interest relevant to this article were reported.

Figures

Fig. 1
Fig. 1
Individual patient PCR values at each pre-defined time point: third, second and first PCR pre- and post-switch.
Fig. 2
Fig. 2
Adverse events (AEs) with frequencies >1% and number and percentage of G3-G4 for each event pre- and post-switch.

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