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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)139-145
Number of pages7
JournalBlood Research
Volume55
Issue number3
DOIs
Publication statusPublished - Sep 2020

Keywords

  • Adverse events
  • BCR/ABL
  • Chronic myeloid leukemia
  • Generic
  • Generic imatinib
  • Imatinib

ASJC Scopus subject areas

  • Hematology

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