Loading...
Please wait, while we are loading the content...
Similar Documents
Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study.
| Content Provider | Europe PMC |
|---|---|
| Author | Gemelli, Maria Elli, Elena Maria Elena, Chiara Iurlo, Alessandra Intermesoli, Tamara Maffioli, Margherita Pungolino, Ester Carraro, Maria Cristina D’Adda, Mariella Lunghi, Francesca Anghileri, Michela Polverelli, Nicola Rossi, Marianna Bacciocchi, Mattia Bono, Elisa Bucelli, Cristina Passamonti, Francesco Antolini, Laura Gambacorti-Passerini, Carlo |
| Copyright Year | 2020 |
| 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. |
| Related Links | https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC7536566&blobtype=pdf |
| ISSN | 2287979X |
| Volume Number | 55 |
| DOI | 10.5045/br.2020.2020130 |
| PubMed Central reference number | PMC7536566 |
| Issue Number | 3 |
| PubMed reference number | 32792470 |
| Journal | Blood research [Blood Res] |
| e-ISSN | 22880011 |
| Language | English |
| Publisher | Korean Society of Hematology |
| Publisher Date | 2020-09-01 |
| Access Restriction | Open |
| Rights License | This is an open-access article distributed under 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. © 2020 Korean Society of Hematology |
| Subject Keyword | Imatinib Generic Chronic myeloid leukemia Generic imatinib BCR/ABL Adverse events |
| Content Type | Text |
| Resource Type | Article |
| Subject | Hematology |
