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

Blood Research 2020년 55권 3호 p.139 ~ 145
Gemelli Maria, Elli Elena Maria, Elena Chiara, Iurlo Alessandra, Intermesoli Tamara, Maffioli Margherita, Pungolino Ester, Carraro Maria Cristina, D’Adda Mariella, Gambacorti-Passerini Carlo,
소속 상세정보
 ( Gemelli Maria ) - ASST-Monza San Gerardo Hospital Oncology Unit
 ( Elli Elena Maria ) - ASST-Monza Ospedale San Gerardo Hematology Division and Bone Marrow Unit
 ( Elena Chiara ) - Fondazione IRCCS Policlinico San Matteo Division of Hematology
 ( Iurlo Alessandra ) - Foundation IRCCS Ca’ Granda Ospedale Maggiore Policlinico Hematology Division
 ( Intermesoli Tamara ) - ASST Papa Giovanni XXIII Hematology and Bone Marrow Transplant Unit
 ( Maffioli Margherita ) - Ospedale di Circolo Hematology Unit
 ( Pungolino Ester ) - ASST Grande Ospedale Metropolitano Niguarda Division of Hematology
 ( Carraro Maria Cristina ) - ASST Fatebenefratelli Sacco Hematology and Transfusional Medicine Unit
 ( D’Adda Mariella ) - ASST Spedali Civili di Brescia Department of Hematology
 ( Gambacorti-Passerini Carlo ) - ASST-Monza Ospedale San Gerardo Hematology Division and Bone Marrow Unit

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.

키워드

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

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