Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients

Objective: Constantly increasing health expenditures lead use of generic molecules and generics of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects and reliability of generic bortezomib in newly diagnosed multiple myeloma...

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Main Authors: Sinan Mersin, Ayfer Gedük, Özgür Mehtap, Pınar Tarkun, Serkan Ünal, Merve Gökçen Polat, Kemal Aygün, Emel Merve Yenihayat, Hayrunnisa Albayrak, Abdullah Hacıhanefioğlu
Format: Article
Language:English
Published: Galenos Publishing House 2021-08-01
Series:Turkish Journal of Hematology
Subjects:
Online Access:https://jag.journalagent.com/z4/download_fulltext.asp?pdir=tjh&un=TJH-56750
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author Sinan Mersin
Ayfer Gedük
Özgür Mehtap
Pınar Tarkun
Serkan Ünal
Merve Gökçen Polat
Kemal Aygün
Emel Merve Yenihayat
Hayrunnisa Albayrak
Abdullah Hacıhanefioğlu
author_facet Sinan Mersin
Ayfer Gedük
Özgür Mehtap
Pınar Tarkun
Serkan Ünal
Merve Gökçen Polat
Kemal Aygün
Emel Merve Yenihayat
Hayrunnisa Albayrak
Abdullah Hacıhanefioğlu
author_sort Sinan Mersin
collection DOAJ
description Objective: Constantly increasing health expenditures lead use of generic molecules and generics of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects and reliability of generic bortezomib in newly diagnosed multiple myeloma (MM) patients. Materials and Methods: The data of 95 patients who received four cycles of bortezomib as a first- or second-line therapy in a single center were retrospectively recorded. Treatment responses, side effects and progression free survival (PFS) rates have been calculated and compared. Results: Of the 95 patients, 42 used the original and 53 used the generic molecule. Epidemiological data, MM types, genetic risk groups, laboratory values at diagnosis and bortezomib treatment lines (as a first line or second) were evaluated, and there was no statistical difference between the two groups. When the response rates were evaluated with International Myeloma Working Group (IMWG) criteria, there were no significant difference (p: 0,42). Partial response (PR) and above response rates were similar (%81 vs %79,2 p: 0,836). PFS values were 42.8 months in the original and 37.8 months in the generic molecule group (p: 0,68). Side effects were seen in 44,2% of patients, and the most common side effects were neuropathy, cytopenias and infections. They were similar in both groups (p: 0,67). Conclusion: Although this retrospective study is limited, it is the first study comparing the original molecule of bortezomib with its generic. There was no statistical difference between the two groups in terms of treatment responses, PFS times and side effects. However, large-scale evaluations can help obtain healthier data on this subject.
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spelling doaj.art-b5e4e5205dd44c599fbe6cbff037820b2023-02-15T16:09:17ZengGalenos Publishing HouseTurkish Journal of Hematology1308-52632021-08-0138321121710.4274/tjh.galenos.2021.2020.0555TJH-56750Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma PatientsSinan Mersin0Ayfer Gedük1Özgür Mehtap2Pınar Tarkun3Serkan Ünal4Merve Gökçen Polat5Kemal Aygün6Emel Merve Yenihayat7Hayrunnisa Albayrak8Abdullah Hacıhanefioğlu9Kocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyKocaeli University Faculty of Medicine, Department of Hematology, Kocaeli, TurkeyObjective: Constantly increasing health expenditures lead use of generic molecules and generics of bortezomib have been used for a long time. The aim of this study is to retrospectively examine the effectiveness, side effects and reliability of generic bortezomib in newly diagnosed multiple myeloma (MM) patients. Materials and Methods: The data of 95 patients who received four cycles of bortezomib as a first- or second-line therapy in a single center were retrospectively recorded. Treatment responses, side effects and progression free survival (PFS) rates have been calculated and compared. Results: Of the 95 patients, 42 used the original and 53 used the generic molecule. Epidemiological data, MM types, genetic risk groups, laboratory values at diagnosis and bortezomib treatment lines (as a first line or second) were evaluated, and there was no statistical difference between the two groups. When the response rates were evaluated with International Myeloma Working Group (IMWG) criteria, there were no significant difference (p: 0,42). Partial response (PR) and above response rates were similar (%81 vs %79,2 p: 0,836). PFS values were 42.8 months in the original and 37.8 months in the generic molecule group (p: 0,68). Side effects were seen in 44,2% of patients, and the most common side effects were neuropathy, cytopenias and infections. They were similar in both groups (p: 0,67). Conclusion: Although this retrospective study is limited, it is the first study comparing the original molecule of bortezomib with its generic. There was no statistical difference between the two groups in terms of treatment responses, PFS times and side effects. However, large-scale evaluations can help obtain healthier data on this subject.https://jag.journalagent.com/z4/download_fulltext.asp?pdir=tjh&un=TJH-56750bortezomibmultiple myelomaequivalent
spellingShingle Sinan Mersin
Ayfer Gedük
Özgür Mehtap
Pınar Tarkun
Serkan Ünal
Merve Gökçen Polat
Kemal Aygün
Emel Merve Yenihayat
Hayrunnisa Albayrak
Abdullah Hacıhanefioğlu
Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
Turkish Journal of Hematology
bortezomib
multiple myeloma
equivalent
title Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
title_full Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
title_fullStr Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
title_full_unstemmed Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
title_short Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
title_sort evaluation of a generic bortezomib molecule in newly diagnosed multiple myeloma patients
topic bortezomib
multiple myeloma
equivalent
url https://jag.journalagent.com/z4/download_fulltext.asp?pdir=tjh&un=TJH-56750
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