Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
Yıl: 2021 Cilt: 38 Sayı: 3 Sayfa Aralığı: 211 - 217 Metin Dili: İngilizce DOI: 10.4274/tjh.galenos.2021.2020.0555 İndeks Tarihi: 25-05-2022
Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients
Öz: Objective: Constantly increasing health expenditures lead to the use
of generic molecules and generic versions 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 first- or second-line therapy in a single center
were retrospectively recorded. Treatment responses, side effects, and
progression-free survival (PFS) rates were 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 according to International Myeloma Working Group criteria,
there was no significant difference (p=0.42). Rates of partial response
and higher responses were similar (81% vs. 79.2%, p=0.84). PFS rates
were 42.8 months with the original and 37.8 months with the generic
molecule (p=0.68). Side effects were seen in 44.2% of all patients,
and the most common side effects were neuropathy, cytopenia, and
infection. These rates were similar in the two groups (p=0.55).
Conclusion: Although this retrospective study is limited in scope, it is
the first study comparing the original molecule of bortezomib with a
generic version. There were no statistical differences between the two
groups in terms of treatment responses, PFS, or side effects. However,
large-scale evaluations will help obtain more data on this subjec
Anahtar Kelime: Yeni Tanı Multipl Myelom Hastalarında Eşdeğer Bortezomib Molekülünün Değerlendirilmesi
Öz: Amaç: Sürekli artan sağlık harcamaları jenerik moleküllerin
kullanımına yol açmaktadır ve bortezomibin jenerik molekülleri uzun
süredir kullanılmaktadır. Bu çalışmanın amacı, yeni tanı konmuş
multipl myelom (MM) hastalarında jenerik bortezomibin etkinliğini,
yan etkilerini ve güvenilirliğini retrospektif olarak incelemektir.
Gereç ve Yöntemler: Tek merkezli çalışmamızda birinci veya ikinci
basamak tedavide dört kür bortezomib alan 95 hastanın verileri geriye
dönük olarak incelendi. Tedavi yanıtları, yan etkiler ve progresyonsuz
sağkalım (PFS) oranları hesaplandı ve karşılaştırıldı.
Bulgular: Doksan beş hastanın 42’si orijinal molekülü, 53’ü eşdeğer
molekülü kullanmıştır. Epidemiyolojik veriler, MM tipleri, genetik risk
grupları, tanı anındaki laboratuvar değerleri ve bortezomib tedavi
sıraları (birinci sıra veya ikinci sıra olarak) değerlendirildiğinde iki grup
arasında istatistiksel fark olmadığı izlendi. Uluslararası Myelom Çalışma
Grubu kriterlerine göre yanıt oranları değerlendirildiğinde anlamlı bir
fark bulunmadı (p=0,42). Kısmi yanıt ve daha yüksek yanıt oranları
benzerdi (%81’e karşı %79,2, p=0,84). PFS süreleri orijinal molekül için
42,8 ay ve eşdeğer molekül için 37,8 ay olarak hesaplandı (p=0,68).
Yan etkiler tüm hastaların %44,2’sinde görüldü ve en sık görülen yan
etkiler nöropati, sitopeni ve enfeksiyondu. Bu yan etkilerin görülme
oranları iki grupta benzerdi (p=0,55).
Sonuç: Bu retrospektif çalışma, kapsamı sınırlı olmakla birlikte, orijinal
bortezomib molekülünü eşdeğeri ile karşılaştıran ilk çalışmadır. Tedavi
yanıtları, PFS veya yan etkiler açısından iki grup arasında istatistiksel
fark izlenmemiştir. Ancak geniş çaplı değerlendirmeler bu konuda
daha fazla veri elde edilmesine yardımcı olacaktır.
Anahtar Kelime: Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
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APA | MERSİN S, GEDÜK A, MEHTAP Ö, Tarkun P, Ünal S, Polat M, AYGÜN K, YENİHAYAT E, ALBAYRAK H, Hacıhanefioğlu A (2021). Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. , 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
Chicago | MERSİN Sinan,GEDÜK Ayfer,MEHTAP Özgür,Tarkun Pinar,Ünal Serkan,Polat Merve Gökçen,AYGÜN Kemal,YENİHAYAT Emel Merve,ALBAYRAK Hayrunnisa,Hacıhanefioğlu Abdullah Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. (2021): 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
MLA | MERSİN Sinan,GEDÜK Ayfer,MEHTAP Özgür,Tarkun Pinar,Ünal Serkan,Polat Merve Gökçen,AYGÜN Kemal,YENİHAYAT Emel Merve,ALBAYRAK Hayrunnisa,Hacıhanefioğlu Abdullah Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. , 2021, ss.211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
AMA | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. . 2021; 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
Vancouver | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. . 2021; 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
IEEE | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A "Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients." , ss.211 - 217, 2021. 10.4274/tjh.galenos.2021.2020.0555 |
ISNAD | MERSİN, Sinan vd. "Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients". (2021), 211-217. https://doi.org/10.4274/tjh.galenos.2021.2020.0555 |
APA | MERSİN S, GEDÜK A, MEHTAP Ö, Tarkun P, Ünal S, Polat M, AYGÜN K, YENİHAYAT E, ALBAYRAK H, Hacıhanefioğlu A (2021). Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turkish Journal of Hematology, 38(3), 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
Chicago | MERSİN Sinan,GEDÜK Ayfer,MEHTAP Özgür,Tarkun Pinar,Ünal Serkan,Polat Merve Gökçen,AYGÜN Kemal,YENİHAYAT Emel Merve,ALBAYRAK Hayrunnisa,Hacıhanefioğlu Abdullah Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turkish Journal of Hematology 38, no.3 (2021): 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
MLA | MERSİN Sinan,GEDÜK Ayfer,MEHTAP Özgür,Tarkun Pinar,Ünal Serkan,Polat Merve Gökçen,AYGÜN Kemal,YENİHAYAT Emel Merve,ALBAYRAK Hayrunnisa,Hacıhanefioğlu Abdullah Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turkish Journal of Hematology, vol.38, no.3, 2021, ss.211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
AMA | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turkish Journal of Hematology. 2021; 38(3): 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
Vancouver | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients. Turkish Journal of Hematology. 2021; 38(3): 211 - 217. 10.4274/tjh.galenos.2021.2020.0555 |
IEEE | MERSİN S,GEDÜK A,MEHTAP Ö,Tarkun P,Ünal S,Polat M,AYGÜN K,YENİHAYAT E,ALBAYRAK H,Hacıhanefioğlu A "Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients." Turkish Journal of Hematology, 38, ss.211 - 217, 2021. 10.4274/tjh.galenos.2021.2020.0555 |
ISNAD | MERSİN, Sinan vd. "Evaluation of a Generic Bortezomib Molecule in Newly Diagnosed Multiple Myeloma Patients". Turkish Journal of Hematology 38/3 (2021), 211-217. https://doi.org/10.4274/tjh.galenos.2021.2020.0555 |