Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience

Objective: Redditux® (RED), as a biosimilar rituximab, was approved in Turkey for all indications of the original Mabthera® (MAB) in March 2018. The aim of our study was to evaluate the efficacy and safety of RED in de novo diffuse large B-cell lymphoma. Materials and Methods: Fifty-one patients received RED combined with the CHOP regimen. The median follow-up was 31 months. The historical control group included 219 patients treated with the MAB-CHOP regimen and the median follow-up time was 38 months. We compared the response rates and survival outcomes of these RED-CHOP and MAB-CHOP cohorts. Results: In the RED cohort, the overall response rate (ORR) at the end of the treatment protocol was 86%, with 37 (72.5%) cases of complete response (CR) and 7 (13.5%) cases of partial response (PR). In the historical MAB cohort, the ORR was 84%, with CR and PR rates of 82% and 2%, respectively. The 24-month progression-free survival (PFS) rates were 73.76% (95% confidence interval [CI]: 0.59-0.84) and 85.2% (95% CI: 0.79-0.90) for the RED and MAB cohorts, respectively (p=0.0106). The 24-month overall survival rates were 78.4% (95% CI: 0.64-0.87) and 81.4% (95% CI: 0.75-0.86) for the RED and MAB cohorts, respectively (p=0.7461). For patients with high revised International Prognostic Index scores, 24-month PFS was 45.5% (95% CI: 0.17-0.71) and 63% (95% CI: 0.37-0.80) for the RED and MAB cohorts, respectively (p=0.0711). In the RED cohort, central nervous system (CNS) relapse was significantly increased compared to the MAB cohort (10% vs. 1.83%, p=0.004). Among the RED cohort, bone involvement at the time of diagnosis was a risk factor for CNS relapse (p=0.028). Thirteen patients died in follow-up. There were no serious adverse events causing the cessation of the drugs. Conclusion: RED has an ORR similar to that of MAB. However, PFS rates were worse in the RED cohort. Additionally, CNS relapse ratio was a major concern for our RED cohort. Large prospective controlled studies and real-life data with longer follow-up are needed to document the non-inferiority of RED compared to MAB.

Anahtar Kelime:

Biyobenzer Rituksimab (Redditux) ile CHOP Kemoterapisinin Yeni Tanı Diffüz Büyük B-Hücreli Lenfoma Hastalarında Kullanımı: Gerçek Yaşam Tek Merkez Deneyimi

Öz:

Amaç: Rituksimab biyobenzeri olan Redditux® (RED), ülkemizde Mart 2018’de orijinal Mabthera® (MAB) molekülünün tüm endikasyonlarında kullanılmak üzere onaylandı. Çalışmamızda, yeni tanı DBBHL hastalarında RED’in etkinliğini ve güvenirliğini değerlendirmeyi amaçladık. Gereç ve Yöntemler: Elli bir hasta RED ile birlikte CHOP tedavisi aldı. Ortanca takip süresi 31 aydı. Tarihsel kontrol grubunda, MAB-CHOP ile tedavi edilmiş 219 hasta mevcuttu ve ortanca takip süresi 38 aydı. RED ve MAB-CHOP ile tedavi edilmiş grupların tedavi sonuçlarını karşılaştırdık. Bulgular: RED grubunda genel yanıt oranı (GYO) %86 iken, 37 hastada tam yanıt (TY) (%72,5) ve 7 hastada kısmi yanıt (KY) (%13,5) elde edildi. Tarihi MAB grubunda ise GYO %84 iken TY ve KY oranları sırasıyla %82 ve %2 idi. Yirmi dört aylık progresyonsuz sağkalım (PSK), RED ve MAB grupları için sırasıyla %73,76 (%95 güven aralığı [GA] 0,59-0,84) ve %85,2 (%95 GA: 0,79-0,90) olarak saptandı (p=0,0106). 24-aylık genel sağkalım (GSK) oranları ise RED ve MAB grupları için sırasıyla %78,4 (%95 GA: 0,64-0,87) ve %81,4 (%95 GA: 0,75-0,86) idi (p=0,7461). Yüksek R-IPI skoru olan hastalarda 24-aylık PSK, RED ve MAB kohortları için sırasıyla %45,5 (%95 GA: 0,17-0,71) ve %63 (%95 GA: 0,37-0,80) bulundu (p=0,0711). RED grubunda MSS nüksü riski MAB grubuna göre anlamlı derecede artmış bulundu (%10’a karşı %1,83; p=0,004). RED kohortunda, tanı sırasında kemik tutulumu olması, MSS nüksü için risk faktörü olarak tespit edildi (p=0,028). Takipte 13 hasta vefat etti. İlacın sonlanmasına neden olacak ciddi yan etki gözlenmedi. Sonuç: RED, orijinal MAB molekülüne benzer GYO gösterdi. Ancak RED grubunda, MAB grubuna göre PSK oranları daha kötüydü. Ayrıca RED kohortumuzda MSS nüksü önemli bir sorundu. RED’in MAB’a eşdeğer etkinliğini ve güvenirliğini doğrulamak için yüksek katılımlı prospektif kontrollü çalışmalar, uzun takipli gerçek yaşam verilerine ihtiyaç vardır.

Anahtar Kelime:

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık

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APA	Ozbalak M, Mastanzade M, Özlük D, tiryaki t, Erdem S, PINAR OZBALAK E, ELVERDİ T, Yonal-Hindilerden I, Altay A, Yegen G, Eşkazan A, Ar M, Yenerel M, Soysal T, Nalcaci M, Ferhanoğlu B, Kalayoglu Besisik S (2022). Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. , 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
Chicago	Ozbalak Murat,Mastanzade Metban,Özlük Dilek Özden,tiryaki tarık onur,Erdem Simge,PINAR OZBALAK EZGI,ELVERDİ TUĞRUL,Yonal-Hindilerden Ipek,Altay Ali Yılmaz,Yegen Gulcin,Eşkazan Ahmet Emre,Ar Muhlis Cem,Yenerel Mustafa Nuri,Soysal Teoman,Nalcaci Meliha,Ferhanoğlu Burhan,Kalayoglu Besisik Sevgi Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. (2022): 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
MLA	Ozbalak Murat,Mastanzade Metban,Özlük Dilek Özden,tiryaki tarık onur,Erdem Simge,PINAR OZBALAK EZGI,ELVERDİ TUĞRUL,Yonal-Hindilerden Ipek,Altay Ali Yılmaz,Yegen Gulcin,Eşkazan Ahmet Emre,Ar Muhlis Cem,Yenerel Mustafa Nuri,Soysal Teoman,Nalcaci Meliha,Ferhanoğlu Burhan,Kalayoglu Besisik Sevgi Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. , 2022, ss.254 - 261. 10.4274/tjh.galenos.2022.2022.0142
AMA	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. . 2022; 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
Vancouver	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. . 2022; 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
IEEE	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S "Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience." , ss.254 - 261, 2022. 10.4274/tjh.galenos.2022.2022.0142
ISNAD	Ozbalak, Murat vd. "Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience". (2022), 254-261. https://doi.org/10.4274/tjh.galenos.2022.2022.0142

APA	Ozbalak M, Mastanzade M, Özlük D, tiryaki t, Erdem S, PINAR OZBALAK E, ELVERDİ T, Yonal-Hindilerden I, Altay A, Yegen G, Eşkazan A, Ar M, Yenerel M, Soysal T, Nalcaci M, Ferhanoğlu B, Kalayoglu Besisik S (2022). Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. Turkish Journal of Hematology, 39(4), 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
Chicago	Ozbalak Murat,Mastanzade Metban,Özlük Dilek Özden,tiryaki tarık onur,Erdem Simge,PINAR OZBALAK EZGI,ELVERDİ TUĞRUL,Yonal-Hindilerden Ipek,Altay Ali Yılmaz,Yegen Gulcin,Eşkazan Ahmet Emre,Ar Muhlis Cem,Yenerel Mustafa Nuri,Soysal Teoman,Nalcaci Meliha,Ferhanoğlu Burhan,Kalayoglu Besisik Sevgi Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. Turkish Journal of Hematology 39, no.4 (2022): 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
MLA	Ozbalak Murat,Mastanzade Metban,Özlük Dilek Özden,tiryaki tarık onur,Erdem Simge,PINAR OZBALAK EZGI,ELVERDİ TUĞRUL,Yonal-Hindilerden Ipek,Altay Ali Yılmaz,Yegen Gulcin,Eşkazan Ahmet Emre,Ar Muhlis Cem,Yenerel Mustafa Nuri,Soysal Teoman,Nalcaci Meliha,Ferhanoğlu Burhan,Kalayoglu Besisik Sevgi Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. Turkish Journal of Hematology, vol.39, no.4, 2022, ss.254 - 261. 10.4274/tjh.galenos.2022.2022.0142
AMA	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. Turkish Journal of Hematology. 2022; 39(4): 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
Vancouver	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience. Turkish Journal of Hematology. 2022; 39(4): 254 - 261. 10.4274/tjh.galenos.2022.2022.0142
IEEE	Ozbalak M,Mastanzade M,Özlük D,tiryaki t,Erdem S,PINAR OZBALAK E,ELVERDİ T,Yonal-Hindilerden I,Altay A,Yegen G,Eşkazan A,Ar M,Yenerel M,Soysal T,Nalcaci M,Ferhanoğlu B,Kalayoglu Besisik S "Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience." Turkish Journal of Hematology, 39, ss.254 - 261, 2022. 10.4274/tjh.galenos.2022.2022.0142
ISNAD	Ozbalak, Murat vd. "Biosimilar Rituximab (Redditux) Added to CHOP Chemotherapy for De Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single-Center Experience". Turkish Journal of Hematology 39/4 (2022), 254-261. https://doi.org/10.4274/tjh.galenos.2022.2022.0142