B-Hücreli Non-Hodgkin Lenfoma Tanılı Hastalarda Subkutan Rituksimab Tedavi Sonuçlarının Değerlendirilmesi: Tek Merkez Deneyimi

Year 2022, Volume: 44 Issue: 5, 601 - 604, 29.09.2022

Hava Üsküdar Teke , Fatih Yaman , Neslihan Andıc , Eren Gunduz

https://doi.org/10.20515/otd.1074211

Cited By: 1

Abstract

Non-Hodgkin Lenfoma (NHL), en sık görülen hematolojik malignitedir. Diffüz Büyük B Hücreli Lenfoma (DBBHL) en sık görülen histolojik tiptir ve prognoz değişkenlik gösterir. Rituksimab+CHOP standart tedaviyi oluşturmaktadır. İntravenöz rituximab (IV Rtx) doz uygulaması uzun infüzyon süresine (90 dk ile 5-8 saat) sahip iken aynı etkinliğe sahip subkutan rituksimabın uygulaması ise 5-7 dk arasındadır. Amacımız, DBBHL veya folliküler lenfoma tanısı olup IV Rtx sonrası subkutan Rtx kullanan hastalarımızın demografik özelliklerini, klinik bulgularını, tedavi yanıtlarını, varsa yan etkileri ve hastaların memnuniyetini retrospektif olarak değerlendirerek az sayıdaki gerçek yaşam verileri ile karşılaştırmaktır. ESOGÜTF Hematoloji Bilim Dalında takip ve tedavileri yapılan, DBBHL veya folliküler lenfoma tanısı olan, Ocak.2018-Haziran.2021 tarihleri arasında en az 1 doz IV Rtx sonrası SC Rtx alan 28 hasta çalışmaya dahil edildi. Hastaların demografik özellikleri, klinik bulguları, tedavi yanıtları, varsa yan etkileri ve hastaların memnuniyeti kaydedildi. Yirmi sekiz hastanın 16’sı (%57) erkek olup yaşları ortalama 53,8±13,5 (26-78) yıl idi. 19 (%68) hastanın tanısı DBBHL iken, 9’u (%32) folliküler lenfoma tanılı idi. 22 hasta R-CHOP, 3 hasta R-COP, 3 hasta R-Bendamustin tedavisi almıştı. Hastaların hepsine hem IV hem de subkutan Rtx öncesi premedikason uygulanmıştı. 4 hastada nötropeni gözlenmedi. 17 hastada (%60.7) IV Rtx sonrası, 4 (%14.3) hastada SC Rtx sonrası, 3 (%10.7) hastada ise hem IV hem de SC Rtx sonrası nötropeni gelişmişti. IV Rtx alan hiçbir hastada infüzyon ilişkili reaksiyon gelişmedi. Subkutan Rtx uygulanan hastalarda grade 3-4 uygulama ilişkili reaksiyon (ARR) gelişmedi. Lokal reaksiyon olarak enjeksiyon bölgesinde kızarıklık, hafif ödem ve ağrı dışında yan etki gözlenmedi. IV Rtx dozu ortalama 685.2±63,5 (580±790) mg, uygulanan SC Rtx sayısı hasta bazında 3.53±1.37 (1-5) doz, hastaların takip süresi 20±8.2 (7-39) ay idi. BSA düşük, orta ve yüksek olarak sınıflandırıldığında etkinlik açısından fark saptanmadı (p>0.05) Rituximab, CD20 pozitif B hücreli lenfomanın tedavisinde standart bir tedavidir. IV Rtx ile aynı etkinliğe sahip olan SC rituksimabın uygulaması ise 5-7 dk arasında olup daha kolay bir uygulama yolu sağlamakta, klinikte uygulama sürelerini kısaltmakta, hastanın memnuniyetini artırmakta ve hastanede kalış süresi ile ilgili maliyetleri azaltmaktadır Düşük, orta ve yüksek vücut yüzey alanı (BSA) olanlarda fix doz SC Rtx ile yan etki ve etkinlik açısından fark saptanmamıştır. Hiçbir hastada SC Rtx’a bağlı lokal reaksiyon dışında yan etki görülmedi. Hastaların hepsi SC Rtx kullanımından rahat ilaç uygulaması, daha az duygusal sıkıntı, daha az enjeksiyon ağrısı ve günlük yaşam hareketine daha fazla etki en önemlisi de zaman tasarrufu nedeniyle memnun idi. SC Rtx, hem hekim, hem hasta hem de tedaviyi uygulayan hemşireler açısından zaman tasarrufu, uygulama kolaylığı, hasta memnuniyeti, ilaç uygulama konforu sağlamakta hem de IV form gibi etkinlik ve güvenlilik göstermektedir.

Keywords

B hücreli lenfoma, rituksimab, subkutan

Supporting Institution

YOK

Evaluation of Subcutaneous Rituximab Treatment Results in Patients with B-Cell Non-Hodgkin Lymphoma: A Single Center Experience

Abstract

Non-Hodgkin Lymphoma (NHL) is the most common hematological malignancy. Diffuse Large B-Cell Lymphoma (DLBCL) is the most common histological type and the prognosis is variable. Rituximab+CHOP constitutes the standard treatment. Intravenous rituximab (IV Rtx) dosing has a long infusion time (90 minutes to 5-8 hours), while subcutaneous rituximab administration with the same efficacy is between 5-7 minutes. Our aim is to retrospectively evaluate the demographic characteristics, clinical findings, treatment responses, side effects, if any, and patient satisfaction of our patients with DLBCL or follicular lymphoma using subcutaneous Rtx after IV Rtx, and compare them with a small number of real-life data. Who were followed up and treated in ESOGÜTF Hematology Department, diagnosed with DLBCL or follicular lymphoma, and received SC Rtx after at least 1 dose of IV Rtx between January 2018-June 2021 28 patients were included in the study. Demographic features, clinical findings, treatment responses, side effects, if any, and patient satisfaction were recorded. Sixteen (57%) of 28 patients were male, with a mean age of 53.8±13.5 (26-78) years. While 19 (68%) patients were diagnosed with DLBCL, 9 (32%) patients were diagnosed with follicular lymphoma. 22 patients received R-CHOP, 3 patients R-COP, 3 patients R-Bendamustine treatment. Premedication was administered to all patients before both IV and subcutaneous Rtx. Neutropenia was not observed in 4 patients. Neutropenia developed after IV Rtx in 17 patients (60.7%), after SC Rtx in 4 (14.3%) patients, and after both IV and SC Rtx in 3 (10.7%) patients. No infusion-related reaction developed in any patient receiving IV Rtx. Grade 3-4 ARR did not develop in patients who received subcutaneous Rtx. As a local reaction, no side effects were observed except redness, mild edema and pain at the injection site. The mean dose of IV Rtx was 685.2±63.5 (580±790) mg, the number of SC Rtx administered was 3.53±1.37 (1-5) doses on a patient basis, and the follow-up period of the patients was 20±8.2 (7-39) months. There was no difference in efficacy and side effects when BSA was classified as low, medium and high (p>0.05). Rituximab is standard therapy for the treatment of CD20-positive B-cell lymphoma. The administration of SC rituximab, which has the same efficacy as IV Rtx, takes 5-7 minutes, provides an easier way of administration, shortens the time of application in the clinic, increases patient satisfaction and reduces the costs associated with the hospital stay. There was no difference in terms of side effects and efficacy with fixed dose SC Rtx in those with low, medium and high body surface area (BSA). No side effects were observed in any of the patients except for the local reaction related to SC Rtx. All of the patients were satisfied with the use of SC Rtx due to comfortable drug administration, less emotional distress, less injection pain and more effect on daily life activities, most importantly time saving. In conclusion, SC Rtx provides time saving, ease of application, patient satisfaction, drug administration comfort in terms of both physicians, patients and nurses applying the treatment, as well as showing efficacy and safety like the IV form.

Keywords

B-cell lymphoma, rituximab, subcutaneous

References

• Kaynaklar: 1. Swerdlow SH CE, Harris NL, et al. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. Lyon, France: IARC Press;; 2008.
• 2. Morton LM, Wang SS, Devesa SS, Hartge P, Weisenburger DD, Linet MS. Lymphoma incidence patterns by WHO subtype in the United States, 1992-2001. Blood. 2006; 107(1): 265-76.
• 3. Sant M, Allemani C, Tereanu C, De Angelis R, Capocaccia R, Visser O, MarcosGragera R, Maynadie M, Simonetti A, Lutz JM, Berrino F. Incidence of hematologic malignancies in Europe by morphologic subtype: results of the HAEMACARE project. Blood. 2010; 116(19): 3724-34.
• 4. Shenoy PJ, Malik N, Nooka A, Sinha R, Ward KC, Brawley OW, Lipscomb J, Flowers CR. Racial differences in the presentation and outcomes of diffuse large B-cell lymphoma in the United States. Cancer. 2010.
• 5. Sehn LH, Berry B, Chhanabhai M, Fitzgerald C, Gill K, Hoskins P, Klasa R, Savage KJ, Shenkier T, Sutherland J, Gascoyne RD, Connors JM. The revised International Prognostic Index (R-IPI) is a better predictor of outcome than the standard IPI for patients with diffuse large B-cell lymphoma treated with R-CHOP. Blood. 2007; 109(5): 1857-61.
• 6. Salar A, Avivi I, Bittner B, et al. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a twostage, phase IB study. J Clin Oncol. 2014;32:1782–1791.
• 7. Davies A, Merli F, Mihaljevic B, et al. Pharmacokinetics and safety of subcutaneous rituximab in follicular lymphoma (SABRINA): stage 1 analysis of a randomized phase 3 study. Lancet Oncol. 2014;15:343–352.
• 8. Rummel M, Kim TM, Aversa F, et al. “Preference for subcutaneous or intravenous administration of rituximab among patients with untreated CD20+ diffuse large B-cell lymphoma or follicular lymphoma: results from a prospective, randomized, open-label, crossover study (PrefMab). Ann Oncol. 2017;28(4):836-842.
• 9. MacDonald D, Crosbie T, Christofides A, Assaily W, Wiernikowski J.A Canadian perspective on the subcutaneous administration of rituximab in non-Hodgkin lymphoma. Curr Oncol. 2017 Feb;24(1):33-39.