The comparison of the preventive effects of filgrastim and lenograstim in pediatric cancer patients treated with chemotherapy and radiotherapy

Öz

OBJECTIVES To compare the preventive effects of filgrastim and lenograstim in pediatric cancer patients treated with chemotherapy and radiotherapy. METHODS Eighty-two patients treated with myelosuppressive chemotherapy and/or radiotherapy in Pediatric Oncology and Radiation Oncology Departments of Kocaeli University, Faculty of Medicine between September 2005 and March 2007 were randomized to filgrastim and lenograstim arms. Radiotherapy doses and fields 3 weeks prior to the therapy, age, gender, histopathological type of the tumor, stage and chemotherapy protocols were recorded. Patients with bone marrow infiltration due to the tumoral invasion and patients receiving steroid including chemotherapy regimens were excluded from the study. Equivalent doses of two hematopoetic growth factors (filgrastim 5 μg/ kg/ day, S.C; lenograstim 150 μg/ m2/ day, S.C) were applied beginning 24 hours following the completion of the chemotherapy till leukocyte count reached 10.000/mm3. RESULTS Delay in the new chemotherapy cure following chemotherapy protocol was median 5 days in lenograstim arm (16 patients, 37%) while it was 3 days in filgrastim arm (10 patients; %25) however the difference was not statistically significant (p=0.188). In lenogastrim arm, febrile neutropenia occurred in 6 patients and infections without neutropenia were seen in 4 patients (pneumonia in 2 patients, otitis media in 1 patient and pharengitis in 1 patient). In filgrastim arm, febrile neutropenia occurred in 3 patients and gingivitis and gastroenteritis in 2 patients and the difference between two groups was also not significant (p=0.258). However, bone pain was present in 2 patients in lenograstim arm while it was seen in 10 patients in filgrastim arm with a significant difference (p=0.008). CONCLUSION Although preventive effects of filgrastim and lenograstim on febrile neutropenia and non-neutropenic infections in patients receiving radiotherapy and chemotherapy are not significantly different, delay in the new chemotherapy cure following chemotherapy protocol is shorter in filgrastim arm. However, bone pain is also significantly higher in filgrastim arm.

Anahtar Kelimeler

• Chemotherapy,Radiotherapy,Hematopoietic Cell Growth Factors,Neutropenia,Filgrastim,lenograstim

Kemoterapi ve radyoterapi uygulanan kanserli çocuklarda nötropeninin önlenmesinde filgrastim ve lenograstim'in etkinliklerinin karşılaştırılması

Öz

AMAÇ Kemoterapi (KT) ve radyoterapi ( RT) sırasında veya sonrasında kullanılan iki farklı hematopoetik büyüme faktörünün nötropeni ciddiyeti ve süresini azaltma üzerindeki etkinliği değerlendirildi. GEREÇ VE YÖNTEM Eylül 2005-Mart 2007 tarihleri arasında Kocaeli Üniversitesi Çocuk Onkoloji Bilim Dalı ve Radyasyon Onkolojisi Anabilim Dallarında kanser tanısı ile miyelosupresif KT ve/veya RT uygulanan toplam 82 hasta başvuru sıralarına göre filgrastim veya lenograstim koluna randomize edildiler. Çalışmaya dâhil edilmeden önceki 3 hafta içinde uygulanmış olan RT doz ve alanları, yaş, cinsiyet, tümör tipi, evresi ve uygulanan KT protokolleri kaydedildi. Primer malignitesine bağlı kemik iliği disfonksiyonu olanlar ve KT protokolü kapsamında steroid uygulananlar çalışma dışı bırakıldı. Her iki hemopoetik büyüme faktörü (HBF) eşdeğer dozlarda (filgrastim 5 μgr/kg/gün, S.C. ve lenograstim 150 μgr/m2/ gün, S.C), KT bitiminden 24 saat sonra başlanarak lökosit sayısı 10.000/ mm3 olana dek uygulandı. BULGULAR Lenograstim uygulanan 16 hastada (%37.2) yeni KT küründe gecikme süresi ort. 5 gün olarak saptanırken, filgrastim uygulanan grupta gecikme daha azdı (10 hasta; %25.6 ve ort. 3 gün) fakat bu fark anlamlı bulunmadı (p=0.188). Lenograstim uygulanan 6 hastada febril nötropeni ve 4 hastada nötropenik olmayan enfeksiyon atağı (2 atakta pnomoni, 1 atakta otit ve 1 atakta farenjit), filgrastim uygulananlarda ise 3 hastada febril nötropeni, 2 hastada ise gingivit ve gastroenterit olmak üzere febril nötropenik olmayan atak gözlendi. İki grup arasında enfeksiyon sıklığı yönünden farklılık saptanmadı (p=0.258). Lenograstim alan grupta 2 hastada belirgin yan etki olarak kemik ağrısı saptandı. Bununla birlikte filgrastim uygulanan grupta ise 10 hastada kemik ağrısı belirlendi ( p= 0.008). SONUÇ RT ve KT uygulanan hastalarda, tedaviye bağlı nötropeninin ve nötropenik olmayan enfeksiyonların önlenmesinde lenograstim ve filgrastim'in etkinlikleri arasında anlamlı bir farklılık bulunmamaktadır. Filgrastim alanlarda yeni KT sikluslarının başlanmasındaki gecikme daha azdır; filgrastim uygulamasına bağlı kemik ağrısı, lenograstim alanlara göre daha sık görülmektedir.

Anahtar Kelimeler

• Büyüme faktörleri, enfeksiyon, febril nötropeni, kemoterapi, radyoterapi

Kaynakça

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