Relaps veya refrakter akut lösemi hastalarında EMA ve FLAG-İda tedavi protokollerinin karşılaştırılması
Date
2006
Authors
Ozan, Ülkü
Journal Title
Journal ISSN
Volume Title
Publisher
Bursa Uludağ Üniversitesi
Abstract
Günümüzde remisyon oranları yüksek tedavi yaklaşımlarına rağmen, akut lösemi olgularının %15-25'inde primer refrakterlik ve remisyona girenlerin de %40'ında 2 yıl içinde relaps saptanmaktadır. Bu hastalarda uygulanan kurtarma rejimlerinden EMA ve FLAG-lda'nın, %50-80 oranında başarı şansına sahip olduğunu bildiren çok sayıda çalışma vardır ancak iki tedavi protokolünü karşılaştıran randomize bir çalışma bulunmamaktadır. Bu çalışmada, 1998-2005 yıllarında kliniğimizde tedavi gören relaps/refrakter akut lösemi olgularından, EMA (n:20) ve FLAG-İda (n:28) alanları retrospektif olarak karşılaştırdık. Risk profilleri açısından eşdeğer olan bu iki grup arasında aplazik dönem ve destek tedavileri bakımından istatistiksel olarak fark saptanmadı. Hastanede yatış süresi EMA alan grupta daha uzun bulundu (p=0.036). Nötropenik dönemdeki enfeksiyonlar ve diğer non-hematolojik komplikasyonlar açısından her iki protokolün aynı derecede riskli olduğu gözlendi. EMA grubunda %50, FLAG-İda grubunda %57 oranında komplet remisyon elde edildi ve bu veriler literatür ile uyumlu bulundu. İki protokol arasında, toplam yaşam süreleri bakımından fark olmamasına rağmen (sırasıyla median 14 ve 15 ay), hastalıksız sağkalım süresi EMA grubunda anlamlı olarak yüksek saptandı (median 11,5 aya karşılık 3 ay, p= 0.032). EMA grubundan 4 hastaya hematopoetik kök hücre transplantasyonu yapılırken, FLAG-İda grubunda hiçbir hasta bu şansı yakalayamadı (p=0.025). Bu verilere dayanılarak, relaps/refrakter olgularda kür elde etmenin tek yolu olan kök hücre transplantasyonu aşamasında daha uzun süre hastalıksız yaşam sağlayan EMA protokolünün FLAG-İda'ya göre avantajlı olduğu sonucuna varıldı.
Though there are novel therapeutic approaches with high remission rates, 15-25% of acute leukaemia cases are stil primary refractory and 40% of the patients in remission will relapse within 2 years. Many studies revealed 50-80% success rate of EMA and FLAG-lda rescue regimens, however none compared those two regimens in a randomized way. In this study, we compared the relapsed/refractory acute leukaemia patients who had treated with EMA (n:20) and FLAG-lda (n:28) between 1998-2005 retrospectively. Both groups were similar according to risk profiles and there were no statistically significant difference in means of aplasia period and supportive treatments. EMA patients were found to be hospitalized for longer periods (p=0.036). Both treatments were comparably risky for the infections during neutropenia and other non-haematological complications. Complete remissions were observed in 50% of EMA and 57% of FLAG-Ida patients in accordance with the literature. Though there was no statistically significant difference between the groups in means of overall survival (14 months for the EMA and 15 months for the FLAG-Ida group), disease-free survival was significantly better in the EMA group (median 11.5 months in the EMA group vs 3 months in the FLAG-Ida group) (p=0.032). Four EMA patients had bone marrow transplantation (BMT) while non of the FLAG-Ida patients were suitable for this procedure (p=0.025). Our results reveal that the EMA regimen is more advantageous than the FLAG-Ida regimen because it gives longer disease-free survival. The superiority of the EMA is more remarkable when it is thought that the only way of obtaining cure in relapsed/refractory cases is BMT.
Though there are novel therapeutic approaches with high remission rates, 15-25% of acute leukaemia cases are stil primary refractory and 40% of the patients in remission will relapse within 2 years. Many studies revealed 50-80% success rate of EMA and FLAG-lda rescue regimens, however none compared those two regimens in a randomized way. In this study, we compared the relapsed/refractory acute leukaemia patients who had treated with EMA (n:20) and FLAG-lda (n:28) between 1998-2005 retrospectively. Both groups were similar according to risk profiles and there were no statistically significant difference in means of aplasia period and supportive treatments. EMA patients were found to be hospitalized for longer periods (p=0.036). Both treatments were comparably risky for the infections during neutropenia and other non-haematological complications. Complete remissions were observed in 50% of EMA and 57% of FLAG-Ida patients in accordance with the literature. Though there was no statistically significant difference between the groups in means of overall survival (14 months for the EMA and 15 months for the FLAG-Ida group), disease-free survival was significantly better in the EMA group (median 11.5 months in the EMA group vs 3 months in the FLAG-Ida group) (p=0.032). Four EMA patients had bone marrow transplantation (BMT) while non of the FLAG-Ida patients were suitable for this procedure (p=0.025). Our results reveal that the EMA regimen is more advantageous than the FLAG-Ida regimen because it gives longer disease-free survival. The superiority of the EMA is more remarkable when it is thought that the only way of obtaining cure in relapsed/refractory cases is BMT.
Description
Keywords
Refrakter/relaps akut lösemi, Kurtarma rejimleri, EMA, FLAG-İda, Refractory/relapsed acute leukaemia, Salvage regimens, FLAG-Ida
Citation
Ozan, Ü. (2006). Relaps veya refrakter akut lösemi hastalarında EMA ve FLAG-İda tedavi protokollerinin karşılaştırılması. Yayınlanmamış tıpta uzmanlık tezi. Bursa Uludağ Üniversitesi Tıp Fakültesi.