Evaluation Of Hypomethylating Agent Venetoclax Combination In Patients With Acute Myeloid Leukaemia Ineligible For Intensive Treatment

Öz

: In acute myeloid leukaemia (AML), which the median age at diagnosis is 68 years, survival is significantly lower in the elderly group who are ineligible for intensive treatment. Survival and quality of life have been improved with the combination of the hypomethylating agent venetoclax (HMA-V), which has become the standard of care for this group of patients. We aimed to evaluate the results of HMA-V combination therapy in the group of AML patients who are ineligible for intensive treatment at our centre. The median age of the 37 patients included in the study was 70.2 years, and 51.4% were women. 73% of the patients were de novo leukemia while 4 patients were relapse and 1 was refractory disease. The HMA-V combination was given 2 patients who were in remission due to intolerance/side effects of intensive treatment. Azacitidine usage rate was 78.6%. The median number of course was 3. The remission rate was found to be 51.4% in bone marrow evaluation at the end of the 1st/2nd course. The mean follow-up was 11.9 months and 56.75% of patients died. Mean survival was 27.1, 4.1 and 7.5 months for those who achieved remission, those who did not achieve remission and those who could not be assessed, respectively, with a significant difference between groups (p <0.001). While mean and median survival with azacitidine were 22.03 and 23 months, with decitabine 3.87 and 3 months respectively, there was a significant statistical difference (p<0.001). In multivariate Cox regression analysis, the only factor influencing mortality was not being in remission at the end of 1st/2nd cycle assessment. In conclusion, the survival and remission rates seen in our center are found to be similar to real-world studies.

Anahtar Kelimeler

• acute myeloid leukemia
• azacitidine
• decitabine
• venetoclax

İntensif Tedaviye Uygun Olmayan Akut Myeloid Lösemi Hastalarında Hipometilleyici Ajan Venetoklaks Kombinasyonu Sonuçlarının Değerlendirilmesi

Öz

Ortanca tanı yaşı 68 olan akut myeloid lösemide (AML) intensif tedavi adayı olamayan ileri yaş grubunda sağkalım süresi belirgin olarak düşüktür. Günümüzde bu hasta grubu için standart tedavi haline gelen hipometilleyici ajan-venetoklaks (HMA-V) kombinasyonuyla sağkalım süresi ve yaşam kalitesi artmıştır. Biz de merkezimizde intensif tedaviye uygun olmayan AML hasta grubunda HMA-V kombinasyon tedavisi sonuçlarını incelemeyi amaçladık. Çalışmaya dahil edilen 37 hastanın ortanca yaşı 70.2 yıl ve %51.4’ ü kadın idi. Hastaların %73’ü de novo lösemi olup 4 hasta nüks, 1 hasta azasitidin sonrası refrakter hastalıktı. Remisyon sağlanan 2 hastaya intensif tedavi intoleransı/yan etkisi nedeniyle HMA-V kombinasyonu verildi. Azasitidin kullanım oranı %78.6 idi. Ortanca kurs sayısı 3 idi. 1. veya 2. kurs sonunda kemik iliği değerlendirmesinde remisyon oranı %51.4 olarak bulundu. Ortalama izlem süresi 11.9 ay olup hastaların %56.75’i hayatını kaybetti. Sağkalım analizlerinde ortalama ve ortanca yaşam süreleri 18 ve 13 ay olarak saptandı. Ortalama yaşam süreleri remisyon sağlananlarda, sağlanamayanlarda ve değerlendirilemeyenlerde sırasıyla 27.1, 4.1 ay ve ve 7.5 ay idi ve gruplar arasında anlamlı farklılık saptandı (p <0.001). Azasitidin ile ortalama ve ortanca yaşam süreleri 22.03 ve 23 ay iken, desitabin ile bu süreler sırasıyla 3.87 ve 3 ay idi ve belirgin istatiksel farklılık mevcuttu (p <0.001). Cox regresyon multivariate analizinde mortalite üzerinde etkili tek faktör 1./2. siklus sonu değerlendirmesinde remisyonda olmamak olarak bulundu (p 0.004). Sonuç olarak, merkezimizin sağkalım ve remisyon oranları gerçek yaşam çalışmalarıyla benzer olarak bulunmuştur.

Anahtar Kelimeler

• akut myeloid lösemi
• azasitidin
• desitabin
• venetoklaks

Kaynakça

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