12-Cycle of Temozolomide Treatment is not Superior To 6-Cycle of Treatment in Glioblastoma Multiforme

INTRODUCTION: Glioblastoma multiforme (GBM), a grade IV malignant glioma, is the most common primary brain tumor in adults. Following biopsy or resection, radiotherapy (RT) and concomitant and adjuvant temozolomide (TMZ) use (6 cycles) have become the standard of treatment for newly diagnosed GBM cases. Although the original treatment regimen involves the use of 6 cycles of TMZ, some centers administer prolonged treatment up to 12 or more cycles in non-progressive patients in the hope of achieving better outcome. This form of administration is controversial. The main purpose of our study is to determine whether prolonging TMZ treatment (from 6 months to 12 months) is beneficial in patients treated with a standard combined treatment approach in terms of disease-free survival (DFS) and OS.
METHODS: Between 2012-2019 years we analyzed 180 GBM patients retrospectively and included 100 patients who met the criteria for inclusion in the study.
RESULTS: 100 GBM patients were retrospectively examined. Median OS was 21 (18.47-23.52) months overall, while it was 24 (18.21-29.78) months in recipients of 6 cycles of TMZ, it was 22 (18.50-25.49) months in the group receiving 12 cycles of TMZ, and 10 months in those who could not complete adjuvant therapy. There was no statistically significant difference between 6 cycles and 12 cycles of TMZ treatment (p = 0.55). Patients who could not complete the adjuvant therapy had lower survival and this group had a statistically significant OS difference compared to patients receiving 6 and 12 cycles of TMZ (p = 0.04 and p = 0.024, respectively).
DISCUSSION AND CONCLUSION: Our study indicate that prolongation of adjuvant TMZ treatment in GBM patients do not provide an additional survival advantage regardless of age, performance status and tumor characteristics. Additionally, GBM patients who could not complete standard 6-cycle adjuvant treatment have lower survival rates.

Glioblastome Multiforme'de 12 Kür Temozolomid Tedavisi 6 Kür Tedaviye Üstün Deðildir

GÝRÝÞ ve AMAÇ: Grade IV gliom olan glioblastoma multiforme (GBM), yetiþkinlerde en sýk görülen primer beyin tümörüdür. Biyopsi veya rezeksiyonu takiben, radyoterapi (RT) eþ zamanlý ve adjuvan temozolomid (TMZ) kullanýmý (6 kür), yeni teþhis edilmiþ GBM vakalarý için standart tedavi haline gelmiþtir. Orijinal tedavi rejimi 6 kür TEMODAL kullanýmýný içermesine raðmen, bazý merkezler daha iyi sonuç elde etme umuduyla progrese olmayan hastalarda 12 veya daha fazla kür tedavi uygulamaktadýr. Butedavi yaklaþýmý tartýþmalýdýr. Çalýþmamýzýn temel amacý, hastalýksýz saðkalým (DFS) ve genel sað kalým (OS) açýsýndan standart kombine tedavi yaklaþýmý ile tedavi edilen hastalarda TEMODAL tedavisinin uzatýlmasýnýn (6 aydan 12 aya kadar) yararlý olup olmadýðýný belirlemektir.
YÖNTEM ve GEREÇLER: 2012-2019 yýllarý arasýnda retrospektif olarak 180 GBM hastasýný analiz ettik ve çalýþmaya dahil edilme kriterlerini karþýlayan 100 hastayý dahil ettik.
BULGULAR: 100 GBM hastasý geriye dönük olarak incelendi. Medyan OS 21 (18.47-23.52) ay iken, 6 kür TMZ alanlarda 24 (18.21-29.78) ay, 12 kür TMZ alan grupta 22 (18.50-25.49) ay ve adjuvan tedaviyi tamamlayamayanlarda 10 aydý. 6 ve 12 kür TMZ tedavisi arasýnda istatistiksel olarak anlamlý bir fark yoktu (p = 0.55). Adjuvan tedaviyi tamamlayamayan hastalar daha düþük sað kalýma sahipti ve bu grup, 6 ve 12 kür TMZ alan hastalara kýyasla istatistiksel olarak anlamlý bir OS farkýna sahipti (sýrasýyla p = 0.04 ve p = 0.024).
TARTIÞMA ve SONUÇ: Çalýþmamýz, GBM hastalarýnda adjuvan TMZ tedavisinin uzatýlmasýnýn yaþ, performans durumu ve tümör özelliklerinden baðýmsýz olarak ek bir sað kalým avantajý saðlamadýðýný göstermektedir.Ayrýca, standart 6 kür adjuvan tedaviyi tamamlayamayan GBM hastalarýnýn hayatta kalma oranlarý daha düþüktür.