(Editor's Notes: This is a big step forward using treatments already available.  This article was translated to English from the original German source at https://forum.hirntumorhilfe.de/neuroonkologie/breaking-news-fortschritte-in-der-glioblastombehandlung-12606.html.  Thanks to Stephen Western for alerting me to this - I usually don't monitor foreign language journals!)

 

 

New therapeutic combination and new standard in glioblastoma treatment?

 

15.09.2017, synexus, studien.de

 

Sensational results were obtained from a recent phase III study in the treatment of glioblastoma. The results of the study were published by the study director Prof. Dr. med. Ulrich Herrlinger from Bonn. The addition of conventional treatment with another chemotherapeutic agent has led to a significant improvement in overall survival in glioblast patients with methylated MGMT status. Due to the excellent data and tolerable toxicity, a new standard is now being discussed in the therapy of glioblastoma.

 

The standard therapy of glioblastoma has hitherto included the most extensive neurosurgical removal of the tumor and a combination of radiation and chemotherapy followed by six cycles of temozolomide chemotherapy. Based on the positive data from the NOA-09 study, the combination of temozolomide with Lomustine (CCNU) will be included in the guidelines.

 

In a non-randomized Phase II study, combination therapy, CCNU and temozolomide were found to be highly effective for MGMT positive patients and far superior to temozolomide monotherapy (Glas et al., J Clin Oncol 27: 1257-1261, 2009). It was found in this publication that the combination of radiation therapy, CCNU and temozolomide provided promising long-term survival data in patients with newly diagnosed glioblastoma, and CCNU intensification of chemotherapy can be highly likely to have an additional survival advantage.

 

Consequently, a further investigation with the designation NOA-09, the so-called CeTeG study, was launched in 2011 for newly diagnosed MGMT-methylated glioblastomas. The efficacy of lomustine / temozolomide combination therapy was determined in a randomized multicentric phase III trial and from 2011 to 2014 over 140 patients were included at 17 German centers.

 

The survival benefit, which was already assumed in 2009, has now been confirmed, according to the latest evaluation of the data, for the mean overall survival time. In patients who were additionally treated with CCNU, a significant increase in overall survival was compared with the group with temozolomide mono chemotherapy. The mean survival time in patients receiving CCNU was 46.9 months compared to 30.4 months in the control group with monochemotherapy. In the Stupp study, the historical study without MGMT discrimination, the mean survival time was 14.6 months.

 

The doctors of the research group recommend a combination therapy with CCNU as standard in the treatment of glioblastoma patients to establish and deploy the new regimen from now, particularly in patients with methylated MGMT promoter.