Voss M, Wagner M, von Mettenheim N, Harter PN, Wenger KJ, Franz K, Bojunga J, Vetter M, Gerlach R, Glatzel M, Paulsen F, Hattingen E, Baehr O, Ronellenfitsch MW, Fokas E, Imhoff D, Steinbach JP, Rödel C, Rieger J. ERGO2: A Prospective, Randomized Trial of Calorie-Restricted Ketogenic Diet and Fasting in Addition to Reirradiation for Malignant Glioma. Int J Radiat Oncol Biol Phys. 2020 Nov 15;108(4):987-995. https://doi.org/10.1016/j.ijrobp.2020.06.021 Epub 2020 Jun 30. PMID: 32619561
Despite a large amount of promising preclinical results, we did not observe any PFS or OS
benefit in the KD-IF group. Several reasons might be responsible for the lacking efficacy of
KD-IF. First, the study population might have been too small to detect differences between
the two intervention groups. In this regard it is worth noting that we achieved our target of
30% PFS6 in the patients of the intervention group who responded with a drop of glucose to
the KD-IF. While overall the groups were well balanced, more patients pretreated with
bevacizumab were randomized into the KD-IF group (6 vs. 3) and more patients in the
control group had received resections for recurrent tumor prior to study treatment (8 vs. 2)
benefit in the KD-IF group. Several reasons might be responsible for the lacking efficacy of
KD-IF. First, the study population might have been too small to detect differences between
the two intervention groups. In this regard it is worth noting that we achieved our target of
30% PFS6 in the patients of the intervention group who responded with a drop of glucose to
the KD-IF. While overall the groups were well balanced, more patients pretreated with
bevacizumab were randomized into the KD-IF group (6 vs. 3) and more patients in the
control group had received resections for recurrent tumor prior to study treatment (8 vs. 2)