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The German Society of Oncology's Neuro-Oncology Working Group initiated a randomized open label phase 3 CeTeG/NOA-09 clinical trial to further analyze the application value of lomostine and tamoxifen in the combination of treatment of GBM patients, the results of which were published in The Lancet in February 2019- From the article chapter
(Ref: Herrlinger U, et alLancet2019 Feb 16;393(10172): 678-688doi: 10.1016/S0140-6736 (18)31791-4Epub 2019 Feb 14.:currently, the standard complementary treatment for newly diagnosed glioblastoma (GBM) patients is a daily dose of 75 mg in doses while the tumor is surgically removed and radiotherapy (59-60Gy, 22-35 days) /m2 tamoxolomide,TMZ); After chemotherapy, then temeamine, I.MTMZ 150-200 mg/m2 per day, 1 course for 4 weeks, 6 coursesThe MGMT promoter methylation state is a predictor of the effects of the treatment of temolyne: patients with MGMT promoter methylation can obtain a longer lifetime from TMZ therapyA single-arm, phase 2 UKT-03 trial (single-arm phase 2 UKT-03 trial) assessed the efficacy of newly diagnosed glioblastoma sedatives for lomustine and tamoxetine combined treatmentIt was found that the overall survival rate of GBM patients with MGMT promoter methylation could be improvedThe German Society of Oncology's Neuro-Oncology Working Group initiated a randomized open label phase 3 CeTeG/NOA-09 clinical trial to further analyze the application value of lomostine and tamoxifen in the combination of treatment of GBM patients, the results of which were published in The Lancet in February 2019the study collected data on GBM patients treated at 17 German university hospitals between 4 May 2011 and 8 April 2014The new diagnostic glioblastoma with MGMT promoter methylation, Karnofsky performance score, KPS, was 70 or older, included in the studyThrough the SAS randomization list, 1:1 randomly assigned to 2 treatment groups for postoperative patients: the pimozine group of the above standard program; At the same time, use Lomustin (day 1, 100mg/m2) plus TMZ (day 2-6, 100-200mg/m2 per day), 6 Monday stake for a total of 6 sessionsThe main observation was the overall survival rate of the intended treatment population, including all patients who started chemotherapy from randomly assigned (Figure 1) The trial was registered at ClinicalTrials.gov under the number NCT01149109 Figure 1 A diagram of the CeTeG/NOA-09 pilot programme in Figure 3 authors randomly grouped 141 patients with newly diagnosed glioblastoma with MGMT promoter methylation The patients were KPS high-scoring, and most tumors were completely removed Compared with the tamoxetine group, the total survival of the lomostine combined with the tamoxetine group was significantly improved (p.0.0492) The median total survival in patients with temomine group was 31.4 months (95% CI, 27.7-47.1), while the median total survival of patients with the tamoxetine group was 48.1 months Observation of adverse events 30 days after treatment showed no treatment-related deaths The rate of adverse events at level 3 or 4 in the Lomoxine combined pyremine group was high, including toxic reactions to blood Compared to the tamoxetine group, no additional non-blood and non-central nervous system toxic reactions were occurred in the lomoxine group, including no liver toxicity overall, lomostine combined with tamoxifen chemotherapy and radiotherapy improved the overall survival rate of patients with MGMT promoter methylation glioblastoma compared to the standard temolamine chemotherapy and radiotherapy after surgical removal If the results are confirmed in clinical trials of a further large sample, lomoxin-combined temequine chemotherapy and radiotherapy may become the standard treatment option.