Glioblastoma (histology slide). Credit score: Wikipedia/CC BY-SA 3.0
Beforehand, outcomes from the photon cohort of the NRG-BN001, a sign looking for Section II randomized trial, indicated that photon radiation dose intensification (75 Gy) didn’t reveal enchancment in total survival (OS) for sufferers with newly identified glioblastoma (GBM).
A latest evaluation of the proton cohort revealed improved survival for sufferers receiving proton remedy at 75 Gy. As a result of these knowledge met the pre-defined survival enchancment threshold, they may very well be used to design and conduct a definitive Section III randomized trial.
These outcomes had been reported on the American Society for Radiation Oncology Annual Assembly in San Francisco, California.
“We had developed this trial to test the potential survival advantage using proton therapy combined with temozolomide for GBM with the dual hypothesis of the benefit of dose-escalation and the sparing effect on lymphocytes in circulation, critical in maintaining an anti-tumor immune response, and are excited to report that the predefined signal to support the development of a definitive Phase III trial of proton dose-escalation for GBM has been achieved,” mentioned Minesh P. Mehta, MD, with Baptist Well being Miami Most cancers Institute and Florida Worldwide College Herbert Wertheim School of Medication and the lead creator of the NRG-BN001 summary.
Information from prior single-arm, non-randomized research using temozolomide established simultaneous built-in enhance (SIB) radiation remedy dose intensification to 75 Gy as protected and efficient in sufferers with GBM.
NRG-BN001 was designed as a Section II examine testing the speculation that this dose intensified routine may very well be probably as or simpler in treating sufferers with GBM. Moreover, lymphopenia is usually related to the low-dose area generally encountered with photon radiotherapy and has been demonstrated to have dose-volume dependency, and a survival decrement with lymphopenia in GBM has been established.
Proton remedy has been demonstrated to lower the incidence of acute extreme lymphopenia, suggesting a possible biologic mechanism of profit for GBM sufferers. NRG-BN001 addressed each hypotheses, evaluating 75 Gy depth modulated radiation remedy (IMRT) and 75 Gy proton remedy to straightforward of care 60 Gy radiation remedy.
The proton remedy cohort of NRG-BN001 included 193 evaluable sufferers. The proton remedy arm demonstrated improved OS (HR= 0.81, 70% CI 0.67-0.98, p =0.11 [prespecified type I error of 0.15]) and the advance in survival remained important when correcting for MGMT methylation standing and recursive partitioning evaluation (RPA) class.
Absolutely the survival enchancment in favor of the proton remedy arm at two and three years was 6.8% (43.1 vs. 49.9%) and 4.6% (25.4 vs. 30%).
As anticipated, OS was superior for each MGMT methylated in addition to for decrease recursive partitioning evaluation (RPA) class sufferers, and with out important interplay between remedy arm and both MGMT standing or RPA.
There was no statistically important distinction in excessive grade toxicities between remedy arms. Particularly, ≥G3 lymphopenia and ≥G4 neurologic toxicity charges for 60 Gy vs. 75 Gy proton remedy had been 23.4 vs. 17.1 (absolute distinction of 6.3%), and 5 vs. 1.8% (absolute distinction of three.2%).
Additional analysis must be performed in a Section III trial setting to find out the total potential profit for proton remedy on this affected person inhabitants.
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Trial evaluation exhibits enchancment in survival outcomes for glioblastoma sufferers receiving proton remedy (2025, October 1)
retrieved 1 October 2025
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