Radiotherapy dose escalation in glioblastoma: the thin ice of of historical controls
Mené sur 298 patients atteints d'un glioblastome supratentoriel (durée médiane de suivi : 17,2 mois ; 43 % de femmes), cet essai randomisé international de phase III évalue l'efficacité, du point de vue de la survie sans progression, d'une radiothérapie à kilovoltage pendant la chirurgie par rapport à la chirurgie seule
In The Lancet Oncology, Frank A Giordano and colleagues report the outcome of the INTRAGO II trial, a randomised, phase 3 study investigating the benefit of radiotherapy dose intensification in 314 patients with glioblastoma. The authors must be congratulated for successfully completing a technically complex trial. The radiotherapy boost was given with an additional 30 Gy single dose of intraoperative radiation by use of low-energy x-rays emitting 50 kV photons to the resection cavity, in addition to standard-of-care chemoradiotherapy.1 The rationale for intraoperative radiotherapy is that most gliomas recur in close proximity of the resection cavity, and the assumption that additional intraoperative radiotherapy administered to the resection cavity might prevent this. In an initial safety phase 1 study of 15 patients, no safety concerns emerged with this approach, and a progression-free survival of 11·3 months (95% CI 10·9–11·6) and an overall survival of 17·8 (13·9–21·7) months were observed.2 Another pooled analysis of 51 patients treated in five centres observed similar outcomes, and after comparison with historical controls, further evaluation of intraoperative radiotherapy in a prospective study was deemed to be warranted.3 INTRAGO II is that follow-up study, designed as a full phase-3 study, with a primary endpoint of progression-free survival assessed by central masked radiology review and overall survival as a secondary endpoint. To be eligible, patients needed to undergo maximal safe surgical resection with the decision to proceed with intraoperative radiotherapy based on the neurosurgeon's intraoperative assessment of having achieved maximal safe resection. Patients in both groups received standard-of-care 60 Gy external radiotherapy in combination with temozolomide after surgery.
The Lancet Oncology , commentaire en libre accès, 2026