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Adding the oral chemotherapy temozolomide during and after radiotherapy extended median survival in glioblastoma by about two and a half months and more than doubled the number of patients alive at two years; twenty years later it is still the standard.
Open-label phase 3 trial (EORTC 26981/NCIC CE.3) of 573 patients aged 18-70 with newly diagnosed glioblastoma randomised to radiotherapy alone (60 Gy) or radiotherapy with concomitant daily temozolomide followed by six cycles of adjuvant temozolomide. Primary endpoint was overall survival.
Median OS was 14.6 vs 12.1 months (HR 0.63) and 2-year OS 26.5% vs 10.4%. The companion paper by Hegi showed that MGMT promoter methylation predicted benefit. The 'Stupp protocol' became the global standard for glioblastoma and remains so, with only tumour-treating fields added since; the trial also illustrates how little progress has been made against this tumour.
Patients with newly diagnosed glioblastoma who are fit and under about 70 receive six weeks of radiotherapy with daily temozolomide followed by six monthly cycles of temozolomide; this is still the backbone of treatment two decades later. Testing MGMT methylation identifies who benefits most and guides decisions in older patients. Median survival with the regimen remains only around 15-20 months, and no drug since has clearly improved on it, which is why glioblastoma is a priority for new approaches.
Shares Martin J. van den Bent, Monika E. Hegi, Michael Weller, Roger Stupp.
Shares Michael Weller, Roger Stupp, The brain: barrier and sanctuary, Failures are hidden.
Shares Roger Stupp, Tumour treating fields (TTFields), The brain: barrier and sanctuary, Glioma & glioblastoma.
Shares Monika E. Hegi, Roger Stupp, EORTC, Glioma & glioblastoma.
Shares Roger Stupp, Tumour treating fields (TTFields), The brain: barrier and sanctuary, Glioma & glioblastoma.
Shares Michael Weller, Tumour treating fields (TTFields), EORTC, Glioma & glioblastoma.
Shares Roger Stupp, Tumour treating fields (TTFields), The brain: barrier and sanctuary, Glioma & glioblastoma.
Shares Standard of care, The undruggable drivers, Overall survival (OS), Cytotoxic chemotherapy.