Meet the new boss, same as the old boss.
The Study: You’re already familiar with the rationale for this study so let’s dive right into the presented results (LBA4). This first analysis includes 805 patients (90% male) receiving definitive conventionally-fractionated radiation delivered 6 days per week. They were randomized to concurrent q3 weekly cisplatin 100 mg/m2 x 2 versus weekly cetuximab x 8 with a primary endpoint of overall survival. Unfortunately, the hazard ratio for death with cetuximab perfectly straddled the maximum upper limit predefined to achieve “non-inferiority” (HR 1.45). What’s more, it was significantly worse, as was risk of death or progression (HR 1.72). These provocative results are further bolstered by those reported this week at ESMO on the similarly designed De-ESCALaTE HPV trial.
Bottom Line: After all this we can now proclaim the new boss of systemic therapy in this setting is...same as the old boss, serving you faithfully since 1971. | Trotti, ASTRO 2018