Cetuximab-radiotherapy versus cetuximab-radiotherapy plus concurrent chemotherapy in patients with N0-N2a squamous cell carcinoma of the head and neck (SCCHN): Results of the GORTEC 2007-01 phase III randomized trial.

Abstract

6003Background: Chemo-radiotherapy (CT/RT) and cetuximab-RT (cetux-RT) were established as standard treatments in non-operated locally advanced (LA) SCCHN. While the addition of cetux to cisplatin/RT offers no benefit as compared to the same CT/RT alone (RTOG 0522 trial), it was not known whether the addition of carboplatin/5FU to cetux-RT would improve outcome, as compared to cetux-RT alone. Methods: The GORTEC 2007-01 trial was restricted to patients (pts) with no or limited nodal spread (N0-N2a) and was run in parallel with GORTEC 2007-02 trial testing induction vs concurrent CT in N2b/c-N3 pts. Inclusion criteria were pts fit for receiving CT, non-metastatic, non-operated stage III-IV SCC of oral cavity, oro/hypopharynx and larynx. The 1:1 randomization between cetux-RT (arm A) and cetux-CT/RT (arm B) was done by minimization on centers, N and T stages. Cetux was given as a loading dose of 400 mg/m2 followed by weekly 250 mg/m2 during RT. RT total dose was 70 Gy (2 Gy/day, 5 days/week). Concurrent CT ...