669P - Neoadjuvant chemotarget therapy with cetuximab, docetaxel, and cisplatin in locally advanced resectable oral/oropharygeal squamous cell carcinoma: A multicenter phase III trial (Eagle trial)

Background

The role of neoadjuvant therapy in head and neck cancer is controversial, this trial aimed to evaluate the efficacy of neoadjuvant chemotarget therapy with docetaxel, cisplatin, and cetuximab (TPE) followed by surgery and postoperative radiotherapy (S+PORT) versus S+PORT in patients with locally advanced resectable oral/oropharyngeal squamous cell carcinoma (OOPSCC).

Methods

In this open-label, multicenter, randomized (1:1 ratio), phase 3 trial (NCT01434394), the patients with stage III or IVA OOPSCC received neoadjuvant TPE followed by S+PORT or S+PORT. Two cycles of neoadjuvant TPE (cetuximab 250mg/m² on d1, d8, d15; cisplatin 75mg/m² on d1; and docetaxel 75mg/m² on d1) was performed with initial cetuximab 400mg/m². The end points included pCR (pathologic complete response), overall survival (OS), disease free survival (DFS), loco-regional recurrence free survival (LRFS), distant metastasis free survival (DMFS), and disease-special survival (DSS).

Results

Of the 284 patients enrolled in this trial, 228 completed all treatment including 81.2% (112/138) in the TPE arm and 85.3% (126/136) in control arm. The incidence of grade 3 or 4 treatment related AEs was 42.0% in the TPE arm and 44.9% in the control arm. The ORR and pCR rate of neoadjuvant therapy was 43.4% (59/136) and 10.5% (14/133). After a median follow-up of 100 months, there was no significant difference in OS (HR=1.14, P=0.43), DFS (HR=1.16, P=0.35), LRFS (HR=1.18, P=0.3), DMFS (HR=1.19, P=0.28), DSS (HR=1.02, P=0.93) between the TPE and control arms. Among the patients completed all treatment, the difference was neither significant between the TPE and control arms, with OS (HR=0.91, P=0.61), DFS (HR=0.96, P=0.82), LRFS (HR=0.99, P=0.97), DMFS (HR=0.98, P=0.89), DSS (HR=0.92, P=0.69). In the TPE arm, patients with pCR had superior OS (HR=0.38, P=0.03) and DFS (HR=0.31, P=0.01) compared with non-pCR patients.

Conclusions

Our study failed to demonstrate that adding neoadjuvant TPE therapy improves survival in patients with locally advanced resectable OOPSCC, while those patients with pCR have survival benefit from neoadjuvant TPE therapy.

Clinical trial identification

NCT01434394.

Editorial acknowledgement

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.