A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy of Afatinib (BIBW2992) in Maintenance Therapy After Post- Operative Radio-chemotherapy in Squamous-cell Carcinoma of the Head and Neck: GORTEC 2010-02
The reference treatment for operated squamous cell carcinoma of the head and the neck is a
radiochemotherapy with Cisplatin (in the dose of intravenous 100 mg / m2 IV) every 3 weeks).
The Receptor of EGFR (Epidermal Growth Factor) or REGF is a membrane receptor; it's
activation leads the cellular growth and inhibits apoptotic capacities. This receptor is
overexpressed in numerous solid tumors, including ENT tumors. Several clinical studies
showed that an over expression of the REGF in ENT tumors was a dominant factor of poor
Afatinib (BIBW2992) is a strong and irreversible inhibitor of the EGFR ( type 1 human
epidermic growth factor receptor, also known as HER1) and of the HER2 (human epidermal
growth factor receptor 2).
Currently, 3 phase III clinical studies in postoperative situation and using an anti-REGF
are in progress: 2 in concomitant situation with the radiotherapy and 1 both in concomitance
and in adjuvant therapy with radiotherapy.
The preliminary results of a phase II study show that Afatinib is efficient in patients with
local or metastatic relapse of a squamous cell carcinoma of the sphere ENT after a first
line with Cisplatin and its tolerance is correct.
These data lead us to propose in post-operative situation, in patients with a squamous cell
carcinoma of the head and neck, a radiochemotherapy with Cisplatin followed by a treatment
of maintenance by Afatinib or by placebo.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Disease Free Survival 2 years after the end of radiotherapy
2 years after the end of radiotherapy
Séverine RACADOT, MD
Centre Léon Bérard; Lyon
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)