Open AccessPhase III Randomized Study of Induction Chemotherapy Followed by Definitive Radiotherapy + Cetuximab Versus Chemoradiotherapy in Squamous Cell Carcinoma of Head and Neck: The INTERCEPTOR-GONO Study (NCT00999700)
Author(s) -
Marco Merlano,
Nerina Denaro,
Stefania Vecchio,
Lisa Licitra,
Paola Curcio,
Marco Benasso,
Almalina Bagicalupo,
Gianmauro Numico,
Elvio Russi,
Renzo Corvò,
Paolo Bruzzi
Publication year - 2020
Publication title -
oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.987
H-Index - 98
eISSN - 1423-0232
pISSN - 0030-2414
DOI - 10.1159/000507733
Subject(s) - cetuximab , medicine , cisplatin , neutropenia , radiation therapy , chemotherapy , head and neck cancer , chemoradiotherapy , toxicity , oncology , urology , surgery , cancer , colorectal cancer
Objectives: Induction chemotherapy followed by cetuximab and RT (IBRT) (Arm A) was compared to cisplatin/RT (CRT) (Arm B) in a randomized phase III study. Patients and Methods: Naïve patients with stage III-IVa, histologically proven locally advanced head and neck cancer (LASCCHN) were eligible. Arm A (IBRT): 3 TPF induction followed by cetuximab-RT (equivalent daily dose 2 Gy up to 70 Gy); Arm B: 3 cisplatin concurrent with the same RT scheduling. Due to slow accrual and incomplete data collection a futility analysis was performed. Results: 236/282 patients were evaluable. Therefore, no formal analyses can be made between the two arms. OS was 45.2/53.6 months in Arm A/B. Complete responses were achieved in 64% of patients in both arms. Neutropenia and skin toxicity were significantly worse in Arm A and body weight loss was significantly worse in Arm B. Compliance with the planned drug administration was higher in Arm B ( p = 0.0008). Conclusion: The study suggests that IBRT and CRT have similar efficacy, activity and toxicity.