As reported in the Journal of Clinical Oncology by Geoffrois et al, the European phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-02 trial has shown no improvement in progression-free survival with induction chemotherapy followed by cetuximab and radiotherapy (RT) vs concurrent chemoradiotherapy in patients with squamous cell carcinoma of the head and neck with bulky nodal spread.
In the open-label trial, 370 patients were randomized between 2009 and 2013 to receive induction therapy with docetaxel, cisplatin, and fluorouracil (TPF) followed by cetuximab and RT (TPF+cetux-RT; n = 181) or standard of care with concurrent chemoradiotherapy with carboplatin and fluorouracil (CT-RT; n = 179). Patients had to have nonmetastatic N2b, N2c, or N3 disease.
The primary endpoint was progression-free survival at 2 years.
Median follow-up was 2.8 years. Progression-free survival at 2 years was 36% in the TPF+cetux-RT group vs 38% in the CT-RT group (hazard ratio [HR] = 0.93, P = .58). No significant differences between the TPF+cetux-RT vs CT-RT group were observed in locoregional control (HR = 0.98, P = .90) or overall survival (HR = 1.12, P = .39). Outcomes were similar regardless of p16 status. Rate of distant metastasis was lower in TPF group (HR = 0.54, P = .05).
Grade 3 and 4 fever (9% vs 0.6%, P < .001), grade 3 and 4 neutropenia (26% vs 6%, P < .001), and febrile neutropenia (17% vs 0%, P < .001) were more common with TPF+cetux-RT, as were grade 3 and 4 skin reactions inside RT fields (53% vs 29%, P < .001). Treatment-related death occurred in 6.6% of patients in the TPF+cetux-RT group vs 1 death in the CT-RT group (P = .0016).
The investigators concluded, “Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.”
The study was supported by Merck Serono (France).
Jean Bourhis, MD, of the Centre Hospitalier Universitaire de Lausanne, is the corresponding author for the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.