Induction cetuximab, paclitaxel and carboplatin followed by chemoradiation with cetuximab, paclitaxel and carboplatin for stage III/IV head and neck squamous cancer: A Phase II ECOG-ACRIN trial (E2303)
Mené sur 74 patients atteints d'un carcinome épidermoïde de la tête et du cou de stade III/IV, cet essai de phase II évalue l'efficacité, du point de vue de la survie sans événement et de la survie globale à 3 ans, et la toxicité d'un traitement d'induction par cetuximab-paclitaxel-carboplatine suivi d'une chimioradiothérapie utilisant les mêmes agents anticancéreux
Background : E2303 evaluated cetuximab, paclitaxel and carboplatin used as induction therapy and concomitant with radiation therapy in patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) determining pathologic complete response, event-free survival, and toxicity. Patients and Methods : Patients with resectable stage III/IV HNSCC underwent induction therapy with planned primary site restaging biopsies (at week 8 in clinical complete responders and at week 14 if disease persisted). Chemoradiation began week 9. If week 14 biopsy was negative, patients completed chemoradiation (68-72 Gy); otherwise, resection was performed. p16 protein expression status was correlated with response/survival. Results : Seventy-four patients were enrolled; 63 were eligible. Forty-four (70%) were free of surgery to the primary site, progression, and death 1-year post treatment. Following induction 41 (23 complete response (CR)) underwent week 8 primary site biopsy and 24 (59%) had no tumor (pathologic CR). Week 14 biopsy during chemoradiation (50 Gy) in 34 (15 previously positive biopsy; 19 no prior biopsy) was negative in 33. Thus 90% of eligible patients completed chemoradiation. Overall survival and event-free survival were 78% and 55% at 3 years, respectively. Disease progression in 23 patients (37%) was local only in 10 (16%), regional in 5 (8%), local and regional in 2 (3%), and distant in 5 patients (8%). There were no treatment-related deaths. Toxicity was primarily hematologic or radiation-related. p16 AQUA score was not associated with response/survival. Conclusions : Induction cetuximab, paclitaxel and carboplatin followed by same drug chemoradiation is safe and induces high primary site response and promising survival. Clinical Trials number NCT 00089297
Annals of Oncology 2014