Cetuximab Plus Chemoradiotherapy in Immunocompetent Patients With Anal Carcinoma : A Phase II Eastern Cooperative Oncology Group–American College of Radiology Imaging Network Cancer Research Group Trial (E3205)
Mené sur 61 patients atteints d'un carcinome épidermoïde du canal anal de stade I à III, cet essai de phase II évalue, du point de vue du taux de récidive locorégionale à 3 ans et de la toxicité, l'intérêt d'ajouter le cétuximab à une chimiothérapie par cisplatine-fluorouracile en combinaison avec une radiothérapie de la tumeur primitive et des ganglions lymphatiques régionaux
Résumé en anglais
Purpose : Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after sphincter-preserving definitive chemoradiation (CRT) and is typically associated with anogenital human papilloma virus infection. Because cetuximab enhances the effect of radiation therapy in human papilloma virus–associated oropharyngeal squamous cell carcinoma, we hypothesized that adding cetuximab to CRT would reduce LRF in SCCAC.
Methods : Sixty-one patients with stage I to III SCCAC received CRT including cisplatin, fluorouracil, and radiation therapy to the primary tumor and regional lymph nodes (45 to 54 Gy) plus eight once-weekly doses of concurrent cetuximab. The study was designed to detect at least a 50% reduction in 3-year LRF rate (one-sided
