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)

摘要: Purpose Squamous cell carcinoma of the anal canal (SCCAC) is characterized by high locoregional failure (LRF) rates after sphincter-preserving definitive chemoradiation (CRT) and typically associated with anogenital human papilloma virus infection. Because cetuximab enhances effect radiation therapy in virus-associated oropharyngeal squamous carcinoma, we hypothesized that adding to CRT would reduce LRF SCCAC. Methods Sixty-one patients stage I III SCCAC received including cisplatin, fluorouracil, primary tumor regional lymph nodes (45 54 Gy) plus eight once-weekly doses concurrent cetuximab. The study was designed detect at least a 50% reduction 3-year rate (one-sided α, 0.10; power 90%), assuming 35% from historical data. Results Poor risk features included disease 64% male sex 20%. 23% (95% CI, 13% 36%; one-sided P = .03) binomial proportional estimate using prespecified end point 21% 7% 26%) Kaplan-Meier post hoc analysis methods consistent Three-year were 68% 55% 79%) for progression-free survival 83% 71% 91%) overall survival. Grade 4 toxicity occurred 32%, 5% had treatment-associated deaths. Conclusion Although addition lower than data alone, substantial, still occurs approximately 20%, indicating continued need more effective less toxic therapies.