• T Ruhstaller, P Thuss-Patience, S Hayoz, S Schacher, J R Knorrenschild, A Schnider, L Plasswilm, W Budach, W Eisterer, H Hawle, C Mariette, V Hess, W Mingrone, M Montemurro, M Girschikofsky, S C Schmidt, M Bitzer, L Bedenne, P Brauchli, M Stahl, Swiss Group for Clinical Cancer Research (SAKK), German Esophageal Cancer Study Group, Austrian ‘Arbeitsgemeinschaft Medikamentöse Tumortherapie’ (AGMT), and Fédération Francophone de Cancérologie Digestive (FFCD)/Fédération de Recherche en Chirurgie (FRENCH).
• Cantonal Hospital of St. Gallen, St. Gallen, Switzerland. Electronic address: thomas.ruhstaller@kssg.ch.
• Ann. Oncol. 2018 Jun 1; 29 (6): 1386-1393.

BackgroundThis open-label, phase III trial compared chemoradiation followed by surgery with or without neoadjuvant and adjuvant cetuximab in patients with resectable esophageal carcinoma.Patients And MethodsPatients were randomly assigned (1 : 1) to two cycles of chemotherapy (docetaxel 75 mg/m2, cisplatin 75 mg/m2) followed by chemoradiation (45 Gy, docetaxel 20 mg/m2 and cisplatin 25 mg/m2, weekly for 5 weeks) and surgery, with or without neoadjuvant cetuximab 250 mg/m2 weekly and adjuvant cetuximab 500 mg/m2 fortnightly for 3 months. The primary end point was progression-free survival (PFS).ResultsIn total, 300 patients (median age, 61 years; 88% male; 63% adenocarcinoma; 85% cT3/4a, 90% cN+) were assigned to cetuximab (n = 149) or control (n = 151). The R0-resection rate was 95% for cetuximab versus 97% for control. Postoperative treatment-related mortality was 6% in both arms. Median PFS was 2.9 years [95% confidence interval (CI), 2.0 to not reached] with cetuximab and 2.0 years (95% CI, 1.5-2.8) with control [hazard ratio (HR), 0.79; 95% CI, 0.58-1.07; P = 0.13]. Median overall survival (OS) time was 5.1 years (95% CI, 3.7 to not reached) versus 3.0 years (95% CI, 2.2-4.2) for cetuximab and control, respectively (HR, 0.73; 95% CI, 0.52-1.01; P = 0.055). Time to loco-regional failure after R0-resection was significantly longer for cetuximab (HR 0.53; 95% CI, 0.31-0.90; P = 0.017); time to distant failure did not differ between arms (HR, 1.01; 95% CI, 0.64-1.59, P = 0.97). Cetuximab did not increase adverse events in neoadjuvant or postoperative settings.ConclusionAdding cetuximab to multimodal therapy significantly improved loco-regional control, and led to clinically relevant, but not-significant improvements in PFS and OS in resectable esophageal carcinoma.Clinical Trial InformationNCT01107639.

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