Journal article
Neoadjuvant chemotherapy followed by chemoradiation and surgery with and without cetuximab in patients with resectable esophageal cancer: a randomized, open-label, phase III trial (SAKK 75/08).
- Ruhstaller T Cantonal Hospital of St. Gallen, St. Gallen, Switzerland. Electronic address: thomas.ruhstaller@kssg.ch.
- Thuss-Patience P Charité - University Medicine, Berlin, Germany.
- Hayoz S SAKK Coordinating Center, Berne, Switzerland.
- Schacher S Cantonal Hospital of Winterthur, Winterthur, Switzerland.
- Knorrenschild JR University Hospital of Giessen and Marburg, Germany.
- Schnider A City Hospital Triemli, Zürich, Switzerland.
- Plasswilm L Cantonal Hospital of St. Gallen, St. Gallen, Switzerland; University of Berne, Berne, Switzerland.
- Budach W University Hospital Düsseldorf, Düsseldorf, Germany.
- Eisterer W Medical University of Innsbruck, Innsbruck, Austria.
- Hawle H SAKK Coordinating Center, Berne, Switzerland.
- Mariette C Hôpital Universitaire C. Huriez, Lille, France.
- Hess V University Hospital of Basel, Basel, Switzerland.
- Mingrone W Cantonal Hospital of Olten, Olten, Switzerland.
- Montemurro M University Hospital of Lausanne, Lausanne, Switzerland.
- Girschikofsky M Ordensklinikum Linz Elisabethinen, Linz, Austria.
- Schmidt SC Charité - University Medicine, Berlin, Germany.
- Bitzer M University Hospital of Tübingen, Tübingen, Germany.
- Bedenne L Hospital Center Regional University of Dijon, Dijon, France.
- Brauchli P SAKK Coordinating Center, Berne, Switzerland.
- Stahl M Kliniken Essen-Mitte, Essen, Germany.
- 2018-04-11
Published in:
- Annals of oncology : official journal of the European Society for Medical Oncology. - 2018
Adenocarcinoma
Aged
Antineoplastic Combined Chemotherapy Protocols
Carcinoma, Squamous Cell
Cetuximab
Chemoradiotherapy
Cisplatin
Combined Modality Therapy
Docetaxel
Esophageal Neoplasms
Esophagectomy
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neoadjuvant Therapy
Prognosis
Prospective Studies
Survival Rate
English
Background
This 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 methods
Patients 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).
Results
In 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.
Conclusion
Adding 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 information
NCT01107639.
This 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 methods
Patients 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).
Results
In 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.
Conclusion
Adding 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 information
NCT01107639.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1093/annonc/mdy105
- PMID 29635438
- Persistent URL
- https://folia.unifr.ch/global/documents/241838
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