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).

Details

Serval ID
serval:BIB_187C909027A6
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
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).
Journal
Annals of oncology
Author(s)
Ruhstaller T., Thuss-Patience P., Hayoz S., Schacher S., Knorrenschild J.R., Schnider A., Plasswilm L., Budach W., Eisterer W., Hawle H., Mariette C., Hess V., Mingrone W., Montemurro M., Girschikofsky M., Schmidt S.C., Bitzer M., Bedenne L., Brauchli P., Stahl M.
Working group(s)
Swiss Group for Clinical Cancer Research (SAKK), the German Esophageal Cancer Study Group, the Austrian ‘Arbeitsgemeinschaft Medikamentöse Tumortherapie' (AGMT), and the Fédération Francophone de Cancérologie Digestive (FFCD)/Fédération de Recherche en Ch
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Publication state
Published
Issued date
01/06/2018
Peer-reviewed
Oui
Volume
29
Number
6
Pages
1386-1393
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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 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).
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.
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.
NCT01107639.
Keywords
Adenocarcinoma/pathology, Adenocarcinoma/therapy, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Squamous Cell/pathology, Carcinoma, Squamous Cell/therapy, Cetuximab/administration & dosage, Chemoradiotherapy/mortality, Cisplatin/administration & dosage, Combined Modality Therapy, Docetaxel/administration & dosage, Esophageal Neoplasms/pathology, Esophageal Neoplasms/therapy, Esophagectomy/mortality, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoadjuvant Therapy/mortality, Prognosis, Prospective Studies, Survival Rate
Pubmed
Web of science
Open Access
Yes
Create date
14/04/2018 9:11
Last modification date
16/11/2019 6:16
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