Author:
Rades Dirk,Bartscht Tobias,Hunold Peter,Schmidberger Heinz,König Laila,Debus Jürgen,Belka Claus,Homann Nils,Spillner Patrick,Petersen Cordula,Kuhnt Thomas,Fietkau Rainer,Ridwelski Karsten,Karcher-Kilian Kerstin,Kranich Anne,Männikkö Sofia,Schild Steven E.,Maderer Annett,Moehler Markus
Abstract
Abstract
Purpose
To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer.
Methods
This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H0), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H0 was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated early after 74 patients; 68 patients were evaluable.
Results
Two-year OS was 71% in arm A (95% CI: 55–87%) vs. 53% in arm B (95% CI: 36–71%); H0 was rejected. Median OS was 49.1 vs. 24.1 months (p = 0.147). Hazard ratio (HR) for death was 0.60 (95% CI: 0.30–1.21). At 2 years, PFS was 56% vs. 44%, LC 84% vs. 72%, and MFS 74% vs. 54%. HRs were 0.51 (0.25–1.04) for progression, 0.43 (0.13–1.40) for locoregional failure, and 0.43 (0.17–1.05) for distant metastasis. Overall response was 81% vs. 69% (p = 0.262). Twenty-six and 27 patients, respectively, experienced at least one toxicity grade ≥3 (p = 0.573). A significant difference was found for grade ≥3 allergic reactions (12.5% vs. 0%, p = 0.044).
Conclusion
Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.
Funder
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Publisher
Springer Science and Business Media LLC
Subject
Oncology,Radiology Nuclear Medicine and imaging
Cited by
10 articles.
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