Radiochemotherapy with or without cetuximab for unresectable esophageal cancer
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Radiochemotherapy with or without cetuximab for unresectable esophageal cancer : final results of a randomized phase 2 trial (LEOPARD-2). / 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.
in: STRAHLENTHER ONKOL, Jahrgang 196, Nr. 9, 09.2020, S. 795-804.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Radiochemotherapy with or without cetuximab for unresectable esophageal cancer
T2 - final results of a randomized phase 2 trial (LEOPARD-2)
AU - Rades, Dirk
AU - Bartscht, Tobias
AU - Hunold, Peter
AU - Schmidberger, Heinz
AU - König, Laila
AU - Debus, Jürgen
AU - Belka, Claus
AU - Homann, Nils
AU - Spillner, Patrick
AU - Petersen, Cordula
AU - Kuhnt, Thomas
AU - Fietkau, Rainer
AU - Ridwelski, Karsten
AU - Karcher-Kilian, Kerstin
AU - Kranich, Anne
AU - Männikkö, Sofia
AU - Schild, Steven E
AU - Maderer, Annett
AU - Moehler, Markus
PY - 2020/9
Y1 - 2020/9
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Agents, Immunological/adverse effects
KW - Cetuximab/adverse effects
KW - Chemoradiotherapy/adverse effects
KW - Disease-Free Survival
KW - Esophageal Neoplasms/therapy
KW - Female
KW - Humans
KW - Male
KW - Middle Aged
KW - Progression-Free Survival
U2 - 10.1007/s00066-020-01646-4
DO - 10.1007/s00066-020-01646-4
M3 - SCORING: Journal article
C2 - 32533228
VL - 196
SP - 795
EP - 804
JO - STRAHLENTHER ONKOL
JF - STRAHLENTHER ONKOL
SN - 0179-7158
IS - 9
ER -