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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, Vol. 196, No. 9, 09.2020, p. 795-804.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Rades, D, Bartscht, T, Hunold, P, Schmidberger, H, König, L, Debus, J, Belka, C, Homann, N, Spillner, P, Petersen, C, Kuhnt, T, Fietkau, R, Ridwelski, K, Karcher-Kilian, K, Kranich, A, Männikkö, S, Schild, SE, Maderer, A & Moehler, M 2020, 'Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2)', STRAHLENTHER ONKOL, vol. 196, no. 9, pp. 795-804. https://doi.org/10.1007/s00066-020-01646-4

APA

Rades, D., Bartscht, T., Hunold, P., Schmidberger, H., König, L., Debus, J., Belka, C., Homann, N., Spillner, P., Petersen, C., Kuhnt, T., Fietkau, R., Ridwelski, K., Karcher-Kilian, K., Kranich, A., Männikkö, S., Schild, S. E., Maderer, A., & Moehler, M. (2020). Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2). STRAHLENTHER ONKOL, 196(9), 795-804. https://doi.org/10.1007/s00066-020-01646-4

Vancouver

Rades D, Bartscht T, Hunold P, Schmidberger H, König L, Debus J et al. Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2). STRAHLENTHER ONKOL. 2020 Sep;196(9):795-804. https://doi.org/10.1007/s00066-020-01646-4

Bibtex

@article{f10363a9f48d42af834ec82e39dcfd7b,
title = "Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2)",
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.",
keywords = "Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological/adverse effects, Cetuximab/adverse effects, Chemoradiotherapy/adverse effects, Disease-Free Survival, Esophageal Neoplasms/therapy, Female, Humans, Male, Middle Aged, Progression-Free Survival",
author = "Dirk Rades and Tobias Bartscht and Peter Hunold and Heinz Schmidberger and Laila K{\"o}nig and J{\"u}rgen Debus and Claus Belka and Nils Homann and Patrick Spillner and Cordula Petersen and Thomas Kuhnt and Rainer Fietkau and Karsten Ridwelski and Kerstin Karcher-Kilian and Anne Kranich and Sofia M{\"a}nnikk{\"o} and Schild, {Steven E} and Annett Maderer and Markus Moehler",
year = "2020",
month = sep,
doi = "10.1007/s00066-020-01646-4",
language = "English",
volume = "196",
pages = "795--804",
journal = "STRAHLENTHER ONKOL",
issn = "0179-7158",
publisher = "Urban und Vogel",
number = "9",

}

RIS

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 -