Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating

Michel M. van den Heuvel; Wilma Uyterlinde; Andrew D. Vincent; Jeroen de Jong; Joachim Aerts; Frederike Koppe; Joost Knegjens; Henk Codrington; Peter W. E. Kunst; Edith Dieleman; Marcel Verheij; José Belderbos

doi:https://doi.org/10.1016/j.radonc.2013.10.009

Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating

Michel M. van den Heuvel, Wilma Uyterlinde, Andrew D. Vincent, Jeroen de Jong, Joachim Aerts, Frederike Koppe, Joost Knegjens, Henk Codrington, Peter W. E. Kunst, Edith Dieleman, Marcel Verheij, José Belderbos

Research output: Contribution to journal › Article › Academic › peer-review

40 Citations (Scopus)

Abstract

Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well. Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity

Original language	English
Pages (from-to)	126-131
Journal	Radiotherapy and oncology
Volume	110
Issue number	1
DOIs	https://doi.org/10.1016/j.radonc.2013.10.009
Publication status	Published - 2014

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https://doi.org/10.1016/j.radonc.2013.10.009

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van den Heuvel, M. M., Uyterlinde, W., Vincent, A. D., de Jong, J., Aerts, J., Koppe, F., Knegjens, J., Codrington, H., Kunst, P. W. E., Dieleman, E., Verheij, M., & Belderbos, J. (2014). Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating. Radiotherapy and oncology, 110(1), 126-131. https://doi.org/10.1016/j.radonc.2013.10.009

@article{75c37673d8ef4535bcfea6d035d4cfe0,

title = "Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating",

abstract = "Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well. Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity",

author = "{van den Heuvel}, {Michel M.} and Wilma Uyterlinde and Vincent, {Andrew D.} and {de Jong}, Jeroen and Joachim Aerts and Frederike Koppe and Joost Knegjens and Henk Codrington and Kunst, {Peter W. E.} and Edith Dieleman and Marcel Verheij and Jos{\'e} Belderbos",

year = "2014",

doi = "https://doi.org/10.1016/j.radonc.2013.10.009",

language = "English",

volume = "110",

pages = "126--131",

journal = "Radiotherapy and oncology",

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van den Heuvel, MM, Uyterlinde, W, Vincent, AD, de Jong, J, Aerts, J, Koppe, F, Knegjens, J, Codrington, H, Kunst, PWE, Dieleman, E, Verheij, M & Belderbos, J 2014, 'Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating', Radiotherapy and oncology, vol. 110, no. 1, pp. 126-131. https://doi.org/10.1016/j.radonc.2013.10.009

Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating. / van den Heuvel, Michel M.; Uyterlinde, Wilma; Vincent, Andrew D. et al.
In: Radiotherapy and oncology, Vol. 110, No. 1, 2014, p. 126-131.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating

AU - van den Heuvel, Michel M.

AU - Uyterlinde, Wilma

AU - Vincent, Andrew D.

AU - de Jong, Jeroen

AU - Aerts, Joachim

AU - Koppe, Frederike

AU - Knegjens, Joost

AU - Codrington, Henk

AU - Kunst, Peter W. E.

AU - Dieleman, Edith

AU - Verheij, Marcel

AU - Belderbos, José

PY - 2014

Y1 - 2014

N2 - Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well. Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity

AB - Modest benefits from concurrent chemoradiotherapy in patients with locally advanced NSCLC warrant further clinical investigations to identify more effective treatment regimens. Cetuximab, a monoclonal antibody against the epidermal growth factor receptor has shown activity in NSCLC. We report on the safety and efficacy of the combination of daily dose Cisplatin and concurrent radiotherapy with or without weekly Cetuximab. Patients received high dose accelerated radiotherapy (66 Gy in 24 fractions) and concurrent daily Cisplatin (6 mg/m(2)) without (Arm A) or with (Arm B) weekly Cetuximab (400 mg/m(2) loading dose one week prior to radiotherapy followed by weekly 250 mg/m(2)). The primary endpoint of the trial was objective local control rate (OLCR) determined at 6-8 weeks after treatment. Toxicity was reported as well. Between February 2009 and May 2011, 102 patients were randomized. Median follow up was 29 months. The OLCR was 84% in Arm A and 92% in Arm B (p=0.36). The one-year local progression free interval (LPFI) and overall survival (OS) were 69% and 82% for Arm A and 73% and 71% for Arm B, respectively (LPFI p=0.39; OS p=0.99). Toxicity compared equally between both groups. The addition of Cetuximab to radiotherapy and concurrent Cisplatin did not improve disease control in patients with locally advanced NSCLC but increased treatment related toxicity

U2 - https://doi.org/10.1016/j.radonc.2013.10.009

DO - https://doi.org/10.1016/j.radonc.2013.10.009

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van den Heuvel MM, Uyterlinde W, Vincent AD, de Jong J, Aerts J, Koppe F et al. Additional weekly Cetuximab to concurrent chemoradiotherapy in locally advanced non-small cell lung carcinoma: efficacy and safety outcomes of a randomized, multi-center phase II study investigating. Radiotherapy and oncology. 2014;110(1):126-131. doi: https://doi.org/10.1016/j.radonc.2013.10.009