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Does the addition of cetuximab to radiochemotherapy improve outcome of patients with locally advanced rectal cancer?: long-term results from phase II trials

Purpose. The addition of cetuximab to radiochemotherapy (RCT) failed to improve complete response rates in locally advanced rectal cancer (LARC). We report the long-term results in patients treated within two sequential clinical trials. Methods. Patients receiving neoadjuvant RCT using capecitabine...

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Main Authors: Kripp, Melanie (Author) , Horisberger, Karoline (Author) , Mai, Sabine (Author) , Kienle, Peter (Author) , Gaiser, Timo (Author) , Post, Stefan (Author) , Wenz, Frederik (Author) , Merx, Kirsten (Author) , Hofheinz, Ralf-Dieter (Author)
Format: Article (Journal)
Language:English
Published: 2015
In: Gastroenterology research and practice

ISSN:1687-630X
DOI:10.1155/2015/273489
Online Access:Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1155/2015/273489
Verlag, kostenfrei, Volltext: https://www.hindawi.com/journals/grp/2015/273489/abs/
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Author Notes:M. Kripp, K. Horisberger, S. Mai, P. Kienle, T. Gaiser, S. Post, F. Wenz, K. Merx, R.-D. Hofheinz
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Summary:Purpose. The addition of cetuximab to radiochemotherapy (RCT) failed to improve complete response rates in locally advanced rectal cancer (LARC). We report the long-term results in patients treated within two sequential clinical trials. Methods. Patients receiving neoadjuvant RCT using capecitabine and irinotecan (CapIri) within a phase I/II trial or CapIri + cetuximab within a phase II trial were evaluated for analysis of disease-free survival (DFS) and overall survival (OS). KRAS exon 2 mutational status had been analyzed in patients receiving cetuximab. Results. 37 patients from the CapIri trial and 49 patients from the CapIri-cetuximab treatment group were evaluable. Median follow-up time was 75.2 months. The 5-year DFS rate was 82% (CapIri) and 79% (CapIri-cetuximab) . The median OS was 127.4 months. 5-year OS was 73% for both groups (CapIri and CapIri-cetuximab) . No significant difference in DFS or OS was noticed between patients receiving CapIri and those receiving CapIri-cetuximab with KRAS wild-type tumors. Conclusions. As the addition of cetuximab did not improve neither DFS nor OS it should not play a role in the perioperative treatment of patients with LARC, not even of patients with (K)RAS WT tumors.
Item Description:Gesehen am 31.05.2017
Physical Description:Online Resource
ISSN:1687-630X
DOI:10.1155/2015/273489

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