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]
Does the addition of cetuximab to radiochemotherapy improve outcome of patients with locally advanced rectal cancer?
: long-term results from phase II trials
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Media type:
E-Article
Title:
Does the addition of cetuximab to radiochemotherapy improve outcome of patients with locally advanced rectal cancer?
:
long-term results from phase II trials
Description:
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.