Purpos.: Although controvers.al, as.es.ment of epidermal growth factor receptor (EGFR) expres.ion is.required for the approved indications.of Cetuximab in metas.atic colorectal cancer (mCRC). With the objective of imp...
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Purpos.: Although controvers.al, as.es.ment of epidermal growth factor receptor (EGFR) expres.ion is.required for the approved indications.of Cetuximab in metas.atic colorectal cancer (mCRC). With the objective of improving patient s.lection, “ERBITUX-OUEs.” s.udy aimed at analyzing EGFR s.atus.in a large cohort of mCRC patients.who received cetuximab without preliminary EGFR s.reening, and as.es.ing the correlation between EGFR s.atus.and res.ons. to treatment retros.ectively. Patients.and methods. 332 patients.treated with Irinotecan Cetuximab bas.d regimen after progres.ion on irinotecan or oxaliplatin therapy were included. EGFR s.atus.was.as.es.ed us.ng three available immunohis.ochemis.ry (IHC) tes.s.and in s.tu hybridization in cas. of negativity. Clinical outcomes.of EGFR-pos.tive and EGFR-non-detected (or cons.dered as.negative with at leas. one tes.) patients.were compared. Res.lts. Of the 332 s.mples.centrally s.reened, 194 were clas.ified as.full-pos.tive (i.e., EGFR-pos.tive for all three tes.s., 86 as.full-negative, and 52 as.dis.ordant. One third of the 131 negative s.mples.with FDA approved tes. s.ould be reclas.ified as.pos.tive with at leas. one of the two others.tes.s. Regarding res.lts.from FDA approved tes. only, neither objective res.ons. rate (ORR), progres.ion-free s.rvival (PFs. nor overall s.rvival (Os. differed s.gnificantly between EGFR-negative and EGFR-pos.tive patients.(P = 0.788, 0.326 and 0.888, res.ectively). s.milarly, comparis.n of full-negative to other groups.did not s.ow any s.gnificant difference in terms.of ORR (P = 0.507), PFs.(P = 0.222) or Os.(P = 0.686). Conclus.on: Thes. data s.rongly argue agains. mCRC patients.s.lection for Cetuximab treatment bas.d on EGFR expres.ion as.meas.red by currently available IHC technics.
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