PMID- 17987340 OWN - NLM STAT- MEDLINE DCOM- 20080313 LR - 20220408 IS - 1534-4681 (Electronic) IS - 1068-9265 (Linking) VI - 15 IP - 2 DP - 2008 Feb TI - Cetuximab shows activity in colorectal cancer patients with tumors for which FISH analysis does not detect an increase in EGFR gene copy number. PG - 649-54 AB - BACKGROUND: EGFR (epidermal growth factor receptor) gene gain assessed by FISH (fluorescence in situ hybridization) has been shown to be predictive of response to EGFR-targeted therapies in patients with non-small cell lung cancer. The aim or our study was to relate the EGFR gene copy number to therapeutic results in patients with metastatic colorectal cancer (CRC) treated with a cetuximab-containing regimen. METHODS: Forty-seven patients with metastatic CRC treated with a cetuximab-containing regimen between August 2004 and September 2006 were included in our study. EGFR status was assessed by immunohistochemistry (IHC) and by FISH on fixed paraffin-embedded sections of tumor specimens. RESULTS: By IHC (n = 47), 39 patients (83%) had EGFR-positive tumors. EGFR gene copy gain was detected in 8 (19.5%) of 41 tumors. Neither EGFR expression assessed by IHC nor EGFR gene copy gain assessed by FISH were statistically significantly correlated with objective response rate, disease control rate, progression-free survival, and overall survival. Of the 33 patients whose tumors were FISH negative, 8 patients (24.2%) had a partial response, and 10 (30.3%) had stable disease. CONCLUSIONS: EGFR FISH analysis does not seem to be a sufficiently robust test for selecting candidate CRC patients for cetuximab therapy. FAU - Italiano, Antoine AU - Italiano A AD - Department of Medical Oncology, Centre Antoine-Lacassagne, Canceropole PACA, Nice, France. antoine.italiano@unice.fr FAU - Follana, Philippe AU - Follana P FAU - Caroli, Francois-Xavier AU - Caroli FX FAU - Badetti, Jean-Luc AU - Badetti JL FAU - Benchimol, Daniel AU - Benchimol D FAU - Garnier, Georges AU - Garnier G FAU - Gugenheim, Jean AU - Gugenheim J FAU - Haudebourg, Juliette AU - Haudebourg J FAU - Keslair, Frederique AU - Keslair F FAU - Lesbats, Gerard AU - Lesbats G FAU - Lledo, Gerard AU - Lledo G FAU - Roussel, Jean-Francois AU - Roussel JF FAU - Pedeutour, Florence AU - Pedeutour F FAU - Francois, Eric AU - Francois E LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20071107 PL - United States TA - Ann Surg Oncol JT - Annals of surgical oncology JID - 9420840 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) RN - EC 2.7.10.1 (EGFR protein, human) RN - EC 2.7.10.1 (ErbB Receptors) RN - PQX0D8J21J (Cetuximab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal/administration & dosage/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Agents/administration & dosage/*therapeutic use MH - Cetuximab MH - Colorectal Neoplasms/*drug therapy/*genetics/mortality MH - Disease Progression MH - ErbB Receptors/*genetics/metabolism MH - Female MH - *Gene Dosage MH - Humans MH - *In Situ Hybridization, Fluorescence MH - Male MH - Middle Aged MH - Patient Selection MH - Treatment Outcome EDAT- 2007/11/08 09:00 MHDA- 2008/03/14 09:00 CRDT- 2007/11/08 09:00 PHST- 2007/08/11 00:00 [received] PHST- 2007/09/25 00:00 [accepted] PHST- 2007/09/21 00:00 [revised] PHST- 2007/11/08 09:00 [pubmed] PHST- 2008/03/14 09:00 [medline] PHST- 2007/11/08 09:00 [entrez] AID - 10.1245/s10434-007-9667-2 [doi] PST - ppublish SO - Ann Surg Oncol. 2008 Feb;15(2):649-54. doi: 10.1245/s10434-007-9667-2. Epub 2007 Nov 7.