机构地区：[1]Observatoire dédié au Cancer des régions Bretagne et Pays de la Loire, France [2]Centre Hospitalier Régional Universitaire (CHRU), Brest, France [3]Institut de Cancérologie de l’Ouest (ICO) Paul Papin, Angers, France [4]Centre Catherine de Sienne, Nantes, France [5]CRLCC Eugène Marquis, Rennes, France [6]ICO René Gauducheau, Nantes, France [7]Centre CARIO-HCPA, Plérin, France [8]Centre Hospitalier Bretagne Sud (CHBS), Lorient, France [9]Clinique Victor Hugo, Le Mans, France [10]Centre Hospitalier Départemental (CHD), La Roche-sur-Yon, France [11]CH, Le Mans, France [12]Clinique Mutualiste de l’Estuaire, Saint-Nazaire, France [13]CHIC Quimper, France [14]Clinique Pasteur Lanroze, Brest, France [15]CH, MORLAIX, France [16]CH, Saint-Brieuc, France [17]CHBA Vannes, France [18]CHP, Saint-Grégoire, France [19]CHU, Nantes, France [20]Hopital Privé Océane, Vannes, France [21]Clinique Saint-Michel et Sainte-Anne, Quimper, France [22]Pole Santé Sarthe et Loire, La Flèche, France [23]Polyclinique du Maine, Laval, France [24]Polyclinique Sud Quimper, France [25]CH Laval, France [26]Polyclinique Cesson Sévigné, France [27]Laboratoire d’anatomie et de cytologie pathologiques, Cholet, France [28]Cabinet d’anatomie et de cytologie pathologiques, Saint-Malo, France [29]Laboratoire d’anatomie et de cytologie pathologiques, Lorient, France [30]Institut d’histopathologie, Nantes, France [31]Laboratoire de Pathologie Médicale, Laval, France [32]ARMOR Pathologie, Plérin, France [33]Laboratoire d’anatomie et de cytologie pathologiques, Rennes, France [34]Laboratoire d’anatomie et de cytologie pathologiques, Angers, France [35]Laboratoire Analyses Biologie Glasgow, Brest, France [36]CHU Angers, France [37]Centre d’anatomie et de cytologie pathologiques, Le Mans, France [38]Cabinet d’anatomie et de cytologie pathologiques, Vannes, France [39]Laboratoire d’anatomie et de cytologie pathologiques, Quimper, France [40]CHU Rennes, France
出 处：《Open Journal of Internal Medicine》2016年第2期56-67,共13页内科学期刊（英文）
摘 要：Purpose: Although controversial, assessment of epidermal growth factor receptor (EGFR) expression is required for the approved indications of Cetuximab in metastatic colorectal cancer (mCRC). With the objective of improving patient selection, “ERBITUX-OUEST” study aimed at analyzing EGFR status in a large cohort of mCRC patients who received cetuximab without preliminary EGFR screening, and assessing the correlation between EGFR status and response to treatment retrospectively. Patients and methods: 332 patients treated with Irinotecan Cetuximab based regimen after progression on irinotecan or oxaliplatin therapy were included. EGFR status was assessed using three available immunohistochemistry (IHC) tests and in situ hybridization in case of negativity. Clinical outcomes of EGFR-positive and EGFR-non-detected (or considered as negative with at least one test) patients were compared. Results: Of the 332 samples centrally screened, 194 were classified as full-positive (i.e., EGFR-positive for all three tests), 86 as full-negative, and 52 as discordant. One third of the 131 negative samples with FDA approved test should be reclassified as positive with at least one of the two others tests. Regarding results from FDA approved test only, neither objective response rate (ORR), progression-free survival (PFS) nor overall survival (OS) differed significantly between EGFR-negative and EGFR-positive patients (P = 0.788, 0.326 and 0.888, respectively). Similarly, comparison of full-negative to other groups did not show any significant difference in terms of ORR (P = 0.507), PFS (P = 0.222) or OS (P = 0.686). Conclusion: These data strongly argue against mCRC patients selection for Cetuximab treatment based on EGFR expression as measured by currently available IHC technics.Purpose: Although controversial, assessment of epidermal growth factor receptor (EGFR) expression is required for the approved indications of Cetuximab in metastatic colorectal cancer (mCRC). With the objective of improving patient selection, “ERBITUX-OUEST” study aimed at analyzing EGFR status in a large cohort of mCRC patients who received cetuximab without preliminary EGFR screening, and assessing the correlation between EGFR status and response to treatment retrospectively. Patients and methods: 332 patients treated with Irinotecan Cetuximab based regimen after progression on irinotecan or oxaliplatin therapy were included. EGFR status was assessed using three available immunohistochemistry (IHC) tests and in situ hybridization in case of negativity. Clinical outcomes of EGFR-positive and EGFR-non-detected (or considered as negative with at least one test) patients were compared. Results: Of the 332 samples centrally screened, 194 were classified as full-positive (i.e., EGFR-positive for all three tests), 86 as full-negative, and 52 as discordant. One third of the 131 negative samples with FDA approved test should be reclassified as positive with at least one of the two others tests. Regarding results from FDA approved test only, neither objective response rate (ORR), progression-free survival (PFS) nor overall survival (OS) differed significantly between EGFR-negative and EGFR-positive patients (P = 0.788, 0.326 and 0.888, respectively). Similarly, comparison of full-negative to other groups did not show any significant difference in terms of ORR (P = 0.507), PFS (P = 0.222) or OS (P = 0.686). Conclusion: These data strongly argue against mCRC patients selection for Cetuximab treatment based on EGFR expression as measured by currently available IHC technics.
关 键 词：Metastatic Colorectal Cancer CETUXIMAB EGFR Expression
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