Updated guidelines for biomarker testing in colorectal carcinoma: a national consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology

Abstract

Publication of this consensus statement is a joint initiative of the Spanish Society of Pathology (SEAP) and the Spanish Society of Medical Oncology (SEOM), intended to revise and update the diagnostic and treatment recommendations published 2 years ago on biomarker use and the management of patients with colorectal carcinoma (CRC), thereby providing an opportunity to improve healthcare efficiency and resource use in these patients. This expert group recommends testing for KRAS and NRAS status in all patients with metastatic CRC being considered for anti-epidermal growth factor receptor (anti-EGFR) therapy, as this type of treatment should only be used in patients not harbouring mutations in these genes. In contrast, testing for BRAF, EGFR, PI3K and PTEN mutation status is not necessary for therapeutic decision making, so does not need to be done routinely.

Overexpression of microRNA‐98 inhibits cell proliferation and promotes cell apoptosis via claudin‐1 in human colorectal carcinoma

“…17 More recently, accumulating investigations into miRs and genes have been conducted, which has drawn increasing attention due to their positive involvements in the progression of human CRC 1,18,19 ; however lack of knowledge still persists focusing on distinct delineation for the combination of miR-98 and CLDN1 in CRC. 17 More recently, accumulating investigations into miRs and genes have been conducted, which has drawn increasing attention due to their positive involvements in the progression of human CRC 1,18,19 ; however lack of knowledge still persists focusing on distinct delineation for the combination of miR-98 and CLDN1 in CRC.…”

Validation of New Cancer Biomarkers: A Position Statement from the European Group on Tumor Markers

“…Furthermore, for difficult or manual assays, consensus-based guidelines detailing preanalytical, analytical, and reporting issues should be published. Exemplary guidelines are currently available for measuring established biomarkers such as estrogen receptors, progesterone receptors, and human epidermal growth factor receptor 2 (HER2) protein in breast cancer (12,13 ), for epidermal growth factor receptor (EGFR) 10 mutations and anaplastic lymphoma receptor tyrosine kinase (ALK) translocations in nonsmall cell lung cancer (14 ), and for KRAS mutation testing in colorectal cancer (15 ). In addition to these guidelines for measuring specific biomarkers, general guidelines, including analyte stability and laboratory QC, for performing analysis of tissue-based molecular biomarkers, have been published by Cree et al (16 ).…”

Cost-Effectiveness of RAS Genetic Testing Strategies in Patients With Metastatic Colorectal Cancer: A Systematic Review

“…International guidelines 5,10,11,30 recommend that RAS screening should include KRAS and NRAS analysis as predictors of response to anti-EGFR antibodies, but none of the economic evaluations included in this review took NRAS mutation status into consideration. In the study by Saito et al, 24 KRAS testing correctly guided the first-line treatment regimen with panitumumab, but the comprehensive screening strategy included not recommended genes as predictors of anti-EGFR response (ie, PTEN, ERBB2, SRC, BRAF, and RNF43).…”

“…In the study by Saito et al, 24 KRAS testing correctly guided the first-line treatment regimen with panitumumab, but the comprehensive screening strategy included not recommended genes as predictors of anti-EGFR response (ie, PTEN, ERBB2, SRC, BRAF, and RNF43). 5,10,11,30 Furthermore, Behl et al 25 and Blank et al 27 used BRAF genetic testing to guide the therapy of mCRC patients with cetuximab, which is not recommended because the BRAF test is a prognostic marker and thus cannot predict the response to anti-EGFR antibodies. 5,10,11,30 Anti-EGFR therapy as the first-line treatment of RAS wild-type mCRC patients is recommended unless contraindicated (by, for example, reduced organ function or cardiovascular insufficiency).…”