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10.1007/s40291-016-0193-4 http://scihub22266oqcxt.onion/10.1007/s40291-016-0193-4 C4879158!4879158 !26984642     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=26984642 &cmd=llinks): Failed to open stream: HTTP request failed! 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Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer |pdf=|usr=}}{{26984642 }} gab.com Text Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer JO: Mol Diagn Ther http://www.kidney.de/pget.php?&tw=1&pmid=26984642 #FOAvip AIM: Our objective was to assess the performance of the cobas test versus comparators for KRAS mutation status and predicting clinical response to anti-epidermal growth factor receptor (EGFR) therapy in patients with metastatic colorectal cancer (mCRC). METHODS: mCRC samples from 398 patients from Roche study NO16968 (XELOXA) and 82 supplemental samples were tested with the cobas(®) KRAS mutation test (cobas test), the therascreen(®) KRAS RGQ PCR kit test (therascreen test), and Sanger sequencing as the reference method for detecting mutations in codons 12/13. RESULTS: For 461 eligible samples, the cobas test, therascreen test, and sequencing had invalid results for 5.2, 10.8, and 2.6 % of specimens, respectively. Valid cobas and therascreen test results had similar KRAS mutation-positive rates (37.3 vs. 36.3 %, respectively); sequencing was 28.5 %. Positive and negative percent agreement (PPA/NPA) between the cobas test and sequencing was 96.9 % (95 % confidence interval [CI] 92.2-98.8), and 88.7 % (95 % CI 84.7-91.8), respectively. PPA/NPA between the cobas and therascreen tests was 93.3 % (95 % CI 88.1-96.3) and 96.5 % (95 % CI 93.5-98.1), respectively. Bridging analysis from NCIC-CO.17 and NCT00113763 using the cobas test yielded modeled hazard ratios for overall survival and progression-free survival (PFS) of 0.558 (95 % CI 0.422-0.752) and 0.413 (95 % CI 0.304-0.550), respectively, for cetuximab and 0.989 (95 % CI 0.778-1.299) and 0.471 (95 % CI 0.360-0.626), respectively, for panitumumab, demonstrating significant efficacy in the KRAS-negative population for PFS. CONCLUSION: The cobas test showed similar accuracy to the therascreen test for detecting KRAS mutations and could appropriately identify mCRC patients ineligible for anti-EGFR therapy as demonstrated by bridging analysis results. Twit Text FOAVip Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer ????Mol Diagn Ther http://www.kidney.de/pget.php?&tw=1&pmid=26984642 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=26984642 #FOAvip English Wikipedia <ref>{{Cite pmid|26984642 }}</ref> Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer #MMPMID26984642 Sharma A ; Zhang G ; Aslam S ; Yu K ; Chee M ; Palma JF Mol Diagn Ther 2016[Jun]; 20 (3 ): 231-40 PMID26984642 show ga AIM: Our objective was to assess the performance of the cobas test versus comparators for KRAS mutation status and predicting clinical response to anti-epidermal growth factor receptor (EGFR) therapy in patients with metastatic colorectal cancer (mCRC). METHODS: mCRC samples from 398 patients from Roche study NO16968 (XELOXA) and 82 supplemental samples were tested with the cobas(®) KRAS mutation test (cobas test), the therascreen(®) KRAS RGQ PCR kit test (therascreen test), and Sanger sequencing as the reference method for detecting mutations in codons 12/13. RESULTS: For 461 eligible samples, the cobas test, therascreen test, and sequencing had invalid results for 5.2, 10.8, and 2.6 % of specimens, respectively. Valid cobas and therascreen test results had similar KRAS mutation-positive rates (37.3 vs. 36.3 %, respectively); sequencing was 28.5 %. Positive and negative percent agreement (PPA/NPA) between the cobas test and sequencing was 96.9 % (95 % confidence interval [CI] 92.2-98.8), and 88.7 % (95 % CI 84.7-91.8), respectively. PPA/NPA between the cobas and therascreen tests was 93.3 % (95 % CI 88.1-96.3) and 96.5 % (95 % CI 93.5-98.1), respectively. Bridging analysis from NCIC-CO.17 and NCT00113763 using the cobas test yielded modeled hazard ratios for overall survival and progression-free survival (PFS) of 0.558 (95 % CI 0.422-0.752) and 0.413 (95 % CI 0.304-0.550), respectively, for cetuximab and 0.989 (95 % CI 0.778-1.299) and 0.471 (95 % CI 0.360-0.626), respectively, for panitumumab, demonstrating significant efficacy in the KRAS-negative population for PFS. CONCLUSION: The cobas test showed similar accuracy to the therascreen test for detecting KRAS mutations and could appropriately identify mCRC patients ineligible for anti-EGFR therapy as demonstrated by bridging analysis results. |*Mutation [MESH] |Adult [MESH] |Aged [MESH] |Aged, 80 and over [MESH] |Antineoplastic Agents/pharmacology/therapeutic use [MESH] |Colorectal Neoplasms/*diagnosis/drug therapy/*genetics/mortality [MESH] |DNA Mutational Analysis/methods [MESH] |Female [MESH] |Humans [MESH] |Male [MESH] |Middle Aged [MESH] |Neoplasm Staging [MESH] |Protein Kinase Inhibitors/pharmacology/therapeutic use [MESH] |Reagent Kits, Diagnostic [MESH] |Reproducibility of Results [MESH] |Sensitivity and Specificity [MESH] |Sequence Analysis, DNA [MESH] |Treatment Outcome [MESH]Novel Approach for Clinical Validation of the cobas KRAS Mutation Test(epmc).pdf DeepDyve Pubget Overpricing