Novel Approach for Clinical Validation of the cobas KRAS Mutation Test in Advanced Colorectal Cancer

Molecular Diagnosis and Therapy

Volumn 20, Issue 3, 2016, Pages 231-240

  Sharma, Abha ^a   Zhang, Guili ^a   Aslam, Shagufta ^a   Yu, Karen ^a   Chee, Melody ^a   Palma, John F ^a  

^a ROCHE MOLECULAR SYSTEMS   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; K RAS PROTEIN; OXALIPLATIN; PANITUMUMAB; ANTINEOPLASTIC AGENT; DIAGNOSTIC KIT; PROTEIN KINASE INHIBITOR; RAS PROTEIN;

ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER SURVIVAL; COBAS MUTATION TEST; CODON; COHORT ANALYSIS; DRUG EFFICACY; EXON; FEMALE; GENE MUTATION; GENETIC SCREENING; HUMAN; HUMAN TISSUE; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; METASTATIC COLORECTAL CANCER; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL (TOPIC); POLYMERASE CHAIN REACTION; POLYMERASE CHAIN REACTION SYSTEM; PREDICTIVE VALUE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT RESPONSE; CANCER STAGING; COLORECTAL NEOPLASMS; DIAGNOSTIC KIT; DNA MUTATIONAL ANALYSIS; DNA SEQUENCE; GENETICS; MIDDLE AGED; MORTALITY; MUTATION; PROCEDURES; REPRODUCIBILITY; SENSITIVITY AND SPECIFICITY; TREATMENT OUTCOME; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; COLORECTAL NEOPLASMS; DNA MUTATIONAL ANALYSIS; FEMALE; HUMANS; MALE; MIDDLE AGED; MUTATION; NEOPLASM STAGING; PROTEIN KINASE INHIBITORS; RAS PROTEINS; REAGENT KITS, DIAGNOSTIC; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SEQUENCE ANALYSIS, DNA; TREATMENT OUTCOME;

EID: 84961211364     PISSN: 11771062     EISSN: 11792000     Source Type: Journal    
DOI: 10.1007/s40291-016-0193-4     Document Type: Article

References (26)

1. Jonker DJ, O’Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ, et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med. 2007;357:2040–8.
2. Karapetis CS, Khambata-Ford S, Jonker DJ, O’Callaghan CJ, Tu D, Tebbutt NC, et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008;359:1757–65.
3. Harbison CT, Horak CE, Ledeine JM, Mukhopadhyay P, Malone DP, O’Callaghan C, et al. Validation of companion diagnostic for detection of mutations in codons 12 and 13 of the KRAS gene in patients with metastatic colorectal cancer: analysis of the NCIC CTG CO.17 trial. Arch Pathol Lab Med. 2013;137:820–7.
4. Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360:1408–17.
5. Peeters M, Douillard JY, Van Cutsem E, Siena S, Zhang K, Williams R, et al. Mutant KRAS codon 12 and 13 alleles in patients with metastatic colorectal cancer: assessment as prognostic and predictive biomarkers of response to panitumumab. J Clin Oncol. 2013;31:759–65.
6. Pentheroudakis G, Kotoula V, De Roock W, Kouvatseas G, Papakostas P, Makatsoris T, et al. Biomarkers of benefit from cetuximab-based therapy in metastatic colorectal cancer: interaction of EGFR ligand expression with RAS/RAF, PIK3CA genotypes. BMC Cancer. 2013;13:49.
7. Douillard JY, Siena S, Cassidy J, Tabernero J, Burkes R, Barugel M, et al. Randomized, phase III trial of panitumumab with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX4) versus FOLFOX4 alone as first-line treatment in patients with previously untreated metastatic colorectal cancer: the PRIME study. J Clin Oncol. 2010;28:4697–705.
8. Peeters M, Oliner KS, Parker A, Siena S, Van Cutsem E, Huang J, et al. Massively parallel tumor multigene sequencing to evaluate response to panitumumab in a randomized phase III study of metastatic colorectal cancer. Clin Cancer Res. 2013;19:1902–12.
9. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F, et al. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol. 2009;27:663–71.
10. Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26:1626–34.
11. De Roock W, Claes B, Bernasconi D, De Schutter J, Biesmans B, Fountzilas G, et al. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol. 2010;11:753–62.
12. Sorich MJ, Wiese MD, Rowland A, Kichenadasse G, McKinnon RA, Karapetis CS. Extended RAS mutations and anti-EGFR monoclonal antibody survival benefit in metastatic colorectal cancer: a meta-analysis of randomized, controlled trials. Ann Oncol. 2015;26:13–21.
13. Douillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, et al. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013;369:1023–34.
14. National Comprehensive Cancer Network. Colon cancer. Clinical practice guidelines in oncology, version 3.2015.
15. Allegra CJ, Jessup JM, Somerfield MR, Hamilton SR, Hammond EH, Hayes DF, et al. American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. J Clin Oncol. 2009;27:2091–6.
16. Van Cutsem E, Cervantes A, Nordlinger B, Arnold D; ESMO Guidelines Working Group. Metastatic colorectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2014;25(Suppl 3):iii1–9.
17. van Krieken JH, Jung A, Kirchner T, Carneiro F, Seruca R, Bosman FT, et al. KRAS mutation testing for predicting response to anti-EGFR therapy for colorectal carcinoma: proposal for an European quality assurance program. Virchows Arch. 2008;453:417–31.
18. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. J Clin Oncol. 2011;29:1465–71.
19. Denne JS, Pennello G, Zhao L, Chang SC, Althouse S. Identifying a subpopulation for a tailored therapy: bridging clinical efficacy from a laboratory-developed assay to a validated diagnostic test kit. Stat Biopharm Res. 2014;6:78–88.
20. Lee S, Brophy VH, Cao J, Velez M, Hoeppner C, Soviero S, et al. Analytical performance of a PCR assay for the detection of KRAS mutations (codons 12/13 and 61) in formalin-fixed paraffin-embedded tissue samples of colorectal carcinoma. Virchows Arch. 2012;460:141–9.
21. Harlé A, Busser B, Rouyer M, Harter V, Genin P, Leroux A, et al. Comparison of COBAS 4800 KRAS, TaqMan PCR and high resolution melting PCR assays for the detection of KRAS somatic mutations in formalin-fixed paraffin embedded colorectal carcinomas. Virchows Arch. 2013;462:329–35.
22. Gonzalez de Castro D, Angulo B, Gomez B, Mair D, Martinez R, Suarez-Gauthier A, et al. A comparison of three methods for detecting KRAS mutations in formalin-fixed colorectal cancer specimens. Br J Cancer. 2012;107:345–51.
23. Dudley J, Tseng LH, Rooper L, Harris M, Haley L, Chen G, et al. Challenges posed to pathologists in the detection of KRAS mutations in colorectal cancers. Arch Pathol Lab Med. 2015;139:211–8.
24. Roth AD, Tejpar S, Delorenzi M, Yan P, Fiocca R, Klingbiel D, et al. Prognostic role of KRAS and BRAF in stage II and III resected colon cancer: results of the translational study on the PETACC-3, EORTC 40993, SAKK 60-00 trial. J Clin Oncol. 2010;28:466–74.
25. Brink M, de Goeij AF, Weijenberg MP, Roemen GM, Lentjes MH, Pachen MM, et al. K-ras oncogene mutations in sporadic colorectal cancer in The Netherlands Cohort Study. Carcinogenesis. 2003;24:703–10.
26. Soulieres D, Greer W, Magliocco AM, Huntsman D, Young S, Tsao MS, et al. KRAS mutation testing in the treatment of metastatic colorectal cancer with anti-EGFR therapies. Curr Oncol. 2010;17(Suppl 1):S31–40.