Lab Med Online.  2015 Jan;5(1):44-54. 10.3343/lmo.2015.5.1.44.

Translation: Companion Biomarkers: Paving the Pathway to Personalized Treatment for Cancer

Affiliations
  • 1UCD School of Medicine and Medical Science, Conway Institute, University College of Dublin, Ireland.
  • 2Clinical Research Centre, St Vincent's University Hospital, Dublin, Ireland.
  • 3Department of Medical Oncology, St Vincent's University Hospital, Dublin, Ireland.

Abstract

BACKGROUND
Companion biomarkers are biomarkers that are used in combination with specific therapies and that prospectively help predict likely response or severe toxicity. In this article we review the role of companion biomarkers in guiding treatment in patients with cancer. CONTENT: In addition to the established companion biomarkers such as estrogen receptors and HER 2 (human epidermal growth factor receptor 2) in breast cancer, several new companion biomarkers have become available in recent years. These include v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutations for the selection of patients with advanced colorectal cancer who are unlikely to benefit from anti-epidermal growth factor receptor antibodies (cetuximab or panitumumab), epidermal growth factor receptor (EGFR) mutations for selecting patients with advanced non-small cell lung cancer (NSCLC) for treatment with tyrosine kinase inhibitors (gefitinib or erlotinib), v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutations for selecting patients with advanced melanoma for treatment with anti-BRAF agents (vemurafenib and dabrafenib), and anaplastic lymphoma receptor tyrosine kinase (ALK) translocations for identifying patients with NSCLC likely to benefit from crizotinib. Summary: The availability of companion biomarkers should improve drug efficacy, decrease toxicity, and lead to a more individualized approach to cancer treatment. SUMMARY: The availability of companion biomarkers should improve drug efficacy, decrease toxicity, and lead to a more individualized approach to cancer treatment.


MeSH Terms

Animals
Antibodies
Biomarkers*
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Friends*
Humans
Lymphoma
Melanoma
Oncogenes
Protein-Tyrosine Kinases
Rats
Receptor, Epidermal Growth Factor
Receptors, Estrogen
Sarcoma
Antibodies
Protein-Tyrosine Kinases
Receptor, Epidermal Growth Factor
Receptors, Estrogen

Reference

References

1. Khleif SN, Doroshow JH, Hait WN. AACR-FDA-NCI Cancer Biomarkers Collaborative consensus report: advancing the use of biomarkers in cancer drug development. Clin Cancer Res. 2010; 16:3299–318.
2. Jensen EV, Block GE, Smith S, Kyser K, DeSombre ER. Estrogen receptors and breast cancer response to adrenalectomy. Natl Cancer Inst Monogr. 1971; 34:55–70.
3. McGuire WL, Carbone PP, Sears ME, Escher GC. Estrogen receptors in human breast cancer: an overview. McGuire WL, Carbone PP, editors. Estrogen receptors in human breast cancer. New York: Raven Press;2006. p. 1–8.
4. Early Breast Cancer Trialists'Collaborative Group (EBCTCG). Davies C, Godwin J, Gray R, Clarke M, Cutter D, Darby S, et al. Relevance of breast cancer hormone receptors and other factors to the efficacy of adjuvant tamoxifen: patient-level metaanalysis of randomised trials. Lancet. 2011; 378(9793):771–84.
5. Chia SK and Wolff AC. With maturity comes confidence: EBCTCG tamoxifen update. Lancet. 2011; 378:747–9.
6. Tung N. What is the optimal endocrine therapy for postmenopausal women with hormone receptor-positive early breast cancer? J Clin Oncol. 2013; 31:1391–7.
Article
7. Burstein HJ, Prestrud AA, Seidenfeld J, Anderson H, Buchholz TA, Davidson NE, et al. American Society of Clinical Oncology clinical practice guideline: update on adjuvant endocrine therapy for women with hormone receptor-positive breast cancer. J Clin Oncol. 2010; 28:3784–96.
Article
8. Goldhirsch A, Wood WC, Coates AS, Gelber RD, Thurlimann B, Senn HJ. Strategies for subtypes dealing with the diversity of breast cancer: highlights of the St. Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011. Ann Oncol. 2011; 22:1736–47.
9. Aebi S, Davidson T, Gruber G, Cardoso F. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and followup. Ann Oncol. 2011; 22(Suppl 6):vi12–24.
Article
10. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology, Colon Cancer, Version 3. 2012. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. (Accessed 6 November 2012).
11. Sturgeon CM, Duffy MJ, Stenman UH, Lilja H, Brunner N, Chan DW, et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin Chem. 2008; 54:e11–79.
Article
12. Hammond MEH, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, et al. American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer [Review]. J Clin Oncol. 2010; 28:2784–95. Erratum in: J Clin Oncol 010;28: 3543.
13. Ross JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortob-agyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009; 14:320–68.
Article
14. Slamon D and Pegram M. Rationale for trastuzumab (Herceptin) in adjuvant breast cancer trials. Semin Oncol. 2001; 28:13–9.
15. Abramson V and Arteaga CL. New strategies in HER2-overexpressing breast cancer: many combinations of targeted drugs available. Clin Cancer Res. 2011; 17:952–8.
Article
16. Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001; 344:783–92.
Article
17. Maitland ML and Schilsky RL. Clinical trials in the era of personalized oncology. CA Cancer J Clin. 2011; 61:365–81.
18. Trusheim MR, Burgess B, Hu SX, Long T, Averbuch SD, Flynn AA, et al. Quantifying factors for the success of stratified medicine. Nat Rev Drug Discov. 2011; 10:817–33.
Article
19. Harris CA, Ward RL, Dobbins TA, Drew AK, Pearson S. The efficacy of HER2-targeted agents in metastatic breast cancer: a metaanalysis. Ann Oncol. 2011; 22:1308–17.
Article
20. Yin W, Jiang Y, Shen Z, Shao Z, Lu J. Trastuzumab in the adjuvant treatment of HER2-positive early breast cancer patients: a metaanalysis of published randomized controlled trials. PLoS One. 2011; 6:e21030.
Article
21. Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011; 29:4491–7.
Article
22. Geyer CE, Forster J, Lindquist D, Chan S, Romieu CG, Pienkowski T, et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med. 2006; 355:2733–43.
Article
23. Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010; 15:122–9.
Article
24. Finn RS, Press MF, Dering J, Arbushites M, Koehler M, Oliva C, et al. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. J Clin Oncol. 2009; 27:3908–15.
Article
25. Press MF, Finn RS, Cameron D, Di Leo A, Geyer CE, Villalobos IE, et al. HER-2 gene amplification, HER-2 and epidermal growth factor receptor mRNA and protein expression, and lapatinib efficacy in women with metastatic breast cancer. Clin Cancer Res. 2008; 14:7861–70.
Article
26. Untch M, Loibl S, Bischoff J, Eidtmann H, Kaufmann M, Blohmer JU, et al. Lapatinib versus trastuzumab in combination with neoadjuvant anthracycline-taxane-based chemotherapy (GeparQuinto, GBG 44): a randomised phase 3 trial. Lancet Oncol. 2012; 13:135–44.
Article
27. Baselga J, Bradbury I, Eidtmann H, Di Cosimo S, de Azambuja E, Aura C, et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012; 379:633–40.
Article
28. Ahn ER and Vogel CL. Dual HER2-targeted approaches in HER2-positive breast cancer. Breast Cancer Res Treat. 2012; 131:371–83.
Article
29. Baselga J, Cortes J, Kim SB, Im SA, Hegg R, Im YH, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012; 366:109–19.
Article
30. Verma S, Miles D, Gianni L, Krop IE, Welslau M, Baselga J, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012; 367:1783–91.
Article
31. Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007; 25:118–45.
Article
32. Bardelli A and Siena S. Molecular mechanisms of resistance to cetuximab and panitumumab in colorectal cancer. J Clin Oncol. 2010; 28:1254–61.
33. Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005; 23:1803–10.
Article
34. Adelstein BA, Dobbins TA, Harris CA, Marschner IC, Ward RL. A systematic review and metaanalysis of KRAS status as the determinant of response to anti-EGFR antibodies and the impact of partner chemotherapy in metastatic colorectal cancer. Eur J Cancer. 2011; 47:1343–54.
Article
35. 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.
Article
36. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology; breast cancer, version 3. 2012. http://www.nccn.org/professionals/physician. gls/pdf/breast.pdf (Accessed November 2012).
37. European Group on Tumor Marker (EGTM). Guidelines on colorectal cancer. http://www.egtm.eu/recommendations.html. (Accessed January 2013).
38. De Roock W, Jonker DJ, Di Nicolantonio F, Sartore-Bianchi A, Tu D, Siena S, et al. Association of KRAS p.G13D mutation with outcome in patients with chemotherapy-refractory metastatic colorectal cancer treated with cetuximab. Jama. 2010; 304:1812–20.
Article
39. Shackelford RE, Whitling NA, McNab P, Japa S, Coppola D. KRAS Testing: A Tool for the Implementation of Personalized Medicine. Genes Cancer. 2012; 3:459–66.
Article
40. Soria JC, Mok TS, Cappuzzo F, Janne PA. EGFR-mutated oncogene-addicted non-small cell lung cancer: current trends and future prospects. Cancer Treat Rev. 2012; 38:416–30.
Article
41. Keedy VL, Temin S, Somerfield MR, Beasley MB, Johnson DH, McShane LM, et al. American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) Mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol. 2011; 29:2121–7.
Article
42. Ma C, Wei S, Song Y. T790M and acquired resistance of EGFR TKI: a literature review of clinical reports. J Thorac Dis. 2011; 3:10–8.
43. Ellison G, Zhu G, Moulis A, Dearden S, Speake G, McCormack R. EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumour tissue and cytology samples. J Clin Pathol. 2013; 66:79–89.
Article
44. Cantwell-Dorris ER, O'Leary JJ, Sheils OM. BRAFV600E: implications for carcinogenesis and molecular therapy. Mol Cancer Ther. 2011; 10:385–94.
Article
45. Flaherty KT, Puzanov I, Kim KB, Ribas A, McArthur GA, Sosman JA, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. 2010; 363:809–19.
Article
46. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011; 364:2507–16.
Article
47. Menzies AM, Haydu LE, Visintin L, Carlino MS, Howle JR, Thompson JF, et al. Distinguishing clinicopathologic features of patients with V600E and V600K BRAF-mutant metastatic melanoma. Clin Cancer Res. 2012; 18:3242–9.
Article
48. Hauschild A, Grob JJ, Demidov LV, Jouary T, Gutzmer R, Millward M, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2012; 380:358–65.
Article
49. Sasaki T and Janne PA. New strategies for treatment of ALK-rearranged non-small cell lung cancers. Clin Cancer Res. 2011; 17:7213–8.
Article
50. Camidge DR, Kono SA, Flacco A, Tan AC, Doebele RC, Zhou Q, et al. Optimizing the detection of lung cancer patients harboring anaplastic lymphoma kinase (ALK) gene rearrangements potentially suitable for ALK inhibitor treatment. Clin Cancer Res. 2010; 16:5581–90.
Article
51. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010; 363:1693–703.
52. Shaw AT, Yeap BY, Solomon BJ, Riely GJ, Gainor J, Engelman JA, et al. Effect of crizotinib on overall survival in patients with advanced nonsmall-cell lung cancer harbouring ALK gene rearrangement: a retrospective analysis. Lancet Oncol. 2011; 12:1004–12.
Article
53. Mano H. ALKoma: a cancer subtype with a shared target. Cancer Discov. 2012; 2:495–502.
Article
54. Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gas-tro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010; 376:687–97.
Article
55. Blay JY, von Mehren M, Blackstein ME. Perspective on updated treatment guidelines for patients with gastrointestinal stromal tumors. Cancer. 2010; 116:5126–37.
Article
56. Reichardt P, Blay JY, Mehren Mv. Towards global consensus in the treatment of gastrointestinal stromal tumor. Expert Rev Anticancer Ther. 2010; 10:221–32.
57. Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, et al. Inhibition of poly (ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009; 361:123–34.
58. Tutt A, Robson M, Garber JE, Domchek SM, Audeh MW, Weitzel JN, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet. 2010; 376:235–44.
59. Schilsky RL, Doroshow JH, Leblanc M, Conley BA. Development and use of integral assays in clinical trials. Clin Cancer Res. 2012; 18:1540–6.
Article
60. Williams PM, Lively TG, Jessup JM, Conley BA. Bridging the gap: moving predictive and prognostic assays from research to clinical use. Clin Cancer Res. 2012; 18:1531–9.
Article
61. Sharma SV, Haber DA, Settleman J. Cell line-based platforms to evaluate the therapeutic efficacy of candidate anticancer agents. Nat Rev Cancer. 2010; 10:241–53.
Article
62. Colburn WA. Biomarkers in drug discovery and development: from target identification through drug marketing. J Clin Pharmacol. 2003; 43:329–41.
Article
63. Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI. A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment. J Natl Cancer Inst. 2009; 101:1453–63.
Article
64. Yap TA, Sandhu SK, Workman P, de Bono JS. Envisioning the future of early anticancer drug development. Nat Rev Cancer. 2010; 10:514–23.
Article
65. Garcia VM, Cassier PA, de Bono J. Parallel anticancer drug development and molecular stratification to qualify predictive biomarkers: dealing with obstacles hindering progress. Cancer Discov. 2011; 1:207–12.
Article
66. Sargent DJ, Conley BA, Allegra C, Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol. 2005; 23:2020–7.
Article
67. Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst. 2010; 102:152–60.
Article
68. Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012; 13:239–46.
69. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst. 2009; 101:1446–52.
Article
70. Paik S, Kim C, Wolmark N. HER2 status and benefit from adjuvant trastuzumab in breast cancer. N Engl J Med. 2008; 358:1409–11.
71. Perez EA, Suman VJ, Davidson NE, Gralow JR, Kaufman PA, Visscher DW, et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J Clin Oncol. 2011; 29:4491–7.
Article
72. Cummings J, Raynaud F, Jones L, Sugar R, Dive C. Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs. Br J Cancer. 2010; 103:1313–7.
Article
73. Sturgeon C, Hill R, Hortin GL, Thompson D. Taking a new biomarker into routine use a perspective from the routine clinical biochemistry laboratory. Proteomics Clin Appl. 2010; 4:892–903.
74. MacConaill LE, Van Hummelen PV, Meyerson M, Hahn WC. Clinical implementation of comprehensive strategies to characterize cancer genomes: opportunities and challenges. Cancer Discov. 2011; 1:297–311.
Article
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