GUCY2C reverse transcriptase PCR to stage pN0 colorectal cancer patients

Expert Review of Molecular Diagnostics

Volumn 9, Issue 8, 2009, Pages 777-785

  Mejia, Alex ^a   Schulz, Stephanie ^a   Hyslop, Terry ^a   Weinberg, David S ^b   Waldman, Scott A ^a  

^a THOMAS JEFFERSON UNIVERSITY   (United States)

^b FOX CHASE CANCER CENTER   (United States)

Author keywords

Colorectal cancer; Guanylyl cyclase; GUCY2C; Lymph node; Metastatic disease; Predictive marker; Prognostic marker; Quantitative reverse transcriptase PCR; Staging

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; GUANYLYL CYCLASE C; MESSENGER RNA; PROTEIN; UNCLASSIFIED DRUG;

ADJUVANT CHEMOTHERAPY; CANCER CHEMOTHERAPY; CANCER DIAGNOSIS; CANCER PATIENT; CANCER RECURRENCE; CANCER RISK; CANCER STAGING; CANCER SURGERY; CLINICAL TRIAL; COLORECTAL CANCER; DIAGNOSTIC ACCURACY; DIAGNOSTIC PROCEDURE; DISEASE FREE SURVIVAL; HISTOPATHOLOGY; HUMAN; LYMPH NODE BIOPSY; LYMPH NODE METASTASIS; NONHUMAN; PROGNOSIS; PROTEIN EXPRESSION; RECURRENT CANCER; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; REVIEW; TUMOR CELL;

CHEMOTHERAPY, ADJUVANT; COLORECTAL NEOPLASMS; GUANYLATE CYCLASE; HUMANS; LYMPHATIC METASTASIS; NEOPLASM STAGING; PATHOLOGY, MOLECULAR; PROGNOSIS; PROSPECTIVE STUDIES; RECEPTORS, PEPTIDE; REPRODUCIBILITY OF RESULTS; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION; TUMOR MARKERS, BIOLOGICAL;

EID: 70449647026     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/erm.09.67     Document Type: Review

References (104)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J. Clin. 57, 43-66 (2007).
2. Compton CC, Greene FL. The staging of colorectal cancer. 2004 and beyond. CA Cancer J. Clin. 54, 295-308 (2004).
3. Greene FL. AJCC Cancer Staging Manual. (6th Edition). Springer, NY, USA (2002).
4. Iddings D, Ahmad A, Elashoff D, Bilchik A. The prognostic effect of micrometastases in previously staged lymph node negative (N0) colorectal carcinoma. a meta-analysis. Ann. Surg. Oncol. 13, 1386-1392 (2006).
5. Nicastri DG, Doucette JT, Godfrey TE, Hughes SJ. Is occult lymph node disease in colorectal cancer patients clinically significant? A review of the relevant literature. J. Mol. Diagn. 9, 563-571 (2007).
6. Meyerhardt JA, Mayer RJ. Systemic therapy for colorectal cancer. N. Engl. J. Med. 352, 476-487 (2005).
7. Ries LA, Wingo PA, Miller DS et al. The annual report to the nation on the status of cancer, 1973-1997, with a special section on colorectal cancer. Cancer 88, 2398-2424 (2000).
8. Sobrero A, Kerr D, B Glimelius et al. New directions in the treatment of colorectal cancer. a look to the future. Eur. J. Cancer 36, 559-566 (2000). (Pubitemid 30156840)
9. Wolpin BM, Meyerhardt JA, Mamon HJ, Mayer RJ. Adjuvant treatment of colorectal cancer. CA Cancer J. Clin. 57, 168-185 (2007).
10. Allee PE, Tepper JE, Gunderson LL, Munzenrider JE. Postoperative radiation therapy for incompletely resected colorectal carcinoma. Int. J. Radiat. Oncol. Biol. Phys. 17, 1171-1176 (1989).
11. Dukes CE, Bussey HJ. The spread of rectal cancer and its effect on prognosis. Br. J. Cancer 12, 309-320 (1958).
12. Galandiuk S, Wieand HS, Moertel CG et al. Patterns of recurrence after curative resection of carcinoma of the colon and rectum. Surg. Gynecol. Obstet. 174, 27-32 (1992).
13. Minsky BD, Mies C, Rich TA, Recht A, Chaffey JT. Potentially curative surgery of colon cancer. the influence of blood vessel invasion. J. Clin. Oncol. 6, 119-127 (1988).
14. Newland RC, Chapuis PH, Pheils MT, MacPherson JG. The relationship of survival to staging and grading of colorectal carcinoma. a prospective study of 503 cases. Cancer 47, 1424-1429 (1981).
15. Olson RM, Perencevich NP, Malcolm AW, Chaffey JT, Wilson RE. Patterns of recurrence following curative resection of adenocarcinoma of the colon and rectum. Cancer 45, 2969-2974 (1980).
16. Phillips RK, Hittinger R, Blesovsky L, Fry JS, Fielding LP. Large bowel cancer. surgical pathology and its relationship to survival. Br. J. Surg. 71, 604-610 (1984). (Pubitemid 14098944)
17. Rubio CA, Emas S, Nylander G. A critical reappraisal of Dukes' classification. Surg. Gynecol. Obstet. 145, 682-684 (1977). (Pubitemid 8225363)
18. Sinicrope FA, Sugarman SM. Role of adjuvant therapy in surgically resected colorectal carcinoma. Gastroenterology 109, 984-993 (1995).
19. Willett CG, Tepper JE, Cohen AM, Orlow E, Welch CE. Failure patterns following curative resection of colonic carcinoma. Ann. Surg. 200, 685-690 (1984).
20. Andre T, Boni C, L Mounedji-Boudiaf et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N. Engl. J. Med. 350, 2343-2351 (2004). (Pubitemid 38702845)
21. Bilchik AJ, Hoon DS, S Saha et al. Prognostic impact of micrometastases in colon cancer. interim results of a prospective multicenter trial. Ann. Surg. 246, 568-575; discussion 575-577 (2007).
22. Mamounas E, Wieand S, N Wolmark et al. Comparative efficacy of adjuvant chemotherapy in patients with Dukes' B versus Dukes' C colon cancer. Results from four National Surgical Adjuvant Breast and Bowel Project adjuvant studies (C-01, C-02, C-03, and C-04). J. Clin. Oncol. 17, 1349-1355 (1999). (Pubitemid 29220839)
23. Quasar Collaborative Group, Gray R, Barnwell J et al. Adjuvant chemotherapy versus observation in patients with colorectal cancer. a randomised study. Lancet 370, 2020-2029 (2007).
24. Iddings D, Bilchik A. The biologic significance of micrometastatic disease and sentinel lymph node technology on colorectal cancer. J. Surg. Oncol. 96, 671-677 (2007).
25. Ratto C, Sofo L, Ippoliti M et al. Accurate lymph-node detection in colorectal specimens resected for cancer is of prognostic significance. Dis. Colon Rectum 42, 143-154; discussion 154-158 (1999).
26. Buie WD, Rothernberger DA. Surveillance after curative resection o colorectal cancer. individualing follow-up. Gastrointest. Endosc. Clin. N. Am. 3, 691-713 (1993).
27. Sloane JP. Molecules and micrometastases. Lancet 345, 1255-1256 (1995).
28. Greenson JK, Isenhart CE, Rice R, Mojzisik C, Houchens D, Martin EW Jr. Identification of occult micrometastases in pericolic lymph nodes of Duke's B colorectal cancer patients using monoclonal antibodies against cytokeratin and CC49. Correlation with long-term survival. Cancer 73, 563-569 (1994). (Pubitemid 24046594)
29. Liefers GJ, AM Cleton-Jansen, CJ van de Velde et al. Micrometastases and survival in stage II colorectal cancer. N. Engl. J. Med. 339, 223-228 (1998).
30. Andre T, Sargent D, Tabernero J et al. Current issues in adjuvant treatment of stage II colon cancer. Ann. Surg. Oncol. 13, 887-898 (2006). (Pubitemid 43727375)
31. de Gramont A, Tournigand C, Andre T, Larsen AK, Louvet C. Targeted agents for adjuvant therapy of colon cancer. Semin. Oncol. 33, S42-S45 (2006).
32. de Gramont A, Tournigand C, Andre T, Larsen AK, Louvet C. Adjuvant therapy for stage II and III colorectal cancer. Semin. Oncol. 34, S37-S40 (2007).
33. Fuchs CS, Mayer RJ. Adjuvant chemotherapy for colon and rectal cancer. Semin. Oncol. 22, 472-487 (1995).
34. Krook JE, Moertel CG, Gunderson LL et al. Effective surgical adjuvant therapy for high-risk rectal carcinoma. N. Engl. J. Med. 324, 709-715 (1991).
35. Moertel CG, Fleming TR, Macdonald JS et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N. Engl. J. Med. 322, 352-358 (1990).
36. Wolmark N, Rockette H, B Fisher et al. The benefit of leucovorin-modulated fluorouracil as postoperative adjuvant therapy for primary colon cancer. results from National Surgical Adjuvant Breast and Bowel Project protocol C-03. J. Clin. Oncol. 11, 1879-1887 (1993).
37. Kopetz S, Chang GJ, Overman MJ et al. Improved survival in metastatic colorectal cancer is associated with adoption of hepatic resection and improved chemotherapy. J. Clin. Oncol. 27(22), 3677-3683 (2009).
38. Benson AB, 3rd, Schrag D, Somerfield MR et al. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J. Clin. Oncol. 22, 3408-3419 (2004).
39. Figueredo A, Charette ML, Maroun J, Brouwers MC, Zuraw L. Adjuvant therapy for stage II colon cancer. a systematic review from the Cancer Care Ontario Program in evidence-based care's gastrointestinal cancer disease site group. J. Clin. Oncol. 22, 3395-3407 (2004). (Pubitemid 41103699)
40. Winn R, McClure J. The NCCN clinical practice guidelines in oncology. J. Natl Compr. Canc. Netw. 1, 9 (2005).
41. Frick GS, Pitari GM, Weinberg DS, Hyslop T, Schulz S, Waldman SA. Guanylyl cyclase C: a molecular marker for staging and postoperative surveillance of patients with colorectal cancer. Expert Rev. Mol. Diagn. 5, 701-713 (2005). (Pubitemid 41337465)
42. Gelmann A, Desnoyers R, Cagir B, Weinberg D, Boman BM, Waldman SA. Colorectal cancer staging and adjuvant chemotherapy. Expert Opin. Pharmacother. 1, 737-755 (2000).
43. Waldman SA, Hyslop T, S Schulz et al. Association of GUCY2C expression in lymph nodes with time to recurrence and disease-free survival in pN0 colorectal cancer. JAMA 301, 745-752 (2009).
44. Cagir B, Gelmann A, J Park et al. Guanylyl cyclase C messenger RNA is a biomarker for recurrent stage II colorectal cancer. Ann. Intern. Med. 131, 805-812 (1999).
45. Almenoff JS, Williams SI, Scheving LA, Judd AK, Schoolnik GK. Ligand-based histochemical localization and capture of cells expressing heat-stable enterotoxin receptors. Mol. Microbiol. 8, 865-873 (1993).
46. Carrithers SL, Barber MT, Biswas S et al. Guanylyl cyclase C is a selective marker for metastatic colorectal tumors in human extraintestinal tissues. Proc. Natl Acad. Sci. USA 93, 14827-14832 (1996). (Pubitemid 26419054)
47. Carrithers SL, Parkinson SJ, Goldstein S, Park P, Robertson DC, Waldman SA. Escherichia coli heat-stable toxin receptors in human colonic tumors. Gastroenterology 107, 1653-1661 (1994). (Pubitemid 124006525)
48. Cohen MB, Guarino A, Shukla R, Giannella RA. Age-related differences in receptors for Escherichia coli heat-stable enterotoxin in the small and large intestine of children. Gastroenterology 94, 367-373 (1988). (Pubitemid 18054771)
49. Cohen MB, Moyer MS, Luttrell M, Giannella RA. The immature rat small intestine exhibits an increased sensitivity and response to Escherichia coli heat-stable enterotoxin. Pediatr. Res. 20, 555-560 (1986). (Pubitemid 16096757)
50. Guarino A, Cohen M, Thompson M, Dharmsathaphorn K, Giannella R. T84 cell receptor binding and guanyl cyclase activation by Escherichia coli heat-stable toxin. Am. J. Physiol. 253, G775-G780 (1987).
51. Guarino A, Cohen MB, Giannella RA. Small and large intestinal guanylate cyclase activity in children. effect of age and stimulation by Escherichia coli heat-stable enterotoxin. Pediatr. Res. 21, 551-555 (1987). (Pubitemid 17076186)
52. Guarino A, Cohen MB, Overmann G, Thompson MR, Giannella RA. Binding of E. coli heat-stable enterotoxin to rat intestinal brush borders and to basolateral membranes. Dig. Dis. Sci. 32, 1017-1026 (1987). (Pubitemid 17137984)
53. Lucas KA, Pitari GM, Kazerounian S et al. Guanylyl cyclases and signaling by cyclic GMP. Pharmacol. Rev. 52, 375-414 (2000).
54. Rao MC, Guandalini S, Smith PL, Field M. Mode of action of heat-stable Escherichia coli enterotoxin. Tissue and subcellular specificities and role of cyclic GMP. Biochim. Biophys. Acta 632, 35-46 (1980). (Pubitemid 11233185)
55. Carrithers SL, Ott CE, Hill MJ et al. Guanylin and uroguanylin induce natriuresis in mice lacking guanylyl cyclase-C receptor. Kidney Int. 65, 40-53 (2004).
56. Field M. Mechanisms of action of cholera and Escherichia coli enterotoxins. Am. J. Clin. Nutr. 32, 189-196 (1979).
57. Field M, Graf LH Jr, Laird WJ, Smith PL. Heat-stable enterotoxin of Escherichia coli. in vitro effects on guanylate cyclase activity, cyclic GMP concentration, and ion transport in small intestine. Proc. Natl Acad. Sci. USA 75, 2800-2804 (1978). (Pubitemid 8374996)
58. Guerrant RL, Hughes JM, Chang B, Robertson DC, Murad F. Activation of intestinal guanylate cyclase by heat-stable enterotoxin of Escherichia coli. Studies of tissue specificity, potential receptors, and intermediates. J. Infect. Dis. 142, 220-228 (1980). (Pubitemid 10004075)
59. Hughes JM, Murad F, Chang B, Guerrant RL. Role of cyclic GMP in the action of heat-stable enterotoxin of Escherichia coli. Nature 271, 755-756 (1978).
60. Kuno T, Kamisaki Y, Waldman SA, Gariepy J, Schoolnik G, Murad F. Characterization of the receptor for heat-stable enterotoxin from Escherichia coli in rat intestine. J. Biol. Chem. 261, 1470-1476 (1986). (Pubitemid 16144798)
61. Schulz S, Green CK, Yuen PS, Garbers DL. Guanylyl cyclase is a heat-stable enterotoxin receptor. Cell 63, 941-948 (1990). (Pubitemid 120034935)
62. Li P, Lin JE, Chervoneva I, Schulz S, Waldman SA, Pitari GM. Homeostatic control of the crypt-villus axis by the bacterial enterotoxin receptor guanylyl cyclase C restricts the proliferating compartment in intestine. Am. J. Pathol. 171, 1847-1858 (2007).
63. Li P, Lin JE, Snook AE et al. Colorectal cancer as a paracrine deficiency syndrome amenable to oral hormone replacement therapy. Clin. Trans. Sci. 1, 163-167 (2008).
64. Li P, Lin JE, Snook AE, Schulz S, Pitari GM, Waldman SA. Colorectal cancer is a paracrine deficiency syndrome which can be prevented and treated by oral hormone replacement therapy. Curr. Mol. Pharm. 1(2), 163-167. (2008).
65. Li P, Schulz S, A Bombonati et al. Guanylyl cyclase C suppresses intestinal tumorigenesis by restricting proliferation and maintaining genomic integrity. Gastroenterology 133, 599-607 (2007). (Pubitemid 47187356)
66. Lin EJ, Li P, Snook AE, Schulz S, Pitari GM, Waldman SA. Guanylyl cyclase C in colorectal cancer. susceptibility gene and potential therapeutic target. Future Oncol. 5(4), 509-522 (2009).
67. Lin JE, Li P, Snook AE et al. GUCY2C establishes lineage dependence in intestinal tumorigenesis through AKT. Gastroenterology (2009) (In press).
68. Pitari GM, Baksh RI, Harris DM, Li P, Kazerounian S, Waldman SA. Interruption of homologous desensitization in cyclic guanosine 3′,5′-monophosphate signaling restores colon cancer cytostasis by bacterial enterotoxins. Cancer Res. 65, 11129-11135 (2005). (Pubitemid 41713384)
69. Pitari GM, MD Di Guglielmo, Park J, Schulz S, Waldman SA. Guanylyl cyclase C agonists regulate progression through the cell cycle of human colon carcinoma cells. Proc. Natl Acad. Sci. USA 98, 7846-7851 (2001).
70. Pitari GM, Li P, Lin JE et al. The paracrine hormone hypothesis of colorectal cancer. Clin. Pharmacol. Ther. 82, 441-447 (2007). (Pubitemid 47414353)
71. Pitari GM, Lin JE, Shah FJ et al. Enterotoxin preconditioning restores calcium-sensing receptor-mediated cytostasis in colon cancer cells. Carcinogenesis 29, 1601-1607 (2008).
72. Pitari GM, Zingman LV, Hodgson DM et al. Bacterial enterotoxins are associated with resistance to colon cancer. Proc. Natl Acad. Sci. USA 100, 2695-2699 (2003).
73. Shailubhai K, Yu HH, Karunanandaa K et al. Uroguanylin treatment suppresses polyp formation in the Apc(Min/+) mouse and induces apoptosis in human colon adenocarcinoma cells via cyclic GMP. Cancer Res. 60, 5151-5157 (2000). (Pubitemid 30739773)
74. Steinbrecher KA, Wowk SA, Rudolph JA, Witte DP, Cohen MB. Targeted inactivation of the mouse guanylin gene results in altered dynamics of colonic epithelial proliferation. Am. J. Pathol. 161, 2169-2178 (2002).
75. Birkenkamp-Demtroder K, Christensen LL, Harder Olesen S et al. Gene expression in colorectal cancer. Cancer Res. 62, 4352-4363 (2002).
76. Cohen MB, Hawkins JA, Witte DP. Guanylin mRNA expression in human intestine and colorectal adenocarcinoma. Lab. Invest. 78, 101-108 (1998).
77. Notterman DA, Alon U, Sierk AJ, Levine AJ. Transcriptional gene expression profiles of colorectal adenoma, adenocarcinoma, and normal tissue examined by oligonucleotide arrays. Cancer Res. 61, 3124-3130 (2001). (Pubitemid 32691964)
78. Steinbrecher KA, Tuohy TM, Heppner Goss K et al. Expression of guanylin is downregulated in mouse and human intestinal adenomas. Biochem. Biophys. Res. Commun. 273, 225-230 (2000). (Pubitemid 30426891)
79. Wilson C, Schulz S, Hyslop, Waldman SA, Silencing of guanylin and uroguanylin expression in colon cancer. (2009) (In press).
80. Birbe R, Palazzo JP, Walters R, Weinberg D, Schulz S, Waldman SA. Guanylyl cyclase C is a marker of intestinal metaplasia, dysplasia, and adenocarcinoma of the gastrointestinal tract. Hum. Pathol. 36, 170-179 (2005). (Pubitemid 40313574)
81. Fava TA, Desnoyers R, S Schulz et al. Ectopic expression of guanylyl cyclase C in CD34+ progenitor cells in peripheral blood. J. Clin. Oncol. 19, 3951-3959 (2001).
82. Waldman SA, Barber M, Pearlman J, Park J, George R, Parkinson SJ. Heterogeneity of guanylyl cyclase C expressed by human colorectal cancer cell lines in vitro. Cancer Epidemiol. Biomarkers Prev. 7, 505-514 (1998).
83. Waldman SA, Cagir B, J Rakinic et al. Use of guanylyl cyclase C for detecting micrometastases in lymph nodes of patients with colon cancer. Dis. Colon Rectum 41, 310-315 (1998). (Pubitemid 28141595)
84. Schulz S, Hyslop T, Haaf J et al. A validated quantitative assay to detect occult micrometastases by reverse transcriptase-polymerase chain reaction of guanylyl cyclase C in patients with colorectal cancer. Clin. Cancer Res. 12, 4545-4552 (2006). (Pubitemid 44297803)
85. Witek ME, Nielsen K, R Walters et al. The putative tumor suppressor Cdx2 is overexpressed by human colorectal adenocarcinomas. Clin. Cancer Res. 11, 8549-8556 (2005). (Pubitemid 43005899)
86. Phillips B, Ball C, D Sackett et al. Levels of Evidence. Oxford Centre for Evidence-Based Medicine, Oxford, UK (2009).
87. Chervoneva I, Li Y, Iglewicz B, Waldman S, Hyslop T. Relative quantification based on logistic models for individual polymerase chain reactions. Stat. Med. 26, 5596-5611 (2007). (Pubitemid 351193584)
88. Moertel CG, O'Fallon JR, Go VL, O'Connell MJ, Thynne GS. The preoperative carcinoembryonic antigen test in the diagnosis, staging, and prognosis of colorectal cancer. Cancer 58, 603-610 (1986).
89. Punt CJ, Buyse M, Kohne CH et al. Endpoints in adjuvant treatment trials. A systematic review of the literature in colon cancer and proposed definitions for future trials. J. Natl Cancer Inst. 99, 998-1003 (2007). (Pubitemid 47232601)
90. Le Voyer, TE, Sigurdson ER, Hanlon AL et al. Colon cancer survival is associated with increasing number of lymph nodes analyzed. a secondary survey of intergroup trial INT-0089. J. Clin. Oncol. 21, 2912-2919 (2003).
91. Swanson RS, Compton CC, Stewart AK, Bland KI. The prognosis of T3N0 colon cancer is dependent on the number of lymph nodes examined. Ann. Surg. Oncol. 10, 65-71 (2003).
92. Brown HG, Luckasevic TM, Medich DS, Celebrezze JP, Jones SM. Efficacy of manual dissection of lymph nodes in colon cancer resections. Mod. Pathol. 17, 402-406 (2004).
93. Herrera-Ornelas, L, Justiniano J, Castillo N, Petrelli NJ, Stulc JP, Mittelman A. Metastases in small lymph nodes from colon cancer. Arch. Surg. 122, 1253-1256 (1987). (Pubitemid 18021277)
94. Hitchcock CL, Sampsel J, Young DC, Martin EW Jr, Arnold MW. Limitations with light microscopy in the detection of colorectal cancer cells. Dis. Colon Rectum 42, 1046-1052 (1999). (Pubitemid 29383835)
95. Nolan T, Hands RE, Bustin SA. Quantification of mRNA using real-time RT-PCR. Nat. Protoc. 1, 1559-1582 (2006).
96. Abati A, Liotta LA. Looking forward in diagnostic pathology. the molecular superhighway. Cancer 78, 1-3 (1996). (Pubitemid 26189896)
97. Krishna R, Herman G, Wagner JA. Accelerating drug development using biomarkers. a case study with sitagliptin, a novel DPP4 inhibitor for Type 2 diabetes. AAPS J. 10, 401-409 (2008).
98. Lee JW, Devanarayan V, Barrett YC et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm. Res. 23, 312-328 (2006). (Pubitemid 43237862)
99. Lee JW, Weiner RS, Sailstad JM et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development. a conference report. Pharm. Res. 22, 499-511 (2005).
100. Wagner JA. Overview of biomarkers and surrogate endpoints in drug development. Dis. Markers 18, 41-46 (2002).
101. Wagner JA. Back to the future. Driving innovation in drug development. Clin. Pharmacol. Ther. 83, 199-202 (2008).
102. Wagner JA. Strategic approach to fit-for-purpose biomarkers in drug development. Ann. Rev. Pharmacol. Toxicol. 48, 631-651 (2008).
103. Wagner JA, Williams SA, Webster CJ. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin. Pharmacol. Ther. 81, 104-107 (2007).
104. Williams SA, Slavin DE, Wagner JA, Webster CJ. A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nat. Rev. Drug Discov. 5, 897-902 (2006).