Seminars in Oncology
Volume 29, Issue 3 , Pages 213-221 , June 2002

Issues and barriers to development of clinically useful tumor markers: A development pathway proposal

References 

  1. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer. Adopted on May 17, 1996 by the American Society of Clinical Oncology. J Clin Oncol. 1996;14:2843–2877
  2. 1997 Update of recommendations for the use of tumor markers in breast and colorectal cancer. Adopted on November 7, 1997 by the American Society of Clinical Oncology. J Clin Oncol. 1998;16:793–795
  3. Henson DE, Fielding LP, Grignon DJ, et al.  College of American Pathologists Conference XXVI on clinical relevance of prognostic markers in solid tumors. Summary. Members of the Cancer Committee. Arch Pathol Lab Med. 1995;119:1109–1112
  4. Hammond ME, Fitzgibbons PL, Compton CC, et al.  College of American Pathologists Conference XXXV: Solid tumor prognostic factors—Which, how and so what? Summary document and recommendations for implementation. Cancer Committee and Conference Participants. Arch Pathol Lab Med. 2000;124:958–965
  5. Simon R. Design and conduct of clinical trials. In: ed 4.  DeVita V,  Hellman S,  Rosenberg S editor. Cancer: Principles and Practice of Oncology. Philadelphia: PA, Lippincott; 1993;p. 418–440
  6. Simon R, Altman DG. Statistical aspects of prognostic factor studies in oncology. Br J Cancer. 1994;69:979–985
  7. McGuire WL. Breast cancer prognostic factors: Evaluation guidelines. J Natl Cancer Inst. 1991;83:154–155
  8. Halling KC, French AJ, McDonnell SK, et al.  Microsatellite instability and 8p allelic imbalance in stage B2 and C colorectal cancers. J Natl Cancer Inst. 1999;91:1295–1303
  9. Boland CR, Thibodeau SN, Hamilton SR, et al.  A National Cancer Institute Workshop on microsatellite instability for cancer detection and familial predisposition: Development of international criteria for the determination of microsatellite instability in colorectal cancer. Cancer Res. 1998;58:5248–5257
  10. Hemminki A, Mecklin JP, Jarvinen H, et al.  Microsatellite instability is a favorable prognostic indicator in patients with colorectal cancer receiving chemotherapy. Gastroenterology. 2000;119:921–928
  11. Wright CM, Dent OF, Barker M, et al.  Prognostic significance of extensive microsatellite instability in sporadic clinicopathological stage C colorectal cancer. Br J Surg. 2000;87:1197–1202
  12. Gasparini G, Pozza F, Harris AL. Evaluating the potential usefulness of new prognostic and predictive indicators in node-negative breast cancer patients. J Natl Cancer Inst. 1993;85:1206–1219
  13. Kononen J, Bubendorf L, Kallioniemi A, et al.  Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998;4:844–847
  14. Ashba J, Traish AM. Estrogen and progesterone receptor concentrations and prevalence of tumor hormonal phenotypes in older breast cancer patients. Cancer Detect Prev. 1999;23:238–244
  15. Floiras JL, Hacene K, Turpin F, et al.  Is adjuvant tamoxifen recommended in post-menopausal node-negative breast cancer patients with high estrogen receptor values?. Int J Biol Markers. 2000;15:135–138
  16. Johnston PG, Lenz HJ, Leichman CG, et al.  Thymidylate synthase gene and protein expression correlate and are associated with response to 5-fluorouracil in human colorectal and gastric tumors. Cancer Res. 1995;55:1407–1412
  17. Aschele C, Debernardis D, Casazza S, et al.  Immunohistochemical quantitation of thymidylate synthase expression in colorectal cancer metastases predicts for clinical outcome to fluorouracil-based chemotherapy. J Clin Oncol. 1999;17:1760–1770
  18. Cascinu S, Graziano F, Valentini M, et al.  Vascular endothelial growth factor expression, S-phase fraction and thymidylate synthase quantitation in node-positive colon cancer: Relationships with tumor recurrence and resistance to adjuvant chemotherapy. Ann Oncol. 2001;12:239–244
  19. Elsaleh H, Powell B, Soontrapornchai P, et al.  p53 gene mutation, microsatellite instability and adjuvant chemotherapy: Impact on survival of 388 patients with Dukes' C colon carcinoma. Oncology. 2000;58:52–59
  20. Srivastava S, Verma M, Henson DE. Biomarkers for early detection of colon cancer. Clin Cancer Res. 2001;7:1118–1126
  21. Soong R, Grieu F, Robbins P, et al.  p53 alterations are associated with improved prognosis in distal colonic carcinomas. Clin Cancer Res. 1997;3:1405–1411
  22. Tubbs RR, Pettay JD, Roche PC, et al.  Discrepancies in clinical laboratory testing of eligibility for trastuzumab therapy: Apparent immunohistochemical false-positives do not get the message. J Clin Oncol. 2001;19:2714–2721
  23. Mitchell MS, Press MF. The role of immunohistochemistry and fluorescence in situ hybridization for HER2/neu in assessing the prognosis of breast cancer. Semin Oncol. 1999;26:108–116
  24. Jacobs TW, Gown AM, Yaziji H, et al.  Specificity of HercepTest in determining HER-2/neu status of breast cancers using the United States Food and Drug Administration-approved scoring system. J Clin Oncol. 1999;17:1983–1987
  25. Ellis IO, Dowsett M, Bartlett J, et al.  Recommendations for HER2 testing in the UK. J Clin Pathol. 2000;53:890–892
  26. O'Leary TJ, Edmonds F, Floyd AD, et al.  Quality Assurance for Immunohistochemistry. Approved Guideline. Wayne, PA: National Committee for Clinical Laboratory Standards; 1999;
  27. Shi SR, Cote RJ, Chaiwun B. Standardization of immunohistochemistry based on antigen retrieval technique for routine formalin fixed tissue sections. Appl Immunohistochem. 1998;6:89–96
  28. Hsi ED. A practical approach for evaluating new antibodies in the clinical immunohistochemistry laboratory. Arch Pathol Lab Med. 2001;125:289–294
  29. Taylor C. An exaltation of experts: Concerted efforts in the standardization of immunohistochemistry. Appl Immunohistochem. 1993;1:232–243
  30. Rhodes A, Jasani B, Balaton AJ, et al.  Frequency of oestrogen and progesterone receptor positivity by immunohistochemical analysis in 7016 breast carcinomas: Correlation with patient age, assay sensitivity, threshold value, and mammographic screening. J Clin Pathol. 2000;53:688–696
  31. Leake R, Barnes D, Pinder S, et al.  Immunohistochemical detection of steroid receptors in breast cancer: A working protocol. UK Receptor Group, UK NEQAS, The Scottish Breast Cancer Pathology Group, and The Receptor and Biomarker Study Group of the EORTC. J Clin Pathol. 2000;53:634–635
  32. Bostwick DG, Grignon DJ, Hammond ME, et al.  Prognostic factors in prostate cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med. 2000;124:995–1000
  33. Srigley JR, Amin MB, Bostwick DG, et al.  Updated protocol for the examination of specimens from patients with carcinomas of the prostate gland: A basis for checklists. Cancer Committee. Arch Pathol Lab Med. 2000;124:1034–1039
  34. Marchetti E, Querzoli P, Moncharmont B, et al.  Immunocytochemical demonstration of estrogen receptors by monoclonal antibodies in human breast cancer: Correlation with estrogen receptor assay by dextran-coated charcoal method. Cancer Res. 1987;47:2508–2513
  35. Pertschuk LP, Eisenberg KB, Carter AC, et al.  Immunohistologic localization of estrogen receptors in breast cancer with monoclonal antibodies. Correlation with biochemistry and clinical endocrine response. Cancer. 1985;55:1513–1518
  36. Brenner H, Gefeller O. Variation of sensitivity, specificity, likelihood ratios and predictive values with disease prevalence. Stat Med. 1997;16:981–991
  37. Ransohoff DF, Feinstein AR. Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med. 1978;299:926–930
  38. Etzioni R, Pepe M, Longton G, et al.  Incorporating the time dimension in receiver operating characteristic curves: A case study of prostate cancer. Med Decis Making. 1999;19:242–251
  39. Altaye M, Donner A, Klar N. Inference procedures for assessing interobserver agreement among multiple raters. Biometrics. 2001;57:584–588
  40. Griner PF, Mayewski R. Principles of test interpretation, in Griner PF. In:  Panzer RJ,  Greenland P editor. Clinical Diagnosis and the Clinical Laboratory: Logical Strategies for Common Medical Problems. Chicago, IL: Year Book Medical; 1986;p. 1–16
  41. Einstein AJ, Bodian CA, Gil J. The relationships among performance measures in the selection of diagnostic tests. Arch Pathol Lab Med. 1997;121:110–117
  42. Hayes DF, Bast RC, Desch CE, et al.  Tumor marker utility grading system: A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst. 1996;88:1456–1466
  43. Janicke F, Schmitt M, Pache L, et al.  Urokinase (uPA) and its inhibitor PAI-1 are strong and independent prognostic factors in node-negative breast cancer. Breast Cancer Res Treat. 1993;24:195–208
  44. Bouchet C, Spyratos F, Martin PM, et al.  Prognostic value of urokinase-type plasminogen activator (uPA) and plasminogen activator inhibitors PAI-1 and PAI-2 in breast carcinomas. Br J Cancer. 1994;69:398–405
  45. Grondahl-Hansen J, Hilsenbeck SG, Christensen IJ, et al.  Prognostic significance of PAI-1 and uPA in cytosolic extracts obtained from node-positive breast cancer patients. Breast Cancer Res Treat. 1997;43:153–163
  46. Janicke F, Pache L, Schmitt M, et al.  Both the cytosols and detergent extracts of breast cancer tissues are suited to evaluate the prognostic impact of the urokinase-type plasminogen activator and its inhibitor, plasminogen activator inhibitor type 1. Cancer Res. 1994;54:2527–2530
  47. de Witte JH, Sweep CG, Klijn JG, et al.  Prognostic impact of urokinase-type plasminogen activator (uPA) and its inhibitor (PAI-1) in cytosols and pellet extracts derived from 892 breast cancer patients. Br J Cancer. 1999;79:1190–1198
  48. Foekens JA, Peters HA, Look MP, et al.  The urokinase system of plasminogen activation and prognosis in 2780 breast cancer patients. Cancer Res. 2000;60:636–643
  49. Stephenson J. Study indicates utility for new breast cancer prognostic marker. JAMA. 2001;285:3077–3078
  50. Janicke F, Prechtl A, Thomssen C, et al.  Randomized adjuvant chemotherapy trial in high-risk, lymph node-negative breast cancer patients identified by urokinase-type plasminogen activator and plasminogen activator inhibitor type 1. J Natl Cancer Inst. 2001;93:913–920
  51. Medical Device Amendments of 1976. Stat. 1976;539: Pub L No. 94-295, 90
  52. Safe Medical Devices Act of 1990. Stat. 1990;4523: Pub L No. 101-629, 104
  53. Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents. Federal Register. 1997;62(225):62243–62260
  54. Tamoxifen for early breast cancer: An overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998;351:1451–1467
  55. Fryback DG, Thornbury JR. The efficacy of diagnostic imaging. Med Decis Making. 1991;11:88–94
  56. Ravdin PM, Siminoff IA, Harvey JA. Survey of breast cancer patients concerning their knowledge and expectations of adjuvant therapy. J Clin Oncol. 1998;16:515–521

 Address reprint requests to M. Elizabeth H. Hammond MD, MD, Department of Pathology, LDS Hospital, 8th Ave and C St, Salt Lake City, UT 84143.

PII: S0093-7754(02)50177-9

doi: 10.1053/sonc.2002.32896

Seminars in Oncology
Volume 29, Issue 3 , Pages 213-221 , June 2002