« Previous
Next »
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
- 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
- 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
- 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
- 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
-
.
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
- . Statistical aspects of prognostic factor studies in oncology. Br J Cancer. 1994;69:979–985
- . Breast cancer prognostic factors: Evaluation guidelines. J Natl Cancer Inst. 1991;83:154–155
- Microsatellite instability and 8p allelic imbalance in stage B2 and C colorectal cancers. J Natl Cancer Inst. 1999;91:1295–1303
- 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
- Microsatellite instability is a favorable prognostic indicator in patients with colorectal cancer receiving chemotherapy. Gastroenterology. 2000;119:921–928
- Prognostic significance of extensive microsatellite instability in sporadic clinicopathological stage C colorectal cancer. Br J Surg. 2000;87:1197–1202
- . Evaluating the potential usefulness of new prognostic and predictive indicators in node-negative breast cancer patients. J Natl Cancer Inst. 1993;85:1206–1219
- Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998;4:844–847
- . Estrogen and progesterone receptor concentrations and prevalence of tumor hormonal phenotypes in older breast cancer patients. Cancer Detect Prev. 1999;23:238–244
- 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
- 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
- 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
- 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
- p53 gene mutation, microsatellite instability and adjuvant chemotherapy: Impact on survival of 388 patients with Dukes' C colon carcinoma. Oncology. 2000;58:52–59
- . Biomarkers for early detection of colon cancer. Clin Cancer Res. 2001;7:1118–1126
- p53 alterations are associated with improved prognosis in distal colonic carcinomas. Clin Cancer Res. 1997;3:1405–1411
- 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
- . 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
- 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
- Recommendations for HER2 testing in the UK. J Clin Pathol. 2000;53:890–892
-
Quality Assurance for Immunohistochemistry. Approved Guideline.
Wayne, PA: National Committee for Clinical Laboratory Standards; 1999;
-
.
Standardization of immunohistochemistry based on antigen retrieval technique for routine formalin fixed tissue sections.
Appl Immunohistochem. 1998;6:89–96
- . A practical approach for evaluating new antibodies in the clinical immunohistochemistry laboratory. Arch Pathol Lab Med. 2001;125:289–294
-
.
An exaltation of experts: Concerted efforts in the standardization of immunohistochemistry.
Appl Immunohistochem. 1993;1:232–243
- 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
- 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
- Prognostic factors in prostate cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med. 2000;124:995–1000
- 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
- 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
- Immunohistologic localization of estrogen receptors in breast cancer with monoclonal antibodies. Correlation with biochemistry and clinical endocrine response. Cancer. 1985;55:1513–1518
- . Variation of sensitivity, specificity, likelihood ratios and predictive values with disease prevalence. Stat Med. 1997;16:981–991
- . Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med. 1978;299:926–930
- Incorporating the time dimension in receiver operating characteristic curves: A case study of prostate cancer. Med Decis Making. 1999;19:242–251
- . Inference procedures for assessing interobserver agreement among multiple raters. Biometrics. 2001;57:584–588
-
.
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
- . The relationships among performance measures in the selection of diagnostic tests. Arch Pathol Lab Med. 1997;121:110–117
- Tumor marker utility grading system: A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst. 1996;88:1456–1466
- 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
- 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
- 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
- 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
- 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
- The urokinase system of plasminogen activation and prognosis in 2780 breast cancer patients. Cancer Res. 2000;60:636–643
- . Study indicates utility for new breast cancer prognostic marker. JAMA. 2001;285:3077–3078
- 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
-
Medical Device Amendments of 1976. Stat. 1976;539:
Pub L No. 94-295, 90
-
Safe Medical Devices Act of 1990. Stat. 1990;4523:
Pub L No. 101-629, 104
- Medical Devices; Classification/Reclassification; Restricted Devices; Analyte Specific Reagents. Federal Register. 1997;62(225):62243–62260
- Tamoxifen for early breast cancer: An overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998;351:1451–1467
- . The efficacy of diagnostic imaging. Med Decis Making. 1991;11:88–94
- . 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
« Previous
Next »
Seminars in Oncology
Volume 29, Issue 3
, Pages 213-221
, June 2002
