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Table 9. Currently Available Markers for Colorectal Cancer Cancer Marker Proposed Use/Uses Phase of Development LOE* Reference Blood-Based Markers CEA Determining prognosis Preoperative levels may provide prognostic information but this is III (239-241) rarely used for clinical purposes Surveillance following curative In clinical use, usually in combination with radiology and I (251-255) resection clinical history Monitoring therapy in advanced In clinical use, usually in combination with radiology and III (239-241) disease clinical history CA19.9 Determining prognosis Undergoing evaluation III (264-269) Surveillance following curative Undergoing evaluation IV (262, 263) resection and monitoring therapy in advanced disease CA 242 Determining prognosis Undergoing evaluation III (270, 271) TIMP-1 Determining prognosis/Screening Undergoing evaluation III (274, 275) high risk populations Tissue-Based Markers TS Determining prognosis Undergoing evaluation, a meta-analysis suggested that high levels I (276-279, 564) of TS predicted poor outcome (279). Assay not standardized Predicting response to Undergoing evaluation. High levels may predict lack of response to III (276-280, 564) chemotherapy (5-FU) in 5-FU in advanced disease. Some studies suggest that TS should advanced disease be determined on metastatic site to be treated MSI Determining prognosis Undergoing evaluation, a pooled analysis showed that MSI-tumors I (282-284, 565) were associated with a 15% better prognosis compared with MS-stable tumors (285). Overall, data conflicting Predicting response to Results conflicting, undergoing further evaluation III (284, 285, 565, 566) chemotherapy DCC/18q Determining prognosis Undergoing evaluation, prognostic value validated in a meta-analysis. I (286-288) phenotype Assay not standardized. uPA/PAI-1 Determining prognosis Undergoing evaluation III (289-291) Ras Determining prognosis A pooled analysis showed that a mutant ras gene was weakly I (292) prognostic in Dukes’ C but not in Dukes’ B disease. Unlikely to be used for clinical purposes Predicting benefit from therapy May be of value in predicting benefit from the anti-EGFR III (294-297) antibodies, cetuximab and panitumumab P53 Determining prognosis A meta-analysis showed that abnormal p53 was weakly associated I (293) with poor outcome. Unlikely to be used for clinical purposes
Fecal Markers FOBT Screening asymptomatic Shown in randomized trials that screening with FOBT reduced I (300, 302-306) populations mortality from CRC. Used for ad hoc CRC screening. Feasibility screening trials underway in a number of countries. Lacks sensitivity for early CRC and advanced adenomas and gives rise to many false-positive results DNA Panels Screening asymptomatic A large study on asymptomatic subjects showed that a DNA panel III/IV for (313-317) populations was more sensitive than FOBT for detecting both advanced most adenomas and invasive CRC (79) panels. I for a specific panel 28(317) Genetic Markers APC For identifying subjects at high In clinical use in specialised centers Expert (322, 323, 326, risk of developing FAP opinion 567, 568) MSI Pre-screen for HNPCC In clinical use in specialised centers III (322, 323, 567-569) MLH1/MSH2/ For identifying subjects at high In clinical use in specialised centers III/IV (322, 323, 326, MSH6/PMS2 risk of developing HNPCC 567-569) Abbreviations: TIMP-1, tissue inhibitor of metalloproteinase type 1; TS, thymidylate synthase: uPA, urokinase plasminogen activator; MSI, microsatellite instability: uPA, urokinase plasminogen activator; PAI, plasminogen activator inhibitor 1; 5-FU, 5-fluorouracil; DCC, deleted in colon cancer; FOBT, fecal occult blood testing; FAP, familial adenomatous polyposis; HNPCC, hereditary non-polyposis colorectal cancer and CRC, colorectal cancer. *LOE, (120): level 1, evidence from a single, high-powered, prospective, controlled study that is specifically designed to test the marker, or evidence from a meta-analysis, pooled analysis or overview of level II or III studies; level II evidence from a study in which marker data are determined in relationship to prospective therapeutic trial that is performed to test therapeutic hypothesis but not specifically designed to test marker utility; level III, evidence from large prospective studies; level IV, evidence from small retrospective studies; level V, evidence from small pilot studies. [LOE are not included for genetic tests.]
Page 1 and 2: The National Academy of Clinical Bi
Page 3 and 4: Rolf Lamerz Department of Medicine,
Page 5: Table of Contents 1. Introduction 1
Page 9 and 10: Chapter 2 Tumor Markers in Testicul
Page 11 and 12: Table 2. Recommendations for Use of
Page 13 and 14: Tumor Markers in Testicular Cancers
Page 19: Tumor Markers in Testicular Cancers
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Page 24 and 25: Table 8. Biomarkers Currently Being
Page 33: Chapter 4 Tumor Markers in Colorect
Page 37 and 38: Table 10. Recommendations for Use o
Page 39 and 40: Tumor Markers in Colorectal Maligna
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Page 46 and 47: Table 11. Useful and Potentially Us
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78 Use of Tumor Markers in Testicul
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Acknowledgment We would like to tha
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