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National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines for Use of Tumor Markers in Testicular, Prostate, Colorectal, Breast, and Ovarian Cancers

¹ Department of Clinical Biochemistry, Royal Infirmary of Edinburgh, Edinburgh, UK; ² Department of Pathology and Laboratory Medicine, St Vincent’s University Hospital and UCD School of Medicine and Medical Science, Conway Institute of Biomolecular and Biomedical Research, University College Dublin, Dublin, Ireland; ³ Department of Clinical Chemistry, Helsinki University Central Hospital, Helsinki, Finland; ⁴ Departments of Clinical Laboratories, Urology, and Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY; ⁵ Section of Biomedicine, Department of Veterinary Pathobiology, Faculty of Life Sciences, University of Copenhagen, Denmark; ⁶ Departments of Pathology and Oncology, Johns Hopkins Medical Institutions, Baltimore, MD; ⁷ Department of Urology, The University of Texas Anderson Cancer Center, Houston, TX; ⁸ Department of Experimental Therapeutics, University of Texas Anderson Cancer Center, Houston, Texas, USA.; ⁹ Abbott Laboratories, Abbott Park, IL; ¹⁰ Departments of Breast Medical Oncology, Molecular and Cellular Oncology, University of Texas M.D. Anderson Cancer Center, Houston TX; ¹¹ Department of Surgery, Helsinki University Central Hospital, Helsinki, Finland; ¹² Frauenklinik der Technischen Universität München, Klinikum rechts der Isar, Munich, Germany; ¹³ Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; ¹⁴ Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine, Rochester, MN; ¹⁵ Department of Medicine, Klinikum of the University of Munich, Grosshadern, Germany; ¹⁶ Laboratory of Experimental Patho-Oncology, Erasmus MC-University Medical Center Rotterdam, and Daniel den Hoed Cancer Center, Rotterdam, the Netherlands; ¹⁷ Laboratory of Biochemistry, Hospital Clinico Provincial, Barcelona, Spain; ¹⁸ Department of Surgical Gastroenterology, Hvidovre Hospital, Copenhagen, Denmark; ¹⁹ Gen-Probe, San Diego, CA; ²⁰ Prostate Center, Department of Urology, University Clinic Muenster, Muenster, Germany; ²¹ Siemens Medical Solutions Diagnostics, Glyn Rhonwy, Llanberis, Gwynedd, UK; ²² Department of Clinical Biochemistry, Hillerød Hospital, Hillerød, Denmark; ²³ Department of Urology, Charité Hospital, Universitätsmedizin Berlin, Berlin, Germany; ²⁴ Department of Pathology and Laboratory Medicine, Mount Sinai Hospital, and Department of Laboratory Medicine and Pathobiology, University of Toronto, Ontario, Canada.

^aAddress correspondence to this author at: the Department of Clinical Biochemistry, Royal Infirmary, Edinburgh EH16 4SA, UK. Fax +44 131 242 6882; e-mail c.sturgeon{at}ed.ac.uk.

Background: Updated National Academy of Clinical Biochemistry (NACB) Laboratory Medicine Practice Guidelines for the use of tumor markers in the clinic have been developed.

Methods: Published reports relevant to use of tumor markers for 5 cancer sites—testicular, prostate, colorectal, breast, and ovarian—were critically reviewed.

Results: For testicular cancer, -fetoprotein, human chorionic gonadotropin, and lactate dehydrogenase are recommended for diagnosis/case finding, staging, prognosis determination, recurrence detection, and therapy monitoring. -Fetoprotein is also recommended for differential diagnosis of nonseminomatous and seminomatous germ cell tumors. Prostate-specific antigen (PSA) is not recommended for prostate cancer screening, but may be used for detecting disease recurrence and monitoring therapy. Free PSA measurement data are useful for distinguishing malignant from benign prostatic disease when total PSA is <10 µg/L. In colorectal cancer, carcinoembryonic antigen is recommended (with some caveats) for prognosis determination, postoperative surveillance, and therapy monitoring in advanced disease. Fecal occult blood testing may be used for screening asymptomatic adults 50 years or older. For breast cancer, estrogen and progesterone receptors are mandatory for predicting response to hormone therapy, human epidermal growth factor receptor-2 measurement is mandatory for predicting response to trastuzumab, and urokinase plasminogen activator/plasminogen activator inhibitor 1 may be used for determining prognosis in lymph node–negative patients. CA15-3/BR27–29 or carcinoembryonic antigen may be used for therapy monitoring in advanced disease. CA125 is recommended (with transvaginal ultrasound) for early detection of ovarian cancer in women at high risk for this disease. CA125 is also recommended for differential diagnosis of suspicious pelvic masses in postmenopausal women, as well as for detection of recurrence, monitoring of therapy, and determination of prognosis in women with ovarian cancer.

Conclusions: Implementation of these recommendations should encourage optimal use of tumor markers.

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