This is the current release of the guideline.

This guideline updates a previous version: 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001 Mar 15;19(6):1865-1878.

Carcinoembryonic Antigen as a Marker for Colorectal Cancer

2006 recommendation for carcinoembryonic antigen as a screening test. Carcinoembryonic antigen (CEA) is not recommended for use as a screening test for colorectal cancer.

2006 recommendation for preoperative carcinoembryonic antigen (CEA) testing. CEA may be ordered preoperatively in patients with colorectal carcinoma if it would assist in staging and surgical treatment planning. Although elevated preoperative CEA (>5 mg/mL) may correlate with poorer prognosis, data are insufficient to support the use of CEA to determine whether to treat a patient with adjuvant therapy.

2006 recommendation for postoperative CEA testing. Postoperative serum CEA testing should be performed every 3 months in patients with stage II or III disease for at least 3 years after diagnosis if the patient is a candidate for surgery or systemic therapy. An elevated CEA, if confirmed by retesting, warrants further evaluation for metastatic disease, but does not justify the institution of adjuvant therapy or systemic therapy for presumed metastatic disease (Ueno et. al, 2000). CEA elevations within a week or two following chemotherapy should be interpreted with caution (Sorbye & Dahl, 2003).

2006 recommendation for CEA testing to monitor metastatic colorectal cancer. CEA is the marker of choice for monitoring metastatic colorectal cancer during systemic therapy. CEA should be measured at the start of treatment for metastatic disease and every 1 to 3 months during active treatment. Persistently rising values above baseline should prompt restaging, but suggest progressive disease even in the absence of corroborating radiographs. Caution should be used when interpreting a rising CEA level during the first 4 to 6 weeks of a new therapy, since spurious early rises may occur especially after oxaliplatin use (Sorbye & Dahl, 2003; Sorbye & Dahl, 2004).

CA 19-9 As a Marker for Colon Cancer

2006 recommendation for use of CA 19-9 in colon cancer. Present data are insufficient to recommend CA 19-9 for screening, diagnosis, staging, surveillance, or monitoring treatment of patients with colorectal cancer.

DNA Ploidy or Flow Cytometric Proliferation Analysis As a Marker for Colon Cancer

2006 recommendation for DNA ploidy or DNA flow cytometric proliferation analysis to determine prognosis. Neither flow-cytometrically derived DNA ploidy (DNA index) nor DNA flow cytometric proliferation analysis (%S phase) should be used to determine prognosis of early-stage colorectal cancer.

p53 As a Marker for Colorectal Cancer

2006 recommendations for p53 testing. Present data are insufficient to recommend the use of p53 expression or mutation for screening, diagnosis, staging, surveillance, or monitoring treatment of patients with colorectal cancer.

ras As a Marker for Colorectal Cancer

2006 recommendation for ras testing. Present data are insufficient to recommend the use of the ras oncogene for screening, diagnosis, staging, surveillance, or monitoring treatment of patients with colorectal cancer.

Thymidine Synthase, Dihydropyrimidine Dehydrogenase, and Thymidine Phosphorylase As Markers in Colorectal Cancer

Note: These topics are new to the guideline.

2006 recommendation for thymidine synthase, dihydropyrimidine dehydrogenase, and thymidine phosphorylase as screening tests. Thymidine synthase (TS), dihydropyrimidine dehydrogenase (DPD), and thymidine phosphorylase (TP) are tissue markers that have been used to predict response to treatment of established carcinomas and thus are not useful for screening.

2006 recommendation for use of TS, DPD, or TP for prognosis. None of the three markers—TS, DPD, or TP—are recommended for use to determine the prognosis of colorectal carcinoma.

2006 recommendation for use of TS, DPD, or TP in predicting response to therapy. There is insufficient evidence to recommend use of TS, DPD, or TP as predictors of response to therapy.

2006 recommendation for use of TS, DPD, or TP in monitoring response to therapy. There is insufficient evidence to recommend use of TS, DPD, or TP for monitoring response to therapy.

Microsatellite Instability/hMSH2 or hMLH1 As Markers in Colorectal Cancer

Note: This topic is new to the guideline.

2006 recommendation for use of microsatellite instability to determine prognosis. Microsatellite instability (MSI) ascertained by polymerase chain reaction (PCR) is not recommended at this time to determine the prognosis of operable colorectal cancer nor to predict the effectiveness of FU adjuvant chemotherapy.

1 8q-LOH/DCC As Markers for Colorectal Cancer

Note: This topic is new to the guideline.

2006 recommendation for use of 18q-LOH/DCC to determine prognosis or to predict response to therapy. Assaying for loss of heterozygosity (LOH) on the long arm of chromosome 18 (18q) or deleted in colon cancer (DCC) protein determination by IHC should not be used to determine the prognosis of operable colorectal cancer, nor to predict response to therapy.

CA 19-9 as a Marker for Pancreatic Cancer

Note: This topic is new to the guideline.

2006 recommendation for use of CA 19-9 as a screening test. CA 19-9 is not recommended for use as a screening test for pancreatic cancer.

2006 recommendation for use of CA 19-9 to determine operability. The use of CA19- 9 testing alone is not recommended for use in determining operability or the results of operability in pancreatic cancer.

2006 recommendation for use of CA 19-9 to provide evidence of recurrence. CA 19-9 determinations by themselves cannot provide definitive evidence of disease recurrence without seeking confirmation with imaging studies for clinical findings and/or biopsy.

2006 recommendation for use of CA19-9 for monitoring response to therapy. Present data are insufficient to recommend the routine use of serum CA 19-9 rules alone for monitoring response to treatment. However, CA19-9 can be measured at the start of treatment for locally advanced metastatic disease and every 1 to 3 months during active treatment. If there is an elevation in serial CA19-9 determinations, this may be an indication of progressive disease, and confirmation with other studies should be sought.

None provided

The evidence supporting each recommendation is presented in the original guideline document under "literature update and discussion" following each recommendation. The Update Committee's literature review focused attention on available systematic reviews and meta-analyses of published tumor marker studies. By and large, however, the literature is characterized by studies that included small patient numbers, studies that were retrospective, and studies that commonly performed multiple analyses until one revealed a statistically significant result (P<.05). In the scale for grading the clinical utility of tumor markers used by the Update Committee, these studies are designated as Level of Evidence III.

Not applicable: The guideline was not adapted from another source.

1996 (revised 2006 Nov 20)

American Society of Clinical Oncology - Medical Specialty Society

American Society of Clinical Oncology

American Society of Clinical Oncology (ASCO) Expert Panel

Panel Members: Robert C. Bast Jr, MD (Co-Chair) M.D. Anderson Cancer Center; Daniel F. Hayes, MD (Co-Chair) University of Michigan Medical Center; Dean F. Bajorin, MD,  Memorial Sloan-Kettering Cancer Center; Jonathan S. Berek, MD, UCLA School of Medicine; Ross S. Berkowitz, MD, Brigham & Women's Hospital; Roy Beveridge, MD, Fairfax Northern VA Hem-Onc; Herbert Fritsche Jr, PhD, M.D. Anderson Cancer Center; Timothy Gilligan, MD, Dana-Farber Cancer Institute; Stanley Hamilton, MD, M.D. Anderson Cancer Center; Jules Harris, MD, Rush University Medical Center; Lyndsay Harris, MD, Dana-Farber Cancer Institute; John M. Jessup, MD, Georgetown University Medical Center; Philip W. Kantoff, MD, Dana-Farber Cancer Institute; Nancy E. Kemeny, MD, Memorial Sloan-Kettering Cancer Center; Ann Kolker Ovarian Cancer National Alliance, consultant and founding director; Susan Leigh, BSN, RN, National Coalition for Cancer Survivorship, patient representative; Gershon Y. Locker, MD, Evanston Northwestern Healthcare; Juanita Lyle, George Washington University, patient representative; John S. Macdonald, MD, St Vincent's Comprehensive Cancer Center; Pam McAllister, PhD, Science advocate with the Colorectal Cancer Coalition, patient representative; Robert G. Mennel, MD, Texas Oncology PA; Larry Norton, MD, Memorial Sloan-Kettering Cancer Center; Peter Ravdin, MD, The University of Texas Health Science Center; Sheila Taube, PhD National Cancer Institute

Although all authors completed the disclosure declaration, the following authors or their immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

This is the current release of the guideline.

This guideline updates a previous version: 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001 Mar 15;19(6):1865-1878.

This NGC summary was completed by ECRI on November 21, 2006. The information was verified by the guideline developer on December 6, 2006.

This summary is based on the original guideline, which is subject to the American Society of Clinical Oncology's copyright restrictions.