Colon Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI]

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The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.

Stage III Colon Cancer

Added text to the drug combinations described in this section to include the FOLFOX4 regimen of oxaliplatin, leucovorin, and 5-FU and its infusion/dosing schedule.

Added text to state that based on results from the MOSAIC trial, adjuvant FOLFOX4 demonstrated prolonged overall survival (OS) for patients with stage III colon cancer compared with patients receiving 5-FU/LV without oxaliplatin (cited André et al. as reference 6).

Added text to state that initially there was no difference in OS (cited André et al. as reference 6 and level of evidence 1iiDii). Also added that further follow-up at 6 years demonstrated that the OS for all patients entered into the study was not significantly different, and on subset analysis, the 6-year OS in patients with stage III colon cancer was greater in the patients receiving FOLFOX and less in the patients receiving 5-FU/LV (cited André et al. as reference 6 and level of evidence 1iiA).

Added text to state that FOLFOX has become the reference standard for the next generation of clinical trials for patients with stage III colon cancer.

Stage IV and Recurrent Colon Cancer

Added text to state that despite the lack of direct data, in standard practice, bevacizumab was added to FOLFOX as a standard first-line regimen based on the results of NCCTG-N9741 (cited Sanoff et al. as reference 63). Also added that in a randomized phase III study, patients with untreated, stage IV colorectal cancer were randomly assigned in a 2 × 2 factorial design to CAPOX versus FOLFOX4, then to bevacizumab versus placebo, with progression-free survival (PFS) the primary endpoint (cited Saltz et al. as reference 64 and level of evidence 1iiDiii). Added that with the median OS at 21.3 months for patients receiving bevacizumab and 19.9 months for patients receiving placebo, the median PFS was 8.0 months in the pooled CAPOX-containing arms versus 8.5 months in the FOLFOX4-containing arms, with the upper limit of the 97.5% CI being below the predefined noninferiority margin of 1.23 (cited Cassidy et al. as reference 65). Concluded with text to state that the effect of bevacizumab on OS is likely to be less than what was seen in the original Hurwitz study.

Added text to state that there are currently no completed randomized controlled studies evaluating whether continued use of bevacizumab in the second line or third line after progressing on a first-line bevacizumab regimen is worthwhile.

Added text to state that cetuximab is a partially humanized monoclonal antibody against the epidermal growth factor receptor and that for patients who progressed on irinotecan-containing regimens, a randomized phase II study was performed of either cetuximab or irinotecan and cetuximab; the median time to progression (TTP) for patients receiving cetuximab was 1.5 months, and the median TTP for patients receiving irinotecan and cetuximab was 4.2 months (cited Cunningham et al. as reference 72 and level of evidence 3iiiDiv). Concluded with text to state that on the basis of this study, cetuximab was approved for use in patients with metastatic colorectal cancer refractory to 5-FU and irinotecan.

Added text about the PRIME study in which patients were randomly assigned to FOLFOX4 with or without panitumumab as first-line therapy for metastatic colorectal cancer; however, the study was amended to enlarge the sample size to address patients with KRAS wild-type tumors and patients with mutant KRAS tumors separately and found that for patients with KRAS wild-type tumors, a statistically significant improvement in PFS was observed in those who received panitumumab-FOLFOX4 compared with those who received FOLFOX4 alone (cited Douillard et al. as reference 76 and level of evidence 1iiDiii).

Added text about the addition of panitumumab to a regimen of FOLFOX/bevacizumab that resulted in a worse PFS and worse toxicity compared to a regimen of FOLFOX/bevacizumab alone in patients not selected for KRAS mutation in metastatic colon cancer (cited Hecht et al. as reference 77 and level of evidence 1iiDiii).

Added text about another study in which patients with metastatic colorectal cancer who had already received a fluoropyrimidine regimen were randomly assigned to either FOLFIRI or FOLFIRI plus panitumumab; in a post hoc analysis, patients with KRAS wild-type tumors experienced a statistically significant PFS advantage (cited Peeters et al. as reference 78 and level of evidence 1iiDiii). Concluded with text to state that patients with mutant KRAS tumors experienced no benefit from the addition of panitumumab.

Added text to state that it is unproven whether these EGFR agents should be combined or used in a sequential approach.

Purpose of This Summary

This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the treatment of colon cancer. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.

Reviewers and Updates

This summary is reviewed regularly and updated as necessary by the PDQ Adult Treatment Editorial Board. Board members review recently published articles each month to determine whether an article should:

  • be discussed at a meeting,
  • be cited with text, or
  • replace or update an existing article that is already cited.

Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.

The lead reviewers for Colon Cancer Treatment are:

  • Russell S. Berman, MD (New York University School of Medicine)
  • David P. Ryan, MD (Massachusetts General Hospital)
  • Raymond C. Wadlow, MD (Massachusetts General Hospital)

Any comments or questions about the summary content should be submitted to Cancer.gov through the Web site's Contact Form. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.

Levels of Evidence

Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Adult Treatment Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.

Permission to Use This Summary

PDQ is a registered trademark. Although the content of PDQ documents can be used freely as text, it cannot be identified as an NCI PDQ cancer information summary unless it is presented in its entirety and is regularly updated. However, an author would be permitted to write a sentence such as "NCI's PDQ cancer information summary about breast cancer prevention states the risks succinctly: [include excerpt from the summary]."

The preferred citation for this PDQ summary is:

National Cancer Institute: PDQ® Colon Cancer Treatment. Bethesda, MD: National Cancer Institute. Date last modified <MM/DD/YYYY>. Available at: http://cancer.gov/cancertopics/pdq/treatment/colon/HealthProfessional. Accessed <MM/DD/YYYY>.

Images in this summary are used with permission of the author(s), artist, and/or publisher for use within the PDQ summaries only. Permission to use images outside the context of PDQ information must be obtained from the owner(s) and cannot be granted by the National Cancer Institute. Information about using the illustrations in this summary, along with many other cancer-related images, is available in Visuals Online, a collection of over 2,000 scientific images.

Disclaimer

Based on the strength of the available evidence, treatment options may be described as either "standard" or "under clinical evaluation." These classifications should not be used as a basis for insurance reimbursement determinations. More information on insurance coverage is available on Cancer.gov on the Coping with Cancer: Financial, Insurance, and Legal Information page.

Contact Us

More information about contacting us or receiving help with the Cancer.gov Web site can be found on our Contact Us for Help page. Questions can also be submitted to Cancer.gov through the Web site's Contact Form.

Last Revised: 2011-04-13

© 1995-2011 Healthwise, Incorporated. Healthwise, Healthwise for every health decision, and the Healthwise logo are trademarks of Healthwise, Incorporated. This information does not replace the advice of a doctor. Healthwise, Incorporated disclaims any warranty or liability for your use of this information. Your use of this information means that you agree to the Terms of Use. How this information was developed to help you make better health decisions.

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