Originally published as JCO Early Release 10.1200/JCO.2008.18.5710 on March 9 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Fields, A. L.A. Articles by Wissel, P. Search for Related Content PubMed PubMed Citation Articles by Fields, A. L.A. Articles by Wissel, P. Related Articles Related Editorial Social Bookmarking                            What's this?

Adjuvant Therapy With the Monoclonal Antibody Edrecolomab Plus Fluorouracil-Based Therapy Does Not Improve Overall Survival of Patients With Stage III Colon Cancer

From the Cross Cancer Institute, Edmonton, Alberta, Canada; US Oncology, Tulsa, OK; West Clinic, Memphis, TN; University of North Carolina, Chapel Hill, NC; Ochsner Clinic, New Orleans, LA; The Consultant Group, Nashville, TN; US Oncology, Newport News, VA; Calfornia Cancer Care, Greenbrae, CA; and GlaxoSmithKline, Greenford, United Kingdom, and Collegeville, PA.

Corresponding author: Paul Wissel, MD, 1250 South Collegeville Rd, Collegeville, PA 19426; e-mail: paul.s.wissel{at}gsk.com.

Purpose Edrecolomab (ED) is a murine monoclonal antibody targeting the EpCam antigen. This phase III randomized multicenter trial investigated the benefit of adding ED to fluorouracil (FU) based therapy in patients with stage III colorectal cancer.

Patients and Methods Patients with stage III colon cancer were randomly assigned to one of two treatments after curative surgery. Patients in arm 1 received five infusions of ED together with FU-based chemotherapy; patients in arm 2 received FU-based chemotherapy alone. The primary end point was overall survival (OS).

Results One thousand eight hundred thirty-nine patients were randomly assigned; results were analyzed on an intent-to-treat basis. Patient characteristics were well-balanced across treatment arms. Five-year follow-up has been completed. Patients randomly assigned to ED plus FU-based therapy showed a 5-year survival rate of 69.6% while for patients receiving FU-based therapy, the rate was 68.2%. The hazard ratio for death with ED plus FU-based therapy compared to FU-based therapy was 0.896 (95% CI, 0.752 to 1.068), which was not statistically significant (P = .220). The adverse effect profiles of the two treatment arms were similar, with the main adverse effects being diarrhea, abdominal pain, and nausea. Anaphylaxis occurred in fewer than 1% of patients receiving ED.

Conclusion For patients with stage III colon cancer, the addition of ED to FU-based therapy had no statistically significant effect on OS.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Editorial

• When Wishful Thinking Leads to a Misty-Eyed Appraisal: The Story of the Adjuvant Colon Cancer Trials With Edrecolomab
  Hans-Joachim Schmoll and Dirk Arnold
  JCO 2009 27: 1926-1929 [Full Text]

This article has been cited by other articles:

				H.-J. Schmoll and D. Arnold When Wishful Thinking Leads to a Misty-Eyed Appraisal: The Story of the Adjuvant Colon Cancer Trials With Edrecolomab J. Clin. Oncol., April 20, 2009; 27(12): 1926 - 1929. [Full Text] [PDF]