Keywords:
CANCER
;
SURVIVAL
;
tumor
;
Germany
;
THERAPY
;
TOXICITY
;
FOLLOW-UP
;
COHORT
;
DRUG
;
MONOCLONAL-ANTIBODY
;
PATIENT
;
murine
;
colon
;
treatment
;
antibodies
;
antibody
;
GLYCOPROTEIN
;
TRIAL
;
COLON-CANCER
;
MONOCLONAL-ANTIBODIES
;
FLUOROURACIL
;
folinic acid
;
ONCOLOGY
;
colon cancer
;
overall survival
;
ADJUVANT THERAPY
;
SWITZERLAND
;
methods
;
PHASE
;
monoclonal antibodies
;
monoclonal antibody
;
edrecolomab
;
MONOCLONAL-ANTIBODY THERAPY
;
stage II
Abstract:
Background: In a phase III study recruiting patients with stage II colon cancer the effect of adjuvant therapy with edrecolomab, a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, was compared to observation alone. Patients and Methods: From January 1997 until July 2000 a total of 377 patients were postoperatively stratified according to tumor stage (T3 vs. T4) and center, and randomly allocated to either treatment with edrecolomab ( cohort A, n = 183) or observation ( cohort B, n = 194). Patients in cohort A received a total of 900 mg edrecolomab. The study was terminated prematurely because of discontinuation of drug supply in Germany. Results: 305 patients were eligible for the primary endpoint of overall survival and 282 patients for disease-free survival. After a median follow-up of 42 months overall survival and disease-free survival were not significantly different. Toxicity was mild. Conclusions: In the present study, postoperative adjuvant treatment with edrecolomab in patients with resected stage II colon cancer did not improve overall or disease-free survival
Type of Publication:
Journal article published
Deep Link:
http://www.dkfz.de/cgi-bin/sel?http://www.dkfz.de/PublicationManager/Show/ShowJournal.aspx%3fpublishedId=2157
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