HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Adjuvant therapy with edrecolomab versus observation in stage II colon cancer: a multicenter randomized phase III study.

AbstractBACKGROUND:
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.
AuthorsG Hartung, R-D Hofheinz, Y Dencausse, J Sturm, A Kopp-Schneider, G Dietrich, I Fackler-Schwalbe, D Bornbusch, M Gonnermann, C Wojatschek, W Lindemann, H Eschenburg, K Jost, L Edler, A Hochhaus, W Queisser
JournalOnkologie (Onkologie) Vol. 28 Issue 6-7 Pg. 347-50 (Jun 2005) ISSN: 0378-584X [Print] Switzerland
PMID15933423 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Murine-Derived
  • Antineoplastic Agents
  • Edrecolomab
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal (administration & dosage)
  • Antibodies, Monoclonal, Murine-Derived
  • Antineoplastic Agents (therapeutic use)
  • Chemotherapy, Adjuvant (methods)
  • Cohort Studies
  • Colonic Neoplasms (drug therapy, mortality, pathology, surgery)
  • Disease-Free Survival
  • Female
  • Germany (epidemiology)
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Prognosis
  • Risk Assessment (methods)
  • Risk Factors
  • Severity of Illness Index
  • Survival Analysis
  • Treatment Outcome

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: