Abstract | BACKGROUND: 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.
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Authors | G 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 |
Journal | Onkologie
(Onkologie)
Vol. 28
Issue 6-7
Pg. 347-50
(Jun 2005)
ISSN: 0378-584X [Print] Switzerland |
PMID | 15933423
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Murine-Derived
- Antineoplastic Agents
- Edrecolomab
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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
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