Original Article · Originalarbeit

Adjuvant Therapy with Edrecolomab versus Observation in Stage II Colon Cancer: A Multicenter Randomized Phase III Study*
G. Hartung^a; R-D. Hofheinz^b; Y. Dencausse^b; J. Sturm^c; A. Kopp-Schneider^d; G. Dietrich^e; I. Fackler-Schwalbe^f; D. Bornbusch^g; M. Gonnermann^h; C. Wojatschekⁱ; W. Lindemann^j; H. Eschenburg^k; K. Jost^a; L. Edler^d; A. Hochhaus^b; W. Queißer^b

^aAbteilung Hämatologie und Onkologie, Universität Rostock, ^bOnkologisches Zentrum, III. Medizinische Klinik, ^cChirurgische Klinik, Fakultät für Klinische Medizin Mannheim der Universität Heidelberg, ^dAbteilung Biostatistik, Deutsches Krebsforschungszentrum, Heidelberg, ^eInnere Medizin, Krankenhaus Bietigheim-Bissingen, ^fChirurgische Klinik, Klinikum Passau, ^gChirurgische Klinik, Reinbek, ^hOnkologische Ambulanz, Evangelisches Krankenhaus, Dinslaken, ⁱKlinikum am Plattenwald, Bad Friedrichshall, ^jMedizinische Klinik, Katholisches Kreiskrankenhaus, Hagen, ^kArztpraxis, Güstrow, Germany

Onkologie 2005;28:347-350
(DOI: 10.1159/000084595)

  Summary

iBackground: 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.

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