Adjuvant Therapy with Edrecolomab versus Observation in Stage II Colon Cancer: A Multicenter Randomized Phase III Study*

Publisher： Karger

E-ISSN： 2296-5262|28|6-7|347-350

ISSN： 2296-5270

Source： Oncology Research and Treatment, Vol.28, Iss.6-7, 2005-06, pp. : 347-350

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Abstract

iBackground: In a phase III study recruiting patients with stage IIcolon cancer the effect of adjuvant therapy with edrecolomab, amurine monoclonal antibody to the cell-surface glycoprotein 17-1A,was compared to observation alone. Patients and Methods: FromJanuary 1997 until July 2000 a total of 377 patients were postoperativelystratified according to tumor stage (T3 vs. T4) and center, andrandomly allocated to either treatment with edrecolomab (cohortA, n = 183) or observation (cohort B, n = 194). Patients in cohort Areceived a total of 900 mg edrecolomab. The study was terminatedprematurely because of discontinuation of drug supply in Germany.Results: 305 patients were eligible for the primary endpoint of overallsurvival and 282 patients for disease-free survival. After a medianfollow-up of 42 months overall survival and disease-free survivalwere not significantly different. Toxicity was mild. Conclusions: Inthe present study, postoperative adjuvant treatment with edrecolomabin patients with resected stage II colon cancer did not improveoverall or disease-free survival.