Both, CapOx-bevacizumab and mCapIri-bevacizumab, show promising activity and an excellent toxic effect profile. Efficacy is in the range of other bevacizumab-containing combination regimen although lower doses of irinotecan and capecitabine were selected for mCapIri.
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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