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Addition of cetuximab showed safety for advanced colorectal cancer
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Adding cetuximab to capecitabine, oxaliplatin and bevacizumab in the first-line treatment of advanced colorectal cancer did not cause excessive or unexpected toxicity, according to recent data.
From June 2005 to April 2006, researchers from 79 hospitals in the Netherlands randomly assigned 755 patients to two arms. They reported data on toxicity in the first 389 patients: 197 in arm A and 192 in arm B.
Patients in both arms were administered 1,000 mg/m2 of capecitabine (Xeloda, HLR) orally twice daily on days one to 14, 130 mg/m2 of oxaliplatin (Eloxatin, Sanofi-Aventis) IV on day one and 7.5 mg/kg of bevacizumab (Avastin, Genentech) IV on day one. Patients in arm B also received 400 mg/m2 of cetuximab (Erbitux, Merck and ImClone Systems) IV in week one of the first treatment cycle and 250 mg/m2 IV weekly afterward. All cycles were administered every three weeks.
Overall grade 3-4 toxicity was higher in arm B than in arm A: 81% vs. 72% (P=.03). The researchers determined that cetuximab-related skin toxicity caused this difference. When all skin toxicity except hand–foot syndrome was excluded from the analysis of overall grade 3-4 toxicity (P=.87), the difference decreased to 72% in arm A and 71% in arm B, according to the researchers. – by Rob Volansky
Ann Oncol. 2008;19:734-738.
The researchers report that the addition of cetuximab is safe and feasible, with comparable toxicity to the standard chemotherapy plus bevacizumab arm. The only increase in toxicity, as expected, was skin toxicity, which did not translate into problems with therapy delivery or earlier treatment discontinuation due to adverse events. Data on efficacy however, are pending, and this approach is not yet ready for clinical practice because of the negative results of the recent PACCE trial. The researchers from the PACCE trial, who added the EGFR-targeted antibody panitumimab to first-line bevacizumab combination chemotherapy, reported inferior outcomes for the combined antibody therapy approach, with decreased time to progression and decreased overall survival for the combined antibody therapy approach. Unlike in the CAIRO2 trial, the researchers from the PACCE trial also reported greater toxicity for combined antibody therapy. Final efficacy results of the CAIRO2 trial are anxiously awaited. The issue of combination antibody therapy also is being addressed by the ongoing CALGB 80405 trial, comparing first-line FOLFOX or FOLFIRI chemotherapy plus bevacizumab with or without the addition of cetuximab.
– David Ilson, MD
HemOnc Today Editorial Board member