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S-AVANT – Follow-up to the AVANT study up to 8 and 10 years (median follow up) in patients with colon carcinoma

Laufzeit: 01.01.2017 - 31.12.2020

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Kurzfassung


Based on the synergism of bevacizumab in combination with chemotherapy observed in metastatic colorectal cancer, the AVANT study assessed in patients with resected stage II/III colon carcinoma whether bevacizumab provides a benefit when added for 24 weeks to the currently most effective treatment, i.e. FOLFOX-4, as well as XELOX as third arm with capecitabine as an oral fluoropyrimidine, followed by 24 weeks of bevacizumab alone.
The AVANT study aiming at demonstrating superiority of...
Based on the synergism of bevacizumab in combination with chemotherapy observed in metastatic colorectal cancer, the AVANT study assessed in patients with resected stage II/III colon carcinoma whether bevacizumab provides a benefit when added for 24 weeks to the currently most effective treatment, i.e. FOLFOX-4, as well as XELOX as third arm with capecitabine as an oral fluoropyrimidine, followed by 24 weeks of bevacizumab alone.
The AVANT study aiming at demonstrating superiority of bevacizumab in combination with FOLFOX-4 or XELOX compared to FOLFOX-4, did not show prolongation of DFS at 3 year when adding bevacizumab to chemotherapy in resected stage III colon cancer. Of the ITT population (n=3451), 2867 patients had stage III disease (FOLFOX-4 n=955; bevacizumab-FOLFOX-4 n= 960; bevacizumab-XELOX n=952). After a median follow up of 48 months, 237 patients (25) in the FOLFOX-4 group, 280 (29%) in the FOLFOX-4-bevacizumab group and 253 (27%) in the bevacizumab-XELOX group had relapsed, developed a new colon cancer or died. The Disease Free Survival hazard ratio for bevacizumab-FOLFOX-4 versus FOLFOX-4 was 1.17 (95% CI .098-1.39, p=0.07), and for bevacizumab-XELOX versus FOLFOX-4 was 1.07 (95% CI 0.90-1.28; p=0.44). Adverse events were consistent with the known safety profile of bevacizumab. However, more relapses and deaths due to disease progression have been observed in both bevacizumab arms. A more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety.
This S-AVANT study will be an extension at 8 and 10 years median follow-up of patients previously included in the AVANT trial. Further analysis will be performed focusing on DFS, Time to Relapse (TTR) and Overall survival, second cancers, co-morbidities, observed during the follow up period and treatment after relapse if any. It is also an opportunity to evaluate OS and therapy after first relapse.
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