BACKGROUND The bevacizumab-Avastin® adjuVANT (AVANT) study did not meet its primary end point of improving disease-free survival (DFS) with the addition of bevacizumab to oxaliplatin-based chemotherapy in stage III colon cancer (CC). We report here the long-term survival results (S-AVANT). PATIENTS AND METHODS Patients with curatively resected stage III CC were randomly assigned to FOLFOX4, FOLFOX4-bevacizumab, or XELOX-bevacizumab. RESULTS A total of 2867 patients were randomized: FOLFOX4: n = 955, FOLFOX4-bevacizumab: n = 960, XELOX-bevacizumab: n = 952. With a median of 6.73 years follow-up (interquartile range 5.51-10.54), 672 patients died, of whom 198 (20.7%), 250 (26.0%), and 224 (23.5%) were in the FOLFOX4, FOLFOX4-bevacizumab, and XELOX-bevacizumab arms, respectively. The 10-year overall survival (OS) rates were 74.6%, 67.2%, and 69.9%, (P = 0.003) and 5-year disease-free survival (DFS) rates were 73.2%, 68.5%, and 71.0% (P = 0.174), respectively. OS and DFS hazard ratios were 1.29 [95% confidence interval (CI) 1.07-1.55; P = 0.008] and 1.16 (95% CI 0.99-1.37; P = 0.063) for FOLFOX4-bevacizumab versus FOLFOX4 and 1.15 (95% CI 0.95-1.39; P = 0.147) and 1.1 (95% CI 0.93-1.29; P = 0.269) for XELOX-bevacizumab versus FOLFOX4, respectively. CC-related deaths (n = 542) occurred in 157 (79.3%) patients receiving FOLFOX4, 205 (82.0%) receiving FOLFOX4-bevacizumab, and 180 (80.4%) receiving XELOX-bevacizumab (P = 0.764), while non-CC-related deaths occurred in 41 (20.7%), 45 (18.0%), and 44 (19.6%) patients, respectively. Cardiovascular-related and sudden deaths during treatment or follow-up were reported in 13 (6.6%), 17 (6.8%), and 14 (6.3%) patients, in the FOLFOX4, FOLFOX4-bevacizuamb, and XELOX-bevacizumab arms, respectively (P = 0.789). Treatment arm, sex, age, histological differentiation, performance status, T/ N stages, and localization of primary tumor were independent prognostic factors of OS in stage III. CONCLUSIONS S-AVANT confirms the initial AVANT report. No benefit of the bevacizumab addition to FOLFOX4 adjuvant therapy in patients with stage III CC was observed in terms of DFS with a negative effect in OS, without increase in non-CC related deaths. CLINICAL TRIAL IDENTIFICATION NCT00112918.

中文翻译：

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贝伐单抗作为结肠癌的辅助治疗：GERCOR 集团 S-AVANT III 期研究的最新结果。

背景 贝伐单抗-Avastin® 佐剂 (AVANT) 研究未达到其主要终点，即在 III 期结肠癌 (CC) 的基于奥沙利铂的化疗中添加贝伐单抗来改善无病生存期 (DFS)。我们在此报告长期生存结果 (S-AVANT)。患者和方法 治愈性切除的 III 期 CC 患者被随机分配到 FOLFOX4、FOLFOX4-贝伐单抗或 XELOX-贝伐单抗。结果 共有 2867 名患者被随机分组​​：FOLFOX4：n = 955，FOLFOX4-贝伐单抗：n = 960，XELOX-贝伐单抗：n = 952。中位随访时间为 6.73 年（四分位距 5.51-10.54），672 名患者死亡，其中 FOLFOX4、FOLFOX4-贝伐单抗和 XELOX-贝伐单抗组分别有 198 人（20.7%）、250 人（26.0%）和 224 人（23.5%）。10 年总生存率（OS）分别为 74.6%、67.2% 和 69.9%，(P = 0.003) 和 5 年无病生存 (DFS) 率分别为 73.2%、68.5% 和 71.0% (P = 0.174)。OS 和 DFS 风险比为 1.29 [95% 置信区间 (CI) 1.07-1.55；FOLFOX4-贝伐单抗对比 FOLFOX4 和 1.15（95% CI 0.95-1.39；P = 0.147）和 1.1（95% CI 0.93-1.29；P = XELOX-贝伐单抗与 FOLFOX4 分别为 0.269）。CC 相关死亡 (n = 542) 发生在 157 (79.3%) 名接受 FOLFOX4 的患者、205 名 (82.0%) 接受 FOLFOX4-贝伐单抗和 180 (80.4%) 接受 XELOX-贝伐单抗 (P = 0.764) 的患者中，而非 CC相关死亡分别发生在 41 名 (20.7%)、45 名 (18.0%) 和 44 名 (19.6%) 患者中。在 FOLFOX4、分别为 FOLFOX4-贝伐单抗和 XELOX-贝伐单抗组 (P = 0.789)。治疗组、性别、年龄、组织学分化、体能状态、T/N分期和原发肿瘤的定位是III期OS的独立预后因素。结论 S-AVANT 证实了最初的 AVANT 报告。在 III 期 CC 患者中，在 FOLFOX4 辅助治疗中添加贝伐单抗在 DFS 方面没有观察到任何益处，但对 OS 有负面影响，但非 CC 相关死亡人数没有增加。临床试验鉴定 NCT00112918。在 III 期 CC 患者中，在 FOLFOX4 辅助治疗中添加贝伐单抗在 DFS 方面没有观察到任何益处，但对 OS 有负面影响，但非 CC 相关死亡人数没有增加。临床试验鉴定 NCT00112918。在 III 期 CC 患者中，在 FOLFOX4 辅助治疗中添加贝伐单抗在 DFS 方面没有观察到任何益处，但对 OS 有负面影响，但非 CC 相关死亡人数没有增加。临床试验鉴定 NCT00112918。