Hôpital Saint-Antoine, Paris, France.
J Clin Oncol. 2012 Sep 20;30(27):3353-60. doi: 10.1200/JCO.2012.42.5645. Epub 2012 Aug 20.
PURPOSE: Oxaliplatin combined with fluoropyrimidine improves survival in patients with stage III colon cancer. However, adjuvant chemotherapy with oxaliplatin is controversial in stage II and elderly patients. PATIENTS AND METHODS: We performed subgroup analyses of stage II and elderly patients randomly assigned fluorouracil with leucovorin (FL) ± oxaliplatin (FOLFOX4) in the Multicenter International Study of Oxaliplatin/Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer study. Comorbidities, severe adverse events, second cancers, management of relapse and death as a result of causes than other colon cancer were studied. RESULTS: Two thousand two hundred forty-six patients were enrolled. Overall, 899 patients had stage II disease, including 330 low-risk and 569 high-risk patients. A total of 315 patients were ages 70 to 75 years. For stage II patients, the hazard ratio (HR) for comparing FOLFOX4 with FL was 0.84 (95% CI, 0.62 to 01.14) for disease-free survival (DFS), 0.70 (95% CI, 0.49 to 0.99) for time to recurrence (TTR), and 1.00 (95% CI, 0.70 to 1.41) for overall survival (OS). There was no interaction between treatment and stage or age. Low-risk stage II patients did not benefit from oxaliplatin. In high-risk stage II patients, the HR comparing FOLFOX4 with FL was 0.72 (95% CI, 0.51 to 1.01) for DFS, 0.62 (95% CI, 0.41 to 0.92) for TTR, and 0.91 (95% CI, 0.61 to 1.36) for OS. In elderly patients, the HR comparing FOLFOX4 with FL was 0.93 (95% CI, 0.64 to 1.35) for DFS, 0.72 (95% CI, 0.47 to 1.11) for TTR, and 1.10 (95% CI, 0.73 to 1.65) for OS. CONCLUSION: The results of these subset analyses show no statistically significant benefit (OS and DFS) for the addition of oxaliplatin to FL as adjuvant treatment for either stage II and elderly patients.
目的：奥沙利铂联合氟嘧啶可提高 III 期结肠癌患者的生存率。然而，在 II 期和老年患者中，奥沙利铂辅助化疗存在争议。
方法：我们对接受氟尿嘧啶联合亚叶酸钙（FL）±奥沙利铂（FOLFOX4）辅助治疗的 II 期和老年患者进行了多中心国际奥沙利铂/氟尿嘧啶/亚叶酸钙辅助治疗结肠癌研究的亚组分析。研究了合并症、严重不良事件、第二原发癌、复发的处理以及其他结肠癌以外原因导致的死亡。
结果：共纳入 2246 例患者。总体而言，899 例患者为 II 期疾病，包括 330 例低危患者和 569 例高危患者。共有 315 例患者年龄在 70 至 75 岁之间。对于 II 期患者，FOLFOX4 与 FL 相比，无病生存期（DFS）的风险比（HR）为 0.84（95%CI，0.62 至 0.114），复发时间（TTR）为 0.70（95%CI，0.49 至 0.99），总生存期（OS）为 1.00（95%CI，0.70 至 1.41）。治疗与分期或年龄之间无交互作用。低危 II 期患者不能从奥沙利铂中获益。在高危 II 期患者中，FOLFOX4 与 FL 相比，DFS 的 HR 为 0.72（95%CI，0.51 至 1.01），TTR 为 0.62（95%CI，0.41 至 0.92），OS 为 0.91（95%CI，0.61 至 1.36）。在老年患者中，FOLFOX4 与 FL 相比，DFS 的 HR 为 0.93（95%CI，0.64 至 1.35），TTR 的 HR 为 0.72（95%CI，0.47 至 1.11），OS 的 HR 为 1.10（95%CI，0.73 至 1.65）。
结论：这些亚组分析的结果显示，奥沙利铂联合 FL 作为 II 期和老年患者的辅助治疗，在统计学上并没有显著提高 OS 和 DFS。
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