对于高危 II 期和 III 期结肠癌患者，3 个月与 6 个月的辅助 FOLFOX 或 CAPOX 方案：希腊肿瘤研究组（HORG）参与国际辅助化疗持续时间评估（IDEA）项目的疗效结果。
Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project.
机构信息
Hellenic Oncology Research Group, Athens, Greece.
Hellenic Oncology Research Group, Athens, Greece.
出版信息
Ann Oncol. 2019 Aug 1;30(8):1304-1310. doi: 10.1093/annonc/mdz193.
BACKGROUND
The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) aimed to investigate whether a 3 months (3M) of oxaliplatin/fluoropyrimidine-based adjuvant chemotherapy (CT) is non-inferior to the 6-month (6M) administration in 3-year disease-free survival (3yDFS) in high-risk (HR) stage II or stage III colon cancer (CC).
METHODS
Hellenic Oncology Research Group (HORG)-IDEA randomized patients between 3M and 6M of CT with FOLFOX4 or CAPOX.
RESULTS
In total 1115 patients, 413 with HR stage II and 702 with stage III CC, were randomized. The median follow-up was 67.0 (38.3-126.0) months. Overall, 394 DFS events (202 in 3M arm and 192 in 6M arm) where recorded. The 3yDFS rate was 77.2% [95% confidence interval (CI) 72.1% to 82.3%] for 3M and 77.9% (72.6% to 82.5%) for 6M of treatment [hazard ratio (HR) 1.05 (95% CI 0.61-1.55); P = 0.647]. Eighty DFS events (3M N = 41; 6M N = 39) were observed in HR stage II patients for a 3yDFS rate of 82.7% and 83.4%, respectively (HR 1.05; 95% CI 0.68-1.63, P = 0.829). For stage III patients, 314 DFS events (3M N = 161 and 6M N = 153) were observed, for a 3yDFS rate of 72.9% for 3M versus 74.1% for 6M (HR 1.06; 95% CI 0.81-1.42, P = 0.622). For HR stage II patients receiving FOLFOX4, 3yDFS rate was 76.7% for 3M and 79.3% for 6M (HR 1.21; 95% CI 0.54-2.70). For HR stage II patients receiving CAPOX the 3yDFS rate was 85.4% for 3M and 83.8% for 6M (HR 0.99; 95% CI 0.59-1.67). For stage III patients receiving FOLFOX4, the 3yDFS rate was 71.5% for 3M and 77.3% for 6M (HR 1.18; 95% CI 0.74-1.86). For stage III patients receiving CAPOX, the 3yDFS rate was 74.5% for 3M and 74.7% for 6M (HR 0.99; 95% CI 0.70-1.44).
CONCLUSIONS
The results of the HORG-IDEA study are in line with those of the global IDEA project, indicating that the 3yDFS is dependent on the administered adjuvant regimen and the choice and duration of regimen should be personalized.
CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT01308086.
背景
国际辅助化疗持续时间评估（IDEA）旨在研究在高危（HR）Ⅱ期或Ⅲ期结肠癌（CC）患者中，3 个月（3M）的奥沙利铂/氟嘧啶类药物辅助化疗（CT）是否与 6 个月（6M）的给药等效，从而达到 3 年无病生存（3yDFS）。
方法
希腊肿瘤研究组（HORG）-IDEA 将患者随机分为接受 FOLFOX4 或 CAPOX 方案的 3M 和 6M CT 组。
结果
共纳入 1115 例患者，其中 HR Ⅱ期 413 例，Ⅲ期 702 例。中位随访时间为 67.0（38.3-126.0）个月。共记录到 394 例 DFS 事件（3M 臂 202 例，6M 臂 192 例）。3M 和 6M 治疗的 3yDFS 率分别为 77.2%（95%CI 72.1%至 82.3%）和 77.9%（72.6%至 82.5%）（HR 1.05，95%CI 0.61-1.55；P=0.647）。在 HR Ⅱ期患者中，观察到 80 例 DFS 事件（3M 臂 N=41，6M 臂 N=39），3yDFS 率分别为 82.7%和 83.4%（HR 1.05，95%CI 0.68-1.63，P=0.829）。在Ⅲ期患者中，观察到 314 例 DFS 事件（3M 臂 N=161，6M 臂 N=153），3yDFS 率分别为 72.9%和 74.1%（HR 1.06，95%CI 0.81-1.42，P=0.622）。在接受 FOLFOX4 方案治疗的 HR Ⅱ期患者中，3M 组和 6M 组的 3yDFS 率分别为 76.7%和 79.3%（HR 1.21，95%CI 0.54-2.70）。在接受 CAPOX 方案治疗的 HR Ⅱ期患者中，3M 组和 6M 组的 3yDFS 率分别为 85.4%和 83.8%（HR 0.99，95%CI 0.59-1.67）。在接受 FOLFOX4 方案治疗的Ⅲ期患者中，3M 组和 6M 组的 3yDFS 率分别为 71.5%和 77.3%（HR 1.18，95%CI 0.74-1.86）。在接受 CAPOX 方案治疗的Ⅲ期患者中，3M 组和 6M 组的 3yDFS 率分别为 74.5%和 74.7%（HR 0.99，95%CI 0.70-1.44）。
结论
HORG-IDEA 研究的结果与全球 IDEA 项目的结果一致，表明 3yDFS 取决于辅助治疗方案，治疗方案的选择和持续时间应个体化。
临床试验注册号
NCT01308086。
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