Margalit Ofer, Boursi Ben, Rakez Manel, Thierry André, Yothers Greg, Wolmark Norman, Haller Daniel G, Schmoll Hans-Joachim, Shi Qian, Shacham-Shmueli Einat, de Gramont Aimery
Department of Oncology, Sheba Medical Center, Tel-Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Department of Oncology, Sheba Medical Center, Tel-Hashomer, Israel; Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Clin Colorectal Cancer. 2021 Jun;20(2):130-136. doi: 10.1016/j.clcc.2021.02.001. Epub 2021 Feb 19.
The International Duration Evaluation of Adjuvant Chemotherapy (IDEA) pooled analysis compared 3 to 6 months of adjuvant chemotherapy for stage III colon cancer. Patients were classified into low risk and high risk, suggesting low-risk patients may be offered only 3 months of treatment. In this study, we aimed to assess the benefit of oxaliplatin in the adjuvant setting per IDEA risk groups, using data from 3 large adjuvant phase III studies, namely Multicenter International Study of Oxaliplatin/Fluorouracil/ Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC), C-07, and XELOXA.
Using the MOSAIC, C-07, and XELOXA previously published studies, we identified 2810 low-risk and 2124 high-risk patients with stage III colon cancer. We used Cox regression model to evaluate the magnitude of survival differences between IDEA risk groups, according to oxaliplatin use. Based on design similarity and equivalent follow-up data, MOSAIC and C-07 were pooled, whereas XELOXA was analyzed separately. Subgroup analyses were also performed for T4 and/or N2 patients.
Individuals with IDEA low and high risk derived overall survival benefit from the addition of oxaliplatin to adjuvant chemotherapy, with adjusted hazard ratios of 0.79 (0.66-0.95) and 0.84 (0.71-0.99), respectively. Among individuals with IDEA high risk, those with T4 disease did not gain overall survival benefit from addition of oxaliplatin with hazard ratio of 0.95 (0.71-1.27). Similar results were demonstrated using data from the XELOXA study.
IDEA risk classification per se does not predict benefit from addition of oxaliplatin to adjuvant chemotherapy in stage III colon cancer. T4 disease may predict lack of benefit from oxaliplatin addition.
国际辅助化疗持续时间评估（IDEA）汇总分析比较了 III 期结肠癌辅助化疗 3 至 6 个月的疗效。患者被分为低风险和高风险，这表明低风险患者可能仅需接受 3 个月的治疗。在本研究中，我们旨在利用三项大型辅助 III 期研究的数据，即奥沙利铂/氟尿嘧啶/亚叶酸钙辅助治疗结肠癌多中心国际研究（MOSAIC）、C-07 和 XELOXA，评估 IDEA 风险组中奥沙利铂在辅助治疗中的获益情况。
利用 MOSAIC、C-07 和 XELOXA 先前发表的研究，我们确定了 2810 例低风险和 2124 例高风险 III 期结肠癌患者。我们使用 Cox 回归模型，根据奥沙利铂的使用情况，评估 IDEA 风险组之间生存差异的幅度。基于设计相似性和等效的随访数据，将 MOSAIC 和 C-07 合并，而 XELOXA 单独分析。还对 T4 和/或 N2 患者进行了亚组分析。
IDEA 低风险和高风险个体在辅助化疗中添加奥沙利铂均可获得总体生存获益，校正风险比分别为 0.79（0.66 - 0.95）和 0.84（0.71 - 0.99）。在 IDEA 高风险个体中，T4 疾病患者添加奥沙利铂未获得总体生存获益，风险比为 0.95（0.71 - 1.27）。使用 XELOXA 研究的数据也得到了类似结果。
IDEA 风险分类本身并不能预测 III 期结肠癌辅助化疗中添加奥沙利铂的获益情况。T4 疾病可能预示添加奥沙利铂无获益。
