Department of Oncology, Sheba Medical Center, Tel-Hashomer, Israel; Tel-Aviv University, Tel-Aviv, Israel.
Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.
Eur J Cancer. 2018 Jun;96:105-110. doi: 10.1016/j.ejca.2018.03.022. Epub 2018 Apr 24.
The International Duration Evaluation of Adjuvant therapy (IDEA) pooled analysis compared 3 to 6 months of adjuvant chemotherapy for stage III colon cancer. The overarching goal was to reduce chemotherapy-related toxicity, mainly oxaliplatin-induced neuropathy. Patients were classified into low-risk and high-risk groups, suggesting that low-risk patients may be offered only 3 months of treatment. We aimed to evaluate the benefit of monotherapy versus doublet chemotherapy in low and high IDEA risk groups.
Using the National Cancer Database (2004-2014), we identified 56,728 low-risk and 47,557 high-risk individuals with stage III colon cancer, according to the IDEA classification. We used multivariate Cox regression to evaluate the magnitude of survival differences between IDEA risk groups, according to treatment intensity (doublet versus monotherapy). In a secondary analysis, we examined the prognostic and predictive value of subgroups of age, tumour sidedness and lymph node ratio (LNR).
Low and high IDEA risk groups derived similar benefit from doublet adjuvant chemotherapy as compared with monotherapy, with hazard ratios (HRs) of 0.83 (95% confidence interval [CI] 0.79-0.86) and 0.80 (95% CI 0.78-0.83), respectively. The only subpopulations that did not benefit from doublet chemotherapy were low-risk patients older than 72 years (HR = 0.95, 95% CI 0.90-1.01) and high-risk patients older than 85 years (HR = 0.90, 95% CI 0.77-1.05). LNR and tumour sidedness were shown as additional prognostic, but not predictive, factors within the IDEA risk groups.
IDEA risk classification per se does not predict for treatment benefit from doublet chemotherapy in stage III colon cancer. However, omission of oxaliplatin can be considered in IDEA low-risk patients older than 72 years.
国际辅助治疗持续时间评估(IDEA)的汇总分析比较了 III 期结肠癌患者接受 3 至 6 个月的辅助化疗。其首要目标是降低化疗相关毒性,主要是奥沙利铂诱导的周围神经病变。患者被分为低风险和高风险组,提示低风险患者可能只接受 3 个月的治疗。我们旨在评估低危和高危 IDEA 风险组中单药治疗与双联化疗的获益。
利用国家癌症数据库(2004-2014 年),根据 IDEA 分类,我们确定了 56728 例低危和 47557 例高危 III 期结肠癌患者。我们使用多变量 Cox 回归评估 IDEA 风险组之间根据治疗强度(双联化疗与单药化疗)生存差异的幅度。在二次分析中,我们检查了年龄、肿瘤侧和淋巴结比值(LNR)亚组的预后和预测价值。
低危和高危 IDEA 风险组从辅助双联化疗中获得的获益与单药治疗相似,危险比(HR)分别为 0.83(95%置信区间[CI] 0.79-0.86)和 0.80(95% CI 0.78-0.83)。唯一没有从双联化疗中获益的亚组是低危组中年龄大于 72 岁的患者(HR=0.95,95% CI 0.90-1.01)和高危组中年龄大于 85 岁的患者(HR=0.90,95% CI 0.77-1.05)。LNR 和肿瘤侧位被证明是 IDEA 风险组中的额外预后因素,但不是预测因素。
IDEA 风险分类本身并不能预测 III 期结肠癌患者从双联化疗中获益。然而,对于 IDEA 低危组中年龄大于 72 岁的患者,可以考虑省略奥沙利铂。