Department of Gastroenterology and Digestive Oncology, Georges Pompidou European Hospital, SIRIC CARPEM, Paris-Cité University, Paris, France.
Department of Quantitative Health Science, Mayo Clinic, Rochester, MN.
J Clin Oncol. 2024 Jul 1;42(19):2295-2305. doi: 10.1200/JCO.23.01326. Epub 2024 Mar 28.
A number of studies suggest that older patients may have reduced or no benefit from the addition of oxaliplatin to fluoropyrimidines as adjuvant chemotherapy for stage III colon cancer (CC).
We studied the prognostic impact of age, as well as treatment adherence/toxicity patterns according to age, in patients with stage III CC who received 3 or 6 months of infusional fluorouracil, leucovorin, and oxaliplatin/capecitabine and oxaliplatin (CAPOX) on the basis of data collected from trials from the ACCENT and IDEA databases. Associations between age and time to recurrence (TTR), disease-free survival (DFS), overall survival (OS), survival after recurrence (SAR), and cancer-specific survival (CSS) were assessed by a Cox model or a competing risk model, stratified by studies and adjusted for sex, performance status, T and N stage, and year of enrollment.
A total of 17,909 patients were included; 24% of patients were age older than 70 years (n = 4,340). Patients age ≥70 years had higher rates of early treatment discontinuation. Rates of grade ≥3 adverse events were similar between those older and younger than 70 years, except for diarrhea and neutropenia that were more frequent in older patients treated with CAPOX (14.2% 11.2%; = .01 and 12.1% 9.6%; = .04, respectively). In multivariable analysis, TTR was not significantly different between patients <70 years and those ≥70 years, but DFS, OS, SAR, and CSS were significantly shorter in those patients ≥70 years.
In patients ≥70 years with stage III CC fit enough to be enrolled in clinical trials, oxaliplatin-based adjuvant chemotherapy was well tolerated and led to similar TTR compared with younger patients, suggesting similar efficacy. TTR may be a more appropriate end point for efficacy in this patient population.
多项研究表明，对于接受氟嘧啶类药物辅助化疗的 III 期结肠癌（CC）老年患者，添加奥沙利铂可能获益减少或没有获益。
我们根据 ACCENT 和 IDEA 数据库试验数据，研究了 III 期 CC 患者年龄的预后影响，以及根据年龄接受 3 或 6 个月输注氟尿嘧啶、亚叶酸钙和奥沙利铂/卡培他滨或奥沙利铂（CAPOX）治疗的患者的治疗依从性/毒性模式。采用 Cox 模型或竞争风险模型评估年龄与无复发生存时间（TTR）、无病生存（DFS）、总生存（OS）、复发后生存（SAR）和癌症特异性生存（CSS）之间的关联，该模型按研究分层，并按性别、体能状态、T 和 N 分期以及入组年份进行调整。
共纳入 17909 例患者；24%的患者年龄大于 70 岁（n=4340）。年龄≥70 岁的患者早期治疗中断率较高。年龄≥70 岁与年龄<70 岁的患者相比，≥3 级不良事件发生率相似，除 CAPOX 治疗的老年患者腹泻和中性粒细胞减少发生率较高（14.2% vs 11.2%；.01 和 12.1% vs 9.6%；.04）。多变量分析显示，年龄<70 岁和年龄≥70 岁的患者 TTR 无显著差异，但年龄≥70 岁的患者 DFS、OS、SAR 和 CSS 明显较短。
对于体能状况适合参加临床试验的 III 期 CC 老年患者，奥沙利铂为基础的辅助化疗耐受性良好，与年轻患者相比 TTR 相似，提示疗效相似。TTR 可能是该患者人群中疗效的更合适终点。
