Department of Pharmaceutical and Health Economics, USC Schaeffer Center.
USC School of Pharmacy, Schaeffer Center for Health Policy and Economics.
Am J Clin Oncol. 2020 Jun;43(6):428-434. doi: 10.1097/COC.0000000000000684.
Previous SEER (Surveillance, Epidemiology, and End Results)-Medicare analyses have shown no definitive survival benefit for adjuvant chemotherapy (AC) with fluoropyrimidines. Impact of oxaliplatin-containing regimens for elderly stage II patients in real-world setting is unknown. We explored the utilization and outcome of AC after the Food and Drug Administration (FDA) approval of oxaliplatin.
Patients with stage II colon cancer (2004-2011) who underwent resection were selected for this analysis. Medicare claims data were used to ascertain the administration of AC within 120 days after surgery. The primary endpoint of the analysis was overall survival. We used the Cox proportional hazards model to estimate the effect of AC while adjusting for clinical and sociodemographic variables available in SEER. To adjust for referral pattern, a source of selection bias, we conducted an instrumental variable analysis using the surgeon of record and health service area.
A total of 16,468 patients were identified and 12.1% received AC. AC recipients were significantly younger, more likely to be male, nonwhite, married, and had lower comorbidity index. Their tumors had a more advanced stage, more likely to be left sided, and were less differentiated. The hazard ratio (HR) from the Cox model showed a statistically significant survival advantage for AC (HR=0.847, 95% confidence interval: 0.782-0.916). However, results from the instrumental variable analysis indicated that there was no definitive benefit of survival in AC recipients (HR=1.779, 95% confidence interval: 0.927-3.415). AC use decreased over time.
After controlling for referral patterns, administration of AC provided no definitive survival benefit. Future studies may elucidate the elderly population who may benefit from AC.
之前的 SEER(监测、流行病学和最终结果)-医疗保险分析表明,氟嘧啶类辅助化疗(AC)并没有明确的生存获益。在真实世界环境中,奥沙利铂联合方案对老年 II 期患者的影响尚不清楚。我们探讨了在食品和药物管理局(FDA)批准奥沙利铂后,AC 的应用和结果。
选择 2004 年至 2011 年间接受手术切除的 II 期结肠癌患者进行此项分析。使用医疗保险索赔数据确定手术后 120 天内是否接受 AC。分析的主要终点是总生存期。我们使用 Cox 比例风险模型来估计 AC 的效果,同时调整 SEER 中可用的临床和社会人口统计学变量。为了调整转诊模式(选择偏差的一个来源),我们使用记录外科医生和卫生服务区域进行了工具变量分析。
共确定了 16468 名患者,其中 12.1%接受了 AC。AC 接受者明显更年轻,更可能是男性、非裔、已婚,且合并症指数较低。他们的肿瘤分期更晚,更可能位于左侧,分化程度较低。Cox 模型的风险比(HR)显示,AC 具有显著的生存优势(HR=0.847,95%置信区间:0.782-0.916)。然而,工具变量分析的结果表明,AC 接受者的生存没有明确获益(HR=1.779,95%置信区间:0.927-3.415)。AC 的应用随时间减少。
在控制转诊模式后,AC 的应用并不能提供明确的生存获益。未来的研究可能会阐明可能从 AC 中获益的老年人群。