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66 岁及以上 III 期结肠癌患者不同化疗方案生存获益的比较:基于监测、流行病学和最终结果-医疗保险数据的“真实世界”分析。

Comparative effectiveness of different chemotherapeutic regimens on survival of people aged 66 and older with stage III colon cancer: a "real world" analysis using Surveillance, Epidemiology, and End Results-Medicare data.

机构信息

School of Medicine, Graduate Institute of Clinical Pharmacy, National Taiwan University, Taipei, Taiwan.

出版信息

J Am Geriatr Soc. 2011 Sep;59(9):1717-23. doi: 10.1111/j.1532-5415.2011.03501.x. Epub 2011 Aug 10.

Abstract

OBJECTIVES

To compare the effectiveness and utilization trends of irinotecan (IRI)-based and oxaliplatin (OX)-based regimens with those of 5-fluorouracil and leucovorin (5FU/LV) alone in people aged 66 and older with Stage III colon cancer.

DESIGN

Retrospective cohort study.

SETTING

Data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare data.

PARTICIPANTS

People with Stage III surgically resected colon cancer who received adjuvant chemotherapy were categorized into 5FU/LV-alone (n = 3,581), OX-based regimen (n = 814), and IRI-based regimen (n = 219) subgroups.

MEASUREMENTS

Multivariable Cox proportional hazards models examined the effect of chemotherapies on overall survival, colon cancer-specific survival, and non-colon cancer-specific survival.

RESULTS

Use of the OX-based regimen increased, and use of the 5FU/LV-alone and IRI-based regimens decreased over time. OX was statistically significantly associated with longer overall survival (hazard ratio (HR) = 0.73, 95% confidence interval (CI) = 0.62-0.86, P < .001) and colorectal cancer-specific survival (HR = 0.39, 95% CI, 0.28-0.55, P < .001) than 5FU/LV alone. There was a greater risk of overall mortality (HR = 1.38, 95% CI = 1.14-1.67, P<.001) and cancer-specific mortality (HR = 1.92, 95% CI=1.49-2.47, P < .001) associated with IRI than with 5FU/LV. The superiority of OX on survival was found in participants aged 66 to 79 but not in those aged 80 and older.

CONCLUSION

This "real world" comparative effectiveness research extends randomized controlled trial results by documenting the relative survival benefit of OX in older adults with Stage III colon cancer. The associated shift in treatment away from 5FU/LV alone or IRI toward OX is consistent with evidence-based medicine from real-world outcomes research.

摘要

目的

比较伊立替康(IRI)-基于和奥沙利铂(OX)-基于方案与氟尿嘧啶和亚叶酸(5FU/LV)单独用于年龄在 66 岁及以上 III 期结肠癌患者的疗效和利用趋势。

设计

回顾性队列研究。

设置

来自监测、流行病学和最终结果(SEER)-医疗保险数据。

参与者

接受辅助化疗的 III 期手术切除结肠癌患者分为 5FU/LV 单独组(n = 3581)、OX 方案组(n = 814)和 IRI 方案组(n = 219)。

测量

多变量 Cox 比例风险模型检查了化疗对总生存、结肠癌特异性生存和非结肠癌特异性生存的影响。

结果

OX 方案的使用增加,而 5FU/LV 单独组和 IRI 方案组的使用减少。OX 与总生存(风险比(HR)= 0.73,95%置信区间(CI)= 0.62-0.86,P <.001)和结直肠癌特异性生存(HR = 0.39,95%CI,0.28-0.55,P <.001)显著相关,优于 5FU/LV 单独。与 5FU/LV 相比,IRI 组的总死亡率(HR = 1.38,95%CI = 1.14-1.67,P<.001)和癌症特异性死亡率(HR = 1.92,95%CI=1.49-2.47,P <.001)风险更高。OX 在 66 至 79 岁参与者中的生存优势,但在 80 岁及以上参与者中没有。

结论

这项“真实世界”的比较有效性研究通过记录 OX 在 III 期结肠癌老年患者中的相对生存获益,扩展了随机对照试验结果。治疗从 5FU/LV 单独或 IRI 向 OX 的转移与基于真实世界结果的循证医学一致。

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