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根据年龄分层的转移性结直肠癌一线治疗中靶向治疗的使用模式、安全性和有效性:STROMBOLI 队列研究。

Patterns of Use, Safety, and Effectiveness of Targeted Therapies in First-Line Treatment of Metastatic Colorectal Cancer According to Age: The STROMBOLI Cohort Study.

机构信息

Univ Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, Bordeaux, France; Bordeaux PharmacoEpi, INSERM CIC1401, Bordeaux, France; CHU de Bordeaux, Pôle de Sante publique, Service de Pharmacologie médicale, Bordeaux, France.

Univ Bordeaux, Inserm, Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219, Bordeaux, France; CHU de Bordeaux, Pôle de Sante publique, Service de Pharmacologie médicale, Bordeaux, France.

出版信息

Clin Colorectal Cancer. 2019 Mar;18(1):e150-e162. doi: 10.1016/j.clcc.2018.11.005. Epub 2018 Nov 29.

Abstract

BACKGROUND

Metastatic colorectal cancer (mCRC) is increasingly treated using targeted therapies. Their real-life evaluation is insufficient, especially in elderly and frail patients. The aim was to describe use, safety, and effectiveness of targeted therapies in first-line mCRC treatment according to age.

PATIENTS AND METHODS

Two field cohorts of patients initiating bevacizumab or cetuximab for first-line mCRC were pooled. Patients characteristics, use, and safety were compared between younger and elderly patients (<75 vs. ≥75 years). Two-year overall survival (OS) and progression-free survival (PFS) were estimated in both age groups using the Kaplan-Meier method adjusted on factors associated with death or progression identified with Cox multivariate modeling.

RESULTS

Eight hundred patients (n = 411, 51.4% bevacizumab) were included: 498 (62.3%) male, median age 64 years, 118 (14.8%) Eastern Cooperative Oncology Group performance status (ECOG-PS) ≥2. Elderly patients (n = 126, 15.8%) were more often treated with 5-fluorouracil alone than younger. Severe adverse events were equivalent across age groups. ECOG-PS ≥1, abnormal hemoglobin, and abnormal alkaline phosphatases were associated with a higher risk of death; OS adjusted on these factors was similar between elderly and younger patients. ECOG-PS ≥1, lung metastases, abnormal hemoglobin, and abnormal creatinine clearance were associated with a higher risk of progression or death; PFS adjusted on these factors was similar across groups.

CONCLUSION

Despite treatment adaptations, elderly patients could benefit from targeted therapies as younger without safety warning.

摘要

背景

转移性结直肠癌(mCRC)越来越多地采用靶向治疗。其真实世界的评估还不够充分,尤其是在老年和体弱患者中。本研究旨在根据年龄描述一线 mCRC 治疗中靶向治疗的使用、安全性和有效性。

患者和方法

汇总了接受贝伐珠单抗或西妥昔单抗一线治疗 mCRC 的两个现场队列患者。比较了年龄<75 岁和≥75 岁的患者之间的特征、使用和安全性。采用 Kaplan-Meier 法,根据与死亡或进展相关的因素进行 Cox 多变量建模调整,估计两组的 2 年总生存期(OS)和无进展生存期(PFS)。

结果

共纳入 800 例患者(n = 411,51.4%接受贝伐珠单抗治疗):498 例(62.3%)为男性,中位年龄 64 岁,118 例(14.8%)ECOG-PS≥2。老年患者(n = 126,15.8%)比年轻患者更常接受氟尿嘧啶单药治疗。两组严重不良事件发生率相当。ECOG-PS≥1、血红蛋白异常和碱性磷酸酶异常与死亡风险增加相关;调整这些因素后,老年和年轻患者的 OS 相似。ECOG-PS≥1、肺转移、血红蛋白异常和肌酐清除率异常与进展或死亡风险增加相关;调整这些因素后,两组的 PFS 相似。

结论

尽管存在治疗调整,但老年患者与年轻患者一样,可以从靶向治疗中获益,且没有安全性警告。

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