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吉西他滨和 nab-紫杉醇在老年转移性胰腺癌患者中的剂量方案。

Dosing Schedules of Gemcitabine and nab-Paclitaxel for Older Adults With Metastatic Pancreatic Cancer.

机构信息

Department of Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.

Department of Biostatistics, Fox Chase Cancer Center, Philadelphia, PA, USA.

出版信息

JNCI Cancer Spectr. 2021 Aug 23;5(5). doi: 10.1093/jncics/pkab074. eCollection 2021 Oct.

Abstract

BACKGROUND

Gemcitabine and nab-paclitaxel (GA) is a first-line treatment for patients with metastatic pancreatic cancer (mPDAC). The traditional dosing schedule of GA is days 1, 8, and 15 of a 28-day cycle. Frequently, older adults are given a modified dosing schedule using 2 doses per cycle because of toxicity. We retrospectively analyzed treatment patterns and outcomes of older adults with mPDAC given these 2 dosing schedules.

METHODS

Patients 65 years or older with mPDAC treated with GA in a nationwide real-world database between January 1, 2014, and May 31, 2019, were included. Demographic, disease, and treatment information were collected. Patients were grouped by dosing at treatment initiation (traditional vs modified dosing schedules). Endpoints were time on treatment (TOT) and overall survival (OS) in patients receiving at least 2 cycles. All statistical tests were 2-sided.

RESULTS

1317 patients were included (traditional dosing schedule: n = 842; modified dosing schedule: n = 475). Median age at diagnosis was 72 and 73 years for traditional and modified dosing schedules, respectively ( < .001), but sex, race, and performance status were not statistically significantly different. The median TOT and OS were better for the traditional vs modified dosing schedule (unadjusted median TOT, first-line = 4.18 vs 3.26 mo, =.04; OS = 9.44 vs 7.63 mo, =.003).

CONCLUSION

In this real-world cohort, treatment of older mPDAC patients with a modified dosing schedule of GA resulted in shorter TOT and worse OS vs a traditional dosing schedule. With the caveats of potential confounding that exist in a nonrandomized retrospective database, these results suggest that dose intensity may be important, and prospective studies are necessary to ensure we treat our patients most effectively.

摘要

背景

吉西他滨联合白蛋白紫杉醇(GA)是转移性胰腺导管癌(mPDAC)患者的一线治疗药物。GA 的传统给药方案为每 28 天周期的第 1、8 和 15 天给药。由于毒性反应,通常会对老年患者采用每周期 2 个剂量的修改后的给药方案。我们回顾性分析了采用这两种给药方案治疗的老年 mPDAC 患者的治疗模式和结局。

方法

本研究纳入了 2014 年 1 月 1 日至 2019 年 5 月 31 日期间在全国真实世界数据库中接受 GA 治疗的 65 岁及以上 mPDAC 患者。收集了人口统计学、疾病和治疗信息。根据治疗开始时的给药方案(传统或修改后的给药方案)对患者进行分组。在接受至少 2 个周期治疗的患者中,终点是治疗时间(TOT)和总生存(OS)。所有统计检验均为双侧检验。

结果

共纳入 1317 例患者(传统给药方案:n=842;修改给药方案:n=475)。传统给药方案和修改给药方案患者的中位诊断年龄分别为 72 岁和 73 岁( <.001),但性别、种族和表现状态在两组间无统计学差异。与修改给药方案相比,传统给药方案的中位 TOT 和 OS 更好(未调整的中位 TOT,一线治疗=4.18 与 3.26 个月, <.001;OS=9.44 与 7.63 个月, <.001)。

结论

在这项真实世界队列研究中,与传统给药方案相比,老年 mPDAC 患者采用 GA 修改给药方案治疗导致 TOT 更短,OS 更差。在非随机回顾性数据库中存在潜在混杂因素的情况下,这些结果表明剂量强度可能很重要,需要开展前瞻性研究以确保我们为患者提供最有效的治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c01/8438244/7e09dfbc5eff/pkab074f1.jpg

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