癌症恶病质对晚期胰腺癌一线化疗的影响:日本索赔数据库研究。

Effect of cancer cachexia on first-line chemotherapy in patients with advanced pancreatic cancer: a claims database study in Japan.

机构信息

Department of Gastroenterology, Kanagawa Cancer Center, 2-3-2 Nakao, Asahi-Ku, Yokohama, 241-8515, Japan.

Medical Affairs, Ono Pharmaceutical Co., Ltd., 8-2, Kyutaromachi 1-Chome Chuo-Ku, Osaka-Shi, 541-8564, Japan.

出版信息

Int J Clin Oncol. 2024 Apr;29(4):456-463. doi: 10.1007/s10147-024-02467-6. Epub 2024 Feb 14.

Abstract

BACKGROUND

Cancer cachexia is a multifactorial syndrome leading to progressive functional impairment. How cachexia affects the treatment course of chemotherapy in patients with pancreatic cancer has not been well understood.

METHODS

This is an exploratory, retrospective, observational cohort study using the Japanese medical claims database from Medical Data Vision Co., Ltd. The study population included patients diagnosed with pancreatic cancer in whom first-line FOLFIRINOX (FFX) or gemcitabine plus nab-paclitaxel (GnP) was initiated between October 1, 2018, and September 30, 2020. In this study, we defined patients with cancer cachexia as those who had a weight loss of ≥ 5% in the preceding 6 months. The primary outcome was time-to-treatment failure (TTF). The observation period was six months from the initiation of first-line FFX or GnP treatment.

RESULTS

A total of 1897 patients (421 patients into the cachexia group; 1476 patients into the non-cachexia group) were analyzed in this study. The median TTF was 121 days (95% confidence interval [CI] 94-146) in the cachexia group and 143 days (95% CI 134-152) in the non-cachexia group. The hazard ratio for TTF of the cachexia versus non-cachexia group was 1.136 (95% CI 0.979-1.319). The median number of doses was two doses fewer in the cachexia group than in the non-cachexia group for both FFX and GnP.

CONCLUSION

Cancer cachexia was suggested to be associated with shorter TTF and a reduced number of doses in patients with pancreatic cancer who received first-line FFX or GnP treatment. Clinical Trial Registration clinicaltrials.jp: UMIN000045820.

摘要

背景

癌症恶病质是一种导致进行性功能障碍的多因素综合征。恶病质如何影响胰腺癌患者化疗的治疗过程尚未得到很好的理解。

方法

这是一项使用 Medical Data Vision Co.,Ltd. 的日本医疗索赔数据库进行的探索性、回顾性、观察性队列研究。研究人群包括在 2018 年 10 月 1 日至 2020 年 9 月 30 日期间被诊断患有胰腺癌且接受一线 FOLFIRINOX(FFX)或吉西他滨加 nab-紫杉醇(GnP)治疗的患者。在本研究中,我们将患有癌症恶病质的患者定义为在过去 6 个月内体重减轻≥5%的患者。主要结局是治疗失败时间(TTF)。观察期为一线 FFX 或 GnP 治疗开始后 6 个月。

结果

本研究共分析了 1897 例患者(421 例归入恶病质组;1476 例归入非恶病质组)。恶病质组的中位 TTF 为 121 天(95%置信区间[CI]94-146),非恶病质组为 143 天(95% CI 134-152)。恶病质组与非恶病质组的 TTF 风险比为 1.136(95% CI 0.979-1.319)。对于 FFX 和 GnP,恶病质组的中位剂量均比非恶病质组少 2 剂。

结论

在接受一线 FFX 或 GnP 治疗的胰腺癌患者中,癌症恶病质与较短的 TTF 和减少的剂量数有关。

临床试验注册 UMIN000045820。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa7f/10963515/389ac3a36555/10147_2024_2467_Fig1_HTML.jpg

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