Omission of 5-Fluorouracil Bolus From Multidrug Regimens for Advanced Gastrointestinal Cancers: A Multicenter Cohort Study.

IF 14.8 2区医学 Q1 ONCOLOGY Journal of the National Comprehensive Cancer Network Pub Date : 2024-09-05 DOI:10.6004/jnccn.2024.7029

Chengwei Peng, Saad Saffo, Paul E Oberstein, Michael Shusterman, Charlene Thomas, Daniel J Becker, Jordan D Berlin, Lawrence P Leichman, Ben Boursi, Anil B Nagar, Shun Yu

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引用次数: 0

Abstract

Background: 5-Fluorouracil (5-FU) is a major component of gastrointestinal cancer treatments. In multidrug regimens such as FOLFOX, FOLFIRI, and FOLFIRINOX, 5-FU is commonly administered as a bolus followed by an infusion. However, the pharmacologic rationale for incorporating the 5-FU bolus in these regimens is unclear, and there are other effective regimens for gastrointestinal cancers that do not include the bolus. The purpose of this study was to determine whether omission of the 5-FU bolus was associated with a difference in survival and toxicity.

Methods: A real-world database from Flatiron Health was queried for patients with advanced colorectal, gastroesophageal, and pancreatic cancers who received first-line FOLFOX, FOLFIRI, and FOLFIRINOX regimens. Cox proportional hazards and Kaplan-Meier analyses were performed to compare survival outcomes between patients who received the 5-FU bolus and those who did not. Inverse probability of treatment weighted (IPTW) analysis was performed to adjust for treatment selection bias.

Results: This study included 11,765 patients with advanced colorectal (n=8,670), gastroesophageal (n=1,481), and pancreatic (n=1,614) cancers. Among all first-line 5-FU multidrug regimens, 10,148 (86.3%) patients received a 5-FU bolus and 1,617 (13.7%) did not. After IPTW analysis, we found that omitting the bolus was not associated with a decrease in overall survival (hazard ratio, 0.99; 95% CI, 0.91-1.07; P=.74). However, omitting the bolus was associated with reductions in neutropenia (10.7% vs 22.7%; P<.01), thrombocytopenia (11.2% vs 16.1%; P<.01), and use of granulocyte colony-stimulating factors after treatment (19.6% vs 29.1%; P<.01).

Conclusions: After adjusting for baseline clinical factors, we found that omission of the 5-FU bolus from FOLFOX, FOLFIRI, and FOLFIRINOX regimens was not associated with decreased survival, but resulted in decreased toxicity and possible health care savings.

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晚期胃肠道癌症多种药物治疗方案中省略 5-氟尿嘧啶注射液：多中心队列研究

背景：5-氟尿嘧啶（5-FU）是胃肠道癌症治疗的主要成分。在 FOLFOX、FOLFIRI 和 FOLFIRINOX 等多药治疗方案中，5-FU 通常先注射后输注。然而，在这些方案中加入 5-FU 栓剂的药理学原理尚不清楚，而且还有其他治疗胃肠道癌症的有效方案不包括 5-FU 栓剂。本研究旨在确定省略5-FU栓剂是否与生存率和毒性差异有关：方法：查询 Flatiron Health 公司的真实世界数据库，了解接受 FOLFOX、FOLFIRI 和 FOLFIRINOX 一线治疗方案的晚期结直肠癌、胃食管癌和胰腺癌患者的情况。对接受 5-FU 栓注和未接受 5-FU 栓注的患者的生存结果进行了 Cox 比例危险度分析和 Kaplan-Meier 分析。为了调整治疗选择偏倚，还进行了治疗加权反概率（IPTW）分析：这项研究纳入了11765名晚期结直肠癌（8670人）、胃食管癌（1481人）和胰腺癌（1614人）患者。在所有一线 5-FU 多药方案中，10148 例（86.3%）患者接受了 5-FU 栓注，1617 例（13.7%）患者没有接受 5-FU 栓注。经过 IPTW 分析，我们发现省略栓剂与总生存率下降无关（危险比，0.99；95% CI，0.91-1.07；P=.74）。然而，省略栓剂与中性粒细胞减少有关（10.7% vs 22.7%；PConclusions.P＜0.05）：在对基线临床因素进行调整后，我们发现在FOLFOX、FOLFIRI和FOLFIRINOX方案中省略5-FU栓剂与生存率下降无关，但会导致毒性降低，并可能节省医疗费用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the National Comprehensive Cancer Network ONCOLOGY-

CiteScore

20.20

自引率

0.00%

发文量

388

审稿时长

4-8 weeks

期刊介绍： JNCCN—Journal of the National Comprehensive Cancer Network is a peer-reviewed medical journal read by over 25,000 oncologists and cancer care professionals nationwide. This indexed publication delivers the latest insights into best clinical practices, oncology health services research, and translational medicine. Notably, JNCCN provides updates on the NCCN Clinical Practice Guidelines in Oncology® (NCCN Guidelines®), review articles elaborating on guideline recommendations, health services research, and case reports that spotlight molecular insights in patient care. Guided by its vision, JNCCN seeks to advance the mission of NCCN by serving as the primary resource for information on NCCN Guidelines®, innovation in translational medicine, and scientific studies related to oncology health services research. This encompasses quality care and value, bioethics, comparative and cost effectiveness, public policy, and interventional research on supportive care and survivorship. JNCCN boasts indexing by prominent databases such as MEDLINE/PubMed, Chemical Abstracts, Embase, EmCare, and Scopus, reinforcing its standing as a reputable source for comprehensive information in the field of oncology.