比较亚叶酸钙和亚叶酸钠联合5-氟尿嘧啶在FOLFIRI方案中的前瞻性观察研究。

Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination with 5-Fluorouracil in the FOLFIRI Regimen.

作者信息

Passardi Alessandro, Monti Manlio, Donati Caterina, Foca Flavia, Pagan Flavia, Rapposelli Ilario, Ruscelli Silvia, Bartolini Giulia, Valgiusti Martina, Matteucci Laura, Sullo Francesco, Sbaffi Stefania, Crudi Laura, Frassineti Giovanni Luca, Masini Carla

机构信息

Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy.

Oncology Pharmacy Unit, IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori", Meldola, Italy.

出版信息

Oncologist. 2021 Aug;26(8):e1314-e1319. doi: 10.1002/onco.13762. Epub 2021 Apr 22.

DOI:10.1002/onco.13762

PMID:33764600

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8342582/

Abstract

LESSONS LEARNED

The use of sodium levofolinate (Na-Lev) is safe in combination with continuous infusion 5-fluorouracil in patients with gastrointestinal tumors treated with the FOLFIRI regimen. A comparison with calcium levofolinate (Ca-Lev) showed a similar toxicity profile. The advantages of Na-Lev over Ca-Lev might be the faster drug preparation and the shorter time of drug administration.

BACKGROUND

The objectives of this study were to compare the safety profiles of sodium levofolinate (Na-Lev) and calcium levofolinate (Ca-Lev) in combination with 5-fluorouracil (5-FU) in the FOLFIRI regimen and to measure the organizational impact of the introduction of Na-Lev on drug production and administration.

METHODS

The study opened in November 2015 and closed in August 2019. Patients with gastrointestinal cancers who were candidates for treatment with the FOLFIRI regimen were included in this nonrandomized study. Age ≥18 years, life expectancy >3 months, adequate bone marrow reserve, adequate hepatic and renal function, and an ECOG performance status of 0-2 were required. Patients in the Ca-Lev arm received a 2-hour infusion of Ca-Lev followed by 5-FU, whereas those in the Na-Lev arm received Na-Lev and 5-FU administered in a single 48-hour pump.

RESULTS

Sixty patients were enrolled, 30 in each arm. Patient characteristics were balanced. Grade (G)1-2 adverse events occurred in 18 (60.0%) and 19 (63.4%) patients of Na-Lev and Ca-Lev cohorts, respectively, whereas G3-4 adverse events occurred in 12 (40.0%) and 11 (36.6%) patients, respectively. The use of Na-Lev enabled us to save approximately 13 minutes for drug preparation and 2 hours for treatment administration, per patient per cycle.

CONCLUSION

Na-Lev showed a reassuring toxicity profile and a favorable impact on drug preparation and administration.

摘要

经验教训

在采用FOLFIRI方案治疗的胃肠道肿瘤患者中，左亚叶酸钠（Na-Lev）与持续输注5-氟尿嘧啶联合使用是安全的。与亚叶酸钙（Ca-Lev）相比，二者毒性特征相似。Na-Lev相对于Ca-Lev的优势可能在于药物配制更快且给药时间更短。

背景

本研究的目的是比较左亚叶酸钠（Na-Lev）和亚叶酸钙（Ca-Lev）与5-氟尿嘧啶（5-FU）联合用于FOLFIRI方案时的安全性，并评估引入Na-Lev对药物生产和给药的组织影响。

方法

本研究于2015年11月开始，2019年8月结束。本非随机研究纳入了适合采用FOLFIRI方案治疗的胃肠道癌症患者。要求年龄≥18岁、预期寿命>3个月、骨髓储备充足、肝肾功能良好且东部肿瘤协作组（ECOG）体能状态为0-2。Ca-Lev组患者先接受2小时的Ca-Lev输注，然后输注5-FU，而Na-Lev组患者接受Na-Lev和5-FU通过单个48小时泵给药。

结果

共纳入60例患者，每组30例。患者特征均衡。Na-Lev组和Ca-Lev组分别有18例（60.0%）和19例（63.4%）患者发生1-2级不良事件，分别有12例（40.0%）和11例（36.6%）患者发生3-4级不良事件。使用Na-Lev使我们能够为每位患者每个周期节省约13分钟的药物配制时间和2小时的治疗给药时间。