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长效生长抑素类似物治疗神经内分泌肿瘤的使用模式和临床结局:真实环境下法国全国性回顾性队列研究。

Patterns of Use and Clinical Outcomes with Long-Acting Somatostatin Analogues for Neuroendocrine Tumors: A Nationwide French Retrospective Cohort Study in the Real-Life Setting.

机构信息

Ipsen, Cambridge, MA, USA.

CEMKA, Bourg-la-Reine, France.

出版信息

Adv Ther. 2022 Apr;39(4):1754-1771. doi: 10.1007/s12325-022-02060-1. Epub 2022 Feb 22.

DOI:10.1007/s12325-022-02060-1
PMID:35190997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8989892/
Abstract

INTRODUCTION

Long-acting somatostatin analogues such as lanreotide autogel (LAN) and octreotide long-acting release (OCT) are recommended as first-line treatment for patients with neuroendocrine tumors (NETs). However, only few real-world studies have compared the two medications. This retrospective, observational cohort study used a French claims database to compare patterns of use with LAN vs. OCT in patients with NETs.

METHODS

Data on LAN and OCT patterns of use were obtained retrospectively from the National System of Health Data (SNDS), a national French claims database. Patients 18 years of age or older who initiated treatment for NETs between 2009 and 2016, and who received at least six subsequent dispensings of first-line LAN or OCT during the first year of treatment, were included. A subgroup analysis was performed on patients with gastroenteropancreatic (GEP)-NETs.

RESULTS

Patients receiving LAN (n = 2327) vs. OCT (n = 2090) had greater median treatment duration (31.8 months vs. 22.1 months, respectively; p < 0.0001; log-rank test) and were less likely to discontinue treatment; adjusted hazard ratio (HR) 0.74 (95% confidence interval [CI] 0.69-0.80). In year 1, a significantly lower percentage of patients receiving LAN vs. OCT switched treatments (10.4% vs. 22.2%, respectively; p < 0.0001), received an average monthly dose per trimester above recommended dose (3.0% vs. 7.3%, respectively; p < 0.0001), and used rescue medication (3.1% vs. 10.0%, respectively; p < 0.0001). Dispensing of pancreatic enzymes was significantly higher in patients receiving LAN than OCT (16.4% vs. 13.9%, respectively). In the subgroup of patients with GEP-NETs, those receiving LAN (n = 1478) vs. OCT (n = 1278) had greater treatment duration and less treatment discontinuation, switching, dosage above the recommended dose, and rescue medication use, but no significant difference in dispensing of pancreatic enzymes or time to second-line treatment.

CONCLUSION

These real-world data suggest potential clinical and economic advantages of LAN over OCT in the management of patients with NETs in the French population.

摘要

简介

长效生长抑素类似物,如兰瑞肽微球(LAN)和奥曲肽长效释放(OCT),被推荐为神经内分泌肿瘤(NETs)患者的一线治疗药物。然而,只有少数真实世界的研究比较了这两种药物。这项回顾性、观察性队列研究使用法国索赔数据库比较了 NETs 患者使用 LAN 和 OCT 的模式。

方法

从全国健康数据系统(SNDS)中回顾性地获取了 LAN 和 OCT 使用模式的数据,这是一个全国性的法国索赔数据库。2009 年至 2016 年期间,年龄在 18 岁或以上的接受 NETs 一线治疗且在治疗的第一年至少接受了六次后续的 LAN 或 OCT 一线治疗的患者被纳入研究。对胃胰神经内分泌肿瘤(GEP-NETs)患者进行了亚组分析。

结果

接受 LAN(n=2327)与 OCT(n=2090)的患者中位治疗持续时间更长(分别为 31.8 个月和 22.1 个月;p<0.0001;log-rank 检验),停药的可能性更小;调整后的风险比(HR)为 0.74(95%置信区间[CI] 0.69-0.80)。在第一年,接受 LAN 的患者与接受 OCT 的患者相比,转换治疗的比例显著更低(分别为 10.4%和 22.2%;p<0.0001),接受推荐剂量以上的每三个月平均剂量更高(分别为 3.0%和 7.3%;p<0.0001),并使用了急救药物(分别为 3.1%和 10.0%;p<0.0001)。接受 LAN 的患者比接受 OCT 的患者更频繁地开处胰酶(分别为 16.4%和 13.9%)。在胃胰神经内分泌肿瘤患者亚组中,接受 LAN(n=1478)与 OCT(n=1278)的患者治疗时间更长,停药率更低,转换治疗、剂量超过推荐剂量、使用急救药物的比例也更低,但胰酶的开具或二线治疗的时间无显著差异。

结论

这些真实世界的数据表明,在法国人群中,LAN 在 NETs 患者的管理中具有潜在的临床和经济效益优于 OCT。

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