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前列腺癌患者中促性腺激素释放激素(LHRH)激动剂续用标准的评估:ANAREN研究结果

Evaluation of the criteria for renewal of LHRH agonists in patients with prostate cancer: results of the ANAREN Study.

作者信息

Calleja-Escudero Jesús, Barrondo Víctor, Rodriguez-Alonso Andrés, Gómez-Veiga Francisco, Bestard Joan, Gómez-Caamaño Antonio, Grandoulier Anne-Sophie, Pérez-Sampietro Maria, Chantada-Abal Venancio, Poza de Celis Raúl

机构信息

Department of Urology, Hospital Clínico Universitario Valladolid, Valladolid, Spain.

Department of Radiation Oncology, Hospital Universitario Basurto, Bilbao, Spain.

出版信息

Drugs Context. 2024 Jun 19;13. doi: 10.7573/dic.2024-2-2. eCollection 2024.

DOI:10.7573/dic.2024-2-2
PMID:38915919
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11195525/
Abstract

INTRODUCTION

Injectable extended-release formulations of luteinizing hormone-releasing hormone agonists (LHRHa) have simplified the treatment of prostate cancer with a satisfactory level of androgen castration. This study aims to determine the percentage of patients whose initial LHRHa prescription was renewed during follow-up, how many changed formulation and how their quality of life evolved.

METHODS

This is an observational, prospective, multicentre study of men with prostate cancer who were to receive treatment with LHRHa (triptorelin every 3 or 6 months, leuprorelin every 3 or 6 months, or goserelin every 3 months) for 24 months. The treatment used was recorded and quality of life was assessed (QLQ-PR25 questionnaire) at four follow-up visits.

RESULTS

A total of 497 men (median age 75 years) were evaluated. The median exposure to LHRHa was 24 months. The initial prescription was renewed in 95.7% at follow-up 1 and 75% at follow-up 4. The main reason for changing from a 6-month to a 3-month formulation was a preference for sequential treatment (according to the investigator) and to see the physician more frequently (according to the patient). The main reason for switching from the 3-month to 6-month formulation was simplification of treatment (according to the investigator) and for convenience (according to the patient). Findings in the QLQ-PR25 questionnaire revealed no changes in urinary or bowel symptoms, though an improvement in sexual activity was reported. Practically all investigators and patients were satisfied/very satisfied with the treatment.

CONCLUSION

Changes in formulation were scarce and generally justified by convenience factors or personal preferences. Patients maintained a good health status, with a high rate of retention of LHRHa treatment.

CLINICAL TRIAL REGISTRATION

Study number: A-ES-52014-224.A plain language summary is provided as supplementary material (available at: https://www.drugsincontext.com/wp-content/uploads/2024/05/dic.2024-2-2-Suppl.pdf).

摘要

引言

促黄体生成素释放激素激动剂(LHRHa)的注射用缓释制剂简化了前列腺癌的治疗,雄激素去势水平令人满意。本研究旨在确定随访期间初始LHRHa处方得以续签的患者百分比、有多少患者更换了制剂以及他们的生活质量如何变化。

方法

这是一项针对前列腺癌男性患者的观察性、前瞻性、多中心研究,这些患者将接受LHRHa治疗(每3或6个月注射曲普瑞林、每3或6个月注射亮丙瑞林或每3个月注射戈舍瑞林)24个月。记录所使用的治疗方法,并在四次随访时评估生活质量(QLQ-PR25问卷)。

结果

共评估了497名男性(中位年龄75岁)。LHRHa的中位暴露时间为24个月。在随访1时,95.7%的患者续签了初始处方,在随访4时这一比例为75%。从6个月制剂改为3个月制剂的主要原因是倾向于序贯治疗(根据研究者)以及更频繁地看医生(根据患者)。从3个月制剂改为6个月制剂的主要原因是治疗简化(根据研究者)以及方便(根据患者)。QLQ-PR25问卷的结果显示,泌尿或肠道症状没有变化,但据报告性功能有所改善。几乎所有研究者和患者对治疗感到满意/非常满意。

结论

制剂更换情况很少见,通常是出于方便因素或个人偏好。患者保持了良好的健康状态,LHRHa治疗的保留率很高。

临床试验注册

研究编号:A-ES-52014-224。一份通俗易懂的摘要作为补充材料提供(可在以下网址获取:https://www.drugsincontext.com/wp-content/uploads/2024/05/dic.2024-2-2-Suppl.pdf)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/4774ae85775d/DIC-2024-2-2_POZA-Figure_3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/c6fe9e022e0d/DIC-2024-2-2_POZA-Figure_1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/c3a60deb97d4/DIC-2024-2-2_POZA-Figure_2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/4774ae85775d/DIC-2024-2-2_POZA-Figure_3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/c6fe9e022e0d/DIC-2024-2-2_POZA-Figure_1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/c3a60deb97d4/DIC-2024-2-2_POZA-Figure_2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/354e/11195525/4774ae85775d/DIC-2024-2-2_POZA-Figure_3.jpg

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