香港和台湾地区胃肠胰神经内分泌肿瘤 (GEP-NET) 患者在常规治疗中使用兰瑞肽自凝胶的真实世界研究。

IF 3.2 Q2 ONCOLOGY

Oncology and Therapy Pub Date : 2024-08-31 DOI:10.1007/s40487-024-00302-6

Jen-Shi Chen, Li-Yuan Bai, Hsiao-Hsiang Cheng, Stephen Lam Chan, Ji-Yan Zou, Xiaofeng Shi, Aude Houchard, Xuan-Mai Truong-Thanh, Ming-Huang Chen

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引用次数: 0

摘要

简介：关于兰瑞奥肽自凝胶在华裔胃肠胰神经内分泌肿瘤（GEP-NETs）患者中的疗效、有效性和安全性，目前尚缺乏相关数据。这项非干预性、回顾性研究评估了兰瑞奥肽自凝胶在华裔胃肠胰腺神经内分泌肿瘤（GEP-NET）患者临床实践中的有效性和安全性：方法：研究人员从香港和台湾的五家医院（2021年7月至9月）抽取了患者病历，这些医院已批准兰瑞奥肽自动凝胶用于治疗GEP-NET。纳入的患者均为患有不可切除性、转移性或局部晚期GEP-NET的成人患者，他们在2017年1月1日至2020年6月30日期间接受了首次兰瑞肽自动凝胶120毫克注射（指标）（计划样本量：N = 30）。随访时间从指标开始至最长48（±4）周或疾病进展、开始新的抗肿瘤治疗或死亡为止。主要终点是第48周（±4）时的无进展生存率（PFS），次要终点包括第24周（±4）时的PFS，采用卡普兰-梅耶尔分析法估算。所有分析均为描述性分析：结果：在入组的 27 名患者中，22 人（81.5%）接受了 48 周的随访。胰腺肿瘤最为常见（73.9%）。24周的PFS率为0.96（95%置信区间：0.72 - 0.99），48周的PFS率为0.82（0.53 - 0.94）。总体而言，74.1%的患者经历了≥1次治疗突发不良事件；无严重不良事件。无死亡报告：结论：兰雷奥肽自凝胶耐受性良好，在真实世界中显示出良好的肿瘤控制率。这些结果与之前在白种人、日本人和韩国人患者中的研究结果一致，因此支持兰瑞奥肽自凝胶用于治疗华裔GEP-NET患者。

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Real-World Study of Lanreotide Autogel in Routine Practice in Patients with Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) in Hong Kong and Taiwan.

Introduction: There is a lack of data on the efficacy, effectiveness, and safety of lanreotide autogel in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of Chinese ethnicity. This noninterventional, retrospective study evaluated the effectiveness and safety of lanreotide autogel in patients of Chinese ethnicity with GEP-NETs in clinical practice.

Methods: Patients' charts were abstracted from five hospitals in Hong Kong and Taiwan (July-September 2021), where lanreotide autogel is approved for treating GEP-NETs. Included patients were adults with unresectable, metastatic, or locally advanced GEP-NETs who received a first injection (index) of lanreotide autogel 120 mg between 01 January 2017 and 30 June 2020 (planned sample size: N = 30). Follow-up ran from index to a maximum of 48 (± 4) weeks or until disease progression, start of new antitumor treatment, or death. The primary endpoint was progression-free survival (PFS) rate at week 48 (±4), and secondary endpoints included PFS rate at week 24 (±4), estimated using Kaplan-Meier analyses. All analyses were descriptive.

Results: Of 27 patients enrolled, 22 (81.5%) had 48 weeks of follow-up. Tumors of pancreatic origin were the most common (73.9%). PFS rate was 0.96 (95% confidence interval: 0.72 - 0.99) at 24 weeks and 0.82 (0.53-0.94) at 48 weeks. Overall, 74.1% patients experienced ≥ 1 treatment-emergent adverse event; none were serious. No deaths were reported.

Conclusions: Lanreotide autogel was well tolerated and showed good tumor control rate in a real-world setting. These findings align with results from previous studies in Caucasian, Japanese, and Korean patients, thus supporting lanreotide autogel for treating patients with GEP-NETs of Chinese ethnicity.

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来源期刊

Oncology and Therapy ONCOLOGY-

CiteScore

3.40

自引率

0.00%

发文量

审稿时长

6 weeks

期刊介绍： Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. 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All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). 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