背景:缺乏关于疗效的数据,有效性,在中国民族的胃肠胰腺神经内分泌肿瘤(GEP-NETs)患者中,使用自体lanreotide的安全性。这种非干预性的,回顾性研究评估了在临床实践中,自主用兰瑞肽治疗中国民族GEP-NETs患者的有效性和安全性.
方法:从香港和台湾的五家医院(2021年7月至9月)提取了患者图表,其中lanreotideautogel被批准用于治疗GEP-NET。包括的患者是不可切除的成年人,转移性,或在2017年1月1日至2020年6月30日期间首次注射(索引)120mg的Lanreotideautogel的本地高级GEP-NETs(计划样本量:N=30)。随访从指数到最长48(±4)周或直到疾病进展,开始新的抗肿瘤治疗,或死亡。主要终点是第48周的无进展生存率(PFS)(±4),次要终点包括第24周的PFS率(±4),使用卡普兰-迈耶分析进行估计。所有分析都是描述性的。
结果:在27名患者中,22例(81.5%)随访48周。胰腺起源的肿瘤是最常见的(73.9%)。24周时的PFS率为0.96(95%置信区间:0.72-0.99),48周时为0.82(0.53-0.94)。总的来说,74.1%的患者经历了≥1次治疗引起的不良事件;没有严重的事件。没有死亡报告。
结论:在现实环境中,兰瑞肽的耐受性良好,肿瘤控制率良好。这些发现与以前在高加索人的研究结果一致,日本人,韩国病人,从而支持兰瑞肽用于治疗中国种族GEP-NETs患者。
胃肠胰腺神经内分泌肿瘤(GEP-NETs)是在胃中发展的罕见癌症,肠子,或胰腺。Lanreotideautogel用于治疗肿瘤无法通过手术切除或已扩散到其他身体部位的患者的GEP-NETs。在研究的时候,lanreotide自体肽在中国大陆未被批准用于治疗GEP-NETs患者。lanreotideautogel的大多数临床试验是在白种人患者中进行的,因此,我们需要更多的信息来说明,对于治疗中国民族患者的GEP-NETs是否有效且耐受性良好.我们进行这项研究以获得这些信息。在这项研究中,我们从中国人GEP-NETs患者的病历中检索到数据,这些患者在香港和台湾接受了自体lanreotide治疗.我们检查了医疗记录,以了解这些患者对兰瑞肽的反应。这项研究的结果表明,经过24周的lanreotide自体治疗,23例患者中有22例GEP-NETs没有恶化。治疗48周后,其中两名患者的GEP-NETs生长或扩散,导致20例GEP-NETs患者在研究结束时没有恶化。没有患者出现与自体lanreotide相关的严重副作用。总之,这项研究表明,在现实世界中,用GEPNETs治疗中国种族的患者,这与早期白种人患者的研究结果一致。这些结果支持在这些患者中使用lanreotideautogel。
BACKGROUND: 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 non-interventional, retrospective study evaluated the effectiveness and safety of
lanreotide autogel in patients of Chinese ethnicity with GEP-NETs in clinical practice.
METHODS: Patient 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.
Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are rare cancers that develop in the stomach, intestines, or pancreas. Lanreotide autogel is used to treat GEP-NETs in patients whose tumors cannot be removed by surgery or have spread to other body parts. At the time of the study, lanreotide autogel was not approved in mainland China for treating patients with GEP-NETs. Most clinical trials of lanreotide autogel were conducted in Caucasian patients, so more information is needed on whether lanreotide autogel is effective and well tolerated for treating GEP-NETs in patients of Chinese ethnicity. We performed this study to gain this information. In this study, we retrieved data from the medical records of patients of Chinese ethnicity with GEP-NETs who were treated with lanreotide autogel in Hong Kong and Taiwan. We examined the medical records to understand how these patients responded to
lanreotide autogel. The results from this study showed that after 24 weeks of lanreotide autogel treatment, 22 of 23 patients had GEP-NETs that did not worsen. After 48 weeks of treatment, two of these patients had GEP-NETs that grew or spread, resulting in 20 patients with GEP-NETs that did not worsen at the end of the study. No patients had serious side effects related to
lanreotide autogel. In conclusion, this study showed that lanreotide autogel is well tolerated and effective for treating patients of Chinese ethnicity with GEP NETs in the real world, which is consistent with results from earlier studies in Caucasian patients. These results support the use of
lanreotide autogel in these patients.