OPERA:关于兰索蒂德胶囊治疗胃肠道内分泌肿瘤(GEP-NETs)患者信息感知的研究。
OPERA: perception of information in patients with GEP-NETs on lanreotide autogel.
发表日期:2023 Aug 05
作者:
Vincent Hautefeuille, Thomas Walter, Christine Do Cao, Romain Coriat, Sophie Dominguez, Laurent Mineur, Guillaume Cadiot, Eric Terrebonne, Iradj Sobhani, Delphine Gueguen, Aude Houchard, Charbel Mouawad, Amélie Anota, Pascal Hammel
来源:
EUROPEAN JOURNAL OF ENDOCRINOLOGY
摘要:
为了评估胃肠胰神经内分泌肿瘤(GEP-NETs)治疗开始时与治疗6个月后患者对信息提供水平的认知变化,在法国的31个中心进行了一项非干预性研究(NCT03562091)。患者患有1/2级GEP-NETs。开始兰来肽(LAN)治疗的决策与研究入组是独立的。主要终点是EORTC QLQ-INFO25疾病、治疗和支持性护理信息维度在6个月(相对于基线)的绝对变化。次要终点包括其他QLQ-INFO25信息维度的变化,以及用QLQ-C30评估的与健康相关的生活质量(HRQoL)和临床症状的变化。
共有115名患者入组,其中93名完成了≥1个主要终点信息维度的评估。主要终点信息维度的平均(标准偏差)得分在基线时较高(疾病:63.41 [20.71];治疗:58.85 [19.00];支持性护理:26.53 [24.69];最高分为100)。在6个月时,主要信息维度的绝对平均变化值(98.34%置信区间)从基线没有报道出统计学上或临床上显著变化(疾病:-2.84 [-8.69, 3.01;p = 0.24];治疗:-4.37 [-11.26, 2.52;p = 0.13];支持性护理:0.46 [-6.78, 7.70;p = 0.88])。这些结果在原发肿瘤部位(胰腺 vs 中肠)和NETs功能状态亚组之间保持一致。基线和6个月之间没有观察到与HRQoL相关的临床显著变化。
兰来肽治疗最初6个月内患者对疾病、治疗和支持性护理信息的认知没有改变,这可能表明法国医生在兰来肽治疗开始时提供了足够的健康信息。
© 作者 2023. 由牛津大学出版社代表欧洲内分泌学学会发布。保留所有权利。有关权限,请发送电子邮件至:journals.permissions@oup.com。
To evaluate change in patient perceptions of the level of information provided at lanreotide (LAN) treatment initiation for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus after 6 months.A noninterventional study at 31 centers in France (NCT03562091).Patients had grade 1/2 GEP-NETs. The decision to initiate LAN was independent of study enrollment. The primary endpoint was absolute change at 6 months (vs baseline) in EORTC QLQ-INFO25 disease, treatment and supportive care information dimensions. Secondary endpoints included changes in the other QLQ-INFO25 information dimensions, in health-related quality of life (HRQoL) assessed by QLQ-C30 and in clinical symptoms.Of 115 patients enrolled, 93 completed ≥1 primary endpoint information dimension. Mean (standard deviation) scores for the primary endpoint information dimensions were high at baseline (disease, 63.41 [20.71]; treatment, 58.85 [19.00]; supportive care, 26.53 [24.69]; maximum 100). No statistically or clinically significant absolute mean changes from baseline (98.34% confidence interval) were reported for the primary information dimensions at 6 months (disease, -2.84 [-8.69, 3.01; p = 0.24]; treatment, -4.37 [-11.26, 2.52; p = 0.13]; supportive care, 0.46 [-6.78, 7.70; p = 0.88]). These findings were consistent across primary tumor location (pancreas vs midgut) and NETs functional status subgroups. No clinically relevant changes in HRQoL were observed between baseline and 6 months.The lack of change in patient perception of the disease, treatment and supportive care information provided over the first 6 months of LAN treatment may suggest that French physicians provided adequate health information at the time of LAN treatment initiation.© The Author(s) 2023. Published by Oxford University Press on behalf of European Society of Endocrinology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.