PRESTO 2：一项国际调查，评估神经内分泌肿瘤或肢端肥大症患者使用长效生长抑素类似物最新设备/配方的注射体验。
PRESTO 2: An International Survey to Evaluate Patients' Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly.
机构信息
Neuro Endocrine Tumours-ENETS Centre of Excellence, St. Vincent's University Hospital, Dublin, Ireland.
Yale School of Medicine and Yale Cancer Center, New Haven, CT, USA.
出版信息
Adv Ther. 2023 Feb;40(2):671-690. doi: 10.1007/s12325-022-02360-6. Epub 2022 Dec 11.
INTRODUCTION
Real-world data evaluating patients' injection experiences using the latest devices/formulations of the long-acting (LA) somatostatin analogs (SSAs) lanreotide Autogel/Depot (LAN; Somatuline®) and octreotide LA release (OCT; Sandostatin®) are limited.
METHODS
PRESTO 2 was a 2020/2021 e-survey comparing injection experience of adults with neuroendocrine tumors (NETs) or acromegaly treated with LAN prefilled syringe versus OCT syringe for > 3 months in Canada, Ireland, the UK and the USA (planned sample size, 304).
PRIMARY ENDPOINT
the proportion of patients with injection-site pain lasting > 2 days after their most recent injection, analyzed using a multivariate logistic regression model. Secondary endpoints included interference with daily life due to injection-site pain and technical injection problems in patients with current SSA use for ≥ 6 months.
RESULTS
There were 304 respondents (acromegaly, n = 85; NETs, n = 219; LAN, n = 168; OCT, n = 136; 69.2% female; mean age, 59.6 years). Fewer patients had injection-site pain lasting > 2 days after the most recent injection with LAN (6.0%) than OCT (22.8%); the odds of pain lasting > 2 days were significantly lower for LAN than OCT, adjusted for disease subgroup and occurrence of injection-site reactions (odds ratio [95% confidence interval]: 0.13 [0.06-0.30]; p < 0.0001). Injection-site pain interfered with daily life "a little bit" or "quite a bit" in 37.2% and 3.8% (LAN) versus 52.5% and 7.5% (OCT) of patients, respectively. Among patients with ≥ 6 months' experience with current SSA (92.4% of patients), technical injection problems never occurred in 76.8% (LAN) and 42.9% (OCT) of patients.
CONCLUSIONS
Compared with OCT, significantly fewer patients using LAN had injection-site pain lasting > 2 days after their most recent injection. Also, fewer LAN-treated patients experienced technical problems during injection. These findings demonstrate the importance of injection modality for overall LA SSA injection experience for patients with acromegaly or NETs.
简介
使用长效（LA）生长抑素类似物（SSA）兰瑞肽 Autogel/Depot（LAN；Somatuline®）和奥曲肽 LA 释放（OCT；Sandostatin®）的最新设备/配方评估患者注射体验的真实世界数据有限。
方法
PRESTO 2 是一项 2020/2021 年的电子调查，比较了加拿大、爱尔兰、英国和美国的神经内分泌肿瘤（NETs）或肢端肥大症成年患者在使用 LAN 预充注射器与 OCT 注射器治疗超过 3 个月后的注射体验（计划样本量为 304 例）。
主要终点
使用多变量逻辑回归模型分析最近一次注射后超过 2 天持续存在注射部位疼痛的患者比例。次要终点包括因注射部位疼痛而对日常生活产生干扰以及当前 SSA 使用时间≥6 个月的患者存在技术注射问题。
结果
共纳入 304 名受访者（肢端肥大症患者 n=85；NETs 患者 n=219；LAN 患者 n=168；OCT 患者 n=136；69.2%为女性；平均年龄 59.6 岁）。与 OCT 相比，LAN 组最近一次注射后超过 2 天持续存在注射部位疼痛的患者比例（6.0%）较低；调整疾病亚组和注射部位反应的发生情况后，LAN 比 OCT 发生持续疼痛的几率显著降低（比值比[95%置信区间]：0.13[0.06-0.30]；p<0.0001）。注射部位疼痛对日常生活的干扰程度，LAN 组为“有点”或“相当多”的患者占 37.2%和 3.8%，OCT 组为 52.5%和 7.5%。在当前使用 SSA 治疗时间≥6 个月的患者中（92.4%的患者），LAN 组从未发生过技术注射问题的患者占 76.8%，OCT 组为 42.9%。
结论
与 OCT 相比，使用 LAN 的患者最近一次注射后超过 2 天持续存在注射部位疼痛的比例显著更低。此外，接受 LAN 治疗的患者在注射过程中出现技术问题的比例也更低。这些结果表明，对于患有肢端肥大症或 NETs 的患者，注射方式对 LA SSA 整体注射体验非常重要。
Zotero 插件