Department of Pharmacy Practice and Science, College of Pharmacy, University of Kentucky, Lexington, KY, USA.
Institute of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Kentucky, Lexington, KY, USA.
Oncologist. 2023 Jun 2;28(6):479-485. doi: 10.1093/oncolo/oyad057.
Treatment recommendations for patients with neuroendocrine tumors (NETs) include the use of octreotide long-acting release (LAR) for long-term therapy and immediate-release (IR) as rescue therapy to control the breakthrough symptoms of carcinoid syndrome (CS). High doses of LAR are commonly used in clinical practice. This study aimed to evaluate the real-world utilization of LAR and preceding IR use at the prescription and patient levels.
We used an administrative claims database (2009-2018) containing privately insured enrollees. We calculated the normalized LAR dose from pharmacy claims and the initial mean IR daily dose at the prescription level. At the patient level, we conducted a retrospective cohort study that included patients continuously enrolled with ≥1 pharmacy claim of LAR and evaluated the frequency and the clinical reason for dose escalation of LAR. The definition of the above-label maximum dose of LAR was ≥30 mg/4 weeks.
Nineteen percent of LAR prescriptions had an above-label maximum dose. Only 7% of LAR prescriptions had preceding IR use. There were 386 patients with NETs or CS vs. 570 with an unknown diagnosis. Comparing patients with NETs or CS to those with an unknown diagnosis, 22.3% vs. 11.0 % experienced dose escalations and 29.0% vs. 26.6% had IR use before dose escalation, respectively. LAR dose escalation occurred in 50.9% vs. 39.2% for symptom control, 12.3% vs. 7.1% for tumor progression control, and 16.6% vs. 6.0% for both reasons in NETs/CS and unknown groups, respectively.
Octreotide LAR dosing above the label-maximum dose is common and IR rescue dosing appears to be underutilized.
神经内分泌肿瘤(NETs)患者的治疗建议包括使用奥曲肽长效释放(LAR)进行长期治疗和使用即时释放(IR)作为突破性症状的解救治疗,以控制类癌综合征(CS)。在临床实践中,通常使用 LAR 的高剂量。本研究旨在评估 LAR 的真实世界应用以及处方和患者层面上先前 IR 使用的情况。
我们使用了一个包含私人保险参保人的行政索赔数据库(2009-2018 年)。我们从药房索赔中计算了 LAR 的标准化剂量,并在处方层面计算了初始平均 IR 每日剂量。在患者层面,我们进行了一项回顾性队列研究,纳入了连续使用 LAR 至少有 1 次药房索赔的患者,并评估了 LAR 剂量升级的频率和临床原因。LAR 的超说明书最大剂量定义为≥30mg/4 周。
19%的 LAR 处方剂量超过了标签最大剂量。只有 7%的 LAR 处方使用了先前的 IR。NETs 或 CS 患者 386 例,诊断不明者 570 例。与诊断不明者相比,NETs 或 CS 患者中,剂量升级者分别为 22.3%和 11.0%,剂量升级前使用 IR 者分别为 29.0%和 26.6%。NETs/CS 组和诊断不明组因症状控制而进行 LAR 剂量升级的分别占 50.9%和 39.2%,因肿瘤进展控制而进行剂量升级的分别占 12.3%和 7.1%,因上述两种原因而进行剂量升级的分别占 16.6%和 6.0%。
奥曲肽 LAR 的剂量超过标签最大剂量很常见,而 IR 解救剂量似乎使用不足。