Clinique St Pierre Ottignies, Ottignies-Louvain-la-Neuve, Belgium.
CHC Liège, Liège, Belgium.
Clin Ther. 2021 Dec;43(12):2136-2145.e2. doi: 10.1016/j.clinthera.2021.10.014. Epub 2021 Nov 26.
Inoperable malignant intestinal obstruction (IMIO) is a severe complication in patients with cancer, usually gastrointestinal or gynecologic in origin. For patients with IMIO, there is a need to relieve symptoms and limit nasogastric tube (NGT) use. Previous studies have suggested the efficacy of somatostatin analogues in relieving obstruction-related symptoms, such as nausea, vomiting, and pain. The purpose of this study was to assess the efficacy of lanreotide autogel 120 mg (LAN 120 mg) in the management of symptoms resulting from IMIO in patients with advanced cancer.
This single-arm, multicenter study enrolled 52 patients mostly with advanced gastrointestinal or ovarian malignant tumors (35 patients with NGT and 17 patients without NGT). Patients received 1 deep subcutaneous injection of LAN 120 mg. Evaluations were performed on days 7, 14, and 28. The primary end point was the percentage of responding patients before or at day 7. Response was defined as ≤2 vomiting episodes per day (for patients without NGT at baseline) or no vomiting recurrence (after NGT removal) during at least 3 consecutive days at any time point between treatment and day 7. Responders at day 28 were offered a second LAN 120 mg injection and followed up until day 56.
The proportion of responders in the intention-to-treat population was 24 of 52 (46.2%), which was significantly greater than the reference proportion of 30% (P = 0.0055). Patients without NGT had a higher response (88.2%) than patients with NGT (25.7%) and had a steady trend for clinical improvement that led to sustainable responses. Median time to response was 9 days for the overall population, 3 days for patients without NGT, and 14 days for patients with NGT (P < 0.0001).
Our study is the first to use long-acting LAN 120 mg in patients with IMIO and suggests an effect in controlling clinical symptoms in patients with and without NGT at baseline. The safety profile of LAN 120 mg was similar to that reported in other indications. ClinicalTrials.gov identifier: NCT02275338.
不可切除的恶性肠梗阻（IMIO）是癌症患者的一种严重并发症，通常起源于胃肠道或妇科。对于 IMIO 患者，需要缓解症状并限制鼻胃管（NGT）的使用。先前的研究表明，生长抑素类似物在缓解梗阻相关症状方面具有疗效，如恶心、呕吐和疼痛。本研究旨在评估兰瑞肽长效微球 120mg（LAN 120mg）在治疗晚期癌症患者 IMIO 相关症状中的疗效。
这项单臂、多中心研究纳入了 52 名患者，他们主要患有晚期胃肠道或卵巢恶性肿瘤（35 名患者有 NGT，17 名患者没有 NGT）。患者接受了 1 次深部皮下注射 LAN 120mg。在第 7、14 和 28 天进行评估。主要终点是在第 7 天或之前应答患者的百分比。应答定义为在治疗至第 7 天期间的任何时间点，对于基线时无 NGT 的患者，每天呕吐发作次数≤2 次或在至少连续 3 天内无呕吐复发。在第 28 天应答的患者接受了第二次 LAN 120mg 注射，并随访至第 56 天。
意向治疗人群中的应答者比例为 52 例中的 24 例（46.2%），显著高于参考比例 30%（P=0.0055）。无 NGT 的患者的应答率（88.2%）高于有 NGT 的患者（25.7%），并且临床改善呈稳定趋势，导致可持续的应答。总体人群的中位应答时间为 9 天，无 NGT 的患者为 3 天，有 NGT 的患者为 14 天（P<0.0001）。
本研究是首次在 IMIO 患者中使用长效 LAN 120mg，并表明在有和无基线 NGT 的患者中均能控制临床症状。LAN 120mg 的安全性与其他适应证报告的相似。临床试验注册编号：NCT02275338。
