Laval Guillemette, Rousselot Hubert, Toussaint-Martel Sophie, Mayer Françoise, Terrebonne Eric, François Eric, Brixi Hédia, Nguyen Thierry, Bourdeix Isabelle, Bisot-Locard Ségolène, Zelek Laurent
CHU de Grenoble, clinique de soins palliatifs et de coordination en soins de support, pôle de cancérologie, BP 217, 38043 Grenoble, France.
Bull Cancer. 2012 Feb 1;99(2):E1-9. doi: 10.1684/bdc.2011.1535.
This phase II, multicenter, randomized, double-blind, non-comparative study assessed the efficacy and safety of immediate-release octreotide and octreotide LAR, in combination with corticosteroids and standard medical care, on the symptoms of inoperable malignant bowel obstruction (MBO) due to peritoneal carcinomatosis. The primary efficacy endpoint was "success" at day 14 defined as a composite endpoint including the absence of a nasogastric tube, and vomiting less than twice per day and no use of anticholinergic agents. Patients in the octreotide arm received octreotide LAR 30 mg intramuscular (im) on days 1, 29 and 57, as well as daily immediate-release octreotide 600 μg per day plus methylprednisolone on days 1 to 6. Placebo-treated patients received methylprednisolone and matched placebo instead of octreotide. Difficulties associated with enrolling patients at palliative-care stage meant only 64 patients (instead of the planned 102 patients) were randomized, 32 to octreotide and 32 to placebo. Despite randomization, more patients in the octreotide arm (46.4%) than in the placebo arm (21.9%) had a baseline Karnofsky score less than 50. An intention-to-treat analysis showed that in the octreotide and placebo arms, 12 (38%) and nine (28%), respectively, patients were successfully treated at day 14, which increased to 9/15 (60%) and 7/25 (28%), respectively, among patients with a baseline Karnofsky score greater or equal to 50. Octreotide-treated patients reported three drug-related adverse events (AEs), and no drug-related serious AEs or deaths. Octreotide LAR may have a key role in treating patients with a MBO due to peritoneal carcinomatosis, particularly in those with moderately severe disease.
这项II期多中心随机双盲非对照研究评估了速释型奥曲肽和长效奥曲肽联合皮质类固醇及标准医疗护理，对腹膜癌病所致无法手术的恶性肠梗阻（MBO）症状的疗效和安全性。主要疗效终点为第14天的“成功”，定义为一个复合终点，包括无鼻胃管、每天呕吐少于两次且未使用抗胆碱能药物。奥曲肽组患者在第1、29和57天接受30毫克长效奥曲肽肌肉注射，以及在第1至6天每天接受600微克速释型奥曲肽加甲泼尼龙。接受安慰剂治疗的患者接受甲泼尼龙和匹配的安慰剂而非奥曲肽。在姑息治疗阶段招募患者存在困难，这意味着仅64名患者（而非计划的102名患者）被随机分组，32名接受奥曲肽治疗，32名接受安慰剂治疗。尽管进行了随机分组，但奥曲肽组基线卡诺夫斯基评分低于50的患者（46.4%）多于安慰剂组（21.9%）。意向性分析显示，在奥曲肽组和安慰剂组中，分别有12名（38%）和9名（28%）患者在第14天得到成功治疗，在基线卡诺夫斯基评分大于或等于50的患者中，这一比例分别增至9/15（60%）和7/25（28%）。接受奥曲肽治疗的患者报告了3例药物相关不良事件（AE），无药物相关严重AE或死亡。长效奥曲肽可能在治疗腹膜癌病所致MBO患者中发挥关键作用，尤其是在那些患有中度严重疾病的患者中。
