Placebo-Controlled, Double-Blind, Prospective, Randomized Study on the Effect of Octreotide LAR in the Control of Tumor Growth in Patients With Metastatic Neuroendocrine Midgut Tumors: A Report From the PROMID Study Group

医学 奥曲肽 安慰剂 神经内分泌肿瘤 中期分析 内科学 胃肠病学 肿瘤进展 临床终点 生长抑素 危险系数 原发性肿瘤 安慰剂对照研究 转移 肿瘤科 癌症 随机对照试验 病理 双盲 置信区间 替代医学
作者
Anja Rinke,Hans‐Helge Müller,Carmen Schade‐Brittinger,Klaus‐Jochen Klose,Peter Barth,M. Wied,Christina Mayer,Behnaz Aminossadati,Ulrich‐Frank Pape,Michael Bläker,Jan Harder,Christian Arnold,Thomas M. Gress,R. Arnold
出处
期刊:Journal of Clinical Oncology [Lippincott Williams & Wilkins]
卷期号:27 (28): 4656-4663 被引量:2154
标识
DOI:10.1200/jco.2009.22.8510
摘要

Somatostatin analogs are indicated for symptom control in patients with gastroenteropancreatic neuroendocrine tumors (NETs). The ability of somatostatin analogs to control the growth of well-differentiated metastatic NETs is a matter of debate. We performed a placebo-controlled, double-blind, phase IIIB study in patients with well-differentiated metastatic midgut NETs. The hypothesis was that octreotide LAR prolongs time to tumor progression and survival.Treatment-naive patients were randomly assigned to either placebo or octreotide LAR 30 mg intramuscularly in monthly intervals until tumor progression or death. The primary efficacy end point was time to tumor progression. Secondary end points were survival time and tumor response. This report is based on 67 tumor progressions and 16 observed deaths in 85 patients at the time of the planned interim analysis.Median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 months, respectively (hazard ratio [HR] = 0.34; 95% CI, 0.20 to 0.59; P = .000072). After 6 months of treatment, stable disease was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group. Functionally active and inactive tumors responded similarly. The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor. Seven and nine deaths were observed in the octreotide LAR and placebo groups, respectively. The HR for overall survival was 0.81 (95% CI, 0.30 to 2.18).Octreotide LAR significantly lengthens time to tumor progression compared with placebo in patients with functionally active and inactive metastatic midgut NETs. Because of the low number of observed deaths, survival analysis was not confirmatory.
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