Phase II Study of the Novel Peptide-Nucleic Acid OHR118 in the Management of Cancer-Related Anorexia/Cachexia
Phase II Study of the Novel Peptide-Nucleic Acid OHR118 in the Management of Cancer-Related Anorexia/Cachexia
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DOI：
10.1016/j.jamda.2010.02.012
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发表时间：
2011-01-01
影响因子：
7.6
通讯作者：
Bhargava, Ravi
中科院分区：
文献类型：
--
作者：
Chasen, Martin;Hirschman, Shalom Z.;Bhargava, Ravi
背景和目的：OHR 118是一类治疗厌食恶病质的新型免疫调节和细胞保护药物。以前在晚期艾滋病毒/艾滋病患者中，注意到食欲，力量和警觉性增加。目的是确定OHR 118对晚期癌症患者的食欲、早饱感和营养摄入的影响。次要终点包括体能状态，瘦肌肉质量和生活质量（QOL）的变化。方法：合格的患者接受4.0毫升的OHR 118皮下每日注射。在28天初始治疗期间（A期），患者每两个月接受一次评估。评估包括Karnofsky体力状态、埃德蒙顿症状评估量表（ESAS）、患者主观总体评估（PG-SGA）、Simmonds功能评估（SFA）、消化不良症状严重程度指数（DSSI）、体重、瘦体重、皮褶厚度和握力。从A阶段获益的患者可以选择继续治疗（B阶段）。8例患者选择继续OHR 118治疗（B期）。在11例患者中的7例中观察到体重稳定或增加。PG-SGA总分显著改善（P
Background and Objective: OHR118 represents a new class of immunomodulatory and cytoprotective drugs in managing anorexia cachexia. Previously in patients with advanced HIV-AIDS, increases in appetite, strength, and alertness were noted. The objective was to determine the effect of OHR118 on appetite, early satiety, and nutritional intake in patients with advanced cancer. Secondary end points included changes in performance status, lean muscle mass, and quality of life (QOL).Methods: Eligible patients received 4.0 mL of OHR118 in subcutaneous daily injections. Patients underwent bi-monthly evaluations during the 28-day initial treatment (phase A). Evaluations included Karnofsky performance status, Edmonton Symptoms Assessment Scale (ESAS), Patient-Generated Subjective Global Assessment (PG-SGA), Simmonds Functional Assessment (SFA), Dyspepsia Symptom Severity Index (DSSI), weight, lean body mass, skin fold thickness, and grip strength. Patients who benefited from phase A could elect to continue with therapy (phase B).Results: Of 21 enrolled patients, 11 completed phase A. Eight patients chose to continue with OHR118 treatment (phase B). Weight stabilization or gain was observed in 7 of 11 patients. Total PG-SGA scores improved significantly (P