Safety and efficacy of oxycodone in cancer patients with moderate-to-severe cancer pain: A single-medical center experiences

Chien-Chang Lu, Hong Chen
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Abstract

Background: The study aimed at evaluating the safety and tolerability of oxycodone in patients with moderate-to-severe cancer pain at a medical center in southern Taiwan. Materials and Methods: This was a subgroup analysis of a 12-week, uncontrolled, open-label, multicentric study. During the treatment phase, all participants received control-released (CR) oxycodone and/or immediate-released (IR) oxycodone. The primary end point was the number and percentage of patients with adverse events (AEs) and serious adverse events (SAEs). The secondary end points included patient-reported outcomes and titration of oxycodone. Results: A total of 19 patients were enrolled at this medical center. A total of 56 AEs were documented in 12/19 (63.2%) patients, of which, only 4/56 (7.1%) AEs were treatment-related adverse events occurring in 3/19 (15.8%) patients and no treatment-related SAEs were observed. Most AEs were mild and typical for opioids administered to patients with cancer pain. The most AEs involved the gastrointestinal systems (23%), such as nausea, constipation, and vomiting. At the study end, pain intensity of Numeric Rating Scale score had significantly decreased from 6.3 to 1.6 points; the quality of life on the European Quality of Life Visual Analog Scale (EQ-VAS) median score had improved from 50 to 60 points; and proportion of good/excellent? quality of analgesia (QoA) had increased from 5.3% to 100%. The interesting findings of EQ5D item analyses that the top two improvements were anxiety/depression and pain/discomfort, whereas “mobility” and “self-care” became worse, demonstrated that improvement in cancer pain seems to have more improvement on patients' anxiety/depression.” The median stable dose was 20 mg/day and the median time to reach stable dose was 1 day. Conclusion: CR and IR oxycodone are tolerable and effective in managing moderate-to-severe cancer pain among patients with colorectal cancers s at this medical center. Neither new safety signals nor significant bowel function disorders were noted. Together with the high acceptability and improvements on anxiety/depression and pain/discomfort on Taiwanese cancer patients, CR and IR oxycodone can be another valuable pain management option used for the daily control of moderate-to-severe cancer pain.
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羟考酮治疗中重度癌症疼痛患者的安全性和有效性:单一医疗中心的经验
背景:本研究旨在评估台湾南部医疗中心对中重度癌症疼痛患者使用羟考酮的安全性和耐受性。材料和方法:这是一项为期12周的非对照、开放标签、多中心研究的亚组分析。在治疗阶段,所有参与者接受对照释放(CR)羟考酮和/或立即释放(IR)羟考顿。主要终点是不良事件(AE)和严重不良事件(SAE)患者的数量和百分比。次要终点包括患者报告的结果和羟考酮的滴定。结果:共有19名患者进入该医疗中心。12/19(63.2%)患者共记录了56例AE,其中只有4/56(7.1%)AE是3/19(15.8%)患者发生的治疗相关不良事件,未观察到治疗相关SAE。对于癌症疼痛患者服用的阿片类药物来说,大多数不良事件都是轻微的和典型的。大多数AE涉及胃肠道系统(23%),如恶心、便秘和呕吐。在研究结束时,数字评定量表评分的疼痛强度从6.3分显著降低到1.6分;欧洲生活质量视觉模拟量表(EQ-VAS)中位评分的生活质量从50分提高到60分;好/优秀的比例?镇痛质量由5.3%提高到100%。EQ5D项目分析的有趣发现表明,前两个改善是焦虑/抑郁和疼痛/不适,而“行动能力”和“自我护理”变得更糟,这表明癌症疼痛的改善似乎对患者的焦虑/抑郁有更多的改善。”中位稳定剂量为20mg/天,达到稳定剂量的中位时间为1天。结论:CR和IR羟考酮在该医疗中心治疗结直肠癌患者中重度癌症疼痛是可耐受和有效的。既没有发现新的安全信号,也没有发现明显的肠功能紊乱。加上台湾癌症患者的高可接受性和对焦虑/抑郁和疼痛/不适的改善,CR和IR羟考酮可以成为另一种有价值的疼痛管理选择,用于日常控制中重度癌症疼痛。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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自引率
0.00%
发文量
16
审稿时长
24 weeks
期刊介绍: JCRP aims to provide an exchange forum for the cancer researchers and practitioners to publish their timely findings in oncologic disciplines. The scope of the Journal covers basic, translational and clinical research, Cancer Biology, Cancer Immunotherapy, Hemato-oncology, Digestive cancer, Urinary tumor, Germ cell tumor, Breast cancer, Lung cancer, Head and Neck Cancer in a vast range of cancer related topics. The Journal also seeks to enhance and advance the cancer care standards in order to provide cancer patients the best care during the treatments.
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