头颈癌患者放疗和化疗的癌病毒:来自II期随机双盲研究的结果

I. Rivas, Jose A. Silva, Gagmar Alfonso, Helga Candanedo, Y. Cuervo, Braulio F. Mestre, J. R. M. Cabello, J. Lence, Martha Lugoyo, E. Sanz
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引用次数: 7

摘要

目的:抗氧化剂补充剂似乎可以降低头颈部(H&N)癌症患者放疗(RT)和化疗(CT)相关的毒性。Ocoxin-Viusid (OV)具有公认的抗氧化、免疫刺激和抗肿瘤作用。我们的研究旨在评估OV在H&N肿瘤患者RT和CT治疗期间的疗效和安全性。方法:选择60例诊断为H&N癌且放疗伴化疗指征的患者,随机、前瞻性、对照、双盲研究,分为两个治疗组:2015年1月至2016年1月在三级转诊学术中心(古巴哈瓦那国家肿瘤研究所)进行为期一年的RT+CT+安慰剂(n=30)和RT+CT+OV (n=30),目的是评估RT-CT毒性降低和改善患者生活质量。结果:两组在男性优势方面无显著差异;中位年龄60岁,组织学诊断为局部晚期口咽部鳞状细胞癌。OV试验组在RT中断次数和中断时间较短,RT- ct毒性水平较低,局部肿瘤控制良好,总生存期与疾病临床分期相符。没有记录到与OV补充剂有关的不良反应。结论:我们的研究结果表明,在放疗和化疗期间给予奥柯辛病毒通过减少这些治疗的毒性的数量和水平而改善患者的生活质量,而不干扰其作用机制。
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Oncoxin-Viusid with Radiotherapy and Chemotherapy in Patients with Head and Neck Cancer: Results from a Phase II, Randomised, Double-Blind Study
Objective: Antioxidant supplements seem to reduce toxicity associated with radiotherapy (RT) and chemotherapy (CT) in patients with head and neck (H&N) cancers. Ocoxin-Viusid (OV) has recognized antioxidant, immunostimulant, and anti-tumor effects. Our study was aimed to evaluate the efficacy and safety of OV in patients with H&N tumors during treatment with RT and CT. Methods: A total of 60 patients with a diagnosis of H&N carcinoma and indication of radiotherapy concurrent with chemotherapy were included in a phase II, randomized, prospective, controlled, double-blind study with two treatment arms: RT+CT+Placebo (n=30) and RT+CT+OV (n=30) during one year at a tertiary referral academic center (National Institute of Oncology from Havana, Cuba) from January 2015 to January 2016, with the objective of evaluating RT-CT toxicity reduction and improving patient quality of life. Results: There was no significant difference between the two groups in regard to male predominance; median age of 60, histological diagnosis of squamous cell carcinoma of the oropharynx in locally-advanced stages. The experimental OV group obtained better results insofar as a lower number and duration of interruptions in RT and lower severity of RT-CT toxicity levels, with acceptable local tumor control and overall survival in accordance with the clinical stage of the disease. No adverse effects were recorded in relation to the OV supplement. Conclusion: Our results suggest that administration of ocoxin-viusid during radiotherapy and chemotherapy improves patient quality of life by decreasing the number and level of toxicities from these treatments without interfering with their mechanism of action.
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