Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients
Randomized trial of antioxidant vitamins to prevent acute adverse effects of radiation therapy in head and neck cancer patients
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DOI：
10.1200/jco.2005.05.514
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发表时间：
2005-08-20
影响因子：
45.3
通讯作者：
Roy, J
中科院分区：
文献类型：
--
作者：
Bairati, I;Meyer, F;Roy, J
许多癌症患者服用抗氧化维生素补充剂，希望改善常规治疗的结果，减少这些治疗的副作用。进行了一项随机试验，以确定是否补充抗氧化剂维生素可以减少放射治疗的急性不良反应的发生和严重程度，提高生活质量，而不影响治疗efficacy.Patients和Methods我们进行了一项随机，双盲，安慰剂对照试验，540头颈部癌症患者接受放射治疗。患者被随机分为两组。在放射治疗期间和之后的3年中，补充α-生育酚（400 IU/d）和β-胡萝卜素（30 mg/d）或安慰剂。在试验过程中，补充β-胡萝卜素被中止，因为伦理concerns.Results患者随机分配在补充武器往往有严重的急性不良反应在放射治疗（比值比[OR]，0.72; 95%CI，0.52至1.02）。当补充剂组合α-生育酚和β-胡萝卜素时，对喉部（OR，0.38; 95%CI，0.21至0.71）和任何部位的总体（OR，0.38; 95%CI，0.20至0.74）的不良反应的减少具有统计学显著性。生活质量并没有因为补充而得到改善。补充组头颈部肿瘤局部复发率有升高的趋势（危险比，1.37，95%CI，0.93 ~ 2.02）。结论放射治疗中补充大剂量的α-生育酚和β-胡萝卜素可降低治疗不良反应的严重程度。然而，这项试验表明，使用高剂量的抗氧化剂作为辅助治疗可能会损害放射治疗的疗效。
Purpose Many cancer patients take antioxicant vitamin supplements with the hope of improving the outcome of conventional therapies and of reducing the adverse effects of these treatments. A randomized trial was conducted to determine whether supplementation with antioxicant vitamins could reduce the occurrence and severity of acute adverse effects of radiation therapy and improve quality of life without compromising treatment efficacy.Patients and Methods We conducted a randomized, double-blind, placebo-controlled trial among 540 head and neck cancer patients treated with radiation therapy. Patients were randomly assigned into two arms. The supplementation with a-tocopherol (400 IU/d) and beta-carotene (30 mg/d) or placebos was administered during radiation therapy and for 3 years thereafter. During the course of the trial, supplementation with beta-carotene was discontinued because of ethical concerns.Results Patients randomly assigned in the supplement arm tended to have less severe acute adverse effects during radiation therapy (odds ratio [OR], 0.72; 95% Cl, 0.52 to 1.02). The reduction was statistically significant when the supplementation combined a-tocopherol and beta-carotene for adverse effects to the larynx (OR, 0.38; 95% Cl, 0.21 to 0.71) and overall at any site (OR, 0.38; 95% Cl, 0.20 to 0.74). Quality of life was not improved by the supplementation. The rate of local recurrence of the head and neck tumor tended to be higher in the supplement arm of the trial (hazard ratio, 1.37; 95% Cl, 0.93 to 2.02).Conclusion Supplementation with high doses of a-tocopherol and beta-carotene during radiation therapy could reduce the severity of treatment adverse effects. However, this trial suggests that use of high doses of antioxidants as adjuvant therapy might compromise radiation treatment efficacy.