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首页> 外文期刊>Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer >Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy--a double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynakologische Onkologoi
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Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy--a double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynakologische Onkologoi

机译：氨磷汀在基于卡铂/紫杉醇的化疗一线治疗晚期卵巢癌中的神经保护作用-来自Arbeitsgemeinschaft Gynakologische Onkologoi的双盲，安慰剂对照，随机II期研究

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GOALS OF WORK: Neurotoxicity is a common side effect of platinum/taxane-based therapy of ovarian cancer. We performed a double-blind randomized placebo-controlled trial to evaluate the influence of the cytoprotectant amifostine on the neurotoxicity of first-line therapy of ovarian cancer with paclitaxel/carboplatin with or without epirubicin. PATIENTS AND METHODS: Of 72 patients randomized, 71 were treated with paclitaxel 175 mg/m2 and carboplatin AUC5 with or without epirubicin 60 mg/m2 (q21 x 6) and randomized for i.v. premedication with amifostine 740 mg/m2 or placebo. Assessment included a questionnaire, NCI-CTC, tendon reflex activity (TRA), two-point discrimination (2-PD), measurement of vibration perception threshold (VPT) and vibration disappearance threshold (VDT), and quality of life. RESULTS: The majority of neurotoxicity criteria showed a significant impairment during therapy in both treatment arms. A significant protective effect of amifostine was observed for 2-PD, TRA, VPT and VDT. Amifostine failed to improve the 'global health status quality of life' score significantly. Toxicities according to NCI-CTC showed improved sensory neuropathy (P = 0.0046) but a worsening in terms of nausea (P = 0.0005) and vomiting (P = 0.0083). No significant differences were observed for single sensory and motor symptoms, except for a better skilfulness in the amifostine group (P = 0.0404). CONCLUSION: Amifostine improved sensory neuropathy according to NCI-CTC and with regard to objective neurological assessment, but there were almost no differences in self-estimated specific sensory or motor symptoms. Disadvantages with regard to non-neurological toxicities and inconsistent results for quality of life demand further evaluation of neuroprotection with amifostine as well as alternative approaches to prevent platinum-taxane induced neurotoxicity.
机译：工作目标：神经毒性是基于铂/紫杉烷的卵巢癌治疗的常见副作用。我们进行了一项双盲随机安慰剂对照试验，以评估细胞保护剂氨磷汀对紫杉醇/卡铂联合或不联合表阿霉素的卵巢癌一线治疗神经毒性的影响。患者与方法：在随机分配的72例患者中，有71例接受了紫杉醇175 mg / m2和卡铂AUC5联合或不联合表柔比星60 mg / m2（q21 x 6）的治疗，并进行了静脉内注射。用740 mg / m2的氨磷汀或安慰剂进行预用药。评估包括问卷，NCI-CTC，腱反射活动（TRA），两点鉴别（2-PD），振动感知阈值（VPT）和振动消失阈值（VDT）的测量以及生活质量。结果：大多数神经毒性标准均显示两个治疗组在治疗期间均存在重大损害。观察到氨磷汀对2-PD，TRA，VPT和VDT具有明显的保护作用。氨磷汀未能显着改善“全球健康状况生活质量”评分。根据NCI-CTC的毒性表现出改善的感觉神经病（P = 0.0046），但恶心（P = 0.0005）和呕吐（P = 0.0083）恶化。除了氨磷汀组的熟练度较高外，在单一的感觉和运动症状上没有观察到显着差异（P = 0.0404）。结论：根据NCI-CTC和客观神经学评估，氨磷汀可改善感觉神经病，但自我估计的特定感觉或运动症状几乎没有差异。关于非神经毒性和生活质量结果不一致的缺点，需要进一步评估用氨磷汀的神经保护作用以及防止铂-紫杉烷引起的神经毒性的替代方法。

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