Selective Cytoprotection with Amifostine: A New Strategy in Supportive Care of Head and Neck Malignancies
Selective Cytoprotection with Amifostine: A New Strategy in Supportive Care of Head and Neck Malignancies
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氨磷汀的选择性细胞保护：头颈恶性肿瘤支持治疗的新策略
DOI：
10.1159/000312947
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发表时间：
1997
期刊：
影响因子：
--
通讯作者：
K. Küttner
中科院分区：
文献类型：
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作者：
J. Büntzel;M. Glatzel;J. Schuth;D. Fröhlich;K. Küttner
目的：三个II期或III期研究的结果的基础上，我们描述了新的选择性细胞保护剂氨磷汀在支持治疗头颈癌患者的可能作用。患者和方法：在101例患者中，我们研究了氨磷汀对同步放化疗（RCT）联合卡铂的毒性的影响，1995年5月至1997年4月。第一步是一项先导性研究（n = 14），在此期间，在第二个卡铂周期之前给予氨磷汀。随后是一项随机试验，39例患者在每次卡铂输注前接受氨磷汀。另外25名患者参加了一项关于在氨磷汀保护下加强联合治疗（卡铂加5-氟尿嘧啶加70戈伊局部放射）的研究。在一项正在进行的III期研究中，我们纳入了37例患者。结果如下：氨磷汀很容易整合到头颈部癌症患者的同期RCT中，并显著减少了联合治疗的主要非血液学副作用粘膜炎、吞咽困难和口干。血液学毒性也降低。由于毒性降低，我们需要更少的其他支持性药物（血小板输注，集落刺激因子，免疫球蛋白）。根据第一个结果，氨磷汀应该有可能加强RCT（增加局部放射剂量，多化疗），而不会显着增加毒性。我们的数据还没有显示任何迹象表明，肿瘤保护由于amifostine。结论：氨磷汀提供了降低头颈癌患者RCT毒性的可能性，并增加了该患者亚组对联合方案的接受程度。强化RCT应是未来试验的主题。
Objectives: On the basis of the results of three phase II or phase III studies, we describe the possible role of the new selective cytoprotectant amifostine in the supportive treatment of patients with head and neck cancer. Patients and Methods: In 101 patients we investigated amifostine’s influence on the toxicity of a simultaneous radiochemotherapy (RCT) combined with carboplatin between May 1995 and April 1997. A first step was a pilot study (n = 14) during which amifostine was given prior to the second carboplatin cycle. This was followed by a randomized trial with 39 patients who received amifostine prior to every carboplatin infusion. A further 25 patients took part in an investigation about the intensification of a combined treatment (carboplatin plus 5-fluorouracil plus 70 Gy local radiation) under the protection of amifostine. In an ongoing phase III study, we included 37 patients. Results: Amifostine’s integration into the simultaneous RCT in head and neck cancer patients was very easy and led to a significant reduction of mucositis, dysphagia, and xerostomia as the main nonhe-matological side effects of the combined treatment. The hematological toxicities were also reduced. As a result of the reduced toxicity, we need less other supportive medications (thrombocyte transfusions, colony-stimulating factor, immunoglobulin). According to the first results, it should be possible with amifostine to intensify the RCT (increased local radiation dose, polychemotherapy) without significantly increased toxicity. Our data have not shown any sign of tumor protection due to amifostine. Conclusions: Amifostine offers the possibility to reduce the toxicity of RCT in head and neck cancer patients and to increase the acceptance of the combined regimen in this patient subgroup. The intensification of RCT should be the topic of future trials.