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氨磷汀用于非小细胞肺癌的放化疗:经验回顾及一项评估皮下和静脉推注给药的II期试验设计

Amifostine in chemoradiation therapy for non-small cell lung cancer: review of experience and design of a phase II trial assessing subcutaneous and intravenous bolus administration.

作者信息

Werner-Wasik Maria, Langer Corey, Movsas Benjamin

机构信息

Department of Radiation Oncology, Kimmel Cancer Center, Jefferson Medical College, Thomas Jefferson University Hospital, 111 South 11th Street, Bodine Center, Philadelphia, PA 19107, USA.

出版信息

Semin Oncol. 2005 Apr;32(2 Suppl 3):S105-8. doi: 10.1053/j.seminoncol.2005.03.018.

DOI:10.1053/j.seminoncol.2005.03.018
PMID:16015544
Abstract

Esophagitis is a major complication of chemoradiation therapy in patients with non-small cell lung cancer, producing significant morbidity and resulting in treatment interruptions. Amifostine at different doses and schedules has been found to reduce frequency or severity of esophagitis in this setting. In the Radiation Therapy Oncology Group 98-01 trial in non-small cell lung cancer patients receiving chemoradiation therapy, amifostine given intravenously four times weekly did not significantly reduce the frequency of grade 3 or 4 esophagitis; however, a significant reduction in severity over time was observed in patient swallowing diaries. The potential benefits of amifostine may have been obscured by inability to provide full amifostine doses due to toxicity associated with infusion, scheduling of doses, and inadequate follow-up to monitor severity of esophagitis over time. These issues are to be addressed in a randomized phase II trial of amifostine given subcutaneously or via intravenous bolus in non-small cell lung cancer patients undergoing chemoradiation treatment.

摘要

食管炎是非小细胞肺癌患者放化疗的主要并发症,会导致严重发病并致使治疗中断。已发现不同剂量和给药方案的氨磷汀可降低这种情况下食管炎的发生频率或严重程度。在放射治疗肿瘤学组98-01针对接受放化疗的非小细胞肺癌患者的试验中,每周静脉注射4次氨磷汀并不能显著降低3级或4级食管炎的发生频率;然而,在患者吞咽日记中观察到随着时间推移严重程度有显著降低。由于与输注相关的毒性、给药方案以及缺乏对食管炎严重程度随时间变化的充分随访监测,无法提供全剂量氨磷汀可能掩盖了其潜在益处。这些问题将在一项针对接受放化疗的非小细胞肺癌患者皮下注射或静脉推注氨磷汀的随机II期试验中得到解决。

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