Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non-small-cell lung cancer: Report of a randomized comparative trial
Effects of amifostine on acute toxicity from concurrent chemotherapy and radiotherapy for inoperable non-small-cell lung cancer: Report of a randomized comparative trial
复制标题
DOI：
10.1016/j.ijrobp.2003.10.005
复制
发表时间：
2004-04-01
影响因子：
7
通讯作者：
Cox, JD
中科院分区：
文献类型：
--
作者：
Komaki, R;Lee, JS;Cox, JD
目的：为了确定氨磷汀的能力，以减少并发化疗和放疗（RT）的急性毒性的严重程度和/或发病率non-small-cell lung cancer.Methods and Materials：患者不能手术，非转移性非小细胞肺癌接受并发放化疗随机分为两个治疗组之一。第1组患者接受胸部RT（总剂量，69.6戈伊，分58次，每次1.2戈伊，每日2次）。5 d/wk），联合口服依托泊苷（50 mg b.i.d.胸部RT前30分钟，持续10天，第29天重复）和顺铂（50 mg/m2，第1、8、29和36天静脉注射）。第2组患者接受相同的治疗加氨磷汀（每周前2天任何治疗前20-30分钟静脉注射500 mg）。急性反应进行了评估，使用美国国家癌症研究所常见的毒性Criterions.Results：六十二例患者参加了1998年11月至2001年1月。最短随访时间为24个月，存活患者的中位随访时间为31个月。两组患者的患者和肿瘤特征分布均匀。第I组患者的中位生存时间为20个月，第2组患者为19个月。第1组中23%的患者的最大食管毒性为轻度（1级），42%为中度（2级），35%为重度（3-4级）;第2组患者的相应发生率分别为48%、35%和16%（p = 0.021）。第1组16%的患者发生重度肺炎，第2组无患者发生（p = 0.020，卡方检验）。39%的第1组患者和16%的第2组患者发生中性粒细胞减少性发热（p = 0.046，卡方检验）。结论：氨磷汀可降低顺铂化疗联合放疗引起的急性食管、肺和血液系统毒性的严重程度和发生率。氨磷汀对不可切除的非小细胞肺癌患者的生存率无明显影响，提示其不具有肿瘤保护作用。(C)2004年爱思唯尔公司
Purpose: To determine the ability of amifostine to reduce the severity and/or incidence of the acute toxicities of concurrent chemotherapy and radiotherapy (RT) for non-small-cell lung cancer.Methods and Materials: Patients with inoperable, nonmetastatic non-small-cell lung cancer receiving concurrent chemoradiotherapy were randomized to one of two treatment groups. Arm 1 patients received thoracic RT (total dose, 69.6 Gy in 58 fractions of 1.2 Gy b.i.d. 5 d/wk), plus oral etoposide (50 mg b.i.d. 30 min before thoracic RT for 10 days, repeated on Day 29) and cisplatin (50 mg/m(2) i.v. on Days 1, 8, 29, and 36). Arm 2 patients received the same treatment plus amifostine (500 mg i.v. 20-30 min before any treatment the first 2 days of each week). Acute effects were assessed using the National Cancer Institute Common Toxicity Criteria.Results: Sixty-two patients were enrolled between November 1998 and January 2001. The minimal follow-up was 24 months, and the median follow-up of living patients was 31 months. The patient and tumor characteristics were equally distributed between the patients in the two arms. The median survival time was 20 months in Arm I patients and 19 months in Arm 2 patients. The maximal esophageal toxicity was mild (Grade 1) in 23%, moderate (Grade 2) in 42%, and severe (Grade 3-4) in 35% of patients in Arm 1; the corresponding rates for the Arm 2 patients were 48%, 35%, and 16% (p = 0.021). Severe pneumonitis occurred in 16% of the Arm 1 and none of the Arm 2 patients (p = 0.020, chi-square test). Neutropenic fever occurred in 39% of Arm 1 and 16% of Arm 2 patients (p = 0.046, chi-square test). Mild hypotension, dysgeusia, and sneezing were significantly more frequent among the patients in Arm 2.Conclusion: Amifostine reduced the severity and incidence of acute esophageal, pulmonary, and hematologic toxicity resulting from concurrent cisplatin-based chemotherapy and RT. Amifostine had no apparent effect on survival in these patients with unresectable non-small-cell lung cancer, suggesting that it does not have a tumor-protective effect. (C) 2004 Elsevier Inc.