A randomized Phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern cooperative oncology group study E8282
A randomized Phase III study of radiotherapy alone or with 5-fluorouracil and mitomycin-C in patients with locally advanced adenocarcinoma of the pancreas: Eastern cooperative oncology group study E8282
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DOI：
10.1016/j.ijrobp.2004.12.074
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发表时间：
2005-08-01
影响因子：
7
通讯作者：
Haller, DG
中科院分区：
文献类型：
--
作者：
Cohen, SJ;Dobelbower, R;Haller, DG
目的：局部晚期胰腺癌患者的中位生存时间为8-10个月。放射治疗已用于改善局部控制和缓解症状。这项随机研究的目的是确定放射治疗中添加 5-氟尿嘧啶 (5-FU) 丝裂霉素-C (MMC) 是否可以改善该患者群体的预后。 患者和方法：114 名患者随机接受 59.4 Gy 外照射放射治疗（1.8 Gy 剂量），单独接受 5-FU（1,000 mg/m(2)/天，持续 4 天，第 2-5 天连续输注） 28-31) 和 MMC (第 2 天 10 mg/m(2))。结果：104 名患者进行了疗效评估。血液学和非血液学毒性在联合治疗组中更为常见。放射治疗组的反应率为 6%，联合治疗组的反应率为 9%。联合治疗组和单独放疗组的中位无病生存时间 (DFS) 或总生存时间 (OS) 没有差异：DFS 分别为 5.1 个月和 5.0 个月 (p = 0.19)，OS 分别为 8.4 个月和 7.1 个月 (p = 0.16)。结论：放疗中添加 5-FU 和 MMC 增加了毒性，但局部晚期胰腺癌患者的 DFS 或 OS 没有改善。放射增敏的替代药物可能会改善结果。 (c) 2005 年爱思唯尔公司。
Purpose: The median survival time of patients with locally advanced adenocarcinoma of the pancreas is 8-10 months. Radiation therapy has been used to improve local control and palliate symptoms. This randomized study was undertaken to determine whether the addition of 5-fluorouracil (5-FU) find mitomycin-C (MMC) to radiation therapy improves outcome in this patient population.Patients and Methods: One hundred fourteen patients were randomized to receive 59.4 Gy external beam radiotherapy in 1.8 Gy fractions alone or in combination with 5-FU (1,000 mg/m(2)/day for 4 days by continuous infusion Days 2-5 and 28-31) and MMC (10 mg/m(2) on Day 2).Results: One hundred four patients were evaluable for efficacy. Hematologic and nonhematologic toxicities were more common in the combination arm. The response rates were 6% in the radiation therapy arm and 9% in the combination arm. There were no differences in median disease-free survival time (DFS) or overall survival time (OS) between the combination and radiation therapy alone arms: 5.1 vs. 5.0 months, respectively, for DFS (p = 0.19) and 8.4 vs. 7.1 months, respectively, for OS (p = 0.16).Conclusion: The addition of 5-FU and MMC to radiotherapy increased toxicity without improving DFS or OS in patients with locally advanced pancreatic cancer. Alternative drugs for radiosensitization may improve outcome. (c) 2005 Elsevier Inc.