Phase II study of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer
Phase II study of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer
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DOI：
10.1038/sj.bjc.6602001
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发表时间：
2004-08-16
影响因子：
8.8
通讯作者：
Ikeda, H
中科院分区：
文献类型：
--
作者：
Okusaka, T;Ito, Y;Ikeda, H
据报道，吉西他滨在人胰腺细胞系中是一种有效的放射增敏剂。本研究旨在评价放疗联合吉西他滨治疗局部晚期胰腺癌的疗效和毒性。总共有42例胰腺癌患者不能切除，但局限于胰腺区域，接受外照射（50.4戈伊，28次，5.5周）和每周一次吉西他滨（250 mg/m2，30分钟输注）治疗。在放化疗完成后1个月开始吉西他滨维持治疗（1000 mg/m2，每周一次，每4周一次，共3次），并持续至疾病进展或出现不可接受的毒性。在42例患者中，38例（90%）完成了预定的放化疗疗程。主要毒副反应为白细胞减少和厌食。有1例死亡归因于十二指肠出血和败血症。中位生存期为9.5个月，1年生存率为28%。中位无进展生存期为4.4个月。在分析时记录到疾病进展的35例患者中，34例（97%）显示远处转移是初始疾病进展的原因。本研究中使用的放化疗对局部晚期胰腺癌具有中等活性，毒性可接受。未来的研究需要更多的全身效应的治疗。
Gemcitabine has been reported to be a potent radiosensitiser in human pancreatic cell lines. This study was conducted to evaluate the efficacy and toxicity of radiotherapy combined with gemcitabine for locally advanced pancreatic cancer. In all, 42 patients with pancreatic cancer that was unresectable but confined to the pancreatic region were treated with external-beam radiation (50.4 Gy in 28 fractions over 5.5 weeks) and weekly gemcitabine (250 mg m(-2), 30-min infusion). Maintenance gemcitabine (1000 mg m(-2) weekly x 3 every 4 weeks) was initiated 1 month after the completion of the chemoradiotherapy and continued until disease progression or unacceptable toxicity. Of the 42 patients, 38 (90%) completed the scheduled course of chemoradiotherapy. The major toxicity was leucopenia and anorexia. There was one death attributed to duodenal bleeding and sepsis. The median survival time was 9.5 months and the 1-year survival rate was 28%. The median progression-free survival time was 4.4 months. In 35 patients with documented disease progression at the time of analysis, 34 (97%) showed distant metastasis as the cause of the initial disease progression. The chemoradiotherapy used in this study has a moderate activity against locally advanced pancreatic cancer and an acceptable toxicity profile. Future investigations for treatment with more systemic effects are warranted.