Hepatobiliary and Pancreatic Division, Cancer Institute Hospital, 3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan.
Jpn J Clin Oncol. 2010 Jun;40(6):573-9. doi: 10.1093/jjco/hyq011. Epub 2010 Feb 25.
Chemoradiotherapy with 5-fluorouracil has been accepted as a standard care for locally advanced pancreatic cancer; however, it has not been shown to be superior to chemotherapy alone in the gemcitabine era. The present multicentre phase II study was conducted to evaluate the efficacy and safety of Gem monotherapy against locally advanced pancreatic cancer in comparison with the historical data of chemoradiotherapy with 5-fluorouracil.
Eligibility criteria included patients with histologically proven locally advanced pancreatic cancer, all lesions encompassed by a square of 15 cm on one side, no prior treatment, good performance status and adequate organ function. Gemcitabine was given intravenously at a dose of 1000 mg/m(2) over 30 min on days 1, 8 and 15, repeated every 4 weeks. The primary endpoint was %1-year survival. Expected and threshold %1-year survival were 40 and 25%, respectively.
Between January 2006 and February 2007, 50 locally advanced pancreatic cancer patients were registered. The major grade 3-4 adverse events were neutropaenia (62%), thrombocytopaenia (18%), fatigue (12%) and infection-biliary tree (12%). Haematological toxicity was mostly transient and there was no episode of infection with grade 3-4 neutropaenia. Up to the final follow-up in February 2009, the median overall survival was 15.0 months with a %1-year survival of 64.0%.
Gemcitabine monotherapy demonstrated far better survival than historical data for chemoradiotherapy with 5-fluorouracil with mild toxicities. Gemcitabine could be consider as a standard treatment for locally advanced pancreatic cancer.
以氟尿嘧啶为基础的化放疗已被接受为局部晚期胰腺癌的标准治疗方法；然而，在吉西他滨时代，它并没有显示出比单独化疗更优越。本多中心 II 期研究旨在评估吉西他滨单药治疗与氟尿嘧啶化学放疗的历史数据相比，对局部晚期胰腺癌的疗效和安全性。
入选标准包括组织学证实的局部晚期胰腺癌患者，所有病变均被一个边长为 15 厘米的正方形所包含，无既往治疗，良好的体能状态和足够的器官功能。吉西他滨静脉滴注，剂量为 1000mg/m2，于第 1、8 和 15 天，每 4 周重复一次。主要终点是 1 年生存率。预期和阈值 1 年生存率分别为 40%和 25%。
2006 年 1 月至 2007 年 2 月期间，共登记了 50 例局部晚期胰腺癌患者。主要的 3-4 级不良事件为中性粒细胞减少（62%）、血小板减少（18%）、乏力（12%）和胆道感染（12%）。血液学毒性多为一过性，无 3-4 级中性粒细胞减少感染。截至 2009 年 2 月的最终随访，中位总生存期为 15.0 个月，1 年生存率为 64.0%。
吉西他滨单药治疗显示出比氟尿嘧啶化学放疗的历史数据更好的生存结果，且毒性较轻。吉西他滨可作为局部晚期胰腺癌的标准治疗方法。
