A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer
A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer
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DOI：
10.1056/nejmoa032295
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发表时间：
2004-03-18
影响因子：
158.5
通讯作者：
Büchler, MW
中科院分区：
文献类型：
--
作者：
Neoptolemos, JP;Stocken, DD;Büchler, MW
背景：辅助治疗对胰腺癌生存率的影响尚不清楚。我们报告欧洲胰腺癌研究组1试验的最终结果，并更新中期结果。在一项采用二乘二析因设计的多中心试验中，我们将73例胰腺导管腺癌切除患者随机分为单纯放化疗组（20戈伊，2周加氟尿嘧啶），75例患者单独化疗结果：69例单纯观察组，72例放化疗联合化疗组，69例观察组。该分析基于289例患者中的237例死亡（82%）和中位随访47个月（四分位数范围，33至62）。在接受放化疗的患者中，估计的五年生存率为10%，而在未接受放化疗的患者中，估计的五年生存率为20%（P=0.05）。接受化疗的患者的5年生存率为21%，未接受化疗的患者为8%（P=0.009）。化疗的好处坚持调整后的主要预后factors.Conclusions：辅助化疗切除胰腺癌患者的生存有显着的好处，而辅助放化疗对生存的有害影响。
Background: The effect of adjuvant treatment on survival in pancreatic cancer is unclear. We report the final results of the European Study Group for Pancreatic Cancer 1 Trial and update the interim results.Methods: In a multicenter trial using a two-by-two factorial design, we randomly assigned 73 patients with resected pancreatic ductal adenocarcinoma to treatment with chemoradiotherapy alone (20 Gy over a two-week period plus fluorouracil), 75 patients to chemotherapy alone (fluorouracil), 72 patients to both chemoradiotherapy and chemotherapy, and 69 patients to observation.Results: The analysis was based on 237 deaths among the 289 patients (82 percent) and a median follow-up of 47 months (interquartile range, 33 to 62). The estimated five-year survival rate was 10 percent among patients assigned to receive chemoradiotherapy and 20 percent among patients who did not receive chemoradiotherapy (P=0.05). The five-year survival rate was 21 percent among patients who received chemotherapy and 8 percent among patients who did not receive chemotherapy (P=0.009). The benefit of chemotherapy persisted after adjustment for major prognostic factors.Conclusions: Adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.