Neoptolemos John P, Stocken Deborah D, Friess Helmut, Bassi Claudio, Dunn Janet A, Hickey Helen, Beger Hans, Fernandez-Cruz Laureano, Dervenis Christos, Lacaine François, Falconi Massimo, Pederzoli Paolo, Pap Akos, Spooner David, Kerr David J, Büchler Markus W
Department of Surgery, Liverpool University, Liverpool, United Kingdom.
N Engl J Med. 2004 Mar 18;350(12):1200-10. doi: 10.1056/NEJMoa032295.
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.
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.
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.
Adjuvant chemotherapy has a significant survival benefit in patients with resected pancreatic cancer, whereas adjuvant chemoradiotherapy has a deleterious effect on survival.
辅助治疗对胰腺癌患者生存率的影响尚不清楚。我们报告了欧洲胰腺癌研究组1试验的最终结果，并更新了中期结果。
在一项采用二乘二析因设计的多中心试验中，我们将73例接受胰腺导管腺癌切除术的患者随机分配至单纯接受放化疗（两周内给予20 Gy放疗加氟尿嘧啶）组、75例单纯接受化疗（氟尿嘧啶）组、72例接受放化疗和化疗组以及69例观察组。
分析基于289例患者中的237例死亡（82%），中位随访时间为47个月（四分位间距，33至62个月）。接受放化疗的患者估计五年生存率为10%，未接受放化疗的患者为20%（P = 0.05）。接受化疗的患者五年生存率为21%，未接受化疗的患者为8%（P = 0.009）。在对主要预后因素进行校正后，化疗的益处依然存在。
辅助化疗对接受胰腺癌切除术的患者有显著的生存益处，而辅助放化疗对生存有不利影响。
