Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study
Adjuvant Gemcitabine Alone Versus Gemcitabine-Based Chemoradiotherapy After Curative Resection for Pancreatic Cancer: A Randomized EORTC-40013-22012/FFCD-9203/GERCOR Phase II Study
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DOI：
10.1200/jco.2010.30.3446
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发表时间：
2010-10-10
影响因子：
45.3
通讯作者：
Haustermans, Karin
中科院分区：
文献类型：
--
作者：
Van Laethem, Jean-Luc;Hammel, Pascal;Haustermans, Karin
目的辅助放化疗（CRT）在可切除胰腺癌中的作用仍有争议。这项随机II期组间研究探讨了胰腺癌R0切除术后以吉西他滨为基础的CRT方案的可行性和耐受性。患者和方法术后8周内，患者被随机分配接受4个周期的吉西他滨治疗（对照组）或2个周期的吉西他滨治疗，随后每周接受吉西他滨同时放疗（50.4 Gy； CRT组）。主要目的是排除CRT组中治疗完成率< 60%和4级血液学或胃肠道毒性发生率低于40%，I型和II型错误为10%。次要终点为晚期毒性、无病生存期（DFS）和总生存期（OS）。结果2004年9月至2007年1月，随机选取90例患者（45:45）。两组患者特征相似。在对照组和CRT组，每个方案的治疗完成率分别为86.7%和73.3% (80% CI， 63.1%至81.9%;95% CI， 58.1%至85.4%)，4级毒性分别为0%和4.7%（43例中的2例；80% CI， 1.2%至11.9%）。在CRT组中，3名患者出现3级相关的晚期毒性。CRT组的中位DFS为12个月，对照组为11个月。两组的中位OS均为24个月。首次局部复发在CRT组较少（11% vs 24%）。结论吉西他滨辅助CRT治疗可行、耐受性好、无不良反应；胰腺癌切除术后将此治疗加入全剂量吉西他滨辅助治疗应在III期试验中进行评估。[J]中华临床杂志，28(2):445 - 456。(C) 2010年由美国临床肿瘤学会出版
Purpose The role of adjuvant chemoradiotherapy (CRT) in resectable pancreatic cancer is still debated. This randomized phase II intergroup study explores the feasibility and tolerability of a gemcitabine-based CRT regimen after R0 resection of pancreatic head cancer.Patients and Methods Within 8 weeks after surgery, patients were randomly assigned to receive either four cycles of gemcitabine (control arm) or gemcitabine for two cycles followed by weekly gemcitabine with concurrent radiation (50.4 Gy; CRT arm). The primary objective was to exclude a < 60% treatment completion and a > 40% rate of grade 4 hematologic or GI toxicity in the CRT arm with type I and II errors of 10%. Secondary end points were late toxicity, disease-free survival (DFS), and overall survival (OS).Results Between September 2004 and January 2007, 90 patients were randomly assigned (45: 45). Patient characteristics were similar in both arms. Treatment was completed per protocol by 86.7% and 73.3% (80% CI, 63.1% to 81.9%; 95% CI, 58.1% to 85.4%) in the control and CRT arms, respectively, and grade 4 toxicity was 0% and 4.7% (two of 43; 80% CI, 1.2% to 11.9%), respectively. In the CRT arm, three patients experienced grade 3-related late toxicity. Median DFS was 12 months in the CRT arm and 11 months in the control arm. Median OS was 24 months in both arms. First local recurrence was less frequent in the CRT arm (11% v 24%).Conclusion Adjuvant gemcitabine-based CRT is feasible, well-tolerated, and not deleterious; adding this treatment to full-dose adjuvant gemcitabine after resection of pancreatic cancer should be evaluated in a phase III trial. J Clin Oncol 28:4450-4456. (C) 2010 by American Society of Clinical Oncology