A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.
A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer.
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DOI：
10.1038/sj.bjc.6605256
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发表时间：
2009-09-15
影响因子：
8.8
通讯作者：
中科院分区：
文献类型：
--
作者：
这项多中心随机 III 期试验旨在确定吉西他滨辅助化疗是否可以改善胰腺癌切除患者的预后。资格标准包括对胰腺浸润性导管癌进行宏观治愈性切除，并且未进行早期放疗或化疗。患者以 1:1 的比例随机分配到吉西他滨组或仅手术组。分配至吉西他滨组的患者在第 1、8 和 15 天接受吉西他滨治疗，剂量为 1000 mg m−2，持续 30 分钟，每 4 周一次，共 3 个周期。 2002年4月至2005年3月期间，119名患者参加了这项研究。其中，118 例符合条件且可分析（吉西他滨组 58 例，仅手术组 60 例）。两组在基线特征方面都非常平衡。虽然吉西他滨组经常观察到血液学毒性，但大多数毒性是暂时的，3 级或 4 级非血液学毒性很少见。吉西他滨组患者的无病生存期 (DFS) 明显长于仅手术组患者（中位 DFS 为 11.4 个月与 5.0 个月；风险比 = 0.60（95% 置信区间 (CI)：0.40–0.89）；P=0.01），尽管吉西他滨组和仅手术组患者的总生存期没有显着差异（中位总生存期为 22.3 个月与 5.0 个月）。 18.4 个月；风险比=0.77（95% CI：0.51-1.14）；目前的结果表明，辅助吉西他滨有助于延长接受宏观治愈性切除胰腺癌的患者的 DFS。
This multicentre randomised phase III trial was designed to determine whether adjuvant chemotherapy with gemcitabine improves the outcomes of patients with resected pancreatic cancer. Eligibility criteria included macroscopically curative resection of invasive ductal carcinoma of the pancreas and no earlier radiation or chemotherapy. Patients were randomly assigned at a 1 : 1 ratio to either the gemcitabine group or the surgery-only group. Patients assigned to the gemcitabine group received gemcitabine at a dose of 1000 mg m−2 over 30 min on days 1, 8 and 15, every 4 weeks for 3 cycles. Between April 2002 and March 2005, 119 patients were enrolled in this study. Among them, 118 were eligible and analysable (58 in the gemcitabine group and 60 in the surgery-only group). Both groups were well balanced in terms of baseline characteristics. Although heamatological toxicity was frequently observed in the gemcitabine group, most toxicities were transient, and grade 3 or 4 non-heamatological toxicity was rare. Patients in the gemcitabine group showed significantly longer disease-free survival (DFS) than those in the surgery-only group (median DFS, 11.4versus 5.0 months; hazard ratio=0.60 (95% confidence interval (CI): 0.40–0.89); P=0.01), although overall survival did not differ significantly between the gemcitabine and surgery-only groups (median overall survival, 22.3 versus 18.4 months; hazard ratio=0.77 (95% CI: 0.51–1.14); P=0.19). The current results suggest that adjuvant gemcitabine contributes to prolonged DFS in patients undergoing macroscopically curative resection of pancreatic cancer.
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影响因子：
8.8
作者：
Neoptolemos, J. P.;Stocken, D. D.;Buechler, M. W.
通讯作者：
Buechler, M. W.
影响因子：
8.8
作者：
通讯作者：
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影响因子：
120.7
作者：
Regine, William F.;Winter, Kathryn A.;Rich, Tyvin A.
通讯作者：
Rich, Tyvin A.
DOI：
10.1007/s00534-008-1357-3
发表时间：
2008-09-01
期刊：
JOURNAL OF HEPATO-BILIARY-PANCREATIC SURGERY
影响因子：
--
作者：
Ueno, Hideki;Kosuge, Tomoo
通讯作者：
Kosuge, Tomoo
影响因子：
11.5
作者：
Marechal, Raphael;Mackey, John R.;Van Laethem, Jean-Luc
通讯作者：
Van Laethem, Jean-Luc