Phase III Trial Comparing Capecitabine Plus Cisplatin Versus Capecitabine Plus Cisplatin With Concurrent Capecitabine Radiotherapy in Completely Resected Gastric Cancer With D2 Lymph Node Dissection: The ARTIST Trial
Phase III Trial Comparing Capecitabine Plus Cisplatin Versus Capecitabine Plus Cisplatin With Concurrent Capecitabine Radiotherapy in Completely Resected Gastric Cancer With D2 Lymph Node Dissection: The ARTIST Trial
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DOI：
10.1200/jco.2011.39.1953
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发表时间：
2012-01-20
影响因子：
45.3
通讯作者：
Kang, Won Ki
中科院分区：
文献类型：
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作者：
Lee, Jeeyun;Lim, Do Hoon;Kang, Won Ki
目的胃癌辅助放化疗（ARIST）试验是我们所知的第一个研究胃癌根治性切除术后D2淋巴结清扫患者术后放化疗的作用的研究。本试验旨在比较卡培他滨联合顺铂（XP）与XP联合卡培他滨放疗（XP/XRT/XP）的术后治疗。患者和方法XP组接受6个周期的XP化疗（卡培他滨2,000 mg/m2，第1 ~ 14天，顺铂60 mg/m2，第1天，每3周重复）。XP/XRT/XP组接受两个周期的XP治疗，然后接受45-戈伊XRT治疗（卡培他滨1,650 mg/m2/d，共5周）和XP两个周期。结果458例患者中，228名患者被随机分配到XP组，230名患者被随机分配到XP/XRT/XP组，75.4%的患者按计划完成治疗总体而言，XRT加XP化疗并没有显著延长无病生存期（DFS; P = 0.0862）。然而，在手术时有病理性淋巴结转移的患者亚组（n = 396）中，随机分配到XP/XRT/XP组的患者与单独接受XP的患者相比，DFS更优（P = 0.0365），在多变量分析中保持统计学显著性（估计风险比，0.6865; 95%CI，0.4735 - 0.9952; P = 0.0471）.结论XRT加XP化疗不能显著降低胃癌根治性切除术和D2淋巴结清扫术后的复发率。计划在淋巴结阳性胃癌患者中进行后续试验（ARTIST-II）。
PurposeThe ARTIST (Adjuvant Chemoradiation Therapy in Stomach Cancer) trial was the first study to our knowledge to investigate the role of postoperative chemoradiotherapy therapy in patients with curatively resected gastric cancer with D2 lymph node dissection. This trial was designed to compare postoperative treatment with capecitabine plus cisplatin (XP) versus XP plus radiotherapy with capecitabine (XP/XRT/XP).Patients and MethodsThe XP arm received six cycles of XP (capecitabine 2,000 mg/m(2) per day on days 1 to 14 and cisplatin 60 mg/m(2) on day 1, repeated every 3 weeks) chemotherapy. The XP/XRT/XP arm received two cycles of XP followed by 45-Gy XRT (capecitabine 1,650 mg/m(2) per day for 5 weeks) and two cycles of XP.Results Of 458 patients, 228 were randomly assigned to the XP arm and 230 to the XP/XRT/XP arm. Treatment was completed as planned by 75.4% of patients (172 of 228) in the XP arm and 81.7% (188 of 230) in the XP/XRT/XP arm. Overall, the addition of XRT to XP chemotherapy did not significantly prolong disease-free survival (DFS; P = .0862). However, in the subgroup of patients with pathologic lymph node metastasis at the time of surgery (n = 396), patients randomly assigned to the XP/XRT/XP arm experienced superior DFS when compared with those who received XP alone (P = .0365), and the statistical significance was retained at multivariate analysis (estimated hazard ratio, 0.6865; 95% CI, 0.4735 to 0.9952; P = .0471).ConclusionThe addition of XRT to XP chemotherapy did not significantly reduce recurrence after curative resection and D2 lymph node dissection in gastric cancer. A subsequent trial (ARTIST-II) in patients with lymph node-positive gastric cancer is planned.