辅助化放疗治疗胃癌（ARTIST）试验是第一项探讨给胃癌患者实施术后放化疗疗效的研究，该治疗方案作为根治性切除和扩大D2淋巴结清扫术患者的辅助治疗。在该项研究中，研究人员对无疾病生存期（DFS）和总生存期（OS）的最终结果进行分析。

研究详情：

在该项试验中，XP组接受6个周期的XP化疗（卡培他滨，每日2000mg/m²，从第1～14天+顺铂，第1天60mg/m²，每3周重复）。XP/XRT/XP组接受2个周期XP化疗序贯45Gy放疗（卡培他滨1650mg/m²/d，维持5周）+2个周期XP化疗。预先计划的亚组分析在Lauren分型和淋巴结状态中开展。在患者队列中对EGFR，HER2和MET的过度表达进行研究，同时对DFS和OS进行相关性分析。

研究结果：

在458例患者中，228例患者随机分配到XP组，230例患者随机分配到XP/XRT/XP组。在最终的分析中，放疗增加到XP化疗没有显著延长DFS（HR 1.352，95% CI 0.952～1.922；P=0.0922）。然而，对于肠道亚型，与只接受XP化疗相比，XP/XRT/XP组的DFS明显延长（HR 2.883，95% CI，1.36～6.111，P=0.0057）。相比之下，在弥漫型胃癌中，RT增加到XP没有明显延长DFS（HR 1.161，95% CI，0.753～1.791；P=0.4985）。根据第一份报告的研究结果，对于LN（+）组，DFS在XP/XRT/XP组优于只接受XP治疗组。目前，包括HER1，HER2，MET的生物标记物分析正在研究。这些标记物和DFS/OS之间的相关性分析不久将提交。

研究结论：

总体而言，ARTIST试验在单独XP治疗和XP/XRT/XP之间是一项关于DFS没有显著差异的负面试验。然而，对于通过Lauren分型的肠道型患者，与只接受XP治疗相比，XP/XRT/XP组患者明显延长DFS。经过一段较长时间的随访期，LN（+）胃癌患者接受XP/XRT/XP治疗似乎获益。因此，随后的ARTIST-II试验（只接受TS-1治疗，TS-1/奥沙利铂，TS-1/奥沙利铂/RT）正在招募病理学LN（+）胃癌患者。临床试验信息：00323830。

医脉通整理报道，转载请注明出处。

会议专题》》》2014年ASCO年会专题报道

阅读摘要原文

Phase III trialto compare capecitabine/cisplatin (XP) versus XP plus concurrentcapecitabine-radiotherapy in gastric cancer (GC): The final report on theARTIST trial.（Abstract 4008）

Authors:Jeeyun Lee, Do Hoon Lim, Sung Kim

Session Type:Oral Abstract Session

Background:The adjuvant chemoradiation therapy in stomachcancer (ARTIST) trial is the first study to investigate the efficacy ofpostoperative chemoradiation therapy as adjuvant treatment in gastric cancerpatients with curative resection and extended D2 lymph node dissection. In thisstudy，we report on the final analysis of the disease free survival（DFS） andsurvival（OS）. 

Methods: XP arm received six cycles of XP (capecitabine 2000 mg/m² per day on days 1 to 14 and cisplatin 60 mg/m² on day 1，repeated every 3 weeks) chemotherapy. XP/XRT/XP armreceived two cycles of XP followed by 45 Gy radiotherapy (capecitabine 1650mg/m²/d for 5 weeks) and two cycles of XP. Preplanned subgroupanalyses on Lauren classification and lymph node status were performed. EGFR，HER2 and MET overexpression were studied in this patient cohort and correaltive analyses with DFS and OS were performed. 

Results:Of 458 patients，228 patients were randomized to the XP arm and 230 patients wererandomized to the XP/XRT/XP arm. At final analysis，the addition ofradiotherapy to XP chemotherapy did not significantly prolong DFS (HR 1.352，95% CI 0.952-1.922；P=0.0922). In the intestinal subtype，however，DFS on the XP/XRT/XP arm was significantly prolonged when compared with XP alone (HR2.883，95% CI，1.36-6.111，P=0.0057). In contrast，the addition of RT to XP in diffuse type GC did not considerably prolong DFS (HR 1.161，95% CI，0.753-1.791；P=0.4985). In accordance with the results from the first report，the DFS was superior in XP/XRT/XP then XP alone in LN(+) group. Currently，biomarker analyses including HER1，HER2，MET are being carried out. The correlative analyses between these markers and DFS/OS will be presented. 

Conclusions:Overall，the ARTIST trial was a negative trial with no significant difference in DFS between XP alone and XP/XRT/XP. However，XP/XRT/XP significantly prolonged DFS in intestinal type byLauren classification when compared to XP alone. After a longer follow upduration，XP/XRT/XP seemed to benefit LN(+) GC patients. Hence, a subsequent ARTIST-II (TS-1 alone，TS-1/oxaliplatin，TS-1/oxaliplatin/RT) is enrolling patients with pathologic LN(+) GC. Clinical trial information: 00323830.

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