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

Abstract

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). CONCLUSION The 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.

FGFR2 in gastric cancer: protein overexpression predicts gene amplification and high H-index predicts poor survival

“…After validation, we performed FGFR2b immunohistochemistry in 1584 gastric cancers from four tissue microarray sets from previous studies (Figure 1). [23][24][25] Of the 1584 specimens, FGFR2b immunohistochemistry was successfully performed in 1574 cases. The samples were obtained from patients who underwent surgical resection for primary gastric cancer at the Samsung Medical Center, Seoul, Korea, between 1996 and 2006.…”

Adjuvant or neoadjuvant therapy for operable esophagogastric cancer?

“…However, a major concern regarding this trial is that 90 % of patients had a limited lymph node dissection (D0 or D1), and therefore chemoradiotherapy may have merely compensated for insufficient resection [9]. This theory is supported by the results of the ARTIST trial [21]. The Asian ARTIST trial randomized 458 patients with curatively resected gastric cancer to either six cycles of postoperative XP (cisplatin and capecitabine) or two cycles of XP followed by chemoradiotherapy (45 Gy ?…”

“…All patients in this trial had a D2 resection, and therefore this study aimed to establish whether the benefits of chemoradiotherapy were also seen in patients who had an optimal resection. Overall, this study did not show a significant improvement in DFS with the addition of chemoradiotherapy (P = 0.0862) [21]. One reason for this may be that approximately 60 % of patients were stage IB-II in whom the relative benefit of any adjuvant approach is likely to be small [21].…”

“…Overall, this study did not show a significant improvement in DFS with the addition of chemoradiotherapy (P = 0.0862) [21]. One reason for this may be that approximately 60 % of patients were stage IB-II in whom the relative benefit of any adjuvant approach is likely to be small [21]. However, patients with pathologic lymph node metastases at the time of surgery had improved DFS (P = 0.0365) with chemoradiotherapy, which suggests that these patients may represent a subgroup who derive benefit from chemoradiotherapy.…”

“…The Asian ARTIST trial randomized 458 patients with curatively resected gastric cancer to either six cycles of postoperative XP (cisplatin and capecitabine) or two cycles of XP followed by chemoradiotherapy (45 Gy ? capecitabine 1,650 mg/m 2 per day for 5 weeks) and a further two cycles of XP [21]. All patients in this trial had a D2 resection, and therefore this study aimed to establish whether the benefits of chemoradiotherapy were also seen in patients who had an optimal resection.…”