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

2012 ◽  
Vol 30 (3) ◽  
pp. 268-273 ◽  
Author(s):  
Jeeyun Lee ◽  
Do Hoon Lim ◽  
Sung Kim ◽  
Se Hoon Park ◽  
Joon Oh Park ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Lymph Node Dissection ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Postoperative Treatment ◽  
Node Dissection ◽  
Cancer Trial ◽  
D2 Lymph Node Dissection ◽  
Resected Gastric Cancer

Purpose The 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 Methods The XP arm received six cycles of XP (capecitabine 2,000 mg/m2 per day on days 1 to 14 and cisplatin 60 mg/m2 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/m2 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). 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.

scholarly journals Comparison of laparoscopic versus open gastrectomy with D2 lymph node dissection for advanced gastric cancer: A meta-analysis

2019 ◽  
Vol 1 (2) ◽  
pp. 110-121
Author(s):  
Sandrie Mariella Mac ◽  
Ashish Bahadur Malla
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Advanced Gastric Cancer ◽  
Lymph Node Dissection ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Open Gastrectomy ◽  
Long Term Results ◽  
Node Dissection ◽  
D2 Lymph Node Dissection

For many decades, D2 procedure has been accepted in the far-east as the standard treatment for both early (EGC) and advanced gastric cancer (AGC). In case of AGC, the debate on the extent of nodal dissection has been open for many years in order to highlight the safety and efficacy of treatment, hence this study. A comprehensive literature research was performed in PubMed to identify studies that compared laparoscopic- assisted gastrectomy (LAG) and open gastrectomy (OG) with D2 lymph node dissection (D2-LND) for treatment of AGC for the last five years. Data of interest were checked and subjected to meta-analysis with RevMan 5.3 software. The pooled risk ratios (RR) and weighted mean difference (WMD) with 95% confidence intervals (CI) were calculated. Overall, 19 studies were included in this meta-analysis. LG had some advantages over OG, including shorter hospitalization (WMD -2.31; 95% CI -4.09 to -0.53; P = 0.01), less blood loss (WMD -120.49; 95% CI -174.27 to -66.71; P < 0.01), faster bowel recovery (WMD -0.55; 95% CI -0.86 to -0.24; P ˂ 0.01) and earlier ambulation (WMD -0.75; 95% CI -1.38 to -0.11; P = 0.02). In terms of surgical and oncological safety, LG could achieve similar lymph nodes (WMD, -0.94, 95% CI, -2.95 to 1.06; P=0.36), a lower complication rate [odds ratio (OR)=0.80; 95%CI, 0.68-0.97; P=0.02], and overall survival (OS) and disease-free survival (DFS) comparable to OG. In conclusion, for AGCs both techniques (LAG and OG) appeared comparable in short- and long-term results. More time was needed to perform LAG; nonetheless, it had some advantages in achieving faster postoperative recovery over OG. In order to clarify this controversial issue ongoing trials and future studies are needed.

POF (paclitaxel/oxaliplatin/5-FU/leucovorin) versus SOX/CAPOX/FOLFOX as a postoperative adjuvant chemotherapy for curatively resected stage III gastric cancer: Study protocol for a randomized controlled trial, FNF-014 trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4647-TPS4647
Author(s):  
Liyu Su ◽  
Chunxiang Li ◽  
Feng Huang ◽  
Lu chuan Chen ◽  
Lisheng Cai ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Lymph Node ◽  
Lymph Node Dissection ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Node Dissection ◽  
Free Survival ◽  
D2 Lymph Node Dissection ◽  
Disease Free

TPS4647 Background: Postoperative chemotherapy (S-1, CAPOX, or Docetaxel/S-1) is a standard treatment for stage II/III gastric cancer in Asia. With regard to single agent or doublet, the need for improvement has consistently been pointed out because of the relatively poor outcome for patients with stage III gastric cancer. Triplet (FLOT) has shown significant survival benefits in perioperative setting. POF, our regiment similar to FLOT, demonstrated priority to doublet (FOLFOX) in advanced setting (2019 ASCO-GI). We conducted a randomized, multicenter, phase III study to compare triplet to doublet regimens for patients with stage III gastric cancer. Methods: This is currently enrolling patients (n = 544) with pathologic stage III gastric cancer after D2 lymph node dissection. Patients are randomized 1:1 and stratified by tumor stage (IIIA, IIIB, or IIIC, AJCC 8th) into POF or SOX/CAPOX/FOLFOX (chosen by the clinicians). SOX: oxaliplatin 130 mg/m2 on day 1, oral S-1 80mg/m2 divided by two on days 1 to 14 every 21 days for 8 cycles. CAPOX: oxaliplatin 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 to 14 every 21 days for 8 cycles. FOLFOX: oxaliplatin 85 mg/m2, levo-leucovorin 200 mg/m2, and 5-FU 400 mg/m2 bolus on day 1, then 5-FU 2400 mg/m2 continuous infusion over 46 hours, every 14 days for 12 cycles. Three doublets were chosen by the clinicians. POF: paclitaxel 135 mg/m2, followed by FOLFOX omitted 5-FU bolus, every 14 days for 12 cycles. Eligibility criteria: patients aged 18-70 years, primary histologically proven gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) of stage III with no evidence of metastatic disease, R0 resection with D2 lymph node dissection, good performance status (ECOG PS ≤1). Subjects must be able to take orally, and without other concomitant medical conditions that required treatment, initially treated with curative surgery followed by chemotherapy within 42 days. Life expectancy estimated more than 6 months. Adequate organ function. All patients provided written informed consent prior to treatment. Key exclusion criteria: patients with other primary malignancies, gastrointestinal bleeding. The primary end point is 3-year disease-free survival. Secondary end points are 3-year overall survival, 5-year overall survival, 5-year disease-free survival, and adverse events. Clinical trial information: NCT03788226 .

Đánh giá kết quả phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư

2021 ◽  
Author(s):  
Van Huong Nguyen
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Total Gastrectomy ◽  
Lymph Node Dissection ◽  
Laparoscopic Total Gastrectomy ◽  
Node Dissection ◽  
Female Ratio ◽  
D2 Lymph Node Dissection ◽  
Totally Laparoscopic Total Gastrectomy ◽  
Totally Laparoscopic

TÓM TẮT Đặt vấn đề: Nghiên cứu nhằm đánh giá kết quả phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư tại Bệnh viện Hữu nghị Đa khoa Nghệ An. Phương pháp: Nghiên cứu mô tả hồi cứu, gồm 126 bệnh nhân ung thư dạ dày được phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày vét hạch D2, từ 2013 đến 2020 Kết quả: Tuổi trung bình 60,6 ± 11,1 tuổi. Tỷ lệ nam/nữ 2.8/1. Ung thư ở giai đoạn I, II, III là 19,0%, 49,2%, 31,7%. Ung thư biểu mô tuyến nhú và ống là 70,6% và tế bào nhẫn là 24,6%. Tỷ lệ tai biến trong mổ của nhóm PTNS hoàn toàn là 4,4% và PTNS hỗ trợ 20,6%. Số hạch nạo vét được trung bình của 2 nhóm PTNS hoàn toàn là 23,7 ± 7,1 hạch và PTNS hỗ trợ là 18,0 ± 7,2 hạch. Lượng máu mất trung bình của PTNS hoàn toàn 30,56 ± 10,2 ml và PTNS hỗ trợ 36,11 ± 9,9 ml. Thời gian phẫu thuật trung bình của nhóm PTNS hoàn toàn là 206,4 ± 30,6 phút và PTNS hỗ trợ 220 ± 40,9 phút. Tỷ lệ biến chứng sau mổ của nhóm PTNS hoàn toàn là 4,4% và PTNS hỗ trợ là 22,3%. Thời gian nằm viện trung bình của nhóm PTNS hoàn toàn là 7,5 ± 2,1 ngày và PTNS hỗ trợ là 10,2 ± 2,4 ngày. Kết luận: Phẫu thuật nội soi hoàn toàn và phẫu thuật nội soi hỗ trợ cắt toàn bộ dạ dày nạo vét hạch D2 do ung thư là kỹ thuật an toàn và hiệu quả trong điều trị ung thư dạ dày. ABSTRACT EVALUATION OF OUTCOMES TOTALLY LAPAROSCOPIC TOTAL GASTRECTOMY AND LAPAROSCOPIC - ASSISTED TOTAL GASTRECTOMY WITH D2 LYMPH NODE DISSECTION DUE TO CANCER Introduction: To evaluate the results of totally laparoscopic total gastrectomy (TLTG) and laparoscopicassisted total gastrectomy (LATG) with D2 lymph node dissection to treat gastric cancer in the Nghean General Friendship Hospital. Materials and Methods: In a retrospective cohort study, 126 patients with gastric cancer underwent TLTG and LATG with D2 lymph node dissection between 2013 and 2020. Results: There were 126 patients with an average age of 60.6 ± 11.1 years. The male/female ratio was 2.8/1. The percent of patients with tumors at stages I, II, III were 19.0%, 49.2%, 31.7%, 70.6% of patients had papillary adenocarcinoma and tubular adenocarcinoma. Patients with ring cell carcinoma wereaccounted for 24.6%. The total percent of incidents during the surgery of the group of TLTG was 4.4%, and the group of LATG was 20.6%. The average number of harvested lymph nodes in the group of TLTG was 23.7 ± 7.1, and the group of LATG was 18.0 ± 7.2. The average blood loss in the group of TLTG was 30.56 ± 10.2 ml, and the group of LATG was 36.11 ± 9.9 ml, and the average operation time in the group of TLTG was 206.4 ± 30.6 minutes, and the group of LATG was 220 ± 40.9 minutes. The total percent of postoperative complications in the group of TLTG was 4.4%, and the group of LATG was 22.3%. The hospital stays in the group of TLTG was 7.5 ± 2.1 days, and the group of LATG was 10.2 ± 2.4 days. Conclusions: TLTG and LATGwith D2 lymph node dissectionwere safe and effective in treating gastric cancer. Keywords: Laparoscopic gastrectomy, gastric cancer, total gastrectomy

Phase III Trial to Compare Adjuvant Chemotherapy With Capecitabine and Cisplatin Versus Concurrent Chemoradiotherapy in Gastric Cancer: Final Report of the Adjuvant Chemoradiotherapy in Stomach Tumors Trial, Including Survival and Subset Analyses

2015 ◽  
Vol 33 (28) ◽  
pp. 3130-3136 ◽  
Author(s):  
Se Hoon Park ◽  
Tae Sung Sohn ◽  
Jeeyun Lee ◽  
Do Hoon Lim ◽  
Min Eui Hong ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Lymph Node ◽  
Adjuvant Chemotherapy ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Adjuvant Chemoradiotherapy ◽  
Final Report ◽  
D2 Lymph Node Dissection ◽  
Node Positive ◽  
Stomach Tumors

Purpose The Adjuvant Chemoradiotherapy in Stomach Tumors (ARTIST) trial tested whether the addition of radiotherapy to adjuvant chemotherapy improved disease-free survival (DFS) in patients with D2-resected gastric cancer (GC). Patients and Methods Between November 2004 and April 2008, 458 patients with GC who received gastrectomy with D2 lymph node dissection were randomly assigned to either six cycles of adjuvant chemotherapy with capecitabine and cisplatin (XP) or to two cycles of XP followed by chemoradiotherapy and then two additional cycles of XP (XPRT). This final update contains the first publication of overall survival (OS), together with updated DFS and subset analyses. Results With 7 years of follow-up, DFS remained similar between treatment arms (hazard ratio [HR], 0.740; 95% CI, 0.520 to 1.050; P = .0922). OS also was similar (HR, 1.130; 95% CI, 0.775 to 1.647; P = .5272). The effect of the addition of radiotherapy on DFS and OS differed by Lauren classification (interaction P = .04 for DFS; interaction P = .03 for OS) and lymph node ratio (interaction P < .01 for DFS; interaction P < .01 for OS). Subgroup analyses also showed that chemoradiotherapy significantly improved DFS in patients with node-positive disease and with intestinal-type GC. There was a similar trend for DFS and OS by stage of disease. Conclusion In D2-resected GC, both adjuvant chemotherapy and chemoradiotherapy are tolerated and equally beneficial in preventing relapse. Because results suggest a significant DFS effect of chemoradiotherapy in subsets of patients, the ARTIST 2 trial evaluating adjuvant chemotherapy and chemoradiotherapy in patients with node-positive, D2-resected GC is under way.

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