The short-term outcomes from TOP-G trial: Ramdomized phase II noninferiority trial comparing gastrectomy with omentectomy and omentum preserving gastrectomy for advanced gastric cancer.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 285-285
Author(s):  
Takanobu Yamada ◽  
Hitoshi Murakami ◽  
Masataka Taguri ◽  
Shinichi Hasegawa ◽  
Takeharu Yamanaka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Postoperative Complication ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Standard Procedure ◽  
Laparoscopic Approach ◽  
Operation Time ◽  
Short Term ◽  
Group A ◽  
Group B

285 Background: A complete resection of the omentum has been believed as a standard procedure for advanced gastric cancer. However, there was no evidence for survival significance of omentectomy. Therefore, we conduct the Phase II trial (TOP-G trial) comparing gastrectomy with omentectomy and omentum preserving gastrectomy. Here, we present the short-term outcomes which was a secondary endpoint of TOP-G trial. Methods: Enrollment criteria included histologically confirmed cT2-4a and N0-2 gastric adenocarcinoma. The extent of nodal dissection was performed based on the Gastric Cancer Treatment Guidelines in Japan. All procedure was performed through laparotomy. Laparoscopic approach was not accepted. Surgical outcomes morbidity, and mortality were compared between gastrectomy with omentectomy group (group A) and omentum preserving gastrectomy group (group B). Postoperative complication was evaluated with Clavien-Dindo classification. Results: A total of 251 patients were randomly assigned to group A (n = 125) or group B (n = 126) between April 2011 and October 2018. After excluding patients who received bypass or no surgery, 246 patients were analyzed as actual treatment group. There was no difference between two groups in patient characteristics and pathological findings. There was no difference in operation time (median 244 vs 204 min, p = 0.156) and in blood loss (median 260 vs. 210 ml, p = 0.371). Median number of totally retrieved lymph nodes was similar (median 36 vs. 37, p = 0.758). There was no difference in the incidence of any postoperative complication (28.9% vs. 25.8%, p = 0.584). There was no mortality in both groups. Conclusions: Omentum preserving gastrectomy for advanced gastric cancer was similar short-term outcomes with gastrectomy with omentectomy. Clinical trial information: UMIN000005421.

A prospective, randomized, controlled, multicenter study of apatinib combined with S-1 plus docetaxel as adjuvant therapy for locally advanced gastric cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16019-e16019
Author(s):  
Zhili Shan ◽  
Feng Guo ◽  
Hong Chen ◽  
Dapeng Li ◽  
Zhongqi Mao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Free Survival ◽  
Randomized Controlled ◽  
Locally Advanced Gastric Cancer ◽  
Group A ◽  
Group B ◽  
Disease Free

e16019 Background: Postoperative adjuvant chemotherapy is commonly given after the curative resection of gastric cancer (GC) in both Eastern and Western countries. Several studies have investigated the feasibility and safety of S-1 plus docetaxel or S-1 plus cisplatin. However, the best choice of adjuvant treatment for patients with gastric cancer is still debated. Apatinib, an oral small molecular of VEGFR-2 TKI, has been confirmed to improve OS and PFS with acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. In this study, we aimed to evaluate the efficacy and safety of apatinib combined with S-1/docetaxel for locally advanced gastric cancer (T3-4aN+M0). Methods: This is a prospective, randomized, controlled, multicenter clinical study. Patients with locally advanced gastric cancer, pathological stage T3-4aN+M0 who underwent D2 lymphadenectomy without prior anti-cancer therapy were included. All these patients were assigned to group A or B. Patients in group A received 6 cycles (21 days a cycle) of adjuvant therapy using S-1 (80-120mg/d, d1-14), and docetaxel (40mg/m2, d1). Group B received the same regimen with the addition of apatinib (250mg, qd.). The primary endpoint was disease-free survival (DFS). The final analysis cutoff date was 30 November, 2020. Results: A total of 45 patients were enrolled from January 2019 to November, 2010 and assigned to group A (21) or group B (24). The DFS was not reached in both of the groups. The 1-year disease-free survival rate was 60% in group A and 90% in the group B, while the difference was not significant. The main AEs in group A were anemia (55%), nausea (50%) and neutropenia (40%); The most common AEs in group B were anemia (45%) neutropenia (40%) and diarrhea (25%). There were no treatment-related deaths. The longest administered time of apatinib with no progression was 457 days. And the median time to receive apatinib was 329 days. Conclusions: Combination of apatinib with S-1/docexal chemotherapy shows clinical benefits in locally advanced gastric cancer (T3-4aN+M0), with tolerable toxicity. The study is still ongoing to reach our final endpoint, DFS. Clinical trial information: ChiCTR2000038900.

scholarly journals Randomized controlled Phase III trial to evaluate omentum preserving gastrectomy for patients with advanced gastric cancer (JCOG1711, ROAD-GC)

2020 ◽  
Vol 50 (11) ◽  
pp. 1321-1324
Author(s):  
Yuya Sato ◽  
Takanobu Yamada ◽  
Takaki Yoshikawa ◽  
Ryunosuke Machida ◽  
Junki Mizusawa ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Standard Procedure ◽  
Locally Advanced ◽  
Operation Time ◽  
Phase Iii ◽  
Current Standard ◽  
Phase Iii Trial ◽  
D2 Lymph Node Dissection ◽  
Randomized Controlled

Abstract Gastrectomy with omentectomy and D2 lymph node dissection is the current standard procedure for locally advanced gastric cancer. However, some retrospective studies have reported that omentectomy increased post-operative abdominal complications but provided no survival advantage over omentum preservation. Therefore, we plan a randomized controlled phase III trial to confirm the non-inferiority of omentum preservation compared with omentectomy in patients with cT3 (SS) or cT4a (SE) gastric cancer. A total of 1050 patients will be enrolled from 62 institutions over a period of 6.5 years. The primary end point is relapse-free survival, and the secondary end points are overall survival, blood loss, operation time and adverse events. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000036253.

A randomized phase II factorial design trial of CPT-11 versus PTX versus each combination with S-1 in patients with advanced gastric cancer refractory to S-1: Final results of OGSG0701.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 117-117 ◽  
Author(s):  
Kazuhiro Nishikawa ◽  
Hiroshi Imamura ◽  
Tomono Kawase ◽  
Masahiro Gotoh ◽  
Yutaka Kimura ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Overall Survival ◽  
Advanced Gastric Cancer ◽  
Progression Free Survival ◽  
Correct Selection ◽  
Line Treatment ◽  
Second Line ◽  
First Line ◽  
Group A ◽  
Group B

117 Background: S1 + platinum (SP) is recognized as standard first-line chemotherapy for advanced gastric cancer(AGC), and S1 monotherapy is suggested for frail AGC patients or adjuvant setting in Japan. However, taxane or CPT-11 were often employed as second-line treatment for the patients who were resistant to S1-containing regimen. A retrospective analysis has reported that S1 combination chemotherapy extended overall survival as second-line treatment for AGC. Methods: Patients with AGC who confirmed disease progression by imaging after the first-line therapy with S1 or SP were randomized in four groups; CPT-11 150 mg/m2, day1, q2w (Group A), PTX 80 mg/m2, day1, 8,15, q4w (Group B), CPT-11 80 mg/m2, day1, 15, S-1 80 mg/m2, day1-21, q5w (Group C1), PTX 50 mg/m2,day1, 8, S1 80 mg/m2, day1-14, q3w (Group C2). Primary endpoint was overall survival (OS), and secondary endpoints were progression free survival (PFS), overall response rate (ORR) and safety. Sample size was set at 100 to 120 to achieve 2 months improvement of OS by using CPT-11 or by adding S1 with approximately 80% probability of the correct selection. Results: From July 2008 to March 2012, 127 patients were enrolled. The OS was 11.3/11.3/14.6/10.5 months(M) (Group A/B/C1/C2), 11.8M in Group A+C1 and 11.1M in Group B+C2 (p=0.922, HR: 0.981 [0.679-1.419]), 11.3M in Group A+B and 11.1M in Group C1+C2 (p=0.808, HR: 0.952 [0.643-1.412]), respectively. The PFS was 3.0/4.4/3.8/3.5M (Group A/B/C1/C2), 3.6M in Group A+C1 and 4.1M in Group B+C2 (p=0.035, HR:0.674 [0.468-0.972]) 3.7M in Group A+B and 3.7M in Group C1+C2 (p=0.931, HR: 1.017 [0.643-1.412]). The ORR was 7.1/16.3/4.5/5.0% (Group A/B/C1/C2), 4.7%[1.7-15.2] in Group A+C1 and 12.7%[5.6-23.5] in Group B+C2 (p=0.241), 11.8%[5.8-20.6] in Group A+B and 4.6%[0.6-16.2] in Group C1+C2 (p=0.572).Major Grade 3/4 toxicity (Group A/B/C1/C2, %), was leukopenia (12/7/5/0), neutropenia (29/16/24/24), nausea (7/2/10/5), diarrhea (5/0/10/0), and fatigue (5/2/10/5). Conclusions: From our results, we do not recommend consecutive use of S1 but CPT-11 or PTX monotherapy as second-line treatment in AGC refractory to S1 or SP. Clinical trial information: 000000677.

Changes in and Prognostic Impact of Chemotherapeutic Strategy in Patients With Advanced Gastric Cancer: A Retrospective Study

2021 ◽  
Author(s):  
Takaaki Arigami ◽  
Daisuke Matsushita ◽  
Keishi Okubo ◽  
Takako Tanaka ◽  
Ken Sasaki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Retrospective Study ◽  
Advanced Gastric Cancer ◽  
Treatment Guidelines ◽  
Prognostic Impact ◽  
Second Line ◽  
Second Line Chemotherapy ◽  
Group A ◽  
Group B ◽  
Line Chemotherapy

Abstract Background: The Japanese Gastric Cancer Treatment Guidelines 2018 have recommended first- to third-line treatment regimens after nivolumab approval for unresectable advanced gastric cancer. However, the clinical impact of chemotherapeutic changes, including post-progression chemotherapy (PPC), remains unclear. Therefore, the current study aimed to investigate changes in PPC before and after nivolumab approval and determine their prognostic impact.Methods: A total of 146 patients with unresectable gastric cancer who had at least progressive disease after first- and/or second-line chemotherapy were retrospectively enrolled. All patients were divided into two groups based on the nivolumab approval period.Results: Among the 146 patients, 46 and 23 received ramucirumab and nivolumab, respectively. Moreover, 95 and 62 patients received PPC after first- and second-line chemotherapy, respectively. Group B (i.e., at least chemotherapy after nivolumab approval) had significantly higher proportions of patients receiving ramucirumab therapy, nivolumab therapy, and PPC after first- or second-line chemotherapy compared to group A (i.e., termination of chemotherapy before nivolumab approval) (all p < 0.0001). Group A had significantly poorer prognosis than group B (p = 0.0002). Multivariate analysis showed that age (< 70 vs. ³ 70), number of distant metastatic sites (1 vs. ³ 2), and ramucirumab therapy were independent prognostic factors (p = 0.0252, p = 0.0036, and p = 0.0076, respectively).Conclusion: Our retrospective study demonstrated that changes in chemotherapeutic strategy might contribute to improved prognosis in patients with advanced gastric cancer.

Use of plasma level of 5-fluorouracil to predict the efficacy in patients with advanced gastric cancer receiving first-line capecitabine plus cisplatin.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14508-e14508
Author(s):  
Weifeng Song ◽  
Xun Cai ◽  
Xiaoyu Li ◽  
Liwei Wang
Keyword(s):  
Gastric Cancer ◽  
Plasma Concentration ◽  
Plasma Level ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Objective Response ◽  
Plasma Concentrations ◽  
First Line ◽  
Group A ◽  
Group B

e14508 Background: Capecitabine is an oral 5-Fluorouracil prodrug that provided prolonged high levels of 5-FU within tumor cells and has improved efficacy and tolerability compared with protracted infusion 5-FU. The aim was to assess the value of plasma level of 5-Fluorouracil predicting the efficacy and safety in patients with advanced gastric cancer receiving first-line capecitabine plus cisplatin. Methods: The clinical data from 113 advanced gastric cancer patients receiving capecitabine plus cisplatin in Shanghai first people hospital from September 2006 to December 2009 were retrospectively collected. Fluorouracil plasma concentrations were examined at each cycle. The relationships between Fluorouracil plasma concentration and overall survival, progress free survival, response rate were determined by statistical analysis. Results: The mean plasma concentration was 24.8ug/L. We divided the patients with high mean 5-FU plasma concentration (> 25ug/L) into group A (n=59) and patients with low mean 5-FU plasma concentration (< 25ug/L) into group B (n=54). Median OS was 14.4 months in the group A and 9.6 months in the group B (HR= 0.36, p=0.000). Median PFS was 8 months in the group A and 4.9 months in the group B (HR= 0.37, p=0.000). The objective response rate was 55.9% for group A and 33.3% for group B (p=0.023). COX multivariate analysis showed that high 5-FU plasma concentration was an independent prognostic factors for improved OS (p=0.000) and PFS (p=0.000). All toxicities occurred more frequently in group A than group B. The grade 3/4 mocositis and hand-foot syndrome were significantly increased in group A compared with group B (19% vs 9%, p=0.08; 22% vs 8%, p=0.036). Conclusions: In advanced gastric cancer, high 5-FU plasma concentration might predict efficacy and toxicities for capecitabine plus cisplatin chemotherapy.

scholarly journals Short-term Outcomes of Robotic- versus Laparoscopic-Assisted Total Gastrectomy for Advanced Gastric Cancer: A Propensity Score Matching Study

2019 ◽  
Author(s):  
Changdong Yang ◽  
Yan Shi ◽  
Shaohui Xie ◽  
Jun Chen ◽  
Yongliang Zhao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Propensity Score Matching ◽  
Total Gastrectomy ◽  
Resection Margin ◽  
Operation Time ◽  
Clinicopathological Characteristics ◽  
Short Term ◽  
Significant Difference

Abstract Background Few studies have been designed to evaluate the short-term outcomes for advanced gastric cancer (AGC) between robotic-assisted total gastrectomy (RATG) and laparoscopy-assisted total gastrectomy (LATG) alone. The purpose of this study was to assess short-term outcomes of RATG compared with LATG for AGC.Methods We retrospectively evaluated 116 and 244 patients who underwent RATG or LATG respectively. Besides, we performed a propensity score matching (PSM) analysis between RATG and LATG for clinicopathological characteristics to reduce bias and compared short-term surgical outcomes.Results After PSM, the RTAG group had longer mean operation time (291.09±58.41 vs. 271.99±48.41min, p=0.007), less intraoperative bleeding (151.98±92.83 vs. 172.59±97.01ml, p=0.032) and more N2 tier RLNs (9.33±5.46 vs. 7.50±3.86, p=0.018) than the LATG group. Besides, the total RLNs of RATG was at the brink of significance compared to LATG (35.09±12.93 vs.32.34±12.05, p=0.062). However, no significant differences were found between the two groups in terms of length of incision, proximal resection margin, distal resection margin, postoperative hospital stay. The conversion rate was 4.92% and 8.61% in the RATG and LATG groups, respectively, with no significant difference. The ratio of splenectomy was 1.7% and 0.4% respectively. There was no significant difference in overall complication rate between RATG and LATG groups before PSM (24.1% vs. 28.7%; p=0.341) and after PSM (24.1% vs. 33.6%; p=0.102). The grade II complications accounted for most of all complications in the two cohorts both before and after PSM.Conclusion This study demonstrates that RATG is comparable to LATG in terms of short-term surgical outcomes.

scholarly journals Short-term Outcomes of Robotic- versus Laparoscopic-Assisted Total Gastrectomy for Advanced Gastric Cancer: A Propensity Score Matching Study

2020 ◽  
Author(s):  
Changdong Yang ◽  
Yan Shi ◽  
Shaohui Xie ◽  
Jun Chen ◽  
Yongliang Zhao ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Propensity Score Matching ◽  
Total Gastrectomy ◽  
Surgical Outcomes ◽  
Resection Margin ◽  
Operation Time ◽  
Short Term ◽  
Significant Difference

Abstract Background: Few studies have been designed to evaluate the short-term outcomes for advanced gastric cancer (AGC) between robotic-assisted total gastrectomy (RATG) and laparoscopy-assisted total gastrectomy (LATG) alone. The purpose of this study was to assess short-term outcomes of RATG compared with LATG for AGC. Methods: We retrospectively evaluated 116 and 244 patients who underwent RATG or LATG respectively. Besides, we performed a propensity score matching (PSM) analysis between RATG and LATG for clinicopathological characteristics to reduce bias and compared short-term surgical outcomes. Results: After PSM, the RATG group had longer operation time (291.09±58.41 vs. 271.99±48.41min, p=0.007), less intraoperative bleeding (151.98±92.83 vs. 172.59±97.01ml, p=0.032) and more N2 tier retrieved lymph nodes (RLNs) (9.33±5.46 vs. 7.50±3.86, p=0.018) than the LATG group. Besides, the total RLNs of RATG was more but not statistically significant compared to LATG (35.09±12.93 vs.32.34±12.05, p=0.062). However, no significant differences were found between the two groups in terms of length of incision, proximal resection margin, distal resection margin, postoperative hospital stay. The conversion rate was 4.92% and 8.61% in the RATG and LATG groups, respectively, with no significant difference (p=0.198). The ratio of splenectomy was 1.7% and 0.4% respectively (p=0.503). There was no significant difference in overall complication rate between RATG and LATG groups after PSM (24.1% vs. 33.6%; p=0.102)and the grade II complications accounted for most of all complications in the two cohorts. The mortality was 0.9% and 0% respectively (p=0.322). Conclusion : This study demonstrates that RATG is comparable to LATG in terms of short-term surgical outcomes.

Prognostic Role of Interleukin-1β Gene and Interleukin-1 Receptor Antagonist Gene Polymorphisms in Patients With Advanced Gastric Cancer

2005 ◽  
Vol 23 (10) ◽  
pp. 2339-2345 ◽  
Author(s):  
Francesco Graziano ◽  
Annamaria Ruzzo ◽  
Daniele Santini ◽  
Bostjan Humar ◽  
Giuseppe Tonini ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Receptor Antagonist ◽  
Advanced Gastric Cancer ◽  
Palliative Chemotherapy ◽  
Interleukin 1 ◽  
Wild Type ◽  
Prognostic Role ◽  
Group A ◽  
Group B

Purpose A high interleukin-1β (IL-1B) and interleukin-1 receptor antagonist (IL-RN) ratio underlies an unfavorable proinflammatory status. Also, it seems to be involved in the mechanisms of cancer cachexia and tumor angiogenesis and metastasis. Two single nucleotide polymorphisms in IL-1B gene (IL-1B-511C/T,IL-1B-31T/C) and a variable number of tandem repeat polymorphisms in IL-RN gene (IL-1RNlong/2) enhance the circulating levels of the two cytokines. The prognostic role of IL-1B/IL-1RN genotypes was investigated in patients with relapsed and metastatic gastric cancer treated with palliative chemotherapy. Patients and Methods Before starting palliative chemotherapy, 123 prospectively enrolled patients supplied peripheral-blood samples for DNA extraction. Survival data were analyzed according to IL-1RN/IL-1B genotypes. Results Forty-two patients showed wild-type genotypes (IL-1RNlong/long, IL-1B-511C/C, and IL-1B-31T/T; group A). Forty-five patients showed the IL-1RN2 polymorphism, with wild-type IL-1B genotypes in seven patients and with IL-1B-511C/T and/or IL-1B-31T/C polymorphisms in 38 patients (group B). The remaining 36 patients demonstrated wild-type IL-1RN, with IL-1B-511C/T and/or IL-1B-31T/C polymorphisms (group C). In group A and B patients, the median progression-free survival (PFS) was 25 and 26 weeks, respectively, and median overall survival (OS) was 42 and 43 weeks, respectively. Group C patients showed worse PFS (median, 16 weeks) and OS (median, 28 weeks) than group A (P = .006 for PFS; P = .0001 for OS) and group B patients (P = .01 for PFS; P = .0001 for OS). The long/T/C haplotype was overrepresented in patients with shortened PFS (P = .001) and OS (P = .0005). Conclusion In patients with advanced gastric cancer, IL-1B polymorphisms showed adverse prognostic influence when coupled with wild-type IL-1RN genotype. These findings deserve further investigation for potential anticancer activity of recombinant IL-RN.

Intensive up-front treatment versus a sequential approach in advanced gastric cancer patients: Does first-line matter?

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14663-e14663
Author(s):  
Alessandro Bittoni ◽  
Mario Scartozzi ◽  
Mirco Pistelli ◽  
Eva Galizia ◽  
Michela Del Prete ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Response Rate ◽  
Chemotherapy Regimen ◽  
Front Line ◽  
First Line ◽  
Sequential Approach ◽  
Group A ◽  
Group B ◽  
Gastric Cancer Patients

e14663 Background: The definition of the standard chemotherapy regimen for advanced gastric cancer is still a matter of debate. A recent meta-analysis suggested that the addition of a third drug to a doublet regimen should be considered the state-of-the-art strategy to improve overall survival. Aim of our analysis was to retrospectively assess whether an intensive, three-drugs, front line approach could be comparable to a sequential (two-drugs front line then second line) in terms of RR (response rate), PFS (progression free survival) and OS (overall survival) in advanced gastric cancer patients. Methods: Patients with metastatic gastric cancer who have received a first-line combination chemotherapy with a two or three-drugs regimen were included in our analysis. We divided our patients into two groups, A and B, based on the first line chemotherapy administered (group A=three drugs; group B= two drugs). Results: A total of 390 patients were eligible for our analysis. 211 patients (54%) received three chemotherapeutic agents (group A) and 179 patients (46%) received a two drugs regimen as first-line combination chemotherapy (group B). The 2 groups of patients resulted comparable for all known prognostic factors of clinical relevance. RR for group A and B was 46.5% and 28%, respectively (p=0,0007), median PFS was 7.12 months in group A and 3.96 months in group B (p<0,0001). No significantly difference resulted for the median OS of patients in the two groups (13 months for group A and 11.8 months for group B; p= 0.962). Conclusions: The addition of a third drug to a doublet chemotherapy regimen appeared more active in terms of response rate and PFS. However median OS resulted comparable. On this basis, a triplet regimen may represent an optimal choice, particularly when response and PFS are relevant treatment endpoints. Nevertheless the use of a sequential approach may also represent a reasonable strategy for patients unwilling or unable to undergo a more intensive treatment without compromising OS.

Sign in / Sign up

Export Citation Format

Share Document