Downstaging depth score as a better surrogate endpoint than pCR, histological response and ypN0 for long-term outcomes in locally advanced gastric cancer patients after preoperative chemo-radiotherapy

2020 ◽  
Author(s):  
Ning Li ◽  
Xin Wang ◽  
Yuan Tang ◽  
Dongbin Zhao ◽  
Yihebali Chi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Surrogate Endpoint ◽  
Histological Response ◽  
Long Term Outcomes ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

Abstract Background: The prediction effect of preoperative chemo-radiotherapy(CRT) is not high and difficult to guide individualized treatment. We explored a surrogate endpoint for long-term outcomes in locally advanced gastric cancer patients after preoperative CRT. Methods: From April 2012 to April 2019, 95 patients enrolled in 4 prospective studies with locally advanced gastric cancer who received preoperative concurrent radio-chemotherapy were included. All patients were stage T3/4, N+. Local control (LC), distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) were evaluated. The clinicopathological factors related to the long-term prognosis were analysed by uni- and multivariant analyses. The downstaging depth score (DDS), a novel method of evaluating the CRT response, was used to predict long-term outcomes. Results: The median follow-up period for survivors was 30 months. The area under the curve (AUC) of the receiver operating characteristic (ROC) curve predicted by the DDS was 0.728, which was better than that of pathological complete response (pCR), histological response and ypN0 (AUC= 0.634, 0.640 and 0.643, respectively). The DDS cut-off value was 4. pCR and ypN0 were associated with OS (p = 0.026, 0.049). Surgery and the DDS were correlated with DMFS, DFS and OS (p = 0.001, 0.000, and 0.000 and 0.009, 0.013, and 0.032, respectively). The multivariate analysis showed that the DDS was an independent prognostic factor of DFS (p = 0.021). Conclusion: The DDS, a simple, short-term indicator, seems to be a better surrogate endpoint than pCR, histological response and ypN0 for DFS.

scholarly journals Long-term results of combined treatment of patients with locally advanced gastric cancer with the inclusion of neoadjuvant chemoradiotherapy.

2021 ◽  
Vol 67 (2) ◽  
pp. 254-259
Author(s):  
Дмитрий Кудрявцев ◽  
Vitaliy Skoropad ◽  
Sergey Gamayunov ◽  
Igor` Gulidov ◽  
Sergey Ivanov ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Combined Treatment ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Independent Effect ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer

ntroduction.  Gastric cancer remains one of the most common malignant neoplasms. In the world, including Russia, high incidence rates and low efficacy rates of long-term treatment outcomes remain. The use of neoadjuvant therapy is now increasingly seen as a standard therapy approach for locally advanced gastric cancer and cardioesophageal junction. Materials and methods. This work presents the results of treatment using a new method – combined treatment of locally advanced stomach cancer (neoadjuvant chemoradiotherapy in the regime of accelerated hyperfraction with daily dose splitting up to SOD 46 Gy against the background of modified polychemotherapy according to the Xelox scheme). The structure of the development of locoregional relapses and metastases, the indicators of overall and relapse-free survival, depending on various clinical and morphological factors, were described. In total, the results were analyzed in 43 patients diagnosed with gastric cancer. Results and discussion. At the time of this analysis, 22 patients died, 21 patients continued to be observed or were lost from the observation. Life expectancy ranged from 6.1 to 122 months. According to the multivariate analysis, two factors were identified that have a statistically significant independent effect on overall survival: the macroscopic type of growth according to Borrmann (P≤0.009) and the degree of therapeutic pathomorphism (P≤0.015). In 3 cases, a complete therapeutic tumor pathomorphism was registered. Patients continue observation for up to 6 years. Local recurrence was not detected in any case. Regional recurrence was detected and morphologically confirmed in one patient. Peritoneal metastases, the development of which more often occurred in the case of low-grade forms of gastric cancer, were observed in 12 cases. Conclusion. All in all, the annual survival rate was 80.5 ± 6.2%, three-year 55.5 ± 7.8%, and five-year 45.0 ± 7.9%. The results show that combined treatment of locally advanced gastric cancer, using a new technique of neoadjuvant chemoradiotherapy, contributes to an increase in overall and relapse-free survival.

scholarly journals Preoperative Versus Postoperative Chemo-Radiotherapy For Locally Advanced Gastric Cancer: A Propensity Score-Matched Analysis

2021 ◽  
Author(s):  
Ning Li ◽  
Xiaoyong Xiang ◽  
Dongbin Zhao ◽  
Xin Wang ◽  
Yuan Tang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Propensity Score ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Postoperative Treatment ◽  
Long Term Outcome ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer

Abstract Background: peri-operative chemo-radiotherapy played important role in locally advanced gastric cancer. Whether preoperative strategy can improve the long-term prognosis compared with postoperative treatment is unclear. The study purpose to compare long-term oncologic outcomes in locally advanced gastric cancer patients treated with preoperative chemo-radiotherapy (pre-CRT) and postoperative chemo-radiotherapy (post-CRT). Methods: From January 2009 to April 2019, 222 patients from 2 centers with stage T3/4 and/or N positive gastric cancer who received pre-CRT and post-CRT were included. After propensity score matching (PSM), comparisons of local regional control (LC), distant metastasis-free survival (DMFS), disease-free survival (DFS) and overall survival (OS) were performed using Kaplan-Meier analysis and log-rank test between pre- and post-CRT groups.Results: The median follow-up period was 30 months. 120 matched cases were generated for analysis. Three-year LC, DMFS, DFS and OS for pre- vs. post-CRT groups were 93.8% vs. 97.2% (p=0.244), 78.7% vs. 65.7% (p=0.017), 74.9% vs. 65.3% (p=0.042) and 74.4% vs. 61.2% (p=0.055), respectively. Pre-CRT were significantly associated with DFS in uni- and multi-variate analysis. Conclusion: Preoperative CRT showed advantages of long-term outcome compared with postoperative CRT. Trial registration: ClinicalTrial.gov NCT01291407, NCT03427684 and NCT04062058, date of registration: Feb 8, 2011

Feasibility study of TAS-118 plus oxaliplatin as perioperative chemotherapy for patients with locally advanced gastric cancer (APOLLO-11).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 205-205
Author(s):  
Daisuke Takahari ◽  
Manabu Ohashi ◽  
Atsuo Takashima ◽  
Takuro Mizukami ◽  
Naoki Ishizuka ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Locally Advanced ◽  
Dose Intensity ◽  
Complete Response ◽  
Free Survival ◽  
D2 Gastrectomy ◽  
Locally Advanced Gastric Cancer ◽  
Grade 3

205 Background:TAS-118 (S-1 and leucovorin) + oxaliplatin (L-OHP) improved overall survival (OS) compared to S-1 + cisplatin for patients (pts) with advanced gastric cancer (GC) (Kang, Lancet Oncol. 2020). This study investigated the feasibility of peri (pre and post)-operative (op) chemotherapy (chemo) with TAS-118 ± L-OHP in pts with locally advanced resectable GC. While it was reported that pre-op TAS-118 + L-OHP followed by D2 gastrectomy was well tolerated and showed promising efficay (Takahari, ASCO-GI. 2020), the recommended post-op chemo regimen, TAS-118 or TAS-118 + L-OHP, has yet to be determined. Methods:Eligible pts with GC of clinical T3-4N1-3M0 were enrolled. The protocol treatment consisted of pre-op chemo with 4 courses of TAS-118 (40-60 mg/body, orally, twice daily, 7 days) + L-OHP (85 mg/m2, intravenously, day 1) in a 2-week cycle, and gastrectomy with D2 lymphadenectomy, followed by post-op chemo with 12 courses of TAS-118 (step 1) and 8 courses of TAS-118 + L-OHP (step 2). Step 2 was started if the dose-limiting toxicity (DLT) occurred in < 6 of 10 pts in step 1. Up to 20 pts were included in the analysis of feasibility after a recommended regimen was determined. Results:Between December 2016 and February 2019, 45 pts were enrolled. The numbers of pts with cT3/4a and cN1/2/3 were 13/32 and 25/17/3, respectively. Excluding 14 pts (4 achieving pathological complete response, 4 not satisfying the criteria for post-op chemo, 3 physician judgement or pt withdrawal, 2 progressive disease, 1 adverse event [AE]), 31 pts (11/20 in step 1/2) received the post-op chemo. No DLT was observed in either step. The post-op chemo completion rate was 90.9% (95% CI, 63.6-99.5) in step 1 and 80.0% (95% CI, 59.9-92.9) in step 2. The median relative dose intensity of TAS-118 in step 1 was 83.3%, and those of TAS-118 and L-OHP in step 2 were 69.9% and 74.3%, respectively. One pt in step 2 discontinued post-op chemo due to AE. Grade ³ 3 AEs observed in ≥ 10% of pts were weight loss in both step 1 and step 2 (2 in each), and hypokalemia (n = 3) and neutropenia (n = 2) in step 2. At 1-year follow-up after the last pt was enrolled, recurrence-free survival and OS rates were 91.1% (95% CI, 78.0-96.6) and 100%, respectively at 12 months, and 69.1% (95% CI, 49.6-82.3) and 95.5% (95% CI, 71.9-99.3), respectively at 24 months. Conclusions:Taken together with the feasibility and efficacy of pre-op chemo, peri-op chemo with TAS-118 + L-OHP with D2 gastrectomy was well tolerated and showed promising efficacy. Clinical trial information: UMIN000024688.

scholarly journals A PHASE II TRIAL EXPLORING THE EXTENSIVE INTRA-OPERATIVE PERITONEAL LAVAGE (EIPL) AS A PROPHYLACTIC STRATEGY FOR PERITONEAL RECURRENCE IN LOCALLY ADVANCED GASTRIC CANCER: reporting postoperative morbidity and mortality after early closure

2015 ◽  
Vol 52 (2) ◽  
pp. 161-164 ◽  
Author(s):  
Thales Paulo BATISTA ◽  
Mário Rino MARTINS ◽  
Euclides Dias MARTINS-FILHO ◽  
Rogerio Luiz dos SANTOS
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Phase Ii ◽  
Peritoneal Lavage ◽  
Locally Advanced ◽  
Open Label ◽  
Safety And Efficacy ◽  
Intention To Treat ◽  
Locally Advanced Gastric Cancer ◽  
Gastric Cancer Patients

Background The Extensive Intraoperative Peritoneal Lavage (EIPL) has been proposed as a practical prophylactic strategy to decrease the risk of peritoneal metastasis in gastric cancer. Objective To explore the safety and efficacy of the EIPL in our locally advanced gastric cancer patients. Methods This study is an open-label, double-center, single-arm phase II clinical trial developed at two tertiary hospitals from Recife (Pernambuco, Brazil). Results The study protocol was prematurely closed due to slow accrual after only 16 patients had been recruited to participate. Eight of them were excluded of the protocol study during the laparotomy, whereas four cases were also excluded from the per-protocol analysis. Two patients had died in hospital before 30 days and six were alive with no evidence of cancer relapses after a follow-up ranging from five to 14,2 months (median of 10.6 months). In the intention-to-treat analysis, three of eight patients suffered of gastrointestinal leakages and two of them had died. On a per-protocol basis, two of four patients presented this type of postoperative complication and one of them had died. All deaths occurred as a somewhat consequence of gastrointestinal leakages. Conclusion We could not make any conclusion about the safety and efficacy of the EIPL, but the possibility of this approach might increase the rate of gastrointestinal leakage is highlighted.

scholarly journals FEATURES OF EMERGENCY SURGERY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER

2020 ◽  
pp. 108-112
Author(s):  
V. V. Boyko ◽  
I. V. Krivorotko ◽  
V. A. Lazirsky
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Surgical Intervention ◽  
Locally Advanced ◽  
Postoperative Mortality ◽  
Surgical Interventions ◽  
Second Stage ◽  
Locally Advanced Gastric Cancer ◽  
Surgical Tactics ◽  
Gastric Cancer Patients

Summary. Materials and methods. The work is based on an analysis of the results of surgical treatment of 418 patients with complicated locally advanced gastric cancer. Patients are divided into two groups: comparisons — 212, and the main — 206 patients who were treated from 2006 to 2010. and from 2011 to 2015 respectively. The complications rating was: bleeding in 252 (60.3 %) patients, stenosis in 89 (21.3 %), perforation in 15 (3.5 %), and their combination in 62 (14.8 %). Results and discussion. Radical operations were performed in 212 (50.7 %) patients, in 145 (34.6 %) — palliative and symptomatic. Postoperative complications occurred in 82 patients (19.6 %), postoperative mortality was 7.2 % (30 patients). A two-stage surgical tactics has been developed, which involves the implementation of minimally invasive endoscopic and endovascular surgical interventions at the first stage with the implementation of a delayed or planned surgical intervention at the second stage. Conclusions. Urgent operations decreased from 21.7 to 6.3 %, which reduced the number of palliative and symptomatic operations from 50.4 to 18.4 %.

scholarly journals Three-year outcomes of the randomized phase III SEIPLUS trial of extensive intraoperative peritoneal lavage for locally advanced gastric cancer

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Jing Guo ◽  
Aman Xu ◽  
Xiaowei Sun ◽  
Xuhui Zhao ◽  
Yabin Xia ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Peritoneal Lavage ◽  
Randomized Study ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Disease Recurrence ◽  
Phase Iii ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer

AbstractWhether extensive intraoperative peritoneal lavage (EIPL) after gastrectomy is beneficial to patients with locally advanced gastric cancer (AGC) is not clear. This phase 3, multicenter, parallel-group, prospective randomized study (NCT02745509) recruits patients between April 2016 and November 2017. Eligible patients who had been histologically proven AGC with T3/4NxM0 stage are randomly assigned (1:1) to either surgery alone or surgery plus EIPL. The results of the two groups are analyzed in the intent-to-treat population. A total of 662 patients with AGC (329 patients in the surgery alone group, and 333 in the surgery plus EIPL group) are included in the study. The primary endpoint is 3-year overall survival (OS). The secondary endpoints include 3-year disease free survival (DFS), 3-year peritoneal recurrence-free survival (reported in this manuscript) and 30-day postoperative complication and mortality (previously reported). The trial meets pre-specified endpoints. Estimated 3-year OS rates are 68.5% in the surgery alone group and 70.6% in the surgery plus EIPL group (log-rank p = 0.77). 3-year DFS rates are 61.2% in the surgery alone group and 66.0% in the surgery plus EIPL group (log-rank p = 0.24). The pattern of disease recurrence is similar in the two groups. In conclusion, EIPL does not improve the 3-year survival rate in AGC patients.

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