scholarly journals Tumor Response and Symptom Palliation from RAINBOW , a Phase III Trial of Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric Cancer

2020 ◽  
Author(s):  
Stefano Cascinu ◽  
György Bodoky ◽  
Kei Muro ◽  
Eric Van Cutsem ◽  
Sang Cheul Oh ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Tumor Response ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Previously Treated ◽  
Symptom Palliation

Identification of patient population with longer survival when treated with S-1 plus cisplatin via predictive enrichment strategy analysis of the FLAGS phase III trial.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15612-e15612
Author(s):  
Jaffer A. Ajani ◽  
Madoka Takeuchi ◽  
Masahiro Takeuchi
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Patient Population ◽  
Model Development ◽  
Enrichment Analysis ◽  
The United States ◽  
Phase Iii ◽  
Strategy Analysis ◽  
Phase Iii Trial ◽  
Enrichment Strategy

e15612 Background: FLAGS, a randomized phase III trial, compared S-1, an oral fluoropyrimidine, plus cisplatin (SP) with 5-fluorouracil plus cisplatin (FP) in the first-line treatment for advanced gastric cancer (AGC). The purpose of this analysis was to discover a clinically significant covariate model using the Predictive Enrichment Strategy Analysis (PESA) to identify a patient population most likely to benefit from the treatment. Methods: PESA is a newly introduced concept proposed by the United States Food and Drug Administration and provides robust results. Consensus-based 15 clinical covariates were selected for enrichment analysis and a large cohort with no missing data (889 patients) was analyzed for model development. The models generated were cross-validated 200 times and ROC-AUC for the Cox PH model with the selected variables by the enrichment analysis were computed. Results: ECOGPerformance status (PS = 1) was the strongest covariate and most significant in identifying the enrichment group for SP. In the population with PS = 1, the OS in the SP group was significantly longer than the FP group (Hazard Ratio [HR] = 0.798, 95%CI = (0.66-0.96) p = 0.0166) Other covariates with high potential to be associated with benefit included: diffuse-type histology, presence of peritoneal metastases, and the lack of liver metastases. Various models using different combinations of the covariates were compared using ROC-AUC analysis and found that the model including all four covariates had the best ROC-AUC (0.566, 95%CI = (0.546-0.587)). Conclusions: PESA identified a cross-validated, robust model (PS, diffuse histology, peritoneal mets, and no liver mets). This patient population is associated with improved OS in Advanced Gastric Cancer patients who receive SP. An independent validation of this model will be carried out with data derived from the DIGEST trial. NCT00400179

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.

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