Randomized controlled trial of adjuvant uracil–tegafurversus surgery alone for serosa-negative, locally advanced gastric cancer

2007 ◽  
Vol 94 (12) ◽  
pp. 1468-1476 ◽  
Author(s):  
T. Nakajima ◽  
T. Kinoshita ◽  
A. Nashimoto ◽  
M. Sairenji ◽  
T. Yamaguchi ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Randomized Controlled Trial ◽  
Advanced Gastric Cancer ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Randomized Controlled ◽  
Locally Advanced Gastric Cancer

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.

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