Chemotherapy with FOLFOX IV in advanced gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14112-14112
Author(s):  
M. A. Garrido. ◽  
G. Melgoza ◽  
H. Galindo ◽  
J. Madrid ◽  
C. Sanchez ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Lung Metastases ◽  
Stage Iv ◽  
Phase Iii ◽  
First Line ◽  
Phase Iii Trial ◽  
Low Toxicity ◽  
Grade 3

14112 Background: Gastric cancer is the first cause of mortality for cancer in Chile. 65% is observed in advanced form and the median survival without surgery is 5,4 months. We hypothesised that chemotherapy and specially FOLFOX IV is an active regimen and has low toxicity in patient with advanced gastric cancer. The main evaluated objectives were: response, toxicity and survival of patient with advanced gastric cancer. Methods: Patients with gastric adenocarcinoma, stage IV that accepted chemotherapy with FOLFOX IV in any time of evolution were included. The evaluation of response was obtained with CT scan every two month. The characteristics of patients, chemotherapy responses, toxicity and global survival were analysed. Results: Between November 2003 and October 2005, 20 patients were included, the median age was 51,5 years (range 28–67), 80% male. Hepatic, peritoneal and lung metastases were the principal places of dissemination. The response rate in first line was: PR 66%, SD 17%, with overall response of 83% (12 patients). In second line the response was: PR 37%, SD 63% (8 patients). The average of treatment was 5,5 months. The median of response was 5 months (2–12). The median overall survival was 12 months. 50% of patients showed toxicity; digestive grade 2 in 2 patients, neurological grade 2 in 4 patients and only 1 patient showed grade 3 toxicity. Conclusions: FOLFOX IV is an active chemotherapy regiment with low toxicity profile in advanced gastric cancer. With these results we propose a Phase III trial would be feasible to perform. No significant financial relationships to disclose.

Clinical observation of nab-paclitaxel plus S-1 as first-line chemotherapy for advanced gastric cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e15554-e15554
Author(s):  
Yi Hu ◽  
Danyang Sun
Keyword(s):  
Gastric Cancer ◽  
Combination Therapy ◽  
Advanced Gastric Cancer ◽  
Median Overall Survival ◽  
Overall Response Rate ◽  
Standard Treatment ◽  
Therapeutic Option ◽  
First Line ◽  
Grade 3 ◽  
Line Setting

e15554 Background: Gastric cancer is the third leading cause of death in the world with poor prognosis. Until recently, no standard treatment was available for patients with advanced gastric cancer in the first-line setting. Nab-paclitaxel and S-1 were both proved to have antitumor activity in many solid tumors including gastric cancer. We aimed to evaluate the efficacy and tolerance of nab-paclitaxel in combination with S-1. Methods: Patients with unresectable or recurrent gastric cancer received combination therapy of nab-paclitaxel plus S-1 every 3 weeks as one cycle. Nab-paclitaxel was administered at total dose of 260mg/ m2 on day 1 and 5 or on day 1 and 8. S-1 was given orally twice a day for 14 days, the doses were assigned according to body surface area. S-1 alone was administered as maintenance therapy after 6 to 8 cycles of combination therapy until disease progression. Results: Among the 33 patients enrolled, 28 patients (84.8%) had KPS 90, one third of patients were recurrent after gastrectomy. They received an average of 5.7 cycles of combination treatment. The median PFS was 6.6 months (95%CI, 5.557-7.716 months). The overall response rate was 51.5%, with one CR, 16 PR, 16 SD, and no PD. The median overall survival time was not obtained at the time of analysis. In safety profile, the highest incidence rate of grade 3 and grade 4 adverse events was neutropenia (12.1%). Conclusions: The combination of nab-paclitaxel plus S-1 was well tolerated and presented antitumor efficacy which may be a new therapeutic option for patients with advanced gastric cancer.

Phase III trial comparing XELOX regimen (oxaliplatin plus capecitabine) versus EOX regimen (epirubicin, oxaliplatin and capecitabine) as first-line treatment for advanced gastric cancer: EXELOX trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4014-4014
Author(s):  
Weijian Guo ◽  
Xiaodong Zhu ◽  
Mingzhu Huang ◽  
Yusheng Wang ◽  
Zhiyu Chen ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Clinical Trial ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Phase Iii Trial ◽  
Grade 3 ◽  
To Receive ◽  
Line Chemotherapy ◽  
First Line Treatment

4014 Background: At present, there is no standard chemotherapy regimen for advanced gastric cancer (AGC), and there is no consensus whether the three-drug combination is better than two-drug combination in first-line treatment. Both of XELOX regimen and EOX regimen are widely recommended as firs-line chemotherapy regimens for AGC. In this EXELOX trial, we aimed to compare the efficacy and safety of EOX and XELOX regimens. Methods: EXELOX is an open-label, multicenter, prospective, randomized phase III trial that enrolled 448 previously untreated patients with histologically confirmed advanced gastric adenocarcinoma from 7 hospitals in China. Patients were randomly assigned (1:1) to receive XELOX regimen (oxaliplatin 130mg/m2 d1; xeloda 1000mg/m2 bid d1-14) or EOX regimen (epirubicin 50mg/m2 d1; oxaliplatin 130mg/m2 d1; xeloda 1000mg/m2 bid d1-14) in this study. Treatment was repeated every 3 weeks until disease progression, intolerable toxicity, patient death, withdrawal of informed consent, or up to eight cycles, followed by xeloda single-agent maintenance. We stratified randomization by Eastern Cooperative Oncology Group status, extent of disease(locally advanced/metastatic) and clinical trial center. Patients and clinicians were not masked to the allocated treatment. The primary endpoint was progression-free survival (PFS) on an intention-to-treat basis with a non-inferiority upper margin of 1.3 for the hazard ratio (HR). The clinical trial was a non-inferiority study that was registered with ClinicalTrials.gov, Number NCT02395640. The study is ongoing, but no longer recruit new participants. Results: Between Apr 10,2015 and Aug 20,2020, a total of 448 AGC patients were randomized to receive XELOX (n = 222) or EOX (n = 226). In ITT basis, the median PFS was 5.0 months (95%CI 4.5-6.0) in XELOX group and 5.5 months (95%CI 5.0-6.0) in EOX group (HR 0.989, 95%CI 0.812-1.203; Pnon-inferiority= 0.0032). In Per-protocol population (n = 428), the median PFS was 5.0 months (95%CI 5.0-6.0) in XELOX group and 5.5 months (95%CI 5.0-6.0) in EOX group (HR 0.983, 95%CI 0.807-1.198; Pnon-inferiority= 0.0028). The incidence of grade 3-4 adverse events (AEs) was 42.2% (90/213) in XELOX group and 72.5(156/215) in EOX group ( p= 0.001). The most common grade 3-4 AEs were neutropenia (affecting 13.1% (28/213) in XELOX group and 48.4%(104/215) in EOX group ( p= 0.000). The incidence of chemotherapy dose reduction was 35% (75/213) in XELOX group and 55% (120/215) in EOX group( p= 0.009). One treatment-related death (lung infection) was observed in EOX group, and none in XELOX group. Conclusions: XELOX regimen is noninferior to EOX regimen in PFS with a better safety profile as first-line treatment for AGC patients, therefore XELOX is a more favorable choice and might be one of the standard first-line chemotherapy regimens. Clinical trial information: NCT02395640.

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