Preoperative Chemotherapy with Cisplatin and Docetaxel Followed by Surgery and Clip-Oriented Postoperative Chemoradiation in Patients with Localized Gastric or Gastroesophageal Junction Adenocarcinoma: Results from a Phase II Feasibility Study

2010 ◽  
Vol 18 (3) ◽  
pp. 677-683 ◽  
Author(s):  
G. Spizzo ◽  
D. Öfner ◽  
A. de Vries ◽  
P. Lukas ◽  
G. Steger ◽  
...  
Keyword(s):  
Feasibility Study ◽  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Gastroesophageal Junction ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Postoperative Chemoradiation

Multicenter Phase II Trial of S-1 Plus Cisplatin in Patients With Untreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

2006 ◽  
Vol 24 (4) ◽  
pp. 663-667 ◽  
Author(s):  
Jaffer A. Ajani ◽  
Fa-Chyi Lee ◽  
Deepti A. Singh ◽  
Daniel G. Haller ◽  
Heinz-Josef Lenz ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Gastroesophageal Junction ◽  
Median Number ◽  
Phase Iii ◽  
Highly Active ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Gastric Cancer Patients

Purpose S-1 plus cisplatin is considered highly active in Japanese gastric cancer patients. We conducted a phase II multi-institutional trial, in the West, in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma to evaluate activity and safety of this combination. Methods Patients received cisplatin intravenously at 75 mg/m2 on day 1 and S-1 orally at 25 mg/m2/dose bid (50 mg/m2/d) on days 1 to 21, repeated every 28 days. Patients with histologic proof of gastric or gastroesophageal junction adenocarcinoma with a Karnofsky performance status (KPS) of ≥ 70% and near-normal organ function were eligible. All patients provided a written informed consent. To observe a 45% confirmed overall response rate (ORR), 41 assessable patients were needed. Results All 47 patients were assessed for safety and survival, and 41 patients were assessed for ORR. The median age was 56 years and median KPS was 80%. The median number of chemotherapy cycles was four. The confirmed ORR was 51% (95% CI, 35% to 67%) and it was 49% by an independent review. At the 6-month interval, 71% of patients were alive, with a median survival time of 10.9 months. Frequent grade 3 or 4 toxicities included fatigue (26%), neutropenia (26%), vomiting (17%), diarrhea (15%), and nausea (15%); however, stomatitis (2%) and febrile neutropenia (2%) were uncommon. There was one (2%) treatment-related death. Conclusion S-1 plus cisplatin is active against gastric cancer and has a favorable toxicity profile. A global phase III study of S-1 plus cisplatin versus fluorouracil plus cisplatin currently is accruing patients.

TOPGEAR: An international randomized phase III trial of preoperative chemoradiotherapy versus preoperative chemotherapy for resectable gastric cancer (AGITG/TROG/EORTC/NCIC CTG).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS4141-TPS4141 ◽  
Author(s):  
Trevor Leong ◽  
Mark Smithers ◽  
Michael Michael ◽  
Val Gebski ◽  
Alex Boussioutas ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Adjuvant Therapy ◽  
Phase Ii ◽  
Preoperative Chemotherapy ◽  
Gastroesophageal Junction ◽  
Phase Iii ◽  
Standards Of Care ◽  
Current Status ◽  
Quality Assurance Program ◽  
Resectable Gastric Cancer

TPS4141 Background: Optimal management of patients with resectable gastric cancer remains unknown. Since the INT0116 and MAGIC trials, there are 2 standards of care for adjuvant therapy: postoperative chemoradiotherapy (CRT) and perioperative ECF chemotherapy. The important question arising from these studies is whether CRT is superior to chemotherapy alone as adjuvant therapy. This randomized phase II/III trial will compare CRT to chemotherapy alone in the preoperative setting. Methods: Patients with resectable adenocarcinoma of the stomach or gastroesophageal junction will be randomized to receive either preoperative chemotherapy alone (ECFx3 as per MAGIC regimen) or preoperative CRT (ECFx2 followed by 45Gy of radiation with concurrent 5-FU). Following surgery, both groups will receive 3 further cycles of ECF. The trial is being conducted in two Parts; Part I (phase II component) will recruit 120 patients with the aim of demonstrating sufficient efficacy and safety of preoperative CRT, as well as trial feasibility. Part II (phase III component) will recruit a further 632 patients to provide a total of 752. The primary endpoint for Part I is pathological complete response rate, and for Part 2 it is overall survival. The trial includes formal quality of life and biological sub-studies. In addition, the trial incorporates a rigorous quality assurance program that includes real time central review of radiotherapy plans and central review of surgical technique. Current status: This study is an international, intergroup trial led by the Australasian Gastro-Intestinal Trials Group (AGITG), in collaboration with the Trans-Tasman Radiation Oncology Group (TROG), European Organisation for Research and Treatment of Cancer (EORTC) and the NCIC Clinical Trials Group. To date, 36 patients have been recruited from 20 sites in Australia and New Zealand; European and Canadian sites will commence recruitment in 2012.

First-line panitumumab plus docetaxel and cisplatin in advanced gastric or gastroesophageal junction adenocarcinoma: Results of a phase II trial (SPIGA).

2016 ◽  
Vol 34 (15_suppl) ◽  
pp. e15507-e15507
Author(s):  
Guillermo Alfonso Quintero Aldana ◽  
Sonia Candamio Folgar ◽  
Jose Carlos Méndez Méndez ◽  
Margarita Reboredo ◽  
Mónica Jorge Fernández ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Gastroesophageal Junction ◽  
First Line ◽  
Gastroesophageal Junction Adenocarcinoma

Patterns of radiotherapy and its impact on survival in patients with locally advanced gastric and gastroesophageal junction adenocarcinoma: Before and after the publication of the MAGIC trial.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 125-125
Author(s):  
Chi Lin ◽  
Abhijeet Bhirud ◽  
Nathan Ronald Bennion
Keyword(s):  
Gastroesophageal Junction ◽  
Locally Advanced ◽  
Survival Rates ◽  
Tumor Resection ◽  
Standard Of Care ◽  
Multivariate Regression Analysis ◽  
Gastroesophageal Junction Adenocarcinoma ◽  
Impact On Survival ◽  
Postoperative Chemoradiation

125 Background: The intergroup 0116 trial for locally advanced gastric (GA) and gastroesophageal junction adenocarcinoma (GEJA) established postoperative chemoradiation therapy as the standard of care. However, since the publication of the MAGIC trial in 2006, some physicians prefer perioperative chemotherapy rather than postoperative chemoradiation. The goal of this study is to examine the use of radiotherapy (RT) and its impact on survival in patients diagnosed 3 years prior to and after the publication of the MAGIC trial. Methods: Patients with stage T2-4 or N+ and M0 GA (3339) or GEJA (1868) diagnosed between 2004 and 2009 who have had a primary tumor resection with at least 3 years of follow up were identified from the SEER database. Regression models were used to analyze factors influencing the use of RT and its effect on survival. Kaplan Meier plots and log-rank tests were used for survival comparisons. Results: From 2004 to 2009, there was no change in the ratio of RT/no RT. About 33% of patients with GA and 53% with GEJA received RT. Multivariate regression analysis showed that patients with T2-3 disease, N+ disease, and younger patients were more likely to receive RT in both GA and GEJA. The median follow-up for GA and GEJA, was 73 and 68 months and median survivals of 27 and 26 months respectively. RT improved median survivals from 20 to 46 months for GA and from 20 to 31 months for GEJA (p < 0.0001). After adjusting for stage and age, patients who received RT had higher odds of surviving 3 years or longer for both GA (OR 2.20, 95% CI 1.86-2.60) and GEJA (OR 1.46, 95% CI 1.19-1.80). Further analysis revealed that RT improved survivals in patients diagnosed either before or after 2006 for both GA and GEJA. Conclusions: The publication of MAGIC trial in 2006 has not affected the patterns of using RT on locally advanced GA or GEJA. Patients who did not receive RT after 2006 continue to have worse survival rates compared to those who have had RT. Further studies are warranted to evaluate the effect of combining the MAGIC chemotherapy regimen and RT on survival and quality of life of these patients.

KEYlargo: A phase II study of first-line pembrolizumab (P), capecitabine (C), and oxaliplatin (O) in HER2-negative gastroesophageal (GE) adenocarcinoma.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 228-228
Author(s):  
Hope Elizabeth Uronis ◽  
Christel Rushing ◽  
Gerard C. Blobe ◽  
Shiaowen David Hsu ◽  
Niharika B. Mettu ◽  
...  
Keyword(s):  
Phase Ii ◽  
Gastroesophageal Junction ◽  
Single Agent ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Clinical Activity ◽  
First Line ◽  
Tumor Biopsy ◽  
Gastroesophageal Junction Adenocarcinoma

228 Background: Gastric and esophageal adenocarcinomas are a leading cause of cancer death worldwide. Many of these patients (pts) present with locally advanced unresectable or metastatic disease and are treated with combination cytotoxic chemotherapy. Single agent P is FDA approved for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GEJ) whose tumors have a combined positive score (CPS) ≥ 1 after disease progression on or after two lines of therapy including fluoropyrimidine and platinum and her2/neu-targeted therapy (if indicated). More effective therapy is needed earlier in the disease trajectory. We conducted a single-arm phase II trial to establish the safety and efficacy of first-line C and O + P. Methods: Pts with previously untreated metastatic GE adenocarcinoma regardless of PDL-1 status received intravenous (IV) P 200mg with IV O 130mg/m2 every three weeks and oral C 850mg/m2 twice daily for 14 days on/7 days off. After the 6 patient safety cohort, pts first completed a biomarker cycle that included fresh tumor biopsy before P and one week after P before chemotherapy started. Archived FFPE tumor samples were also obtained from all pts with available tissue. The primary endpoint was progression free survival (PFS); secondary endpoints included response rate (RR) and overall survival (OS). Results: 36 pts were enrolled and 34 pts were evaluable for efficacy (1 pt withdrew for personal reasons before end of cycle 1 and 1 pt had immune-related toxicity during cycle 1 and was taken off study before any efficacy assessment). 9 pts (26%) had an esophageal primary, 18 pts (53%) had a GEJ primary and 7 pts (21%) had a gastric primary. Median PFS was 7.6 months [95% CI: 5.8 to 12.2], RR was 72.7% [95% CI: 57% to 88%], and median OS was 15.8 months [95% CI: 11.6 to NE]. 27 patients (81.8%) had decrease in disease burden (ranging from -19% to -100%). After > 18 months of follow-up, 5 patients remained in durable complete response (CR). Immune-mediated treatment related adverse events (TRAEs) included thyroid disorders (n=5; 14%), colitis (n=4; 11%), adrenal insufficiency (n=2; 5%), and type 1 diabetes (n=1). Sixteen patients (44%) experienced grade 3 or 4 TRAEs. There were no grade 5 TRAEs. Conclusions: The combination of C and O + P had acceptable safety and significant clinical activity. These promising results indicate that C and O + P merits further study as a first line option for patients with unresectable locally advanced or metastatic GE adenocarcinoma. Updated survival and correlative data will be presented. Clinical trial information: NCT03342937.

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