Saturday, September 14, 2024 Australia - 14 September 2024, 4:30pm AEST The AGITG TOPGEAR study led by the Australasian Gastro-Intestinal Trials Group (AGITG) and coordinated by the NHMRC Clinical Trials Centre (NHMRC CTC) at the University of Sydney, has announced the first randomised evidence of preoperative chemoradiotherapy for gastric cancer. The findings, announced simultaneously at the European Society for Medical Oncology Congress in Barcelona, Spain and published in the New England Journal of Medicine, provide a globally significant answer to a long-standing question and have implications for clinical practice. Gastric cancer is the 5th most common cancer and the 4th leading cause of cancer death worldwide.1 With a low five-year survival rate (below 40% in Australia), there is a considerable need for new treatment options. In Western countries, the current standard of care for resectable gastric cancer is perioperative chemotherapy. There is keen interest in preoperative chemoradiotherapy, but comparison to perioperative chemotherapy is lacking. The AGITG TOPGEAR trial hypothesised that adding concurrent radiotherapy to standard treatment would improve pathological complete response rates and ultimately overall survival compared to perioperative chemotherapy alone.The multidisciplinary study involved the collaborative efforts of radiation oncologists, medical oncologists and surgeons worldwide to determine the optimal adjuvant regimen for potentially curable gastric cancer. Despite improving pathological outcomes, the addition of preoperative chemoradiotherapy to perioperative chemotherapy did not improve overall survival compared to perioperative chemotherapy alone in patients with resectable gastric and gastro-esophageal junction adenocarcinoma.The results will be practice changing as some centres, particularly in the USA currently employ preoperative chemoradiotherapy as standard treatment for gastric cancer. In addition, preoperative chemoradiotherapy is also a standard of care treatment for patients with gastro-esophageal junction cancers who comprised one third of the TOPGEAR patient cohort.Study Chair Professor Trevor Leong says, “The AGITG TOPGEAR findings provide us with important new knowledge to improve our understanding of oesophago-gastric cancer. Recognition of the trial by the European Society for Medical Oncology and the New England Journal of Medicine shows the significant global interest in this Australian-led study.”Between September 2009 and May 2021, 574 patients were enrolled on to the AGITG TOPGEAR study from 70 sites across 15 countries in Australia, Aotearoa New Zealand, Europe, and Canada. The trial involved the collaborative efforts of the European Organisation for Research and Treatment of Cancer (EORTC), the Canadian Cancer Trials Group (CCTG) and the Trans-Tasman Radiation Oncology Group (TROG). Professor Leong says, “Thank you to everyone involved in AGITG TOPGEAR for their tireless efforts over the duration of this large, academic trial. This trial involved hundreds of people around the world and delivering these findings is a significant achievement that we all should be proud of.” AGITG TOPGEAR is funded by successive NHMRC grants and Cancer Australia Priority-driven Collaborative Cancer Research Scheme Grant. Additional funding was provided by AGITG and NHMRC CTC, as well as regional funding from EORTC, CCTG through Canadian Institutes of Health Research and the Canadian Cancer Society, and the Health Research Council of New Zealand (HRC). New England Journal of Medicine publication ----- About the Australasian Gastro-Intestinal Trials GroupThe Australasian Gastro-Intestinal Trials Group (AGITG) is a multi-disciplinary collaborative group that undertakes patient-centric research to advance medical care and practice in the treatment of gastro-intestinal cancer. Since 1991, the AGITG has led 83 GI cancer research studies, enrolling 9,400 patients across 285 sites worldwide. Learn more About the NHMRC Clinical Trials Centre, University of SydneyThe NHMRC Clinical Trials Centre is a flagship research centre at the University of Sydney that designs and coordinates clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. Over the past 35 years the NHMRC Clinical Trials Centre has co-led more than 150 clinicals trials involving over 100,000 patients which have changed global clinical practice. It also undertakes work in health economics, biostatistics, systematic reviews and biomarker research that can help inform healthcare providers about best practice. Learn more About the European Organisation for Research and Treatment of CancerThe European Organisation for Research and Treatment of Cancer (EORTC) is Europe's leading multidisciplinary clinical cancer research organisation whose work spans cancers, treatment types and national borders. For more than 60 years, its mission has been to coordinate and conduct international translational and clinical research to improve the standards of cancer treatment for patients, thereby enhancing both their survival rates and quality of life. Learn more. About the Canadian Cancer Trials Group The Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that runs phase I-III trials to test anti-cancer and supportive therapies at over 85 hospitals and cancer centres across Canada. From their operations centre at Queen's University, CCTG has supported more than 600 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is a national program of the Canadian Cancer Society and their aim is to improve survival and quality of life for all people with cancer. For further information, please visit: www.cctg.ca About the Trans-Tasman Radiation Oncology GroupThe Trans Tasman Radiation Oncology Group (TROG) is committed to revolutionising the delivery of radiation therapy for cancer patients through rigorous clinical trials and the adoption of cutting-edge technology. Now in its 35th year, TROG has facilitated more than 140 clinical trials involving over 15,000 participants, contributing to improving the experience and outcomes for cancer patients globally. AGITG TOPGEAR clinical trial findings published in the New England Journal of Medicine and presented at European Society for Medical Oncology Congress in Barcelona, SpainGlobally significant results will improve understanding of oesophago-gastric cancerThe randomised Phase III clinical trial enrolled 574 patients across 15 countries Key findings:The trial evaluated the addition of chemoradiotherapy before surgery to standard care which involved giving chemotherapy both before and after surgery in 574 patients with cancer of the stomach or oesophagus/stomach junction.Patients receiving chemoradiotherapy were found to have higher rates of complete response of their tumour at the time of surgery, compared with standard care (17% versus 8%).However there was no significant benefit of chemoradiotherapy on long term survival which was the main aim of the trial. The survival rate at 5 years was about 45% in both groups.As a result, it is recommended that chemoradiotherapy not become a routine standard of care. ContactAGITG - Erin Burgess, Head of Communications Email: erin@gicancer.org.au Mobile: 0402 152 592NHMRC CTC - Timara MacFarLane, Communications Officer Email: timara.macfarlane@sydney.edu.au ----- 1. Sung H. Ferlay J. Siegel R.L. et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021; caac.21660.
