Treasurer’s report
A sound and well positioned financial position of the AGITG in 2023 has been achieved in the face of difficult economic circ*mstances, changes to key personnel, complexities of changes to stakeholder engagements and successful implementation of strategic development across the company. For this achievement we express our gratitude to the generosity and belief provided by our donor support, the leadership and dedication of our management team, the increased engagement of the membership, and the considered and constructive support from the Board and associated Committees of the company. The financial position of the company is pleasing in the context of the year passed, and for the new resources initiated for the future of the AGITG.
Prof Niall Tebbutt
Treasurer
BA (Hons), BM BCh, PhD, MRCP, FRACP, MBA
Year at a glance
January
- Our VADER colorectal cancer trial opened to patients.
- INTEGRATE IIa results presented at the American Society of Clinical Oncology (ASCO) GI conference.
February
- The Blue Mountains Gutsy Challenge led by Dr Lauren Bradbury and Dr Andrew Parsonson, raised $37,000 with 19 trek participants.
- John Paduano hosts his annual golf day and raises over $10,000 to support GI cancer research, in memory of his son Alex.
March
- We welcomed two new team members: Sisse Marcussen, Marketing and Communications Specialist and Jennie Vu, Events Coordinator.
- Our ACME ABC biliary tract cancer trial and the iLSTA pancreatic cancer trial opened to patients.
May
- We held our sixth Idea Generation Workshop, this time focused on Late-Stage Colorectal Cancer.
- We launched the In conversation with Julie McCrossin AM video series highlighting important conversations about equity, diversity and inclusion within clinical trials.
June
- We farewelled Jan Mumford and Gill Worden who stepped down from our Community Advisory Panel.
- Our clinical trials PALEO and ASCEND featured at the world-leading cancer research meeting ASCO, drawing the attention of clinicians from all over the globe.
- Following translational research sessions at the 2022 Annual Scientific Meeting, Prof Rob Ramsay, Prof Vicki Whitehall, along with Dr. Michael P. Flood, published a Growth Factors paper titled "Technological Advances in Colorectal Cancer Research," investigating the utilisation of new technologies in understanding normal and metastatic colorectal cancer pathways.
July
- The 2022 AGITG Annual Scientific Meeting featured a multidisciplinary panel discussion on three cases of rectal cancer. Following the Meeting, the panellists, led by Dr Sina Vatandoust, turned their discussion into a manuscript which was published.
August
- We welcomed two new team members: Dr Julia Kuszewski, Clinical Operations Lead and Evie Tran, Finance Assistant.
- We farewelled Madison Shakespeare who stepped down from our Community Advisory Panel.
- We launched the Wonderful Colon Diving Experience website in partnership with Pierre Fabre.
September
- The Blue Mountains Gutsy Challenges led by Dr Megan Barnet, raised $28,000 with 18 trek participants.
- Our pancreatic cancer awareness campaign across the Tonic Media network launched.
- The incredible team at Cox Automative raised close to $10,000 as part of their STEPtember event to support research into Linitis Plastica (a rare type of stomach cancer).
- Jackie Green raised $5,000 from her Heavy Metal benefit concert, in honour of her husband David, who sadly passed away from oesophageal cancer.
October
- The community of Goondiwindi in regional QLD raised over $29,000 to support bowel cancer research during their annual Opera in the Gardens event. Many thanks to their business sponsors and the local community for their support.
November
- Our PR and out of home campaign, supporting Pancreatic Cancer Awareness month, launched.
- The Aotearoa New Zealand Crater Rim Trail Gutsy Challenges led by Dr Ben Lawrence, raised $35,000 with 10 trek participants.
- Our 25th Annual Scientific Meeting was held in Aotearoa, New Zealand for the first time, themed ‘Navigating Paths to Equity in GI Cancer’.
- Our RESOLUTE colorectal cancer trial received ethics approval to access the Australian Tele-trial Support Program for patients travelling from rural, regional and remote areas.
- We were awarded a $298k grant for the PemOla pancreatic cancer clinical trial from PanKind, The Australian Pancreatic Cancer Foundation!
December
- Lewis Moes raised over $15,000 in his epic run along the entire length of the Sunshine Coast to honour his father’s 10 year passing from oesophageal cancer.
- Our friends at the Mike Leeke Golf Day raised $5,000 for bowel cancer research in memory of their sport-loving friend Mike Leeke, who sadly passed from bowel cancer in 2018.
- We were awarded a $50k grant for the PemOla pancreatic cancer clinical trial from Tour de Cure Australia!
- Our STOPNET NeuroEndocrine Tumours (NETs) trial received an MRFF grant and will open in 2024.
Grants
Infrastructure grants
Cancer Australia provides funding through the ‘Support for Cancer Clinical Trials’ program, with the primary aim to support the AGITG in developing industry-independent cancer clinical trials.
Funding
Cancer Australia funding is for two and a half years from 1 January 2022 to 30 June 2024. The grant provides the AGITG with up to $1,250,000 in infrastructure funding over the grant period.
Research grants
Funds provided by Cancer Australia, Cancer Council, the National Health and Medical Research Council and the Medical Research Future Fund in support of trial coordination are managed through Administering Institutions including the University of Sydney NHMRC Clinical Trials Centre and the Walter and Eliza Hall Institute (WEHI). Funds to support site payments and insurance costs relating to these studies are transferred to the AGITG and are reflected in these financial accounts.
Grants supporting trials conducted during the 2022 financial year are outlined below. AGITG grant income and expenditure during the 2022 year for these trials are included in the 2022 Income Statement.
ACTICCA-1
A multi-centre, prospective, randomised, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. observation alone in patients after curative intent resection of Biliary Tract Cancer (BTC).
Funding
- Cancer Australia Grant: $163,600 (2016)
ASCOLT
An international randomised, double blind, placebo controlled phase III multi-centre trial, investigating the effect of aspirin on disease free and overall survival as adjuvant treatment in patients with resected stage II and III colorectal cancer.
Funding
- Cancer Australia and Bowel Cancer Australia Grant: $328,000 (2014)
- Cancer Australia Grant: $465,000 (2019)
CONTROL NETS
Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study.
Funding
- NeuroEndocrine Cancer Australia (formerly Unicorn Foundation): $200,000 (2015), $105,000 (2017) and $200,000 (2019)
- University of Sydney Bridging Grant: $30,000 (2015)
DYNAMIC-Rectal
This initial study has been designed to determine whether a ctDNA-based approach to adjuvant therapy will lead to substantially less patients receiving adjuvant therapy.
Funding – Walter and Eliza Hall Institute
- NHMRC Project Grant $1,316,682 (2017)
MASTERPLAN
This study aims to determine if adding stereotactic body radiotherapy (SBRT) to modern chemotherapy (mFOLFIRINOX or gemcitabine/nab-pacl*taxel) for patients with high-risk or unresectable (also called locally advanced) pancreatic cancer improves cancer control rates in and around the pancreas.
Funding – University of Sydney NHMRC Clinical Trials Centre
- Medical Research Future Fund: $1,512,808 (2018)
NABNEC
A Randomised Phase II Study of NAB-Pacl*taxel In Combination With Carboplatin As First Line Treatment of Gastrointestinal Neuroendocrine Carcinomas.
Funding – University of Sydney NHMRC Clinical Trials Centre
- NHMRC Project Grant: $360,750 (2016)
RESOLUTE
Randomised Phase II Trial to Evaluate the Strategy of Integrating Local Ablative Therapy with First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
Funding – Walter and Eliza Hall Institute
- Cancer Council Victoria Grant: $299,548 (2021)
SPAR
Simvastatin with chemotherapy and radiation in preoperative treatment for rectal cancer: a randomized, placebo-controlled phase 2 trial.
Funding
- Cancer Society of New Zealand Grant: $149,290 NZD (2015)
- Cancer Council NSW Grant: $449,448 AUD (2016)
- Cancer Australia Grant: $148,857 AUD (2017)
SSGXXII
Three or five years of adjuvant imatinib for the treatment of patients with operable GIST with a high risk of relapse: A randomized phase III study.
Funding – University of Sydney NHMRC Clinical Trials Centre
- Medical Research Future Fund: $1,036,125 (2021)
STOPNET
Comparison of patient outcomes with or without continuation of somatostatin injections after the commencement of Peptide Receptor Radionuclide Therapy (PRRT)
Funding
- Tour de Cure Grant 2022 (2023)
TOPGEAR
A randomised phase II/III trial of pre-operative chemoradiotherapy versus pre-operative chemotherapy for resectable gastric cancer.
Funding
- NHMRC Grant: $756,136 (2013)
- NHMRC Grant: $621,644 (2021)
Our publications and presentations
Publications
- GAP TR study
Vanessa F. Bonazzi, Lauren G. Aoude, Sandra Brosda, Julia J. Bradford, James M. Lonie, Kelly A. Loffler, Michael G. Gartside, Kalpana Patel, Pamela Mukhopadhyay, Colm Keane, Val Gebski, James G. Kench, David Goldstein, Nicola Waddell, Andrew P. Barbour, the Australasian Gastro-Intestinal Trials Group (AGITG) GAP investigators. C-reactive protein is a prognostic biomarker in pancreatic ductal adenocarcinoma patients. Asia-Pac J Clin Oncol. 2023;1–10. Published online: 6 July 2023. - Review of the 2022 AGITG Annual Scientific Meeting
Ramsay RG, Whitehall V, Flood MP. Technological advances define shifting pathway signaling from normal to primary and metastatic colorectal cancer. Growth Factors. 2023 Jun 23:1-13. doi: 10.1080/08977194.2023.2227274. - ASCOLT study
Daphne Day, Han Chong Toh, Raghib Ali, Estelle Mei Jye Foo, John Simes, John Whay Kuang Chia, Eva Segelov on behalf of the ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Global Oncology no. 9 (2023) e2300040. Published online June 26, 2023. - ASCEND study
Andrew Dean, Timothy Price, Katrin Sjoquist, Val Gebski, Jan Mumford, Fiona Day, Sonia Yip, Kate Wilson, Chris Jackson, Shamsudheen Padinharakam, Belinda Lee, Matthew Burge, Chris Karapetis, Derrick Siu, Joanna Lee, Lorraine Chantrill, Marion Harris. ASCEND: A randomized, double-blinded phase II study of gemcitabine and nab-pacl*taxel with CEND-1/LSTA1 or placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma. An Australasian Gastro-Intestinal Trials Group (AGITG) Trial. ESMO Gastrointestinal Oncology, Volume 1, p3-8, October 2023 - Review of the AGITG 2022 Annual Scientific Meeting
Ankit Jain, Kirsten L Gormly, Tamara Glyn, Tarik Sammour, Eugene J. Koay, Andrew Oar, Michael B Jameson, Elizabeth C Smyth, Sina Vatandoust. Management of rectal cancer in the era of total neoadjuvant therapy and watch-and-wait: a multidisciplinary team discussion at the Australasian Gastro-Intestinal Trials Group Annual Scientific Meeting 2022. Asia Pac J Clin Oncol. 2023 Jun 21. doi: 10.1111/ajco.13974. - DOCTOR study
James M Lonie, Sandra Brosda, Vanessa F Bonazzi, Lauren G Aoude, Kalpana Patel, Ian Brown, Sowmya Sharma, Guy Lampe, Venkateswar Addala, Lambros T Koufariotis, Scott Wood, AGITG DOCTOR Investigators, Nicola Waddell, Riccardo Dolcetti, Andrew P Barbour. The oesophageal adenocarcinoma immune microenvironment dictates outcomes with different modalities of neoadjuvant therapy. Front. Immunol., 12 October 2023 Sec. Cancer Immunity and Immunotherapy Volume 14 - 2023 | https://doi.org/10.3389/fimmu.2023.1220129 - FORECAST-1 study
Tao Tan, Dmitri Mouradov, Margaret Lee, Grace Gard, Yumiko Hirokawa, Shan Li, Cong Lin, Fuqiang Li, Huijuan Luo, Kui Wu, Michelle Palmieri, Evelyn Leong, Jordan Clarke, Anuratha Sakthianandeswaren, Helen Brasier, Jeanne Tie, Niall Tebbutt, Azim Jalali, Rachel Wong, Peter Gibbs, Oliver Sieber. Unified framework for patient-derived tumour organoid (PDTO)-based predictive testing of standard-of-care therapies in metastatic colorectal cancer: results from an Australian community-based cohort and the AGITG FORECAST-1 study. Cell Reports Medicine, Cell Rep Med. 2023 Dec 19;4(12):101335. doi: 10.1016/j.xcrm.2023.101335. - DOCTOR study
Marjan M. Naeini, Felicity Newell, Lauren G. Aoude, Vanessa F. Bonazzi, Kalpana Patel, Guy Lampe, Lambros T. Koufariotis, Vanessa Lakis, Venkateswar Addala, Olga Kondrashova, Rebecca L. Johnston, Sowmya Sharma, Sandra Brosda, Oliver Holmes, Conrad Leonard, Scott Wood, Qinying Xu, Janine Thomas, Euan Walpole, G. Tao Mai, Stephen P. Ackland, Jarad Martin, Matthew Burge, Robert Finch, Christos S. Karapetis, Jenny Shannon, Louise Nott, Robert Bohmer, Kate Wilson, Elizabeth Barnes, John R. Zalcberg, B. Mark Smithers, John Simes, Timothy Price, Val Gebski, Katia Nones, David I. Watson, John V. Pearson, Andrew P. Barbour & Nicola Waddell. Multi-omic features of oesophageal adenocarcinoma in patients treated with preoperative neoadjuvant therapy. Nat Commun 14, 3155 (2023). https://doi.org/10.1038/s41467-023-38891-x - INTEGRATE II study
Lyn Ley Lam, Nick Pavlakis, Kohei sh*tara, Katrin M Sjoquist, Andrew J Martin, Sonia Yip, Yoon-Koo Kang, Yung-Jue Bang, Li-Tzong Chen, Markus Moehler, Tanios Bekaii-Saab, Thierry Alcindor, Christopher J. O’Callaghan, Niall C. Tebbutt, Wendy Hague, Howard Chan, Sun Young Rha, Keun-Wook Lee, Val Gebski, Anthony Jaworski, John Zalcberg, Timothy Price, John Simes, David Goldstein, on behalf of the INTEGRATE investigator Study Team. INTEGRATE II: Randomised Phase III Controlled Trials of Regorafenib Containing Regimens Versus Standard of Care in Refractory Advanced Gastro-Oesophageal Cancer (AGOC): a study by the Australasian Gastro-Intestinal Trials Group (AGITG). BMC Cancer, 2023 23:180 https://doi.org/10.1186/s12885-023-10642-7
Presentations
- ASCOLT study
John W. Chia, on behalf of the ASCOLT Investigators. LBA29 - Aspirin after standard adjuvant therapy for colorectal cancers (ASCOLT): An international, phase III, randomised, placebo-controlled trial. ESMO 2023 - oral presentation in the proffered papers session (Oct 2023). - NEO-IMPACT study
Sarah Maloney, Niall Tebbutt, Mehrdad Nikfarjam, Jaswinder Samra, Shehara Mendis, Jeanne Tie, Louise Christophersen, Sarah Hayes, Nisha Berthon-Jones, Chi Ho Howard Yim, Emad El-Omar, Lorraine Chantrill. Trial in progress: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer- NEO-IMPACT. ESMO 2023 - poster presentation (Oct 2023). - ASCOLT study
Daphne Day, Anna Starus, Val Gebski, John Simes, Theresa Hayes, Shamsudheen Padinharakam, Andrew Strickland, Karen Briscoe, Suresh Varma, Megan Barnet, Chris Jackson, Lisa Horvath, Tim Price, Niall Tebbutt, Bhaskar Karki, Connie Diakos, John Whay Kuang Chia, Han Chong Toh, Frederick Jones, Eva Segelov. Minimal residual disease (MRD) detection using a tumour naïve circulating tumour DNA (ctDNA) assay in patients (pts) with resected colorectal cancer (CRC) in the phase III ASCOLT trial. ESMO 2023 - poster presentation (Oct 2023). - ASCEND study
Andrew Dean, Timothy Price, Katrin Sjoquist, Val Gebski, Jan Mumford, Fiona Day, Sonia Yip, Nathan Bradshaw, Christopher Jackson, Shamsudheen Padinharakam, Belinda Lee, Matthew Burge, Niall Tebbutt, Christopher Steer, Chris Lomma, Lyn Lam, Joanna Lee, Lorraine Chantrill, Marion Harris. ASCEND - A randomised, double-blinded phase II study of gemcitabine and nab‐pacl*taxel with CEND‐1/LSTA1 or placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma. ASCO 2023 - TiP poster presentation (Jun 2023). - PALEO study
Fiona Day, Swetha Sridharan, Michael Michael, Amitesh Roy, Louise Christophersen, Trevor Leong, Melissa Moore, Melissa Eastgate, Colin Tang, Stephen Thompson, Angela Mweempwa, Christopher Oldmeadow, Allison Fraser, Jarad Martin. Chemoradiotherapy with concurrent durvalumab for the palliative treatment of oligometastatic esophageal and gastroesophageal carcinoma with dysphagia: A single arm phase 2 clinical trial, PALEO. ASCO 2023 - TiP poster presentation (Jun 2023).
PALEO - INTEGRATE IIa study
Nick Pavlakis, Kohei sh*tara, Katrin Sjoquist, Andrew Martin, Anthony Jaworski, Sonia Yip, Yung-Jue Bang, Thierry Alcindor, Chris O'Callaghan, Niall Tebbutt, Andrew Strickland, Sun Young Rha, Keun-Wook Lee, John Zalcberg, Timothy Price, John Simes, David Goldstein. INTEGRATE IIa: Randomised double-blind Phase III study of regorafenib versus placebo in refractory advanced Gastro-Oesophageal Cancer (AGOC). ASCO GI - Oral Presentation and Poster (Jan 23).
INTEGRATE IIa - CO.17 and CO.20 studies
Joao Paulo Solar Vasconcelos, Nan Chen, Dongsheng Tu, Stephanie Yasmin Brule, Rachel Anne Goodwin, Derek J. Jonker, Timothy Jay Price, John Raymond Zalcberg, Malcolm J. Moore, Christos Stelios Karapetis, Lillian L. Siu, Jeremy David Shapiro, John Simes, Christopher J. O’Callaghan, Jonathan M. Loree. A pooled analysis of the CCTG CO.17 and CO.20 randomized trials. ASCO GI - poster (Jan 23).
