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2. NUTMEG: A randomized phase II study of nivolumab and temozolomide versus temozolomide alone in newly diagnosed older patients with glioblastoma

Author

Sim, Hao-Wen, Wachsmuth, Luke, Barnes, Elizabeth H, Yip, Sonia, Koh, Eng-Siew, Hall, Merryn, Jennens, Ross, Ashley, David M, Verhaak, Roel G, Heimberger, Amy B, Rosenthal, Mark A, Hovey, Elizabeth J, Ellingson, Benjamin M, Tognela, Annette, Gan, Hui K, Wheeler, Helen, Back, Michael, McDonald, Kerrie L, Long, Anne, Cuff, Katharine, Begbie, Stephen, Gedye, Craig, Mislang, Anna, Le, Hien, Johnson, Margaret O, Kong, Benjamin Y, Simes, John R, Lwin, Zarnie, and Khasraw, Mustafa

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Orphan Drug, Neurosciences, Clinical Research, Minority Health, Brain Disorders, Cancer, Brain Cancer, Immunotherapy, Clinical Trials and Supportive Activities, Immunization, Vaccine Related, Aging, Rare Diseases, 6.1 Pharmaceuticals, clinical trials, glioblastoma, immunotherapy, older cancer patients, systemic therapy
Abstract

BackgroundThere is an immunologic rationale to evaluate immunotherapy in the older glioblastoma population, who have been underrepresented in prior trials. The NUTMEG study evaluated the combination of nivolumab and temozolomide in patients with glioblastoma aged 65 years and older.MethodsNUTMEG was a multicenter 2:1 randomized phase II trial for patients with newly diagnosed glioblastoma aged 65 years and older. The experimental arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant nivolumab and temozolomide. The standard arm consisted of hypofractionated chemoradiation with temozolomide, then adjuvant temozolomide. The primary objective was to improve overall survival (OS) in the experimental arm.ResultsA total of 103 participants were randomized, with 69 in the experimental arm and 34 in the standard arm. The median (range) age was 73 (65-88) years. After 37 months of follow-up, the median OS was 11.6 months (95% CI, 9.7-13.4) in the experimental arm and 11.8 months (95% CI, 8.3-14.8) in the standard arm. For the experimental arm relative to the standard arm, the OS hazard ratio was 0.85 (95% CI, 0.54-1.33). In the experimental arm, there were three grade 3 immune-related adverse events which resolved, with no unexpected serious adverse events.ConclusionsDue to insufficient evidence of benefit with nivolumab, the decision was made not to transition to a phase III trial. No new safety signals were identified with nivolumab. This complements the existing series of immunotherapy trials. Research is needed to identify biomarkers and new strategies including combinations.

Published
2023

7. Maternal autoimmunity and inflammation are associated with childhood tics and obsessive-compulsive disorder: Transcriptomic data show common enriched innate immune pathways

Author

Jones, Hannah F., Han, Velda X., Patel, Shrujna, Gloss, Brian S., Soler, Nicolette, Ho, Alvin, Sharma, Suvasini, Kothur, Kavitha, Nosadini, Margherita, Wienholt, Louise, Hardwick, Chris, Barnes, Elizabeth H., Lim, Jacqueline R., Alshammery, Sarah, Nielsen, Timothy C., Wong, Melanie, Hofer, Markus J., Nassar, Natasha, Gold, Wendy, Brilot, Fabienne, Mohammad, Shekeeb S., and Dale, Russell C.

Published
2021
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11. Spatial intra-tumour heterogeneity and treatment-induced genomic evolution in oesophageal adenocarcinoma: implications for prognosis and therapy.

Author

Brosda, Sandra, Aoude, Lauren G., Bonazzi, Vanessa F., Patel, Kalpana, Lonie, James M., Belle, Clemence J., Newell, Felicity, Koufariotis, Lambros T., Addala, Venkateswar, Naeini, Marjan M., AGITG DOCTOR Investigators, Simes, John, Walpole, Euan T., Mai, Gang T., Watson, David I., Karapetis, Chris S., Gebski, Val, Barnes, Elizabeth H., Oostendorp, Martijn, and Wilson, Kate

Abstract

Background: Oesophageal adenocarcinoma (OAC) is a highly heterogeneous cancer with poor survival. Standard curative treatment is chemotherapy with or without radiotherapy followed by oesophagectomy. Genomic heterogeneity is a feature of OAC and has been linked to treatment resistance. Methods: Whole-genome sequencing data from 59 treatment-naïve and 18 post-treatment samples from 29 OAC patients was analysed. Twenty-seven of these were enrolled in the DOCTOR trial, sponsored by the Australasian Gastro-Intestinal Trials Group. Two biopsies from each treatment-naïve tumour were assessed to define 'shared' (between both samples) and 'private' (present in one sample) mutations. Results: Mutational signatures SBS2/13 (APOBEC) and SBS3 (BRCA) were almost exclusively detected in private mutation populations of treatment-naïve tumours. Patients presenting these signatures had significantly worse disease specific survival. Furthermore, mutational signatures associated with platinum-based chemotherapy treatment as well as high platinum enrichment scores were only detected in post-treatment samples. Additionally, clones with high putative neoantigen binding scores were detected in some treatment-naïve samples suggesting immunoediting of clones. Conclusions: This study demonstrates the high intra-tumour heterogeneity in OAC, as well as indicators for treatment-induced changes during tumour evolution. Intra-tumour heterogeneity remains a problem for successful treatment strategies in OAC. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Clinical features associated with epilepsy occurrence, resolution, and drug resistance in children with cerebral palsy: A population‐based study.

Author

Feroze, Nimra, Karim, Tasneem, Ostojic, Katarina, Mcintyre, Sarah, Barnes, Elizabeth H., Lee, Byoung Chan, Badawi, Nadia, Mohammad, Shekeeb S, Paget, Simon, Dale, Russell C., Gill, Deepak, and Kothur, Kavitha

Subjects
EPILEPSY, CHILDREN with cerebral palsy, DRUG resistance, RECEIVER operating characteristic curves, CHILDREN with epilepsy, CHILDHOOD epilepsy
Abstract

Aim: To investigate clinicoradiological features associated with epilepsy, its resolution, and drug resistance in children with cerebral palsy (CP). Method: Data were gathered from the New South Wales/Australian Capital Territory CP Register, encompassing children with CP born between 2003 and 2015 (n = 1916). Clinical features and the severity of impairments were compared among three groups: children with current epilepsy (n = 604), those with resolved epilepsy by age 5 years (n = 109), and those without epilepsy (n = 1203). Additionally, a subset of the registry cohort attending Children's Hospital Westmead (n = 256) was analysed to compare epilepsy and treatment characteristics between drug‐responsive (n = 83) and drug‐resistant groups (n = 147) using logistic regression and hierarchical cluster analysis. Results: Manual Ability Classification System levels IV and V, intellectual impairment, and vision impairment were found to be associated with epilepsy in children with CP on multivariable analysis (p < 0.01). Moderate to severe intellectual impairment and bilateral spastic CP were independent positive and negative predictors of epilepsy persistence at the age of 5 years respectively (p < 0.05). Microcephaly and multiple seizure types were predictors of drug‐resistant epilepsy (area under the receiver operating characteristic curve of 0.83; 95% confidence interval 0.77–0.9). Children with a known genetic cause (14%) and CP epilepsy surgery group (4.3%) formed specific clinical subgroups in CP epilepsy. Interpretation: Our study highlights important clinical associations of epilepsy, its resolution, and treatment response in children with CP, providing valuable knowledge to aid in counselling families and identifying distinct prognostic groups for effective medical surveillance and optimal treatment. What this paper adds: Severe motor and non‐motor impairments in cerebral palsy (CP) increase epilepsy risk.Epilepsy more likely resolves in bilateral spastic and milder CP impairments.Epilepsy in CP often manifests at an early age with multiple seizure types and high drug resistance.Children with a known genetic cause and CP epilepsy surgery group represent distinct clinical subgroups. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Managing requirements capture in the healthcare market

Author

Barnes, Elizabeth H. R.

Subjects
338.4
Abstract

The central aims of this research are: 1. To investigate the new product development process in the wound care market 2. To identify the strengths and weaknesses of this process 3. To develop a model to improve processes of requirements capture during the early stages of new product development. Examination and development of the early stages of new product development in a mature industry, like woundcare, have been ignored previously. The principal notion in this area of research is that a new product should include all the elements that will satisfy major stakeholders in the product, both internal and external to the company developing the product, to improve likelihood of success when launched. Current investigations into the early stages of product development have looked at how requirements are integrated into a new product and how this is achieved in high technology firms but have not investigated the processes, competencies and people management involved in mature and heavily regulated industries like wound care. A survey of personnel at a company involved in wound care was carried out, in addition to development of a case study of the same company. This was complemented by a case study of a company operating within the healthcare field and a benchmarking exercise was completed. The new product development and requirements capture processes were described by several individuals, with different perspectives, involved in product development at the companies. This led to the identification of strengths and weaknesses of the process. The questionnaire also elicited information from different individuals who may, or may not, have been directly involved in product development. The benchmarking study enabled the author to compare the product development and requirements capture process of companies involved in the healthcare market. This led to emerging factors for improvement in product development, particularly during the early stages. The research was used to develop a process model of requirements capture to be implemented during the early stages of product development with particular reference to the healthcare market.

Published
2003

22. [18F]-fluoroethyl-L-tyrosine (FET) in glioblastoma (FIG) TROG 18.06 study: protocol for a prospective, multicentre PET/CT trial

Author

Koh, Eng-Siew, primary, Gan, Hui K, additional, Senko, Clare, additional, Francis, Roslyn J, additional, Ebert, Martin, additional, Lee, Sze Ting, additional, Lau, Eddie, additional, Khasraw, Mustafa, additional, Nowak, Anna K, additional, Bailey, Dale L, additional, Moffat, Bradford A, additional, Fitt, Greg, additional, Hicks, Rodney J, additional, Coffey, Robert, additional, Verhaak, Roel, additional, Walsh, Kyle M, additional, Barnes, Elizabeth H, additional, De Abreu Lourenco, Richard, additional, Rosenthal, Mark, additional, Adda, Lucas, additional, Foroudi, Farshad, additional, Lasocki, Arian, additional, Moore, Alisha, additional, Thomas, Paul A, additional, Roach, Paul, additional, Back, Michael, additional, Leonard, Robyn, additional, and Scott, Andrew M, additional

Published
2023
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27. Learning outcomes from a systematic review workshop series for junior doctors.

Author

S. Patabendige, Nounu, Scott, Karen M., Barnes, Elizabeth H., and Caldwell, Patrina H. Y.

Subjects
TEACHING methods, SYSTEMATIC reviews, PROFESSIONAL employee training, QUALITATIVE research, CONCEPTUAL structures, QUALITY assurance, QUESTIONNAIRES, DESCRIPTIVE statistics, CHI-squared test, CONTENT analysis, THEMATIC analysis, ADULT education workshops, EDUCATIONAL outcomes
Abstract

Background: Systematic reviews provide the highest level of evidence about a topic. Ten‐week workshops in conducting systematic reviews were held with hospital doctors in 2019 and 2020. Aim: This study analysed participants' feedback about the systematic review workshops to improve how we teach clinicians about conducting systematic reviews. Methods: Attendees completed a post‐workshop survey (with multiple‐choice and free‐text items) to assess knowledge and skills gained. We compared the responses of senior and junior doctors. We used descriptive statistics for the quantitative data and compared groups using Χ2 testing. Qualitative data were analysed using conceptual content analysis. Results: Of 81 attendees, 52% completed the survey. Of those, 69% had no prior experience with systematic reviews, 93% reported increased knowledge and ability to conduct research and 69% reported increased ability to conduct systematic reviews. More senior than junior clinicians reported gaining knowledge about writing and publishing (37% vs 11%, P = 0.047) and making greater use of skills gained to conduct research (56% vs 23%, P = 0.029). Five themes were identified: learning through course structure; learning through course organisation; teaching style; flexible learning; and suggestions for progression and improvement. Respondents suggested running the workshops during protected teaching time, more time for some sessions, conducting the workshop series more often and making clinicians aware of the workshop series at hospital orientation. Conclusion: The skills learnt from the systematic review workshop series impacted not only participants' research knowledge and skills, and plans to conduct future research, but also facilitated looking up medical literature in daily clinical work, supporting evidence‐based clinical practice. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Adjuvant chemotherapy following chemoradiotherapy as primary treatment for locally advanced cervical cancer versus chemoradiotherapy alone (OUTBACK): an international, open-label, randomised, phase 3 trial

Author

Mileshkin, Linda R, primary, Moore, Kathleen N, additional, Barnes, Elizabeth H, additional, Gebski, Val, additional, Narayan, Kailash, additional, King, Madeleine T, additional, Bradshaw, Nathan, additional, Lee, Yeh Chen, additional, Diamante, Katrina, additional, Fyles, Anthony W, additional, Small, William, additional, Gaffney, David K, additional, Khaw, Pearly, additional, Brooks, Susan, additional, Thompson, J Spencer, additional, Huh, Warner K, additional, Mathews, Cara A, additional, Buck, Martin, additional, Suder, Aneta, additional, Lad, Thomas E, additional, Barani, Igor J, additional, Holschneider, Christine H, additional, Van Dyk, Sylvia, additional, Quinn, Michael, additional, Rischin, Danny, additional, Monk, Bradley J, additional, and Stockler, Martin R, additional

Published
2023
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33. Acetazolamide versus placebo for cerebral oedema requiring dexamethasone in recurrent and/or progressive high-grade glioma: phase II randomised placebo-controlled double-blind study

Author

Agar, Meera R, primary, Nowak, Anna K, additional, Hovey, Elizabeth J, additional, Barnes, Elizabeth H, additional, Simes, John, additional, Vardy, Janette L, additional, Wheeler, Helen R, additional, Kong, Benjamin Y, additional, Leonard, Robyn, additional, Hall, Merryn, additional, Tim, Evonne, additional, Spyridopoulos, Desma, additional, Sim, Hao-Wen, additional, Lwin, Zarnie, additional, Dowling, Anthony, additional, Harrup, Rosemary, additional, Jennens, Ross, additional, Kichenadasse, Ganessan, additional, Dunlop, Tracey, additional, Gzell, Cecelia, additional, and Koh, Eng-Siew, additional

Published
2023
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34. Adjuvant Chemotherapy Following Chemo-Radiation as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemo-Radiation Alone: The Randomised Phase 3 OUTBACK Trial (ANZGOG 0902, RTOG 1174, NRG 0274)

Author

Mileshkin, Linda R., primary, Moore, Kathleen N., additional, Barnes, Elizabeth H., additional, Gebski, Val, additional, Narayan, Kailash, additional, King, Madeleine T., additional, Bradshaw, Nathan, additional, Lee, Yeh Chen, additional, Diamante, Katrina, additional, Fyles, Anthony W., additional, Small Jr., William, additional, Gaffney, David K., additional, Khaw, Pearly, additional, Brooks, Susan, additional, Thompson, J. Spencer, additional, Huh, Warner K., additional, Mathews, Cara A., additional, Buck, Martin, additional, Suder, Aneta, additional, Lad, Thomas E., additional, Barani, Igor J., additional, Holschneider, Christine H., additional, Van Dyk, Sylvia, additional, Quinn, Michael, additional, Rischin, Danny, additional, Monk, Bradley J., additional, and Stockler, Martin R., additional

Published
2023
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35. Standardised treatment and monitoring protocol to assess safety and tolerability of bacteriophage therapy for adult and paediatric patients (STAMP study): protocol for an open-label, single-arm trial

Author

Khatami, Ameneh, primary, Foley, David A, additional, Warner, Morgyn S, additional, Barnes, Elizabeth H, additional, Peleg, Anton Y, additional, Li, Jian, additional, Stick, Stephen, additional, Burke, Nettie, additional, Lin, Ruby C Y, additional, Warning, Julia, additional, Snelling, Thomas L, additional, Tong, Steven Y C, additional, and Iredell, Jonathan, additional

Published
2022
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37. Multi-Arm GlioblastoMa Australasia (MAGMA): protocol for a multiarm randomised clinical trial for people affected by glioblastoma

Author

Kong, Benjamin Y, primary, Sim, Hao-Wen, additional, Barnes, Elizabeth H, additional, Nowak, Anna K, additional, Hovey, Elizabeth J, additional, Jeffree, Rosalind, additional, Harrup, Rosemary, additional, Parkinson, Jonathon, additional, Gan, Hui K, additional, Pinkham, Mark B, additional, Yip, Sonia, additional, Hall, Merryn, additional, Tu, Emily, additional, Carter, Candace, additional, Koh, Eng-Siew, additional, Lwin, Zarnie, additional, Dowling, Anthony, additional, Simes, John S, additional, and Gedye, Craig, additional

Published
2022
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41. Staging locally advanced cervical cancer with FIGO 2018 versus FIGO 2008: Impact on overall survival and progression-free survival in the OUTBACK trial (ANZGOG 0902, RTOG 1174, NRG 0274).

Author

Mileshkin, Linda R., primary, Moore, Kathleen N., additional, Barnes, Elizabeth H, additional, Lee, Yeh Chen, additional, Gebski, Val, additional, Narayan, Kailash, additional, Bradshaw, Nathan, additional, Diamante, Katrina, additional, Fyles, Anthony W., additional, Small, William, additional, Gaffney, David K., additional, Khaw, Pearly, additional, Brooks, Susan, additional, Thompson, J Spencer, additional, Huh, Warner King, additional, Carlson, Matthew, additional, Robison, Katina, additional, Rischin, Danny, additional, Stockler, Martin R., additional, and Monk, Bradley J., additional

Published
2022
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43. A prospective, multi-centre trial of FET-PET in glioblastoma patients - the TROG 18.06 FIG Study: results of the Nuclear Medicine and Radiation Oncology credentialing program

Author

Koh, Eng-Siew, primary, Moore, Alisha, additional, Francis, Roslyn J., additional, Ebert, Martin A., additional, Gan, Hui K., additional, Lee, Sze T., additional, Lau, Eddie, additional, Rossi, Alana, additional, Grose, Andrew, additional, Ng, Sweet P., additional, Barnes, Elizabeth H., additional, Moffat, Bradford A., additional, Scott, Fiona E., additional, Adda, Lucas, additional, Foroudi, Farshad, additional, Nowak, Anna K., additional, Bailey, Dale L., additional, Back, Michael, additional, Lourenco, Richard De Abreu, additional, and Scott, Andrew M., additional

Published
2022
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44. LUMOS - Low and Intermediate Grade Glioma Umbrella Study of Molecular Guided TherapieS at relapse: Protocol for a pilot study

Author

Kong, Benjamin Y, primary, Sim, Hao-Wen, additional, Nowak, Anna K, additional, Yip, Sonia, additional, Barnes, Elizabeth H, additional, Day, Bryan W, additional, Buckland, Michael E, additional, Verhaak, Roel, additional, Johns, Terrance, additional, Robinson, Cleo, additional, Thomas, Marc A, additional, Giardina, Tindaro, additional, Lwin, Zarnie, additional, Scott, Andrew M, additional, Parkinson, Jonathon, additional, Jeffree, Rosalind, additional, Lourenco, Richard de Abreu, additional, Hovey, Elizabeth J, additional, Cher, Lawrence M, additional, Kichendasse, Ganessan, additional, Khasraw, Mustafa, additional, Hall, Merryn, additional, Tu, Emily, additional, Amanuel, Benhur, additional, Koh, Eng-Siew, additional, and Gan, Hui K, additional

Published
2021
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48. NIMG-49. A PROSPECTIVE, MULTI-CENTRE TRIAL OF FET-PET IN GLIOBLASTOMA PATIENTS - THE TROG 18.06 FIG STUDY: KEY ASPECTS OF IMAGING AND RADIATION ONCOLOGY CREDENTIALING

Author

Koh, Eng-Siew, primary, Francis, Roslyn J, additional, Ebert, Martin, additional, Gan, Hui, additional, Lee, Sze Ting, additional, Lau, Eddie, additional, Moore, Alisha, additional, Grose, Andrew, additional, Rossi, Alana, additional, Ng, Sweet Ping, additional, Yap, June, additional, Ly, Tam, additional, Lin, Peter, additional, Pinkham, Mark B, additional, Ngai, Stanley, additional, Yu, Christopher, additional, Gorayski, Peter, additional, Le, Hien, additional, Kirkwood, Ian D, additional, Vallat, Wilson, additional, Syed, Farhan, additional, Krishna, Dayanethee, additional, Khan, Shahroz, additional, Gill, Suki, additional, Thomas, Elizabeth, additional, Back, Michael, additional, Barnes, Elizabeth H, additional, Moffat, Bradford A, additional, Scott, Fiona, additional, Adda, Lucas, additional, Foroudi, Farshad, additional, Lourenco, Richard De Abreu, additional, Nowak, Anna K, additional, Bailey, Dale L, additional, and Scott, Andrew M, additional

Published
2021
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49. RTID-05. THE MULTI-ARM GLIOBLASTOMA AUSTRALASIA (MAGMA) TRIAL

Author

Kong, Benjamin, primary, Sim, Hao-Wen, additional, Koh, Eng-Siew, additional, Gan, Hui, additional, Barnes, Elizabeth H, additional, Yip, Sonia, additional, Nowak, Anna K, additional, Lau, Peter, additional, Cuff, Katharine, additional, Khoo, Eric, additional, Lwin, Zarnie, additional, Cooper, Adam, additional, Dowling, Anthony, additional, Linton, Anthony, additional, Harrup, Rosemary, additional, Dunlop, Tracey, additional, Hovey, Elizabeth, additional, Parkinson, Jonathon, additional, Jeffree, Rosalind, additional, Hall, Merryn, additional, Tu, Emily, additional, Andrew, Diana, additional, Simes, John, additional, and Gedye, Craig, additional

Published
2021
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50. INNV-08. LOW AND INTERMEDIATE GRADE GLIOMA UMBRELLA STUDY OF MOLECULAR GUIDED THERAPIES (LUMOS) STUDY

Author

Kong, Benjamin, primary, Sim, Hao-Wen, additional, Amanuel, Benhur, additional, Day, Bryan, additional, Buckland, Michael, additional, Verhaak, Roel, additional, Yip, Sonia, additional, Johns, Terrance, additional, Lwin, Zarnie, additional, Rosenthal, Mark, additional, Nowak, Anna K, additional, Barnes, Elizabeth H, additional, Scott, Andrew M, additional, Parkinson, Jonathon, additional, Jeffree, Rosalind, additional, Lourenco, Richard De Abreu, additional, Lau, Peter, additional, Whittle, James, additional, Hovey, Elizabeth, additional, Cher, Lawrence, additional, Kichendasse, Ganessan, additional, Hall, Merryn, additional, Robinson, Cleo, additional, Thomas, Marc, additional, Giardina, Tindaro, additional, Tu, Emily, additional, Khasraw, Mustafa, additional, Koh, Eng-Siew, additional, and Gan, Hui, additional

Published
2021
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