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2023

Journal Article

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)

Lam, Lyn Ley, Pavlakis, Nick, Shitara, Kohei, Sjoquist, Katrin M., Martin, Andrew J., Yip, Sonia, Kang, Yoon-Koo, Bang, Yung-Jue, Chen, Li-Tzong, Moehler, Markus, Bekaii-Saab, Tanios, Alcindor, Thierry, O’Callaghan, Christopher J., Tebbutt, Niall C., Hague, Wendy, Chan, Howard, Rha, Sun Young, Lee, Keun-Wook, Gebski, Val, Jaworski, Anthony, Zalcberg, John, Price, Timothy, Simes, John and Goldstein, David (2023). 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, 23 (1) 180, 1-12. doi: 10.1186/s12885-023-10642-7

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)

2023

Conference Publication

An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediateand poor-risk metastatic germ cell tumours (GCTs)

Zebic, Danka, Stockler, Martin R., Martin, Andrew James, Pashankar, Farzana D., Tran, Ben, Mazhar, Danish, Huddart, Robert A., Wheater, Matthew, Walpole, Euan Thomas, Dunwoodie, Elaine, Feldman, Darren R., Birtle, Alison Jane, Stevanovic, Amanda Gwendolyn, Wyld, David, Hanning, Fritha J. and Grimison, Peter S. (2023). An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediateand poor-risk metastatic germ cell tumours (GCTs). Genitourinary Cancers Symposium, Online, 16-18 February 2023. Philadelphia, PA United States: Lippincott Williams & Wilkins.

An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediateand poor-risk metastatic germ cell tumours (GCTs)

2023

Conference Publication

P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs)

Zebic, Danka, Stockler, Martin R., Martin, Andrew James, Pashankar, Farzana D., Tran, Ben, Mazhar, Danish, Huddart, Robert A., Wheater, Matthew, Walpole, Euan Thomas, Dunwoodie, Elaine, Feldman, Darren R., Birtle, Alison Jane, Stevanovic, Amanda Gwendolyn, Wyld, David, Hanning, Fritha J., Grimison, Peter S. and Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) (2023). P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs). 2023 ASCO Genitourinary Cancers Symposium, San Francisco, CA United States, 16-18 February 2023. Alexandria, VA United States: American Society of Clinical Oncology. doi: 10.1200/jco.2023.41.6_suppl.tps431

P3BEP (ANZUP 1302): An international randomized phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate- and poor-risk metastatic germ cell tumours (GCTs)

2023

Conference Publication

Evolution:phase II study of radionuclide 177Lu-PSMA-617 therapy versus 177Lu-PSMA617 in combination with ipilimumab and nivolumab for men with metastatic castrationresistant prostate cancer (mCRPC; ANZUP 2001)

Sandhu, Shahneen, Subramaniam, Shalini, Hofman, Michael S., Stockler, Martin R., Martin, Andrew James, Pokorski, Izabella, Goh, Jeffrey C., Pattison, David A., Dhiantravan, Nattakorn, Gedye, Craig, Rutherford, Natalie K., Joshua, Anthony M., Tan, Thean Hsiang, Kirkwood, Ian D., Weickhardt, Andrew James, Lee, Sze Ting, Alipour, Ramin, Nguyen, Andrew, Davis, Ian D. and Emmett, Louise (2023). Evolution:phase II study of radionuclide 177Lu-PSMA-617 therapy versus 177Lu-PSMA617 in combination with ipilimumab and nivolumab for men with metastatic castrationresistant prostate cancer (mCRPC; ANZUP 2001). Genitourinary Cancers Symposium, Virtual, 16-18 February 2023. Philadelphia, PA USA: Lippincott Williams & Wilkins.

Evolution:phase II study of radionuclide 177Lu-PSMA-617 therapy versus 177Lu-PSMA617 in combination with ipilimumab and nivolumab for men with metastatic castrationresistant prostate cancer (mCRPC; ANZUP 2001)

2023

Conference Publication

Evolution: Phase II study of radionuclide <sup>177</sup>Lu-PSMA-617 therapy versus <sup>177</sup>Lu-PSMA-617 in combination with ipilimumab and nivolumab for men with metastatic castration-resistant prostate cancer (mCRPC; ANZUP 2001)

Sandhu, Shahneen, Subramaniam, Shalini, Hofman, Michael S., Stockler, Martin R., Martin, Andrew James, Pokorski, Izabella, Goh, Jeffrey C., Pattison, David A., Dhiantravan, Nattakorn, Gedye, Craig, Rutherford, Natalie K., Joshua, Anthony M., Tan, Thean Hsiang, Kirkwood, Ian D., Lee, Sze Ting, Weickhardt, Andrew James, Alipour, Ramin, Nguyen, Andrew, Davis, Ian D., Emmett, Louise and The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) (2023). Evolution: Phase II study of radionuclide 177Lu-PSMA-617 therapy versus 177Lu-PSMA-617 in combination with ipilimumab and nivolumab for men with metastatic castration-resistant prostate cancer (mCRPC; ANZUP 2001). 2023 ASCO Genitourinary Cancers Symposium, San Francisco, CA United States, 16-18 February 2023. Alexandria, VA United States: American Society of Clinical Oncology. doi: 10.1200/jco.2023.41.6_suppl.tps271

Evolution: Phase II study of radionuclide <sup>177</sup>Lu-PSMA-617 therapy versus <sup>177</sup>Lu-PSMA-617 in combination with ipilimumab and nivolumab for men with metastatic castration-resistant prostate cancer (mCRPC; ANZUP 2001)

2023

Journal Article

Evaluation of 177Lu-PSMA SPECT quantitation as a response biomarker within a prospective 177Lu-PSMA-617 and NOX66 combination trial (LuPIN)

Pathmanandavel, Sarennya, Crumbaker, Megan, Ho, Bao, Yam, Andrew O., Wilson, Peter, Niman, Remy, Ayers, Maria, Sharma, Shikha, Hickey, Adam, Eu, Peter, Stockler, Martin, Martin, Andrew J., Joshua, Anthony M., Nguyen, Andrew and Emmett, Louise (2023). Evaluation of 177Lu-PSMA SPECT quantitation as a response biomarker within a prospective 177Lu-PSMA-617 and NOX66 combination trial (LuPIN). Journal of Nuclear Medicine, 64 (2), 221-226. doi: 10.2967/jnumed.122.264398

Evaluation of 177Lu-PSMA SPECT quantitation as a response biomarker within a prospective 177Lu-PSMA-617 and NOX66 combination trial (LuPIN)

2023

Journal Article

The prognostic value of posttreatment 68Ga-PSMA-11 PET/CT and 18F-FDG PET/CT in metastatic castration-resistant prostate cancer treated with 177Lu-PSMA-617 and NOX66 in a phase I/II trial (LuPIN)

Pathmanandavel, Sarennya, Crumbaker, Megan, Nguyen, Andrew, Yam, Andrew O., Wilson, Peter, Niman, Remy, Ayers, Maria, Sharma, Shikha, Eu, Peter, Martin, Andrew J., Stockler, Martin R., Joshua, Anthony M. and Emmett, Louise (2023). The prognostic value of posttreatment 68Ga-PSMA-11 PET/CT and 18F-FDG PET/CT in metastatic castration-resistant prostate cancer treated with 177Lu-PSMA-617 and NOX66 in a phase I/II trial (LuPIN). Journal of Nuclear Medicine, 64 (1), 69-74. doi: 10.2967/jnumed.122.264104

The prognostic value of posttreatment 68Ga-PSMA-11 PET/CT and 18F-FDG PET/CT in metastatic castration-resistant prostate cancer treated with 177Lu-PSMA-617 and NOX66 in a phase I/II trial (LuPIN)

2023

Journal Article

Nicotinamide for Skin-Cancer Chemoprevention in Transplantation

Schmults, Chrysalyne D., Jambusaria-Pahlajani, Anokhi, Ruiz, Emily, Trepanowski, Nicole, Kim, Daniel Y., Hartman, Rebecca I., Allen, Nicholas C., Martin, Andrew J. and Damian, Diona L. (2023). Nicotinamide for Skin-Cancer Chemoprevention in Transplantation. New England Journal of Medicine, 388 (26), 2493-2495. doi: 10.1056/NEJMc2303841

Nicotinamide for Skin-Cancer Chemoprevention in Transplantation

2022

Journal Article

Estimation of the treatment effect following a clinical trial that stopped early for benefit

Marschner, Ian C., Schou, Manjula and Martin, Andrew J. (2022). Estimation of the treatment effect following a clinical trial that stopped early for benefit. Statistical Methods in Medical Research, 31 (12), 2456-2469. doi: 10.1177/09622802221122445

Estimation of the treatment effect following a clinical trial that stopped early for benefit

2022

Journal Article

Changes to design and analysis elements of research plans during randomised controlled trials in Australia

Coskinas, Xanthi, Simes, R. John and Martin, Andrew J. (2022). Changes to design and analysis elements of research plans during randomised controlled trials in Australia. Medical Journal of Australia, 217 (10), 526-531. doi: 10.5694/mja2.51715

Changes to design and analysis elements of research plans during randomised controlled trials in Australia

2022

Conference Publication

P3BEP (ANZUP 1302): An international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumours (GCTs)

Zebic, Danka, Stockler, Martin R., Martin, Andrew, Pashankar, Farzana, Ben Tran,, Mazhar, Danish, Huddart, Robert, Wheater, Matthew, Walpole, Euan, Dunwoodie, Elaine, Feldman, Darren, Birtle, Alison, Stevanovic, Amanda G., Wyld, David, Hanning, Fritha J. and Grimison, Peter S. (2022). P3BEP (ANZUP 1302): An international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumours (GCTs). Clinical Oncology Society of Australia (COSA) 49th Annual Scientific Meeting, Brisbane, QLD, Australia, 2-4 November 2022. Chichester, West Sussex, United Kingdom: Wiley-Blackwell Publishing. doi: 10.1111/ajco.13869

P3BEP (ANZUP 1302): An international randomised phase 3 trial of accelerated versus standard BEP chemotherapy for male and female adults and children with intermediate and poor-risk metastatic germ cell tumours (GCTs)

2022

Journal Article

PSMA and FDG-PET as predictive and prognostic biomarkers in patients given [177Lu]Lu-PSMA-617 versus cabazitaxel for metastatic castration-resistant prostate cancer (TheraP): a biomarker analysis from a randomised, open-label, phase 2 trial

Buteau, James P, Martin, Andrew J, Emmett, Louise, Iravani, Amir, Sandhu, Shahneen, Joshua, Anthony M, Francis, Roslyn J, Zhang, Alison Y, Scott, Andrew M, Lee, Sze-Ting, Azad, Arun A, McJannett, Margaret M, Stockler, Martin R, Williams, Scott G, Davis, Ian D, Hofman, Michael S, Akhurst, Tim, Alipour, Ramin, Banks, Patricia, Beaulieu, Alexis, Chua, Wei, Dhiantravan, Nattakorn, Ford, Kate, Gedye, Craig, Goh, Jeffrey C, Guminski, Alex, Hamid, Anis, Haskali, Mohammad B, Hicks, Rodney J ... for the TheraP Trial Investigators and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (2022). PSMA and FDG-PET as predictive and prognostic biomarkers in patients given [177Lu]Lu-PSMA-617 versus cabazitaxel for metastatic castration-resistant prostate cancer (TheraP): a biomarker analysis from a randomised, open-label, phase 2 trial. The Lancet Oncology, 23 (11), 1389-1397. doi: 10.1016/S1470-2045(22)00605-2

PSMA and FDG-PET as predictive and prognostic biomarkers in patients given [177Lu]Lu-PSMA-617 versus cabazitaxel for metastatic castration-resistant prostate cancer (TheraP): a biomarker analysis from a randomised, open-label, phase 2 trial

2022

Journal Article

Hierarchical improvement of regional tissue oxygenation after packed red blood cell transfusion

Balegar, Kiran Kumar V., Jayawardhana, Madhuka, Martin, Andrew J., de Chazal, Philip and Nanan, Ralph Kay Heinrich (2022). Hierarchical improvement of regional tissue oxygenation after packed red blood cell transfusion. PLoS One, 17 (7 July) e0271563, 7. doi: 10.1371/journal.pone.0271563

Hierarchical improvement of regional tissue oxygenation after packed red blood cell transfusion

2022

Journal Article

Using three scenarios to explain life expectancy in advanced cancer: attitudes of patients, family members, and other healthcare professionals

Nahm, Sharon H., Stockler, Martin R., Martin, Andrew J., Grimison, Peter, Fox, Peter, Zielinski, Rob, Hawson, Geoffrey At., Tattersall, Martin Hn. and Kiely, Belinda E. (2022). Using three scenarios to explain life expectancy in advanced cancer: attitudes of patients, family members, and other healthcare professionals. Supportive Care in Cancer, 30 (9), 7763-7772. doi: 10.1007/s00520-022-07167-3

Using three scenarios to explain life expectancy in advanced cancer: attitudes of patients, family members, and other healthcare professionals

2022

Conference Publication

Updated overall survival outcomes in ENZAMET (ANZUP 1304), an international, cooperative group trial of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC)

Davis, Ian D., Martin, Andrew James, Zielinski, Robert Richard, Thomson, Alastair, Tan, Thean Hsiang, Sandhu, Shahneen, Reaume, M. Neil, Pook, David William, Parnis, Francis, North, Scott A., Marx, Gavin M., McCaffrey, John, McDermott, Raymond S., Lawrence, Nicola Jane, Horvath, Lisa, Frydenberg, Mark, Chowdhury, Simon, Chi, Kim N., Stockier, Martin R. and Sweeney, Christopher (2022). Updated overall survival outcomes in ENZAMET (ANZUP 1304), an international, cooperative group trial of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC). Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Electr Network, Jun 03-07, 2022. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS.

Updated overall survival outcomes in ENZAMET (ANZUP 1304), an international, cooperative group trial of enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC)

2022

Conference Publication

TheraP: <sup>177</sup>Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel-Overall survival after median follow-up of 3 years (ANZUP 1603)

Hofman, Michael S., Emmett, Louise, Sandhu, Shahneen, Iravani, Amir, Joshua, Anthony M., Goh, Jeffrey C., Pattison, David A., Tan, Thean Hsiang, Kirkwood, Ian D., Francis, Roslyn J., Gedye, Craig, Rutherford, Natalie K., Zhang, Alison Yan, McJannett, Margaret Mary, Stockler, Martin R., Williams, Scott, Martin, Andrew James and Davis, Ian D. (2022). TheraP: 177Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel-Overall survival after median follow-up of 3 years (ANZUP 1603). Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Virtual, 3-7 June 2022. Philadelphia, PA USA: Lippincott Williams & Wilkins.

TheraP: <sup>177</sup>Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel-Overall survival after median follow-up of 3 years (ANZUP 1603)

2022

Conference Publication

DASL-HiCaP: Darolutamide augments standard therapy for localized very high-risk cancer of the prostate (ANZUP1801)-A randomized phase 3, double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation

Niazi, Tamim, McBride, Sean Matthew, Williams, Scott, Davis, Ian D., Stockler, Martin R., Martin, Andrew James, Bracken, Karen, Roncolato, Felicia, Horvath, Lisa, Sengupta, Shomik, Martin, Jarad, Lim, Tee, Hughes, Simon, McDermott, Raymond S., Catto, James W. F., Kelly, Paul J., Parulekar, Wendy R., Morgan, Scott Carlyle, Rendon, Ricardo A. and Sweeney, Christopher (2022). DASL-HiCaP: Darolutamide augments standard therapy for localized very high-risk cancer of the prostate (ANZUP1801)-A randomized phase 3, double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation. Annual Meeting of the American-Society-of-Clinical-Oncology (ASCO), Electr Network, Jun 03-07, 2022. PHILADELPHIA: LIPPINCOTT WILLIAMS & WILKINS. doi: 10.1200/JCO.2022.40.6_suppl.TPS284

DASL-HiCaP: Darolutamide augments standard therapy for localized very high-risk cancer of the prostate (ANZUP1801)-A randomized phase 3, double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation

2022

Journal Article

‘Pain-free TRUS B’: a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501)

Hayne, Dickon, Grummet, Jeremy, Espinoza, David, McCombie, Steve P., Chalasani, Venu, Ford, Kate S., Frydenberg, Mark, Gilling, Peter, Gordon, Barbara, Hawks, Cynthia, Konstantatos, Alex, Martin, Andrew J., Nixon, Anthony, O’Brien, Colin, Patel, Manish I., Sengupta, Shomik, Shahbaz, Shekib, Subramaniam, Shalini, Williams, Scott, Woo, Henry H., Stockler, Martin R., Davis, Ian D. and Buchan, Nick (2022). ‘Pain-free TRUS B’: a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501). BJU International, 129 (5), 591-600. doi: 10.1111/bju.15552

‘Pain-free TRUS B’: a phase 3 double-blind placebo-controlled randomized trial of methoxyflurane with periprostatic local anaesthesia to reduce the discomfort of transrectal ultrasonography-guided prostate biopsy (ANZUP 1501)

2022

Journal Article

177Lu-PSMA-617 and Idronoxil in Men with End-Stage Metastatic Castration-Resistant Prostate Cancer (LuPIN): Patient Outcomes and Predictors of Treatment Response in a Phase I/II Trial

Pathmanandavel, Sarennya, Crumbaker, Megan, Yam, Andrew O., Nguyen, Andrew, Rofe, Christopher, Hovey, Elizabeth, Gedye, Craig, Kwan, Edmond M., Hauser, Christine, Azad, Arun A., Eu, Peter, Martin, Andrew J., Joshua, Anthony M. and Emmett, Louise (2022). 177Lu-PSMA-617 and Idronoxil in Men with End-Stage Metastatic Castration-Resistant Prostate Cancer (LuPIN): Patient Outcomes and Predictors of Treatment Response in a Phase I/II Trial. Journal of Nuclear Medicine, 63 (4), 560-566. doi: 10.2967/jnumed.121.262552

177Lu-PSMA-617 and Idronoxil in Men with End-Stage Metastatic Castration-Resistant Prostate Cancer (LuPIN): Patient Outcomes and Predictors of Treatment Response in a Phase I/II Trial

2022

Journal Article

Reply to L. Marandino et al

Stockler, Martin R., Martin, Andrew J., Dhillon, Haryana M., Davis, Ian D. and Sweeney, Christopher J. (2022). Reply to L. Marandino et al. Journal of Clinical Oncology, 30 (19) JCO.22.00497, 2176-2177. doi: 10.1200/JCO.22.00497

Reply to L. Marandino et al