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1. Oral Cannabis Extract for Secondary Prevention of Chemotherapy-Induced Nausea and Vomiting: Final Results of a Randomized, Placebo-Controlled, Phase II/III Trial

Author

Grimison, Peter, Mersiades, Antony, Kirby, Adrienne, Tognela, Annette, Olver, Ian, Morton, Rachael L., Haber, Paul, Walsh, Anna, Lee, Yvonne, Abdi, Ehtesham, Della-Fiorentina, Stephen, Aghmesheh, Morteza, Fox, Peter, Briscoe, Karen, Sanmugarajah, Jasotha, Marx, Gavin, Kichenadasse, Ganessan, Wheeler, Helen, Chan, Matthew, Shannon, Jenny, Gedye, Craig, Begbie, Stephen, Simes, R. John, and Stockler, Martin R.

Published
2024
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2. ALKTERNATE: A Pilot Study Alternating Lorlatinib With Crizotinib in ALK-Positive NSCLC With Prior ALK Inhibitor Resistance

Author

Itchins, Malinda, Liang, Shirley, Brown, Chris, Barnes, Tristan, Marx, Gavin, Chin, Venessa, Kao, Steven, Yip, Po Yee, Mersiades, Antony J., Nagrial, Adnan, Bray, Victoria, Peters, Geoffrey, Parakh, Sagun, Garg, Kavita, Li, Bob T., McKay, Matthew, O'Byrne, Kenneth, John, Thomas, Gill, Anthony J., Molloy, Mark P., Solomon, Benjamin J., and Pavlakis, Nick

Published
2024
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4. Final findings from the CONTROL trial: Strategies to reduce the incidence and severity of neratinib-associated diarrhea in patients with HER2-positive early-stage breast cancer

Author

Chan, Arlene, Ruiz-Borrego, Manuel, Marx, Gavin, Chien, A. Jo, Rugo, Hope S., Brufsky, Adam, Thirlwell, Michael, Trudeau, Maureen, Bose, Ron, García-Sáenz, José A., Egle, Daniel, Pistilli, Barbara, Wassermann, Johanna, Cheong, Kerry A., Schnappauf, Benjamin, Semsek, Dieter, Singer, Christian F., Foruzan, Navid, DiPrimeo, Daniel, McCulloch, Leanne, Hurvitz, Sara A., and Barcenas, Carlos H.

Published
2023
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5. Enzalutamide with standard first-line therapy for metastatic hormone-sensitive prostate cancer: a plain language summary of the ENZAMET trial (ANZUP 1304).

Author

Conduit, Ciara, Inderjeeth, Andrisha-Jade, Allen, Raymond, Martin, Andrew J., Parulekar, Wendy, Mulroe, Eibhlin, McJannett, Margaret, Zielinski, Robert R., Thomson, Alastair, Tan, Thean Hsiang, Sandhu, Shahneen K., Reaume, M. Neil, Pook, David W., North, Scott A., Marx, Gavin M., Joshua, Anthony, Horvath, Lisa, McDermott, Ray, Chowdhury, Simon, and Chi, Kim N.

Abstract

Plain Language Summary What is this summary about? ENZAMET is a large international clinical trial involving people with metastatichormone sensitive prostate cancer (mHSPC). Prior to the trial, standard treatment included testosterone suppression and sometimes, chemotherapy. However, the researchers thought enzalutamide, an anti-androgen (hormone) medicine, which helps to block the effects of testosterone, might be helpful if added to testosterone suppression. What are the key takeaways? ENZAMET showed that the addition of enzalutamide to standard testosterone suppression treatment for mHSPC improved survival, resulting in an increase in the percent of participants alive at 5 years from 57% to 67%. Enzalutamide extended the time until the cancer grew. Side effects were in keeping with what was already known about enzalutamide and these risks were outweighed by improved cancer control in the long-term. What are the main conclusions reported by the researchers? The combination of testosterone suppression plus enzalutamide is a very effective first-line treatment for mHSPC. This is an abstract of the Plain Language Summary of Publication article. View the full Plain Language Summary PDF of this article to read the full-text [ABSTRACT FROM AUTHOR]

Published
2025
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7. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Parnis, Francis, Joshua, Anthony M., Horvath, Lisa G., Steer, Christopher, Marx, Gavin, Sandhu, Shahneen, Gurney, Howard, Ferguson, Thomas, Van Bruwaene, Siska, Luyten, Daisy, Schatteman, Peter, Lumen, Nicolaas, Dirix, Luc, Goeminne, Jean-Charles, Gil, Thierry, Seront, Emmanuel, Vulsteke, Christof, Kussumoto, Celio, Franke, Fabio A., Martinelli de Oliveira, Fabricio Augusto, Pereira de Santana Gomes, Andrea Juliana, Pinczowski, Hélio, Preto, Daniel D'Almeida, Zucca, Luis Eduardo, Borges, Giuliano Santos, Murad, Andre M., Saad, Fred, Chi, Kim N., Fradet, Yves, Fleshner, Neil E., Emmenegger, Urban, Brasso, Klaus, Fizazi, Karim, Culine, Stephane, Thiery-Vuillemin, Antoine, Joly, Florence, Fléchon, Aude, Hilgers, Werner, Eymard, Jean-Christophe, Borchiellini, Delphine, Barthélémy, Philippe, Berger, Raanan, Leibowitz-Amit, Raya, Mermershtain, Wilmosh, Rouvinov, Keren, Peer, Avivit, Kovel, Svetlana, Sella, Avishay, Lolkema, Martijn P., van den Eertwegh, Alfonsus J.M., Voortman, Johannes, Aarts, Maureen J., Gietema, Jourik A., Kim, Choung-Soo, Choi, Young-Deuk, Chung, Byung-Ha, Gafanov, Rustem A., Kopyltsov, Evgeniy, Usynin, Evgeny A., Carles, Joan, Mellado, Begoña, Maroto, José Pablo, García-Donás, Jesús, Rodríguez Moreno, Juan Francisco, Durán, Ignacio, Pérez-Valderrama, Begoña, Castro, Elena, Olmos, David, Méndez-Vidal, María José, Estellés, David Lorente, Sarrió, Regina Gironés, Muñoz-Langa, José, Herranz, Urbano Anido, Puente Vázquez, Javier, Castellanos, Enrique, Hellström, Martin, Widmark, Anders, Lissbrant, Ingela Franck, Jellvert, Åsa, Külich, Cecilia, Blom, René, Ståhl, Olof, Chiang, Po-Hui, Kang, Chih-Hsiung, Ou, Yen-Chuan, Wang, Shian-Shiang, Wu, Hsi-Chin, Lu, Yu-Chuan, Attard, Gerhardt, Khoo, Vincent, Bahl, Amit, Kellati, Prasad, Parikh, Omi, Srinivasan, Rajaguru, Lester, Jason F., Staffurth, John N., Cheng, Heather H., Efstathiou, Eleni, Pilié, Patrick G., George, Daniel J., Karsh, Lawrence I., Kelly, W. Kevin, Danila, Daniel C., Sieber, Paul R., Smith, Matthew R., Heath, Elisabeth I., Vaishampayan, Ulka N., Flaig, Thomas W., Emamekhoo, Hamid, Pinski, Jacek K., Kalebasty, Arash Rezazadeh, Maly, Joseph J., Moon, Helen, Smith, Matthew R, Scher, Howard I, Lara, Primo N, Jr, Yu, Evan Y, George, Daniel J, Chi, Kim N, Danila, Daniel C, Mason, Gary E, Espina, Byron M, Zhao, Xin, Urtishak, Karen A, Francis, Peter, and Lopez-Gitlitz, Angela

Published
2022
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8. Overcoming enzalutamide resistance in metastatic prostate cancer by targeting sphingosine kinase

Author

Lin, Hui-Ming, Mak, Blossom, Yeung, Nicole, Huynh, Kevin, Meikle, Thomas G., Mellett, Natalie A., Kwan, Edmond M., Fettke, Heidi, Tran, Ben, Davis, Ian D., Mahon, Kate L., Zhang, Alison, Stockler, Martin R., Briscoe, Karen, Marx, Gavin, Crumbaker, Megan, Stricker, Phillip D., Du, Pan, Yu, Jianjun, Jia, Shidong, Scheinberg, Tahlia, Fitzpatrick, Michael, Bonnitcha, Paul, Sullivan, David R., Joshua, Anthony M., Azad, Arun A., Butler, Lisa M., Meikle, Peter J., and Horvath, Lisa G.

Published
2021
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9. Combined impact of lipidomic and genetic aberrations on clinical outcomes in metastatic castration-resistant prostate cancer

Author

Mak, Blossom, Lin, Hui-Ming, Kwan, Edmond M., Fettke, Heidi, Tran, Ben, Davis, Ian D., Mahon, Kate, Stockler, Martin R., Briscoe, Karen, Marx, Gavin, Zhang, Alison, Crumbaker, Megan, Tan, Winston, Huynh, Kevin, Meikle, Thomas G., Mellett, Natalie A., Hoy, Andrew J., Du, Pan, Yu, Jianjun, Jia, Shidong, Joshua, Anthony M., Waugh, David J., Butler, Lisa M., Kohli, Manish, Meikle, Peter J., Azad, Arun A., and Horvath, Lisa G.

Published
2022
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11. Cabozantinib Versus Mitoxantrone-prednisone in Symptomatic Metastatic Castration-resistant Prostate Cancer: A Randomized Phase 3 Trial with a Primary Pain Endpoint

Author

Basch, Ethan M., Scholz, Mark, de Bono, Johann S., Vogelzang, Nicholas, de Souza, Paul, Marx, Gavin, Vaishampayan, Ulka, George, Saby, Schwarz, James K., Antonarakis, Emmanuel S., O'Sullivan, Joseph M., Kalebasty, Arash Rezazadeh, Chi, Kim N., Dreicer, Robert, Hutson, Thomas E., Dueck, Amylou C., Bennett, Antonia V., Dayan, Erica, Mangeshkar, Milan, Holland, Jaymes, Weitzman, Aaron L., and Scher, Howard I.

Published
2019
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12. Has the COVID‐19 pandemic resulted in more advanced breast cancer? A hospital‐based retrospective study.

Author

Howdle, Gemma, Stephanou, Adam, Barrett, Jordan, Roushdy, Suzannah, Ngui, Nicholas, Hughes, Michael, Marx, Gavin, and Boyages, John

Subjects
METASTATIC breast cancer, NEOADJUVANT chemotherapy, BREAST cancer, EARLY detection of cancer, DOSE fractionation
Abstract

Background: The suspension of breast cancer screening during the COVID‐19 pandemic altered patient diagnosis and management. This study investigates the impact of the COVID‐19 lockdowns, screening delays and reduced healthcare attendance on changes in tumour and treatment characteristics, particularly for biologically more aggressive breast cancers. Methods: This retrospective single‐hospital analysis utilized data from a prospective cancer database between July 2019 and June 2022. Patient, tumour and treatment factors were compared across pre‐pandemic, pandemic and post‐pandemic groups. Results: Symptomatic breast cancer increased from 42.3% in the pre‐, 53.1% in the pandemic and 57% in the post‐ respectively (P ≤ 0.05). Compared to the pre‐pandemic group (4.6%), an increase in stages 3 or 4 breast cancers in the pandemic (8.5%) and post‐pandemic (7.1%) was found. Increased node‐positivity in Ki67 > 20%, grade 3 or ER‐ tumours post‐pandemic (+5.4%, +14.8%, +33.4%, respectively) was identified. More neoadjuvant chemotherapy was found in both the pandemic (+4.3%) and post‐pandemic (+11.3%, P = 0.0261) groups. An increase in hypofractionated radiotherapy in the post‐pandemic group (+9.4%) was also identified. Conclusion: Our study identified a decrease in early‐stage cancers and an increase in node positivity, particularly for biologically more aggressive tumours. An increase in the number of patients receiving neoadjuvant chemotherapy or hypofractionated radiotherapy during the pandemic and post‐pandemic periods was also identified. [ABSTRACT FROM AUTHOR]

Published
2024
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13. A practical guide for the use of apalutamide for non‐metastatic castration‐resistant prostate cancer in Australia.

Author

Marx, Gavin, Chowdhury, Simon, Krieger, Laurence, Hovey, Elizabeth, Shapiro, Jeremy, Tran, Ben, Tan, Thean Hsiang, Ng, Siobhan, and Woo, Henry H.

Subjects
*CASTRATION-resistant prostate cancer, *BONE health, *PROSTATE cancer patients, *RADIONUCLIDE imaging, *DRUG interactions, *COMPUTED tomography
Abstract

Studies of patients with castrate‐resistant prostate cancer at high risk of developing overt metastases but with no current evidence of evaluable disease on computed tomography or bone scan non‐metastatic castrate‐resistant prostrate cancer have demonstrated increased metastasis‐free survival and overall survival following treatment with the next‐generation oral anti‐androgen apalutamide (in addition to therapies that aim to lower testosterone to castrate levels) or luteinizing hormone‐releasing hormone antagonist or surgical castration. Patients receiving apalutamide can be managed by medical oncologists, radiation oncologists, or urologists, preferably as part of a multidisciplinary team. However, the importance of additional safety monitoring for significant adverse effects and drug interactions should not be underestimated. The toxicities of apalutamide are manageable with experience and should be managed proactively to minimize their impact on patients. Monitoring of patients for apalutamide‐specific toxicities, including skin rash, hypothyroidism, and QT prolongation should be carried out regularly, particularly in the first few months following initiation. Monitoring should continue alongside monitoring for toxicities of androgen deprivation, including cardiovascular risk, hot flashes, weight gain, bone health, muscle wasting, and diabetic risk. This review is a practical guide to the use of apalutamide describing the management of patients including dosing and administration, toxicities, potential drug interactions, and safety monitoring requirements. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies

Author

Brown, Michael, Burge, Matthew, Cardaci, Giuseppe, Clarke, Stephen, Eliadis, Paul, Ferguson, Tom, Ganju, Vinod, Gibbs, Peter, van Hazel, Guy, James, Philip, Karapetis, Chris, Liauw, Winston, Marx, Gavin, Matos, Marco, Nott, Louise, Pavlakis, Nick, Powell, Alex, Price, Timothy, Ransom, David, Segelov, Eva, Shannon, Jenny, Singhal, Nimit, Strickland, Andrew, Walpole, Euan, Craninx, Michel, Delaunoit, Thierry, Deleporte, Amélie, Ferrante, Michel, Geboes, Karen, Hendlisz, Alain, Hendrickx, Koen, De Man, Marc, Monsaert, Els, Moons, Veerle, Peeters, Marc, Polus, Marc, Boucher, Eveline, Balosso, Jacques, Chevallier, Patrick, Louafi, Samy, Pracht, Marc, Rebischung, Christine, Smith, Denis, Taieb, Julien, Terrebonne, Eric, Bruch, Harald-Robert, Gehbauer, Gerald, Heinemann, Volker, Helmberger, Thomas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Nusch, Arnd, Pluntke, Stefan, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Riera, Jorge Ramon, Ricke, Jens, Sauerbruch, Tilmann, Scheidhauer, Klemens, Stötzer, Oliver, Tatsch, Klaus, Vehling-Kaiser, Ursula, Vogl, Thomas, Beny, Alex, Geva, Ravit, Shacham-Shmueli, Einat, Stemmer, Salomon, Tichler, Thomas, Wolf, Ido, Angelelli, Bruna, Martoni, Andrea, Findlay, Michael P.N., Isaacs, Richard, O’Donnell, Anne, Perez, David, Robinson, Bridget A., Rodríguez, Javier, Vera-Garcia, Ruth, Amin, Pradip, Bloomgarden, Daniel, Bui, James, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chuong, Michael, Coveler, Andrew, Facchini, Francis, Frenette, Gary, Frick, Jacob, Garofalo, Michael, George, Benjamin, Gordon, Michael, Gulec, Seza, Hannigan, James, Holtzman, Matthew, Kaubisch, Andreas, Kaiser, Adeel, Kooy, Todd, Limentani, Steven, Margolis, Jeffrey, Martin, Robert, Ozer, Howard, Padia, Siddarth, Rilling, William, Savin, Michael, Schneiderman, Elyse, Seeger, Grant, Sharma, Navesh, Shibata, Stephen, Smith, Randall, Wang, Eric, Whiting, Samuel, Aghmesheh, Morteza, Burge, Mathew, Cooray, Prasad, Feeney, Kynan, Lim, Lionel, Singh, Madhu, Underhill, Craig, Deleporte, Amelie, Durand, Aurelie, Faivre, Sandrine, Ferru, Aurelie, Hammel, Pascal, Bremer, Christoph, De Wit, Maike, Ayala, Hubert, Heching, Norman, Shani, Adi, Granetto, Cristina, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Trogu, Antonio, Kim, Yeul Hong, Sae-Won, Han, Jackson, Chris, O'Donnell, Anne, Fragoso, Maria, Tan, Iain, Casado, Ana Ruiz, Liang, Jin Tung, Liu, Jin Hwang, Ades, Steven, Auber, Miklos, Boland, Patrick, Bowers, Charles, Crain, Martin, Dowling, Kyran, Iyer, Renuka, Ratner, Lynn, Sanchez, Federico, Stoltzfus, Patricia, Westcott, Mark, Sharma, Navesh K., Findlay, Michael, Robinson, Bridget, Jackson, Christopher, Gebski, Val, Van Buskirk, Mark, and Zhao, Huaqing

Published
2018
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16. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Adams, Richard, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Mills, Jamie, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Weaver, Andrew, Wilson, Charles, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amélie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Findlay, Michael, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gibbs, Peter, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Heinemann, Volker, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, James, Philip, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Ko, Yon-Dschun, Kröning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Peeters, Marc, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ricke, Jens, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodríguez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stötzer, Oliver, Strickland, Andrew, Taieb, Julien, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, Wasan, Harpreet S, Sharma, Navesh K, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, and Gray, Alastair

Published
2017
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17. Pathological and clinical outcomes following neoadjuvant dual HER2 therapy for early‐stage breast cancer: An Australian institutional real‐world experience.

Author

Narayanan, Sathya, Ngui, Nicholas K., Kinchington, Ben, Choi, Joseph Do Woong, Hughes, Thomas Michael D., Rutovitz, Josie, Hasovits, Csilla, Nahar, Kazi J., Edirimanne, Senarath, and Marx, Gavin

Subjects
HER2 positive breast cancer, BREAST cancer, TREATMENT effectiveness, ADJUVANT chemotherapy, COMBINATION drug therapy, HORMONE receptor positive breast cancer
Abstract

Aim: There has been significant progress made in developing novel targeted therapies in the neoadjuvant setting for non‐metastatic HER2‐positive breast cancer, which may be used in combination with conventional chemotherapy to optimise pathological responses at surgery. However, these therapies, particularly the chemotherapeutic components, may portend significant and long‐lasting toxicity. Hence, de‐escalation of treatment intensity has been an area of interest and was evaluated in the phase II NeoSphere study. Herein, we report the real‐world pathological and survival outcomes from neoadjuvant taxane and dual HER2 blockade recorded at our centre. Methods: This was a retrospective cohort study of patients receiving neoadjuvant pertuzumab, trastuzumab and taxane chemotherapy for non‐metastatic HER2‐positive breast cancer at a single centre in Sydney, Australia. We collected data pertaining to baseline demographic characteristics, pathological response rates, post‐surgical prescribing patterns and also undertook survival analyses for invasive disease‐free survival (iDFS) as well as exploratory analyses for correlations between pre‐specified clinicopathologic factors and pathological response at surgery. Results: Our population was largely similar at baseline to the NeoSphere study. 71 patients were included in the final analysis. 61% achieved a pathological complete response (pCR). Three patients received conventional chemotherapy in the adjuvant setting. 92% of included patients were alive and disease‐free at 3 years of follow‐up. Only 3 events of recurrence or death were recorded at a median follow‐up of 32 months. No significant difference in iDFS was noted between patients achieving pCR and those with residual disease at surgery. Conclusion: This study demonstrates that de‐escalated adjuvant treatment for HER2‐positive early breast cancer achieved favourable pathological and long‐term outcomes comparable to large trials, some utilising more intensive chemotherapeutic components. [ABSTRACT FROM AUTHOR]

Published
2024
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20. Radiographic progression without PSA progression in metastatic hormone-sensitive prostate cancer (mHSPC): A retrospective analysis from the ENZAMET trial (ANZUP 1304).

Author

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., Inderjeeth, Andrisha Jade, Horvath, Lisa, Frydenberg, Mark, Chowdhury, Simon, Chi, Kim N., Stockler, Martin R., and Sweeney, Christopher

Published
2024
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21. Outcomes of endoscopic ultrasound‐guided gastro‐enterostomy for gastric outlet obstruction in a two‐centre Australian Cohort (with video).

Author

Harb, Martin, Kamath, Arvind, Marx, Gavin, and Gupta, Saurabh

Subjects
GASTRIC outlet obstruction, GASTROENTEROSTOMY, LENGTH of stay in hospitals, SURVIVAL rate
Abstract

Purpose: Endoscopic ultrasound‐guided gastro‐enterostomy (EUS‐GE) is a relatively novel technique that has been shown to require less re‐intervention than standard endoscopic enteral stenting for gastric outlet obstruction and is less invasive, quicker, and more cost‐effective than surgery. This study evaluated the outcomes and safety of EUS‐GE in patients treated for gastric outlet obstruction across two Australian centers. Methods: Retrospective data on demographics, presenting symptoms, disease, endoscopic and clinical outcomes, and safety were collected on all patients who underwent EUS‐GE from 2021 to 2022. Descriptive statistics were used to evaluate outcomes and safety and survival were calculated using Kaplan‐Meier analysis. Results: Eleven patients underwent EUS‐GE during the defined period, 10 of whom had a malignant etiology (median age 73 years, interquartile range [IQR] 13; 63.6% male). Technical success was 90.9%. Of those patients, clinical success (the ability to tolerate at least a full liquid diet during follow‐up) was 100%. The median length of hospital stay post‐procedure was 6 days (IQR 14 days). No severe adverse events occurred, and one patient (10%) required a repeat endoscopy. Median survival post‐EUS‐GE was 298 days (95% confidence interval 0–730.1 days) Conclusion: EUS‐GE is an effective, safe, and durable therapy for patients with gastric outlet obstruction. This study presents Australian data on outcomes and safety that is comparable to international literature. EUS‐GE should be considered for patients where local expertise allows. [ABSTRACT FROM AUTHOR]

Published
2024
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29. Overall Survival of Men with Metachronous Metastatic Hormone-sensitive Prostate Cancer Treated with Enzalutamide and Androgen Deprivation Therapy

Author

Sweeney, Christopher J., Martin, Andrew J., Stockler, Martin R., Begbie, Stephen, Chi, Kim N., Chowdhury, Simon, Coskinas, Xanthi, Frydenberg, Mark, Hague, Wendy E., Horvath, Lisa G., Joshua, Anthony M., Lawrence, Nicola J., Marx, Gavin M., McCaffrey, John, McDermott, Ray, McJannett, Margaret, North, Scott A., Parnis, Francis, Parulekar, Wendy, Pook, David W., Reaume, M. Neil, Sandhu, Shahneen K., Tan, Alvin, Tan, Thean Hsiang, Thomson, Alastair, Tu, Emily, Vera-Badillo, Francisco, Williams, Scott G., Yip, Sonia, Zhang, Alison Y., Zielinski, Robert R., and Davis, Ian D.

Published
2021
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30. Physical activity behaviors in cancer survivors treated with neurotoxic chemotherapy.

Author

Mizrahi, David, Goldstein, David, Trinh, Terry, Li, Tiffany, Timmins, Hannah C., Harrison, Michelle, Marx, Gavin M., Hovey, Elizabeth J., Lewis, Craig R., Friedlander, Michael, and Park, Susanna B.

Subjects
PHYSICAL activity, CANCER survivors, FINE motor ability, PHYSICAL mobility, TIBIAL nerve
Abstract

Aim: There are many barriers to physical activity among cancer survivors. Survivors treated with neurotoxic chemotherapy may develop chemotherapy‐induced peripheral neuropathy (CIPN) and experience additional barriers related to sensorimotor and mobility deficits. This study examined physical activity behaviors, including physical activity predictors, among cancer survivors treated with neurotoxic chemotherapies. Methods: A cross‐sectional study of 252 participants, 3–24 months after neurotoxic chemotherapy, was undertaken. Physical activity was self‐reported (IPAQ). CIPN was self‐reported (FACT/GOG‐Ntx‐13), clinically graded (NCI‐CTCAE), and objectively measured using neurological grading scales and neurophysiological techniques (tibial and sural nerve conduction studies). Balance (Swaymeter) and fine motor skills (grooved pegboard) were assessed. Regression models were used to identify clinical, demographic and CIPN predictors of walking and moderate–vigorous physical activity. Results: Forty‐four percent of participants did not meet recommended physical activity guidelines (≥150 min/week). Sixty‐six percent presented with CIPN. Nineteen percent of participants with CIPN reported that symptoms interfered with their ability to be physically active. A lower proportion of survivors aged ≥60, with grade ≥1 CIPN or BMI ≥30, reported meeting physical activity guidelines (all p <.05). Regression models identified older age, higher BMI, and patient‐reported CIPN associated with lower walking, while higher BMI and females were associated with lower moderate–vigorous physical activity. Neurologically assessed CIPN did not associate with walking or moderate–vigorous physical activity. Conclusion: Cancer survivors exposed to neurotoxic chemotherapy have low physical activity levels. Further work should examine the factors causing physical activity limitations in this cohort and designing interventions to improve physical function and quality of life in survivors. [ABSTRACT FROM AUTHOR]

Published
2023
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31. Pertuzumab study in the neoadjuvant setting for HER2‐positive nonmetastatic breast cancer in Australia (PeRSIA).

Author

Lok, Sheau Wen, De Boer, Richard, Baron‐Hay, Sally, Button, Peter, Devitt, Bianca, Forster, Benjamin C., Fox, Peter, Harold, Michael, Ketheeswaran, Sahisha, Kichenadasse, Ganessan, Kiely, Belinda E., Marx, Gavin, Nott, Louise, Pellegrini, Laura, Tafreshi, Ali, and Gibbs, Peter

Subjects
HER2 positive breast cancer, TUMOR classification, NEOADJUVANT chemotherapy, MEDICAL registries
Abstract

The pertuzumab study in the neoadjuvant setting for HER2+ nonmetastatic breast cancer in Australia (PeRSIA—ML39622) is an analysis of safety and effectiveness data from the pertuzumab patient registry. Although the prognosis of patients with early stage HER2+ breast cancer has been greatly improved by advances in chemotherapy approximately 25% to 30% of patients develop recurrent disease. Our study aimed to examine the effectiveness of neoadjuvant pertuzumab on surgical outcomes, describe the medium‐term effectiveness outcomes of patients treated with pertuzumab, and describe the planned and actual anticancer treatment regimens that patients received. Deidentified data were collected from the patients' medical records and entered into REDCap, between March 2018 and July 2019 (n = 95). The adverse events (AEs) reported most frequently were diarrhea (20; 21.1%), rash (4; 4.2%), and LVSD (4; 4.2%; two patients during neoadjuvant treatment and two patients during adjuvant treatment). AEs, ≥Grade 3 were diarrhea (2; 2.1%) and LVSD (1; 1.1%). Following surgery, a breast pathological complete response (bpCR) was achieved in 65 patients (70.7%; 95% CI: 60.2%‐79.7%) and total pathological complete response (tpCR) in 59 patients (64.1%; 95% CI: 53.4%‐73.9%). All patients who did not achieve a tpCR obtained a partial response (33/92, 35.9%). Our study is the first to capture real‐world data on the use of pertuzumab in the neoadjuvant setting in Australia. The effectiveness and safety data are consistent with those reported in clinical trials of pertuzumab in patients with HER2+ breast cancer, with no new safety concerns. [ABSTRACT FROM AUTHOR]

Published
2023
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38. The Utility of the Oncotype DX Test for Breast Cancer Patients in an Australian Multidisciplinary Setting.

Author

Choi, Joseph Do Woong, Hughes, T. Michael D., Marx, Gavin, Boyages, John, Rutovitz, Josie, Hasovits, Csilla, Parasyn, Andrew, Edirimanne, Senarath, and Ngui, Nicholas K.

Subjects
BREAST tumor treatment, GENETIC testing, RETROSPECTIVE studies, CANCER patients, HEALTH care teams, DESCRIPTIVE statistics, GENE expression profiling, DATA analysis software, TUMOR markers
Abstract

Introduction. The Oncotype DX test is a genomic assay that generates a Recurrence Score (RS) predicting the 10-year risk of recurrence and response to adjuvant chemotherapy in ER+/HER2− breast cancer patients. The aims were to determine breast cancer distant recurrence and correlate with adjuvant chemoendocrine prescribing patterns based on the Oncotype DX recurrence score. Methods. We conducted a retrospective single-institution case series of 71 patients who had Oncotype DX assay testing after definitive surgery between 2012 and 2016. Both node-positive and node-negative patients were included. Patients were divided into Oncotype DX low risk (RS < 11) (n = 10, 14%), intermediate risk (RS 11–25) (n = 45, 63%), and high risk (RS > 25) (n = 16, 23%). Median follow-up was 6.1 years (range 4–8.9 years). Adjuvant treatment regimens and oncological outcomes were determined. Results. Mean age at diagnosis was 56 years (range, 33–77). Invasive ductal carcinoma (IDC) accounted for the majority (87%), with most tumors measuring between 10–20 mm (52%). 48% of the cohort were node positive. 15 of 16 high-risk patients (94%) received chemotherapy. 96% of intermediate-risk patients received endocrine therapy alone, one patient received chemoendocrine therapy (2%), and one declined systemic therapy (2%). In the low-risk group, 100% received endocrine therapy only. The high-risk group had the lowest mean ER% (P < 0.05), greatest mean mitotic rate (P < 0.05), and greatest proportion of Ki67% > 14. Five patients developed distant recurrence (7%): three from the intermediate-risk group (7%), one from the low-risk group (10%), and one from the high-risk group (6%). Conclusion. This is the first Australian study reporting the experience with medium-term recurrence outcomes of using the Oncotype DX assay in breast cancer. Chemotherapy was rarely given for patients with low-to-intermediate RS and always offered in high RS. This pattern of prescribing was associated with low rates of distant recurrence. National funding models should be considered. [ABSTRACT FROM AUTHOR]

Published
2022
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39. Erratum to: Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid

Author

von Moos, Roger, Body, Jean-Jacques, Egerdie, Blair, Stopeck, Alison, Brown, Janet E., Damyanov, Danail, Fallowfield, Lesley J., Marx, Gavin, Cleeland, Charles S., Patrick, Donald L., Palazzo, Felipe G., Qian, Yi, Braun, Ada, and Chung, Karen

Published
2014
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47. Pathological outcomes of HER2‐positive non‐metastatic breast cancer patients treated with neoadjuvant dual anti‐HER2 therapy and taxane: An Australian experience.

Author

Choi, Joseph Do Woong, Hughes, Thomas Michael D., Marx, Gavin, Rutovitz, Josie, Hasovits, Csilla, and Ngui, Nicholas K.

Subjects
HORMONE receptor positive breast cancer, CANCER patients, BREAST cancer, BIG data, CARCINOMA in situ, DUCTAL carcinoma
Abstract

Aims: Internationally, there has recently been growing interest in the use of neoadjuvant pertuzumab and trastuzumab in patients with non‐metastatic HER‐2 positive breast cancer following the NEOSPHERE trial in 2012. However, pertuzumab is currently not funded by the Pharmaceutical Benefits Scheme (PBS) in Australia for use in this setting. The authors sought to assess the clinical and pathological response rates at the time of surgery in patients who received neoadjuvant dual anti‐HER2 and taxane therapy in a multidisciplinary breast cancer unit. Methods: A retrospective case series of all patients treated with the neoadjuvant therapy, and who had definitive surgery was conducted. Demographic data, size, grade, tumor type, receptor status prior to neoadjuvant treatment, pathological complete response (pCR) rates, and adverse effects were analyzed. Results: Nineteen patients were included in the study. Sixty‐eight percent of all patients achieved pCR, of which 54% further demonstrated no residual ductal carcinoma in situ. Eight patients (42%) had N1 disease pretreatment, of these 88% demonstrated total pCR in the axilla and the breast. Most adverse effects to treatment were manageable grade 1–2 side effects. Conclusion: This is the first reported Australian experience using neoadjuvant dual anti‐HER2 and taxane therapy for HER‐2 positive nonmetastatic breast cancer. The authors have demonstrated favorable pCR rates for invasive disease compared to the NEOSPHERE trial (68% vs 46%), with reasonable patient tolerability. Larger collaborative data sets are required to fully evaluate correlation of pCR with survival outcomes, and cost‐effectiveness. National funding models need to be considered. [ABSTRACT FROM AUTHOR]

Published
2020
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48. First-line selective internal radiotherapy plus chemotherapy versus chemotherapy alone in patients with liver metastases from colorectal cancer (FOXFIRE, SIRFLOX, and FOXFIRE-Global): a combined analysis of three multicentre, randomised, phase 3 trials

Author

Wasan, Harpreet S, Gibbs, Peter, Sharma, Navesh K, Taieb, Julien, Heinemann, Volker, Ricke, Jens, Peeters, Marc, Findlay, Michael, Weaver, Andrew, Mills, Jamie, Wilson, Charles, Adams, Richard, Francis, Anne, Moschandreas, Joanna, Virdee, Pradeep S, Dutton, Peter, Love, Sharon, Gebski, Val, Gray, Alastair, Bateman, Andrew, Blesing, Claire, Brown, Ewan, Chau, Ian, Cummins, Sebastian, Cunningham, David, Falk, Stephen, Hadaki, Maher, Hall, Marcia, Hickish, Tamas, Hornbuckle, Joanne, Lofts, Fiona, Lowndes, Sarah, Mayer, Astrid, Metcalfe, Matthew, Middleton, Gary, Montazeri, Amir, Muirhead, Rebecca, Polychronis, Andreas, Purcell, Colin, Ross, Paul, Sharma, Ricky A, Sherwin, Liz, Smith, David, Soomal, Rubin, Swinson, Daniel, Walther, Axel, Wasan, Harpreet, Wilson, Greg, Amin, Pradip, Angelelli, Bruna, Balosso, Jacques, Beny, Alex, Bloomgarden, Daniel, Boucher, Evelyn, Brown, Michael, Bruch, Harald-Robert, Bui, James, Burge, Matthew, Cardaci, Giuseppe, Carlisle, James, Chai, Seungjean, Chen, Yi-Jen, Chevallier, Patrick, Chuong, Michael, Clarke, Stephen, Coveler, Andrew, Craninx, Michael, Delanoit, Thierry, Deleporte, Amã©lie, Eliadis, Paul, Facchini, Francis, Ferguson, Thomas, Ferrante, Michel, Frenette, Gary, Frick, Jacob, Ganju, Vinod, Garofalo, Michael, Geboes, Karen, Gehbauer, Gerald, George, Benjamin, Geva, Ravit, Gordon, Michael, Gregory, Kate, Gulec, Seza, Hannigan, James, van Hazel, Guy, Heching, Norman, Helmberger, Thomas, Hendlisz, Alain, Hendrickx, Koen, Holtzman, Matthew, Isaacs, Richard, Jackson, Christopher, MORRISON JR, PHILIP JAMES, Kaiser, Adeel, Karapetis, Chris, Kaubisch, Andreas, Yon-Dschun, Ko, Krã¶ning, Hendrik, Lammert, Frank, Liauw, Winston, Limentani, Steven, Louafi, Samy, de Man, Marc, Margolis, Jeffrey, Martin, Robert, Martoni, Andrea, Marx, Gavin, Matos, Marco, Monsaert, Els, Moons, Veerle, Nott, Louise, Nusch, Arnd, O'Donnell, Anne, Ozer, Howard, Padia, Siddarth, Pavlakis, Nick, Perez, David, Pluntke, Stefan, Polus, Marc, Powell, Alex, Pracht, Marc, Price, Timothy, Ransom, David, Rebischung, Christine, Ridwelski, Karsten, Riera-Knorrenschild, Jorge, Riess, Hanno, Rilling, William, Robinson, Bridget, Rodrã­guez, Javier, Sanchez, Federico, Sauerbruch, Tilmann, Savin, Michael, Scheidhauer, Klemens, Schneiderman, Elyse, Seeger, Grant, Segelov, Eva, Schmueli, Einat Shaham, Shani, Adi, Shannon, Jenny, Sharma, Navesh, Shibata, Stephen, Singhal, Nimit, Smith, Denis, Smith, Randall, Stemmer, Salomon, Stã¶tzer, Oliver, Strickland, Andrew, Tatsch, Klaus, Terrebonne, Eric, Tichler, Thomas, Vehling-Kaiser, Ursula, Vera-Garcia, Ruth, Vogl, Thomas, Walpole, Euan, Wang, Eric, Whiting, Samuel, Wolf, Ido, Ades, Steven, Aghmesheh, Morteza, Auber, Miklos, Ayala, Hubert, Boland, Patrick, Bouche, Eveline, Bowers, Charles, Bremer, Christoph, Burge, Mathew, Casado, Ana Ruiz, Cooray, Prasad, Crain, Martin, De Wit, Maike, Deleporte, Amelie, Dowling, Kyran, Durand, Aurelie, Faivre, Sandrine, Feeney, Kynan, Ferguson, Tom, Ferru, Aurelie, Fragoso, Maria, Granetto, Cristina, Hammel, Pascal, Issacs, Richard, Iyer, Renuka, Kim, Yeul Hong, Liang, Jin Tung, Lim, Lionel, Liu, Jin Hwang, Masi, Gianluca, Mosconi, Stefania, Numico, Gianmauro, Ratner, Lynn, Sae-Won, Han, Singh, Madhu, Stoltzfus, Patricia, Tan, Iain, Trogu, Antonio, Underhill, Craig, Westcott, Mark, FOXFIRE Trial Investigators, SIRFLOX Trial Investigators, and FOXFIRE-Global Trial Investigators

Subjects
Aged, 80 and over, Adult, Male, Radiotherapy, Brachytherapy, Liver Neoplasms, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Colorectal Neoplasms, Disease-Free Survival, Female, Humans, Middle Aged, Radiotherapy, Adjuvant, Treatment Outcome, Oncology, Articles, digestive system diseases, Editorial, Colonic Neoplasms, 80 and over, Human medicine, Adjuvant
Abstract

Background Data suggest selective internal radiotherapy (SIRT) in third-line or subsequent therapy for metastatic colorectal cancer has clinical benefit in patients with colorectal liver metastases with liver-dominant disease after chemotherapy. The FOXFIRE, SIRFLOX, and FOXFIRE-Global randomised studies evaluated the efficacy of combining first-line chemotherapy with SIRT using yttrium-90 resin microspheres in patients with metastatic colorectal cancer with liver metastases. The studies were designed for combined analysis of overall survival. Methods FOXFIRE, SIRFLOX, and FOXFIRE-Global were randomised, phase 3 trials done in hospitals and specialist liver centres in 14 countries worldwide (Australia, Belgium, France, Germany, Israel, Italy, New Zealand, Portugal, South Korea, Singapore, Spain, Taiwan, the UK, and the USA). Chemotherapy-naive patients with metastatic colorectal cancer (WHO performance status 0 or 1) with liver metastases not suitable for curative resection or ablation were randomly assigned (1: 1) to either oxaliplatin-based chemotherapy (FOLFOX: leucovorin, fluorouracil, and oxaliplatin) or FOLFOX plus single treatment SIRT concurrent with cycle 1 or 2 of chemotherapy. In FOXFIRE, FOLFOX chemotherapy was OxMdG (oxaliplatin modified de Gramont chemotherapy; 85 mg/m(2) oxaliplatin infusion over 2 h, L-leucovorin 175 mg or D,L-leucovorin 350 mg infusion over 2 h, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). In SIRFLOX and FOXFIRE-Global, FOLFOX chemotherapy was modified FOLFOX6 (85 mg/m(2) oxaliplatin infusion over 2 h, 200 mg leucovorin, and 400 mg/m(2) bolus fluorouracil followed by a 2400 mg/m(2) continuous fluorouracil infusion over 46 h). Randomisation was done by central minimisation with four factors: presence of extrahepatic metastases, tumour involvement of the liver, planned use of a biological agent, and investigational centre. Participants and investigators were not masked to treatment. The primary endpoint was overall survival, analysed in the intention-to-treat population, using a two-stage meta-analysis of pooled individual patient data. All three trials have completed 2 years of follow-up. FOXFIRE is registered with the ISRCTN registry, number ISRCTN83867919. SIRFLOX and FOXFIRE-Global are registered with ClinicalTrials.gov, numbers NCT00724503 (SIRFLOX) and NCT01721954 (FOXFIRE-Global). Findings Between Oct 11, 2006, and Dec 23, 2014, 549 patients were randomly assigned to FOLFOX alone and 554 patients were assigned FOLFOX plus SIRT. Median follow-up was 43.3 months (IQR 31.6-58.4). There were 411 (75%) deaths in 549 patients in the FOLFOX alone group and 433 (78%) deaths in 554 patients in the FOLFOX plus SIRT group. There was no difference in overall survival (hazard ratio [HR] 1.04, 95% CI 0.90-1.19; p=0.61). The median survival time in the FOLFOX plus SIRT group was 22.6 months (95% CI 21.0-24.5) compared with 23.3 months (21.8-24.7) in the FOLFOX alone group. In the safety population containing patients who received at least one dose of study treatment, as treated, the most common grade 3-4 adverse event was neutropenia (137 [24%] of 571 patients receiving FOLFOX alone vs 186 (37%) of 507 patients receiving FOLFOX plus SIRT). Serious adverse events of any grade occurred in 244 (43%) of 571 patients receiving FOLFOX alone and 274 (54%) of 507 patients receiving FOLFOX plus SIRT. 10 patients in the FOLFOX plus SIRT group and 11 patients in the FOLFOX alone group died due to an adverse event; eight treatment-related deaths occurred in the FOLFOX plus SIRT group and three treatment-related deaths occurred in the FOLFOX alone group. Interpretation Addition of SIRT to first-line FOLFOX chemotherapy for patients with liver-only and liver-dominant metastatic colorectal cancer did not improve overall survival compared with that for FOLFOX alone. Therefore, early use of SIRT in combination with chemotherapy in unselected patients with metastatic colorectal cancer cannot be recommended. To further define the role of SIRT in metastatic colorectal cancer, careful patient selection and studies investigating the role of SIRT as consolidation therapy after chemotherapy are needed. Copyright (C) The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license.

Published
2017

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