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1. Adaptation of the socioecological model to address disparities in engagement of Black men in prostate cancer genetic testing

Author

Leader, Amy E., Rebbeck, Timothy R., Oh, William K., Patel, Alpa V., Winer, Eric P., Bailey, LeeAnn O., Gomella, Leonard G., Lumpkins, Crystal Y., Garraway, Isla P., Aiello, Lisa B., Baskin, Monica L., Cheng, Heather H., Cooney, Kathleen A., Ganzak, Amanda, George, Daniel J., Halabi, Susan, Hathaway, Feighanne, Healy, Claire, Kim, Joseph W., Leapman, Michael S., Loeb, Stacy, Maxwell, Kara N., McNair, Christopher, Morgan, Todd M., Prindeville, Breanne, Soule, Howard R., Steward, Whitney L., Suttiratana, Sakinah C., Taplin, Mary-Ellen, Yamoah, Kosj, Fortune, Thierry, Bennett, Kris, Blanding-Godbolt, Joshua, Gross, Laura, and Giri, Veda N.

Published
2024
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3. Pharmacogenetic and clinical risk factors for bevacizumab-related gastrointestinal hemorrhage in prostate cancer patients treated on CALGB 90401 (Alliance)

Author

Patel, Jai N., Jiang, Chen, Owzar, Kouros, Hertz, Daniel L., Wang, Janey, Mulkey, Flora A., Kelly, William K., Halabi, Susan, Furukawa, Yoichi, Lassiter, Cameron, Dorsey, Susan G., Friedman, Paula N., Small, Eric J., Carducci, Michael A., Kelley, Michael J., Nakamura, Yusuke, Kubo, Michiaki, Ratain, Mark J., Morris, Michael J., and McLeod, Howard L.

Published
2024
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4. The Lancet Commission on prostate cancer: planning for the surge in cases

Author

James, Nicholas D, Tannock, Ian, N'Dow, James, Feng, Felix, Gillessen, Silke, Ali, Syed Adnan, Trujillo, Blanca, Al-Lazikani, Bissan, Attard, Gerhardt, Bray, Freddie, Compérat, Eva, Eeles, Ros, Fatiregun, Omolara, Grist, Emily, Halabi, Susan, Haran, Áine, Herchenhorn, Daniel, Hofman, Michael S, Jalloh, Mohamed, Loeb, Stacy, MacNair, Archie, Mahal, Brandon, Mendes, Larissa, Moghul, Masood, Moore, Caroline, Morgans, Alicia, Morris, Michael, Murphy, Declan, Murthy, Vedang, Nguyen, Paul L, Padhani, Anwar, Parker, Charles, Rush, Hannah, Sculpher, Mark, Soule, Howard, Sydes, Matthew R, Tilki, Derya, Tunariu, Nina, Villanti, Paul, and Xie, Li-Ping

Published
2024
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5. Refining Risk Stratification of High-risk and Locoregional Prostate Cancer: A Pooled Analysis of Randomized Trials

Author

Ravi, Praful, Xie, Wanling, Buyse, Marc, Halabi, Susan, Kantoff, Philip W., Sartor, Oliver, Attard, Gert, Clarke, Noel, D'Amico, Anthony, Dignam, James, James, Nicholas, Fizazi, Karim, Gillessen, Silke, Parulekar, Wendy, Sandler, Howard, Spratt, Daniel E., Sydes, Matthew R., Tombal, Bertrand, Williams, Scott, and Sweeney, Christopher J.

Published
2024
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6. Management of patients with advanced prostate cancer—metastatic and/or castration-resistant prostate cancer: Report of the Advanced Prostate Cancer Consensus Conference (APCCC) 2022

Author

Gillessen, Silke, Bossi, Alberto, Davis, Ian D., de Bono, Johann, Fizazi, Karim, James, Nicholas D., Mottet, Nicolas, Shore, Neal, Small, Eric, Smith, Matthew, Sweeney, Christopher J., Tombal, Bertrand, Antonarakis, Emmanuel S., Aparicio, Ana M., Armstrong, Andrew J., Attard, Gerhardt, Beer, Tomasz M., Beltran, Himisha, Bjartell, Anders, Blanchard, Pierre, Briganti, Alberto, Bristow, Rob G., Bulbul, Muhammad, Caffo, Orazio, Castellano, Daniel, Castro, Elena, Cheng, Heather H., Chi, Kim N., Chowdhury, Simon, Clarke, Caroline S., Clarke, Noel, Daugaard, Gedske, De Santis, Maria, Duran, Ignacio, Eeles, Ross, Efstathiou, Eleni, Efstathiou, Jason, Ekeke, Onyeanunam Ngozi, Evans, Christopher P., Fanti, Stefano, Feng, Felix Y., Fonteyne, Valerie, Fossati, Nicola, Frydenberg, Mark, George, Dan, Gleave, Martin, Gravis, Gwenaelle, Halabi, Susan, Heinrich, Daniel, Herrmann, Ken, Higano, Celestia, Hofman, Michael S., Horvath, Lisa G., Hussain, Maha, Jereczek-Fossa, Barbara A., Jones, Rob, Kanesvaran, Ravindran, Kellokumpu-Lehtinen, Pirkko-Liisa, Khauli, Raja B., Klotz, Laurence, Kramer, Gero, Leibowitz, Raja, Logothetis, Christopher, Mahal, Brandon, Maluf, Fernando, Mateo, Joaquin, Matheson, David, Mehra, Niven, Merseburger, Axel, Morgans, Alicia K., Morris, Michael J., Mrabti, Hind, Mukherji, Deborah, Murphy, Declan G., Murthy, Vedang, Nguyen, Paul L., Oh, William K., Ost, Piet, O’Sullivan, Joe M., Padhani, Anwar R., Pezaro, Carmel J., Poon, Darren M.C., Pritchard, Colin C., Rabah, Danny M., Rathkopf, Dana, Reiter, Robert E., Rubin, Mark A., Ryan, Charles J., Saad, Fred, Sade, Juan Pablo, Sartor, Oliver, Scher, Howard I., Sharifi, Nima, Skoneczna, Iwona, Soule, Howard, Spratt, Daniel E., Srinivas, Sandy, Sternberg, Cora N., Steuber, Thomas, Suzuki, Hiroyoshi, Sydes, Matthew R., Taplin, Mary-Ellen, Tilki, Derya, Türkeri, Levent, Turco, Fabio, Uemura, Hiroji, Uemura, Hirotsugu, Ürün, Yüksel, Vale, Claire L., van Oort, Inge, Vapiwala, Neha, Walz, Jochen, Yamoah, Kosj, Ye, Dingwei, Yu, Evan Y., Zapatero, Almudena, Zilli, Thomas, and Omlin, Aurelius

Published
2023
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7. Breakthrough SARS-CoV-2 infections among patients with cancer following two and three doses of COVID-19 mRNA vaccines: a retrospective observational study from the COVID-19 and Cancer Consortium

Author

Choueiri, Toni K., Labaki, Chris, Bakouny, Ziad, Hsu, Chih-Yuan, Schmidt, Andrew L., de Lima Lopes, Gilberto, Jr., Hwang, Clara, Singh, Sunny R.K., Jani, Chinmay, Weissmann, Lisa B., Griffiths, Elizabeth A., Halabi, Susan, Wu, Ulysses, Berg, Stephanie, O'Connor, Timothy E., Wise-Draper, Trisha M., Panagiotou, Orestis A., Klein, Elizabeth J., Joshi, Monika, Yared, Fares, Dutra, Miriam Santos, Gatson, Na Tosha N., Blau, Sibel, Singh, Harpreet, Nanchal, Rahul, McKay, Rana R., Nonato, Taylor K., Quinn, Ryann, Rubinstein, Samuel M., Puc, Matthew, Mavromatis, Blanche H., Vikas, Praveen, Faller, Bryan, Zaren, Howard A., Del Prete, Salvatore, Russell, Karen, Reuben, Daniel Y., Accordino, Melissa K., Friese, Christopher R., Mishra, Sanjay, Rivera, Donna R., Shyr, Yu, Farmakiotis, Dimitrios, and Warner, Jeremy L.

Published
2023
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8. Management of Patients with Advanced Prostate Cancer. Part I: Intermediate-/High-risk and Locally Advanced Disease, Biochemical Relapse, and Side Effects of Hormonal Treatment: Report of the Advanced Prostate Cancer Consensus Conference 2022

Author

Gillessen, Silke, Bossi, Alberto, Davis, Ian D., de Bono, Johann, Fizazi, Karim, James, Nicholas D., Mottet, Nicolas, Shore, Neal, Small, Eric, Smith, Matthew, Sweeney, Christopher, Tombal, Bertrand, Antonarakis, Emmanuel S., Aparicio, Ana M., Armstrong, Andrew J., Attard, Gerhardt, Beer, Tomasz M., Beltran, Himisha, Bjartell, Anders, Blanchard, Pierre, Briganti, Alberto, Bristow, Rob G., Bulbul, Muhammad, Caffo, Orazio, Castellano, Daniel, Castro, Elena, Cheng, Heather H., Chi, Kim N., Chowdhury, Simon, Clarke, Caroline S., Clarke, Noel, Daugaard, Gedske, De Santis, Maria, Duran, Ignacio, Eeles, Ros, Efstathiou, Eleni, Efstathiou, Jason, Ngozi Ekeke, Onyeanunam, Evans, Christopher P., Fanti, Stefano, Feng, Felix Y., Fonteyne, Valerie, Fossati, Nicola, Frydenberg, Mark, George, Daniel, Gleave, Martin, Gravis, Gwenaelle, Halabi, Susan, Heinrich, Daniel, Herrmann, Ken, Higano, Celestia, Hofman, Michael S., Horvath, Lisa G., Hussain, Maha, Jereczek-Fossa, Barbara Alicja, Jones, Robert, Kanesvaran, Ravindran, Kellokumpu-Lehtinen, Pirkko-Liisa, Khauli, Raja B., Klotz, Laurence, Kramer, Gero, Leibowitz, Raya, Logothetis, Christopher J., Mahal, Brandon A., Maluf, Fernando, Mateo, Joaquin, Matheson, David, Mehra, Niven, Merseburger, Axel, Morgans, Alicia K., Morris, Michael J., Mrabti, Hind, Mukherji, Deborah, Murphy, Declan G., Murthy, Vedang, Nguyen, Paul L., Oh, William K., Ost, Piet, O'Sullivan, Joe M., Padhani, Anwar R., Pezaro, Carmel, Poon, Darren M.C., Pritchard, Colin C., Rabah, Danny M., Rathkopf, Dana, Reiter, Robert E., Rubin, Mark. A., Ryan, Charles J., Saad, Fred, Pablo Sade, Juan, Sartor, Oliver A., Scher, Howard I., Sharifi, Nima, Skoneczna, Iwona, Soule, Howard, Spratt, Daniel E., Srinivas, Sandy, Sternberg, Cora N., Steuber, Thomas, Suzuki, Hiroyoshi, Sydes, Matthew R., Taplin, Mary-Ellen, Tilki, Derya, Türkeri, Levent, Turco, Fabio, Uemura, Hiroji, Uemura, Hirotsugu, Ürün, Yüksel, Vale, Claire L., van Oort, Inge, Vapiwala, Neha, Walz, Jochen, Yamoah, Kosj, Ye, Dingwei, Yu, Evan Y., Zapatero, Almudena, Zilli, Thomas, and Omlin, Aurelius

Published
2023
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9. Management of Patients with Advanced Prostate Cancer: Report from the Advanced Prostate Cancer Consensus Conference 2021

Author

Gillessen, Silke, Armstrong, Andrew, Attard, Gert, Beer, Tomasz M., Beltran, Himisha, Bjartell, Anders, Bossi, Alberto, Briganti, Alberto, Bristow, Robert G., Bulbul, Muhammad, Caffo, Orazio, Chi, Kim N., Clarke, Caroline S., Clarke, Noel, Davis, Ian D., de Bono, Johann S., Duran, Ignacio, Eeles, Ros, Efstathiou, Eleni, Efstathiou, Jason, Ekeke, Onyeanunam Ngozi, Evans, Christopher P., Fanti, Stefano, Feng, Felix Y., Fizazi, Karim, Frydenberg, Mark, George, Dan, Gleave, Martin, Halabi, Susan, Heinrich, Daniel, Higano, Celesta, Hofman, Michael S., Hussain, Maha, James, Nick, Jones, Robert, Kanesvaran, Ravindran, Khauli, Raja B., Klotz, Laurence, Leibowitz, Raya, Logothetis, Chris, Maluf, Fernando, Millman, Robin, Morgans, Alicia K., Morris, Michael J., Mottet, Nicolas, Mrabti, Hind, Murphy, Declan G., Murthy, Vedang, Oh, William K., Ost, Piet, O'Sullivan, Joe M., Padhani, Anwar R., Parker, Chris, Poon, Darren M.C., Pritchard, Colin C., Rabah, Danny M., Rathkopf, Dana, Reiter, Rob E., Rubin, Mark, Ryan, Charles J., Saad, Fred, Sade, Juan P., Sartor, Oliver, Scher, Howard I., Shore, Neal, Skoneczna, Iwona, Small, Eric, Smith, Matthew, Soule, Howard, Spratt, Daniel E., Sternberg, Cora N., Suzuki, Hiroyoshi, Sweeney, Christopher, Sydes, Matthew R., Taplin, Mary-Ellen, Tilki, Derya, Tombal, Bertrand, Türkeri, Levent, Uemura, Hiroji, Uemura, Hirotsugu, van Oort, Inge, Yamoah, Kosj, Ye, Dingwei, Zapatero, Almudena, and Omlin, Aurelius

Published
2022
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12. Reply to J.A. Garcia et al.

Author

Halabi, Susan, Guo, Siyuan, Roy, Akash, Rydzewska, Larysa E., Godolphin, Peter, Hussain, Maha, Tangen, Catherine, Thompson, Ian, Xie, Wanling, Carducci, Michael A., Morris, Michael J., Smith, Matthew R., Gravis, Gwenaelle, Dearnaley, David P., Verhagen, Paul J., Goto, Takayuki J., James, Nick D., Buyse, Marc E., Tierney, Jayne F., and Sweeney, Christopher J.

Published
2024
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13. Combined Longitudinal Clinical and Autopsy Phenomic Assessment in Lethal Metastatic Prostate Cancer: Recommendations for Advancing Precision Medicine

Author

Jasu, Juho, Tolonen, Teemu, Antonarakis, Emmanuel S., Beltran, Himisha, Halabi, Susan, Eisenberger, Mario A., Carducci, Michael A., Loriot, Yohann, Van der Eecken, Kim, Lolkema, Martijn, Ryan, Charles J., Taavitsainen, Sinja, Gillessen, Silke, Högnäs, Gunilla, Talvitie, Timo, Taylor, Robert J., Koskenalho, Antti, Ost, Piet, Murtola, Teemu J., Rinta-Kiikka, Irina, Tammela, Teuvo, Auvinen, Anssi, Kujala, Paula, Smith, Thomas J., Kellokumpu-Lehtinen, Pirkko-Liisa, Isaacs, William B., Nykter, Matti, Kesseli, Juha, and Bova, G. Steven

Published
2021
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15. Intermediate clinical endpoints for surrogacy in localised prostate cancer: an aggregate meta-analysis

Author

Gharzai, Laila A, Jiang, Ralph, Wallington, David, Jones, Gavin, Birer, Samuel, Jairath, Neil, Jaworski, Elizabeth M, McFarlane, Matthew R, Mahal, Brandon A, Nguyen, Paul L, Sandler, Howard, Morgan, Todd M, Reichert, Zachery R, Alumkal, Joshi J, Mehra, Rohit, Kishan, Amar U, Fizazi, Karim, Halabi, Susan, Schaeffer, Edward M, Feng, Felix Y, Elliott, David, Dess, Robert T, Jackson, William C, Schipper, Matthew J, and Spratt, Daniel E

Published
2021
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16. A clinical-grade liquid biomarker detects neuroendocrine differentiation in prostate cancer

Author

Zhao, Shuang G., Sperger, Jamie M., Schehr, Jennifer L., McKay, Rana R., Emamekhoo, Hamid, Singh, Anupama, Schultz, Zachery D., Bade, Rory M., Stahlfeld, Charlotte N., Gilsdorf, Cole S., Hernandez, Camila I., Wolfe, Serena K., Mayberry, Richel D., Krause, Hannah M., Bootsma, Matt, Helzer, Kyle T., Rydzewski, Nicholas, Bakhtiar, Hamza, Shi, Yue, Blitzer, Grace, Kyriakopoulos, Christos E., Kosoff, David, Wei, Xiao X., Floberg, John, Sethakorn, Nan, Sharifi, Marina, Harari, Paul M., Huang, Wei, Beltran, Himisha, Choueiri, Toni K., Scher, Howard I., Rathkopf, Dana E., Halabi, Susan, Armstrong, Andrew J., Beebe, David J., Yu, Menggang, Sundling, Kaitlin E., Taplin, Mary-Ellen, and Lang, Joshua M.

Subjects
Prostate cancer -- Development and progression -- Prognosis, Tumor markers -- Genetic aspects -- Health aspects, Health care industry
Abstract

BACKGROUND. Neuroendocrine prostate cancer (NEPC) is an aggressive subtype, the presence of which changes the prognosis and management of metastatic prostate cancer. METHODS. We performed analytical validation of a Circulating Tumor Cell (CTC) multiplex RNA qPCR assay to identify the limit of quantification (LOQ) in cell lines, synthetic cDNA, and patient samples. We next profiled 116 longitudinal samples from a prospectively collected institutional cohort of 17 patients with metastatic prostate cancer (7 NEPC, 10 adenocarcinoma) as well as 265 samples from 139 patients enrolled in 3 adenocarcinoma phase II trials of androgen receptor signaling inhibitors (ARSIs). We assessed a NEPC liquid biomarker via the presence of neuroendocrine markers and the absence of androgen receptor (AR) target genes. RESULTS. Using the analytical validation LOQ, liquid biomarker NEPC detection in the longitudinal cohort had a per- sample sensitivity of 51.35% and a specificity of 91.14%. However, when we incorporated the serial information from multiple liquid biopsies per patient, a unique aspect of this study, the per-patient predictions were 100% accurate, with a receiver- operatingcurve (ROC) AUC of 1. In the adenocarcinoma ARSI trials, the presence of neuroendocrine markers, even while AR target gene expression was retained, was a strong negative prognostic factor. CONCLUSION. Our analytically validated CTC biomarker can detect NEPC with high diagnostic accuracy when leveraging serial samples that are only feasible using liquid biopsies. Patients with expression of NE genes while retaining AR- target gene expression may indicate the transition to neuroendocrine differentiation, with clinical characteristics consistent with this phenotype. FUNDING. NIH (DP2 OD030734, 1UH2CA260389, R01CA247479, and P30 CA014520), Department of Defense (PC190039 and PC200334), and Prostate Cancer Foundation (Movember Foundation--PCF Challenge Award)., Introduction The majority of prostate cancers are histologically classified as adenocarcinomas. Prostate adenocarcinoma is driven by androgens, expresses prostate-specific antigen (PSA) and other androgen receptor (AR) target genes, and responds [...]

Published
2022
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17. Palbociclib in Patients With Soft Tissue Sarcoma With CDK4 Amplifications: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Schuetze, Scott, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Meric-Bernstam, Funda, Calfa, Carmen J., Farrington, Laura Catherine, Livingston, Michael B., Wentzel, Kristopher, Behl, Deepti, Kier, Yelena, Marr, Alissa S., von Mehren, Margaret, Press, Joshua Z., Thota, Ramya, Grantham, Gina N., Gregory, Abigail, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Subjects
SARCOMA, CYCLIN-dependent kinases, CANCER patients, ALANINE aminotransferase, OVERALL survival
Abstract

PURPOSE: Targeted Agent and Profiling Utilization Registry (TAPUR) is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with soft tissue sarcoma with cyclin-dependent kinase 4 (CDK4) amplification treated with palbociclib are reported. METHODS: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0 to 2, adequate organ function, and no standard treatment options. The primary end point was disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16+ weeks duration (SD16+) according to RECIST v1.1. The DC rate was estimated with a 90% CI. Secondary end points included OR, progression-free survival (PFS), overall survival (OS), duration of response, duration of SD, and safety. RESULTS: Forty-two patients with CDK4 amplification were enrolled. One patient was not evaluable for efficacy. One patient with partial response and 18 with SD16+ were observed for DC and OR rates of 46% (90% CI, 36 to 100) and 2% (95% CI, <1 to 13), respectively. Median PFS was 16 weeks (95% CI, 9 to 28) and median OS was 69 weeks (95% CI, 31 to 111) for evaluable patients. Twenty patients had at least one grade 3 to 4 adverse event (AE) at least possibly related to palbociclib, including alanine aminotransferase increase, anemia, fatigue, hypophosphatemia, leukopenia, neutropenia, and thrombocytopenia. No serious AEs were reported. CONCLUSION: Palbociclib met prespecified criteria to declare a signal of antitumor activity in patients with sarcoma and CDK4 amplification. Palbociclib met @ASCO #TAPUR criteria to declare antitumor activity in patients with CDK4-amplified liposarcoma. [ABSTRACT FROM AUTHOR]

Published
2024
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18. Talazoparib in Patients With Solid Tumors With BRCA1 / 2 Mutation: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Srkalovic, Gordan, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Ahn, Eugene R., Brouse, Gregory, Chan, John, Mehmi, Inderjit, Khalil, Maya, Duvivier, Herbert L., Gaba, Anu, Leuva, Harshraj, Thota, Ramya, Yost, Kathleen J., Grantham, Gina N., Gregory, Abigail, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Subjects
POLY(ADP-ribose) polymerase, EPIDERMAL growth factor receptors, CANCER patients, NON-small-cell lung carcinoma, BRCA genes, HORMONE receptor positive breast cancer, SKIN cancer
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with various solid tumors with germline or somatic BRCA1/2 mutations treated with talazoparib are reported. METHODS: Eligible patients had advanced solid tumors, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options. Patients with germline BRCA -mutated human epidermal growth factor receptor 2–negative locally advanced or metastatic breast cancer were not eligible for this study. Primary end point was disease control (DC) determined by investigator assessment of objective response (OR) or stable disease (SD) of at least 16 weeks duration (SD16+). The results were evaluated on the basis of a one-sided exact binomial test with a null DC rate of 15% versus 35% (power = 0.82; α =.10). Secondary end points were OR, progression-free survival, overall survival, duration of response, duration of SD, and safety. RESULTS: Twenty-eight patients (20 cancer types) with BRCA1/2 mutations were enrolled from December 2019 to September 2021 and collapsed into a single histology pooled cohort for analysis. All patients were evaluable for efficacy. One complete response, nine partial response, and six SD16+ were observed for DC and OR rates of 57% (one-sided 90% CI, 43 to 100) and 36% (95% CI, 19 to 56), respectively. The null hypothesis of a 15% DC rate was rejected (P <.001). Patients with OR had the following tumor types: breast (2), nonmelanoma skin, mesothelioma, stomach, uterus, non–small cell lung cancer, ovary, hepatocellular carcinoma, and pancreas. Thirteen patients had at least one grade 3-5 adverse event (AE) or serious AE at least possibly related to talazoparib. All were consistent with the drug label except bilirubin increase and hyponatremia (both grade 3 AEs). CONCLUSION: Talazoparib demonstrated antitumor activity in patients with advanced solid tumors and BRCA1/2 mutations, including cancer types for which poly ADP-ribose polymerase inhibitors are not yet US Food and Drug Administration–approved. Talazoparib showed activity in patients with BRCA-mutated tumors for which PARP inhibitors are not yet FDA-approved. @ASCO #TAPUR [ABSTRACT FROM AUTHOR]

Published
2024
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19. Current issues in dose-finding designs: A response to the US Food and Drug Adminstration's Oncology Center of Excellence Project Optimus.

Author

Thall, Peter F, Garrett-Mayer, Elizabeth, Wages, Nolan A, Halabi, Susan, and Cheung, Ying Kuen

Subjects
CANCER treatment, EXCELLENCE, ANTINEOPLASTIC agents, IMMUNOTHERAPY, COMMUNITIES, DOSE-effect relationship in pharmacology, EXPERIMENTAL design, PARADIGMS (Social sciences), MEDICAL research, DRUG development, TUMORS, SPECIALTY hospitals
Abstract

With the advent of targeted agents and immunological therapies, the medical research community has become increasingly aware that conventional methods for determining the best dose or schedule of a new agent are inadequate. It has been well established that conventional phase I designs cannot reliably identify safe and effective doses. This problem applies, generally, for cytotoxic agents, radiation therapy, targeted agents, and immunotherapies. To address this, the US Food and Drug Administration's Oncology Center of Excellence initiated Project Optimus, with the goal "to reform the dose optimization and dose selection paradigm in oncology drug development." As a response to Project Optimus, the articles in this special issue of Clinical Trials review recent advances in methods for choosing the dose or schedule of a new agent with an overall objective of informing clinical trialists of these innovative designs. This introductory article briefly reviews problems with conventional methods, the regulatory changes that encourage better dose optimization designs, and provides brief summaries of the articles that follow in this special issue. [ABSTRACT FROM AUTHOR]

Published
2024
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22. Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Fisher, Julie G., Tait, David, Garrett-Mayer, Elizabeth, Halabi, Susan, Mangat, Pam K., Schink, Julian C., Alvarez, Ricardo H., Veljovich, Dan, Cannon, Timothy L., Crilley, Pamela A., Pollock, Theodore, Calfa, Carmen J., Al Baghdadi, Tareq, Thota, Ramya, Fleming, Nicole, Cotta, Jared A., Rygiel, Andrew L., Warren, Sasha L., and Schilsky, Richard L.

Published
2020
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23. Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With BRAF Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Author

Klute, Kelsey A., Rothe, Michael, Garrett-Mayer, Elizabeth, Mangat, Pam K., Nazemzadeh, Reza, Yost, Kathleen J., Duvivier, Herbert L., Ahn, Eugene R., Cannon, Timothy L., Alese, Olatunji B., Krauss, John C., Thota, Ramya, Calfa, Carmen J., Denlinger, Crystal S., OʼLone, Raegan, Halabi, Susan, Grantham, Gina N., and Schilsky, Richard L.

Published
2022
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25. PRESTO: A Phase III, Open-Label Study of Intensification of Androgen Blockade in Patients With High-Risk Biochemically Relapsed Castration-Sensitive Prostate Cancer (AFT-19).

Author

Aggarwal, Rahul, Heller, Glenn, Hillman, David W., Xiao, Han, Picus, Joel, Taplin, Mary-Ellen, Dorff, Tanya, Appleman, Leonard, Weckstein, Douglas, Patnaik, Akash, Bryce, Alan, Shevrin, Daniel, Mohler, James, Anderson, Daniel, Rao, Arpit, Tagawa, Scott, Tan, Alan, Halabi, Susan, Dooley, Katharine, and O'Brien, Patrick

Published
2024
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26. Toward Informed Selection and Interpretation of Clinical Genomic Tests in Prostate Cancer.

Author

Vandekerkhove, Gillian, Giri, Veda N., Halabi, Susan, McNair, Christopher, Hamade, Khaldoun, Bitting, Rhonda L., and Wyatt, Alexander W.

Subjects
MEDICAL personnel, PROSTATE cancer, CELL-free DNA, DNA repair, DNA damage, RESEARCH personnel
Abstract

Clinical genomic testing of patient germline, tumor tissue, or plasma cell-free DNA can enable a personalized approach to cancer management and treatment. In prostate cancer (PCa), broad genotyping tests are now widely used to identify germline and/or somatic alterations in BRCA2 and other DNA damage repair genes. Alterations in these genes can confer cancer sensitivity to poly (ADP-ribose) polymerase inhibitors, are linked with poor prognosis, and can have potential hereditary cancer implications for family members. However, there is huge variability in genomic tests and reporting standards, meaning that for successful implementation of testing in clinical practice, end users must carefully select the most appropriate test for a given patient and critically interpret the results. In this white paper, we outline key pre- and post-test considerations for choosing a genomic test and evaluating reported variants, specifically for patients with advanced PCa. Test choice must be based on clinical context and disease state, availability and suitability of tumor tissue, and the genes and regions that are covered by the test. We describe strategies to recognize false positives or negatives in test results, including frameworks to assess low tumor fraction, subclonal alterations, clonal hematopoiesis, and pathogenic versus nonpathogenic variants. We assume that improved understanding among health care professionals and researchers of the nuances associated with genomic testing will ultimately lead to optimal patient care and clinical decision making. This article provides a helpful framework for choosing and interpreting a genomic test in prostate cancer. [ABSTRACT FROM AUTHOR]

Published
2024
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27. Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer.

Author

Halabi, Susan, Roy, Akash, Rydzewska, Larysa, Guo, Siyuan, Godolphin, Peter, Hussain, Maha, Tangen, Catherine, Thompson, Ian, Xie, Wanling, Carducci, Michael A., Smith, Matthew R., Morris, Michael J., Gravis, Gwenaelle, Dearnaley, David P., Verhagen, Paul, Goto, Takayuki, James, Nick, Buyse, Marc E., Tierney, Jayne F., and Sweeney, Christopher

Published
2024
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28. AMBASSADOR Alliance A031501: Phase III randomized adjuvant study of pembrolizumab in muscle-invasive and locally advanced urothelial carcinoma (MIUC) vs observation.

Author

Apolo, Andrea B., Ballman, Karla V., Sonpavde, Guru P., Berg, Stephanie A., Kim, William Y., Parikh, Rahul Atul, Teo, Min Yuen, Sweis, Randy F., Geynisman, Daniel M., Grivas, Petros, Chatta, Gurkamal S., Reichert, Zachery R, Kim, Joseph W., Bilen, Mehmet Asim, McGregor, Bradley Alexander, Srinivas, Sandy, Halabi, Susan, Perez Burbano, Gabriela, Morris, Michael J., and Rosenberg, Jonathan E.

Published
2024
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29. Cabozantinib versus sunitinib as initial therapy for metastatic renal cell carcinoma of intermediate or poor risk (Alliance A031203 CABOSUN randomised trial): Progression-free survival by independent review and overall survival update

Author

Choueiri, Toni K., Hessel, Colin, Halabi, Susan, Sanford, Ben, Michaelson, M. Dror, Hahn, Olwen, Walsh, Meghara, Olencki, Thomas, Picus, Joel, Small, Eric J., Dakhil, Shaker, Feldman, Darren R., Mangeshkar, Milan, Scheffold, Christian, George, Daniel, and Morris, Michael J.

Published
2018
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33. Abemaciclib in patients (pts) with esophageal cancer (EC) with CDKN2A loss or mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Al Baghdadi, Tareq, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Yost, Kathleen J, Chiu, Vi Kien, Duvivier, Herbert Leon, McKean, Meredith, Rueter, Jens, Taylor, Mark A., Grantham, Gina N., Gregory, Abby, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Published
2024
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34. Talazoparib (Tala) in patients (pts) with colorectal cancer (CRC) with BRCA1/2 mutations (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Author

Yost, Kathleen J, Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Duvivier, Herbert Leon, Ahn, Eugene R., Cannon, Timothy Lewis, Chiu, Vi Kien, Khalil, Maged F., Kim, Brian, Prinz, Allison Marie, Grantham, Gina N., Gregory, Abby, Hinshaw, Dominique C., Halabi, Susan, and Schilsky, Richard L.

Published
2024
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35. Molecular features of prostate cancer after neoadjuvant therapy in the phase 3 CALGB 90203 trial.

Author

Sumiyoshi, Takayuki, Wang, Xiaofei, Warner, Evan W, Sboner, Andrea, Annala, Matti, Sigouros, Michael, Beja, Kevin, Mizuno, Kei, Ku, Shengyu, Fazli, Ladan, Eastham, James, Taplin, Mary-Ellen, Simko, Jeffrey, Halabi, Susan, Morris, Michael J, Gleave, Martin E, Wyatt, Alexander W, and Beltran, Himisha

Subjects
PROSTATE cancer, GENE expression, NEOADJUVANT chemotherapy, RADICAL prostatectomy, ANDROGEN deprivation therapy, DNA sequencing
Abstract

Background The phase 3 CALGB 90203 (Alliance) trial evaluated neoadjuvant chemohormonal therapy for high-risk localized prostate cancer before radical prostatectomy. We dissected the molecular features of post-treated tumors with long-term clinical outcomes to explore mechanisms of response and resistance to chemohormonal therapy. Methods We evaluated 471 radical prostatectomy tumors, including 294 samples from 166 patients treated with 6 cycles of docetaxel plus androgen deprivation therapy before radical prostatectomy and 177 samples from 97 patients in the control arm (radical prostatectomy alone). Targeted DNA sequencing and RNA expression of tumor foci and adjacent noncancer regions were analyzed in conjunction with pathologic changes and clinical outcomes. Results Tumor fraction estimated from DNA sequencing was significantly lower in post-treated tumor tissues after chemohormonal therapy compared with controls. Higher tumor fraction after chemohormonal therapy was associated with aggressive pathologic features and poor outcomes, including prostate-specific antigen–progression-free survival. SPOP alterations were infrequently detected after chemohormonal therapy, while TP53 alterations were enriched and associated with shorter overall survival. Residual tumor fraction after chemohormonal therapy was linked to higher expression of androgen receptor–regulated genes, cell cycle genes, and neuroendocrine genes, suggesting persistent populations of active prostate cancer cells. Supervised clustering of post–treated high-tumor-fraction tissues identified a group of patients with elevated cell cycle–related gene expression and poor clinical outcomes.  Conclusions Distinct recurrent prostate cancer genomic and transcriptomic features are observed after exposure to docetaxel and androgen deprivation therapy. Tumor fraction assessed by DNA sequencing quantifies pathologic response and could be a useful trial endpoint or prognostic biomarker. TP53 alterations and high cell cycle transcriptomic activity are linked to aggressive residual disease, despite potent chemohormonal therapy. [ABSTRACT FROM AUTHOR]

Published
2024
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37. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial

Author

Armstrong, Andrew J, Halabi, Susan, Eisen, Tim, Broderick, Samuel, Stadler, Walter M, Jones, Robert J, Garcia, Jorge A, Vaishampayan, Ulka N, Picus, Joel, Hawkins, Robert E, Hainsworth, John D, Kollmannsberger, Christian K, Logan, Theodore F, Puzanov, Igor, Pickering, Lisa M, Ryan, Christopher W, Protheroe, Andrew, Lusk, Christine M, Oberg, Sadie, and George, Daniel J

Published
2016
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40. Pertuzumab Plus Trastuzumab in Patients With Lung Cancer With ERBB2 Mutation or Amplification: Results From the Targeted Agent and Profiling Utilization Registry Study.

Author

Ganti, Apar K., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Dib, Elie G., Duvivier, Herbert L., Ahn, Eugene R., Behl, Deepti, Borghaei, Hossein, Balmanoukian, Ani S., Gaba, Anu, Li, Rui, Osei-Boateng, Kwabena, Thota, Ramya, Grantham, Gina N., Gregory, Abigail, Halabi, Susan, and Schilsky, Richard L.

Subjects
CANCER patients, LUNG cancer, TRASTUZUMAB, INSERTION mutation, NON-small-cell lung carcinoma
Abstract

PURPOSE: The Targeted Agent and Profiling Utilization Registry Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with lung cancer and ERBB2 mutation or amplification treated with pertuzumab plus trastuzumab (P + T) are reported. METHODS: Eligible patients had advanced lung cancer of any histology, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2 mutation or amplification. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) per RECIST v. 1.1 or stable disease (SD) of at least 16 weeks duration (SD16+). Secondary end points included safety, duration of response, duration of SD, progression-free survival, and overall survival. RESULTS: Twenty-eight patients with lung cancer (27 non–small-cell, 1 small-cell) and ERBB2 mutation (n = 15), ERBB2 amplification (n = 12), or both (n = 1) were enrolled from November 2016 to July 2020. All patients were evaluable for efficacy and toxicity. Three patients with partial response (two ERBB2 mutation; one both mutation and amplification) and seven patients with SD16+ (five ERBB2 mutation; two amplification) were observed for a DC rate of 37% (95% CI, 21 to 50; P =.005) and OR rate of 11% (95% CI, 2 to 28). Five patients had one or more grade 3 or 4 adverse or serious adverse events at least possibly related to P + T. CONCLUSION: Combination P + T showed evidence of antitumor activity in heavily pretreated patients with non–small-cell lung cancer and ERBB2 mutation or amplification, particularly those with ERBB2 exon 20 insertion mutations. Pertuzumab + trastuzumab had antitumor activity in pretreated patients with ERBB2-mutated NSCLC @ASCO #TAPUR. [ABSTRACT FROM AUTHOR]

Published
2023
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41. External Validation of a Prognostic Model of Overall Survival in Men With Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer.

Author

Halabi, Susan, Yang, Qian, Roy, Akash, Luo, Bin, Araujo, John C., Logothetis, Christopher, Sternberg, Cora N., Armstrong, Andrew J., Carducci, Michael A., Chi, Kim N., de Bono, Johann S., Petrylak, Daniel P., Fizazi, Karim, Higano, Celestia S., Morris, Michael J., Rathkopf, Dana E., Saad, Fred, Ryan, Charles J., Small, Eric J., and Kelly, William Kevin

Published
2023
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45. Pertuzumab Plus Trastuzumab in Patients With Endometrial Cancer With ERBB2/3 Amplification, Overexpression, or Mutation: Results From the TAPUR Study.

Author

Ahn, Eugene R., Rothe, Michael, Mangat, Pam K., Garrett-Mayer, Elizabeth, Ali-Ahmad, Hussein M., Chan, John, Maitland, Michael L., Patel, Sapna R., Reese, Zachary, Balmanoukian, Ani S., Drescher, Charles W., Li, Rui, Tsimberidou, Apostolia M., Leath III, Charles A., O'Lone, Raegan, Grantham, Gina N., Halabi, Susan, and Schilsky, Richard L.

Subjects
ENDOMETRIAL cancer, TRASTUZUMAB, CANCER patients, GENETIC overexpression, MUSCLE weakness
Abstract

PURPOSE: The TAPUR Study is a pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers harboring potentially actionable genomic alterations. Data from a cohort of patients with endometrial cancer (EC) with ERBB2 or ERBB3 (ERBB2/3) amplification, overexpression, or mutation treated with pertuzumab plus trastuzumab (P + T) are reported. METHODS: Eligible patients had advanced EC, no standard treatment options, measurable disease (RECIST v1.1), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and tumors with ERBB2/3 amplification, overexpression, or mutation. Simon's two-stage design was used with a primary end point of disease control (DC), defined as objective response (OR) or stable disease (SD) of at least 16 weeks (SD16+) duration. Secondary end points include safety, duration of response, duration of SD, progression-free survival (PFS), and overall survival (OS). RESULTS: Twenty-eight patients were enrolled from March 2017 to November 2019; all patients were evaluable for efficacy and toxicity. Seventeen patients had tumors with ERBB2/3 amplification and/or overexpression, eight with both ERBB2 amplification and ERBB2/3 mutations, and three with only ERBB2 mutations. Ten patients had DC (two partial response and eight SD16+); all 10 had ERBB2 amplification, and 6 of the 10 patients with DC had >1 ERBB2/3 alteration. DC and OR rates were 37% (95% CI, 21 to 50) and 7% (95% CI, 1 to 24), respectively; the median PFS and median OS were 16 weeks (95% CI, 10-28) and 61 weeks (95% CI, 24-105), respectively. One patient experienced a grade 3 serious adverse event (muscle weakness) at least possibly related to P + T. CONCLUSION: P + T has antitumor activity in heavily pretreated patients with EC with ERBB2 amplification and warrants additional study. Pertuzumab + trastuzumab had antitumor activity in patients with endometrial cancer with ERBB2/3 alterations @ASCO #TAPUR. [ABSTRACT FROM AUTHOR]

Published
2023
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46. Olaparib in Patients With Metastatic Prostate Cancer With BRCA1 / 2 Mutation: Results From the TAPUR Study.

Author

Yang, Eddy S., Halabi, Susan, Rothe, Michael, Garrett-Mayer, Elizabeth, Mangat, Pam K., Pisick, Evan, Dib, Elie, Burgess, Earle F., Zakem, Michael, Rohatgi, Nitin, Bilen, Mehmet A., O'Lone, Raegan, Grantham, Gina N., and Schilsky, Richard L.

Subjects
*PROSTATE cancer patients, *PROSTATE cancer, *BRCA genes, *OLAPARIB, *CANCER patients, *PROGRESSION-free survival
Abstract

PURPOSE: The TAPUR Study is a phase II basket trial that aims to evaluate activity of approved targeted agents in patients with advanced cancers with potentially actionable genomic variants. Data from a cohort of patients with metastatic castrate-resistant prostate cancer (mCRPC) and BRCA1 / 2 mutations treated with olaparib are reported. METHODS: Eligible patients with measurable mCRPC were matched to treatment according to protocol-specified genomic matching rules. Patients had no remaining standard treatment options, Eastern Cooperative Oncology Group performance status 0-2, and adequate organ function. Simon's two-stage design was used with a primary end point of disease control, defined as objective response or stable disease of at least 16-week duration. Secondary end points include radiographic progression-free survival, overall survival, duration of response, duration of stable disease, and safety. RESULTS: Thirty patients with mCRPC with BRCA1 / 2 mutations were treated with olaparib. The disease control rate was 69% (95% CI, 51 to 81), and the objective response rate was 58% (95% CI, 37 to 77). The median radiographic progression-free survival and the median overall survival were 38.4 (95% CI, 16.3 to 52.1) weeks and 76.4 (95% CI, 49.3 to 106.0) weeks, respectively. Six of 30 (20%) patients experienced grade 3-4 adverse or serious adverse events including anemia, aspiration, decreased WBC count, and fatigue. CONCLUSION: Olaparib has antitumor activity in patients with mCRPC with BRCA1 / 2 mutations and warrants further study to determine how to best integrate it into the standard treatment of patients with BRCA1 / 2 -mutated prostate cancer. Olaparib showed a positive signal of activity in real-world patients w/prostate cancer w/BRCA1 or BRCA2 mutations @ASCO #TAPUR. [ABSTRACT FROM AUTHOR]

Published
2023
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