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2. Convergent evolution of BRCA2 reversion mutations under therapeutic pressure by PARP inhibition and platinum chemotherapy

Author

Walmsley, Charlotte S., Jonsson, Philip, Cheng, Michael L., McBride, Sean, Kaeser, Christopher, Vargas, Herbert Alberto, Laudone, Vincent, Taylor, Barry S., Kappagantula, Rajya, Baez, Priscilla, Richards, Allison L., Noronha, Anne Marie, Perera, Dilmi, Berger, Michael, Solit, David B., Iacobuzio-Donahue, Christine A., Scher, Howard I., Donoghue, Mark T. A., Abida, Wassim, and Schram, Alison M.

Published
2024
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3. Management of Patients with Advanced Prostate Cancer. Report from the 2024 Advanced Prostate Cancer Consensus Conference (APCCC)

Author

Gillessen, Silke, Turco, Fabio, Davis, Ian D., Efstathiou, Jason A., Fizazi, Karim, James, Nicholas D., Shore, Neal, Small, Eric, Smith, Matthew, Sweeney, Christopher J., Tombal, Bertrand, Zilli, Thomas, Agarwal, Neeraj, Antonarakis, Emmanuel S., Aparicio, Ana, Armstrong, Andrew J., Bastos, Diogo Assed, Attard, Gerhardt, Axcrona, Karol, Ayadi, Mouna, Beltran, Himisha, Bjartell, Anders, Blanchard, Pierre, Bourlon, Maria T., Briganti, Alberto, Bulbul, Muhammad, Buttigliero, Consuelo, Caffo, Orazio, Castellano, Daniel, Castro, Elena, Cheng, Heather H., Chi, Kim N., Clarke, Caroline S., Clarke, Noel, de Bono, Johann S., De Santis, Maria, Duran, Ignacio, Efstathiou, Eleni, Ekeke, Onyeanunam N., El Nahas, Tamer I.H., Emmett, Louise, Fanti, Stefano, Fatiregun, Omolara A., Feng, Felix Y., Fong, Peter C.C., Fonteyne, Valerie, Fossati, Nicola, George, Daniel J., Gleave, Martin E., Gravis, Gwenaelle, Halabi, Susan, Heinrich, Daniel, Herrmann, Ken, Hofman, Michael S., Hope, Thomas A., Horvath, Lisa G., Hussain, Maha H.A., Jereczek-Fossa, Barbara Alicja, Jones, Robert J., Joshua, Anthony M., Kanesvaran, Ravindren, Keizman, Daniel, Khauli, Raja B., Kramer, Gero, Loeb, Stacy, Mahal, Brandon A., Maluf, Fernando C., Mateo, Joaquin, Matheson, David, Matikainen, Mika P., McDermott, Ray, McKay, Rana R., Mehra, Niven, Merseburger, Axel S., Morgans, Alicia K., Morris, Michael J., Mrabti, Hind, Mukherji, Deborah, Murphy, Declan G., Murthy, Vedang, Mutambirwa, Shingai B.A., Nguyen, Paul L., 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, Robert E., Renard-Penna, Raphaele, Ryan, Charles J., Saad, Fred, Sade, Juan Pablo, Sandhu, Shahneen, Sartor, Oliver A., Schaeffer, Edward, Scher, Howard I., Sharifi, Nima, Skoneczna, Iwona A., Soule, Howard R., Spratt, Daniel E., Srinivas, Sandy, Sternberg, Cora N., Suzuki, Hiroyoshi, Taplin, Mary-Ellen, Thellenberg-Karlsson, Camilla, Tilki, Derya, Türkeri, Levent N., Uemura, Hiroji, Ürün, Yüksel, Vale, Claire L., Vapiwala, Neha, Walz, Jochen, Yamoah, Kosj, Ye, Dingwei, Yu, Evan Y., Zapatero, Almudena, and Omlin, Aurelius

Published
2025
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4. Optimal systemic treatment and real-world clinical application of ctDNA in patients with metastatic HER2-mutant lung cancer

Author

Liu, Si-Yang, Erazo, Tatiana, Jee, Justin, Arfe, Andrea, Gupta, Avantika, Pike, Luke R.G., Santini, Fernando C., Daly, Bobby, Schoenfeld, Adam, Eichholz, Jordan, Johnson, Kaylie, Martinez, Andres, Sui, Jane, Riaz, Nadeem, Chang, Jason, Yang, Soo-Ryum, Travis, William, Arcila, Maria E., Guo, Jiannan, Gagne, Eric, Garg, Kavita, Baehner, Frederick, Lee, Nancy Y., Drilon, Alexander, Kris, Mark G., Scher, Howard I., Razavi, Pedram, Gomez, Daniel R., Jones, David R., Rudin, Charles M., Chandarlapaty, Sarat, Isbell, James M., and Li, Bob T.

Published
2024
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5. Evaluating Treatment Tolerability Using the Toxicity Index With Patient-Reported Outcomes Data

Author

Langlais, Blake, Mazza, Gina L, Thanarajasingam, Gita, Rogak, Lauren J, Ginos, Brenda, Heon, Narre, Scher, Howard I, Schwab, Gisela, Ganz, Patricia A, Basch, Ethan, and Dueck, Amylou C

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Patient Safety, Clinical Research, Clinical Trials and Supportive Activities, Prevention, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Clinical Trials as Topic, Humans, Neoplasms, Patient Reported Outcome Measures, PRO-CTCAE, tolerability, toxicity index, patient-reported outcomes, symptomatic adverse event, cancer clinical trials, Medical and Health Sciences, Anesthesiology, Biomedical and clinical sciences, Health sciences
Abstract

ContextSummarizing longitudinal symptomatic adverse events during clinical trials is necessary for understanding treatment tolerability. The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) provides insight for capturing treatment tolerability within trials. Tolerability summary measures, such as the maximum score, are often used to communicate the potential negative symptoms both in the medical literature and directly to patients. Commonly, the proportions of present and severe symptomatic adverse events are used and reported between treatment arms among adverse event types. The toxicity index is also a summary measure previously applied to clinician-reported CTCAE data.ObjectivesApply the toxicity index to PRO-CTCAE data from the COMET-2 trial alongside the maximum score, then present and discuss considerations for using the toxicity index as a summary measure for communicating tolerability to patients and clinicians.MethodsProportions of maximum PRO-CTCAE severity levels and median toxicity index were computed by arm using all trial data and adjusting for baseline symptoms.ResultsGroup-wise statistical differences were similar whether using severity level proportions or the toxicity index. The impact of adjusting for baseline symptoms was equivalently seen when comparing arms using severity rates or the toxicity index.ConclusionThe toxicity index is a useful method when ranking patients from those with the least to most symptomatic adverse event burden. This study showed the toxicity index can be applied to PRO-CTCAE data. Though as a tolerability summary measure, further study is needed to provide a clear clinical or patient-facing interpretation of the toxicity index.

Published
2022

6. Considerations in the development of circulating tumor cell technology for clinical use

Author

Parkinson David R, Dracopoli Nicholas, Petty Brenda, Compton Carolyn, Cristofanilli Massimo, Deisseroth Albert, Hayes Daniel F, Kapke Gordon, Kumar Prasanna, Lee Jerry SH, Liu Minetta C, McCormack Robert, Mikulski Stanislaw, Nagahara Larry, Pantel Klaus, Pearson-White Sonia, Punnoose Elizabeth A, Roadcap Lori T, Schade Andrew E, Scher Howard I, Sigman Caroline C, and Kelloff Gary J

Subjects
Circulating tumor cells, Prognostic biomarker, Predictive biomarker, Analytical validation, Clinical validation, Biomarker qualification, Oncologic drug development, Medicine
Abstract

Abstract This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC) technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA) and the US National Cancer Institute (NCI).

Published
2012
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7. Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancer

Author

Gartrell, Benjamin A, Roach, Mack, Retter, Avi, Sokol, Gerald H, Del Priore, Giuseppe, and Scher, Howard I

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Prostate Cancer, Clinical Research, Urologic Diseases, Cancer, Patient Safety, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Aged, Aged, 80 and over, Androgen Antagonists, Humans, Kaplan-Meier Estimate, Male, Methoxsalen, Middle Aged, Neoplasm Recurrence, Local, Phenytoin, Prostate-Specific Antigen, Prostatic Neoplasms, Quality of Life, Sirolimus, Tyrosine, Metabolism based therapy, SM-88, Pharmacology and Pharmaceutical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis, Pharmacology and pharmaceutical sciences
Abstract

Background Androgen deprivation therapy (ADT) is a standard treatment for high-risk biochemically-recurrent, non-metastatic prostate cancer (BRPC) but is not curative and associated with toxicity. Racemetyrosine (SM-88) is an amino-acid analogue used with methoxsalen, phenytoin, and sirolimus (MPS) to enhance SM-88 activity. Method A phase 1b/2, open-label trial in BRPC and rising PSA. Patients were given daily SM-88 (230 mg BID), methoxsalen (10 mg), phenytoin (50 mg), and sirolimus (0.5 mg)). Outcome measures included changes in PSA, circulating tumor cells (CTCs) and imaging. Results 34 subjects were screened, 23 treated and 21 remained on study for ≥12 weeks. The median PSA was 6.4 ng/ml (range 1.7-80.1); doubling-time 6.2 months (range 1.4-36.6) and baseline testosterone 319.1 ng/ml (range 2.5-913.7). Median duration of therapy was 6.5 months (2.6-14.0). CTCs (median 48.5 cells/4 ml (range 15-268) at baseline) decreased a median of 65.3% in 18 of 19 patients. For patients who achieved an absolute CTC nadir count of

Published
2021

8. Identification of novel androgen receptor target genes in prostate cancer

Author

Gerald William L, Scher Howard I, Arasheben Armin, Tilley Wayne D, Cogan Jon P, Pregizer Steve, Barski Artem, Jia Li, Prescott Jennifer, Jariwala Unnati, Buchanan Grant, Coetzee Gerhard A, and Frenkel Baruch

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background The androgen receptor (AR) plays critical roles in both androgen-dependent and castrate-resistant prostate cancer (PCa). However, little is known about AR target genes that mediate the receptor's roles in disease progression. Results Using Chromatin Immunoprecipitation (ChIP) Display, we discovered 19 novel loci occupied by the AR in castrate resistant C4-2B PCa cells. Only four of the 19 AR-occupied regions were within 10-kb 5'-flanking regulatory sequences. Three were located up to 4-kb 3' of the nearest gene, eight were intragenic and four were in gene deserts. Whereas the AR occupied the same loci in C4-2B (castrate resistant) and LNCaP (androgen-dependent) PCa cells, differences between the two cell lines were observed in the response of nearby genes to androgens. Among the genes strongly stimulated by DHT in C4-2B cells – D-dopachrome tautomerase (DDT), Protein kinase C delta (PRKCD), Glutathione S- transferase theta 2 (GSTT2), Transient receptor potential cation channel subfamily V member 3 (TRPV3), and Pyrroline-5-carboxylate reductase 1 (PYCR1) – most were less strongly or hardly stimulated in LNCaP cells. Another AR target gene, ornithine aminotransferase (OAT), was AR-stimulated in a ligand-independent manner, since it was repressed by AR siRNA knockdown, but not stimulated by DHT. We also present evidence for in vivo AR-mediated regulation of several genes identified by ChIP Display. For example, PRKCD and PYCR1, which may contribute to PCa cell growth and survival, are expressed in PCa biopsies from primary tumors before and after ablation and in metastatic lesions in a manner consistent with AR-mediated stimulation. Conclusion AR genomic occupancy is similar between LNCaP and C4-2B cells and is not biased towards 5' gene flanking sequences. The AR transcriptionally regulates less than half the genes nearby AR-occupied regions, usually but not always, in a ligand-dependent manner. Most are stimulated and a few are repressed. In general, response is stronger in C4-2B compared to LNCaP cells. Some of the genes near AR-occupied regions appear to be regulated by the AR in vivo as evidenced by their expression levels in prostate cancer tumors of various stages. Several AR target genes discovered in the present study, for example PRKCD and PYCR1, may open avenues in PCa research and aid the development of new approaches for disease management.

Published
2007
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9. Meeting report from the Prostate Cancer Foundation PSMA theranostics state of the science meeting

Author

Miyahira, Andrea K, Pienta, Kenneth J, Babich, John W, Bander, Neil H, Calais, Jeremie, Choyke, Peter, Hofman, Michael S, Larson, Steven M, Lin, Frank I, Morris, Michael J, Pomper, Martin G, Sandhu, Shahneen, Scher, Howard I, Tagawa, Scott T, Williams, Scott, and Soule, Howard R

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Urologic Diseases, Prostate Cancer, Aging, Cancer, Biomedical Imaging, Good Health and Well Being, Humans, Male, Molecular Targeted Therapy, Precision Medicine, Prostatic Neoplasms, Theranostic Nanomedicine, clinical trials, medical oncology, nuclear medicine, PET imaging, prostate-specific membrane antigen, radiation therapy, radiology, radionuclides, radiopharmaceuticals, urology, Paediatrics and Reproductive Medicine, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

IntroductionThe Prostate Cancer Foundation (PCF) convened a PCF prostate-specific membrane antigen (PSMA) Theranostics State of the Science Meeting on 18 November 2019, at Weill Cornell Medicine, New York, NY.MethodsThe meeting was attended by 22 basic, translational, and clinical researchers from around the globe, with expertise in PSMA biology, development and use of PSMA theranostics agents, and clinical trials. The goal of this meeting was to discuss the current state of knowledge, the most important biological and clinical questions, and critical next steps for the clinical development of PSMA positron emission tomography (PET) imaging agents and PSMA-targeted radionuclide agents for patients with prostate cancer.ResultsSeveral major topic areas were discussed including the biology of PSMA, the role of PSMA-targeted PET imaging in prostate cancer, the physics and performance of different PSMA-targeted PET imaging agents, the current state of clinical development of PSMA-targeted radionuclide therapy (RNT) agents, the role of dosimetry in PSMA RNT treatment planning, barriers and challenges in PSMA RNT clinical development, optimization of patient selection for PSMA RNT trials, and promising combination treatment approaches with PSMA RNT.DiscussionThis article summarizes the presentations from the meeting for the purpose of globally disseminating this knowledge to advance the use of PSMA-targeted theranostic agents for imaging and treatment of patients with prostate cancer.

Published
2020

10. Management of Patients with Advanced Prostate Cancer: Report of the Advanced Prostate Cancer Consensus Conference 2019

Author

Gillessen, Silke, Attard, Gerhardt, Beer, Tomasz M, Beltran, Himisha, Bjartell, Anders, Bossi, Alberto, Briganti, Alberto, Bristow, Rob G, Chi, Kim N, Clarke, Noel, Davis, Ian D, de Bono, Johann, Drake, Charles G, Duran, Ignacio, Eeles, Ros, Efstathiou, Eleni, Evans, Christopher P, Fanti, Stefano, Feng, Felix Y, Fizazi, Karim, Frydenberg, Mark, Gleave, Martin, Halabi, Susan, Heidenreich, Axel, Heinrich, Daniel, Higano, Celestia Tia S, Hofman, Michael S, Hussain, Maha, James, Nicolas, Kanesvaran, Ravindran, Kantoff, Philip, Khauli, Raja B, 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 MC, Pritchard, Colin C, Reiter, Robert E, Roach, Mack, Rubin, Mark, Ryan, Charles J, Saad, Fred, Sade, Juan Pablo, Sartor, Oliver, Scher, Howard I, Shore, Neal, Small, Eric, Smith, Matthew, Soule, Howard, Sternberg, Cora N, Steuber, Thomas, Suzuki, Hiroyoshi, Sweeney, Christopher, Sydes, Matthew R, Taplin, Mary-Ellen, Tombal, Bertrand, Türkeri, Levent, van Oort, Inge, Zapatero, Almudena, and Omlin, Aurelius

Subjects
Cancer, Urologic Diseases, Aging, Prostate Cancer, Good Health and Well Being, Bone Neoplasms, Humans, Male, Neoplasm Metastasis, Neoplasm Recurrence, Local, Neoplasm Staging, Practice Guidelines as Topic, Prostate-Specific Antigen, Prostatic Neoplasms, Advanced prostate cancer, High-risk localised prostate cancer, Hormone-sensitive prostate cancer, Castration-resistant prostate cancer, Oligometastatic prostate cancer, Progression-free survival, Overall survival, Prostate cancer treatment, Imaging, Genetics, Tumour genomic profiling, Castration-naïve prostate cancer, Clinical Sciences, Urology & Nephrology
Abstract

BackgroundInnovations in treatments, imaging, and molecular characterisation in advanced prostate cancer have improved outcomes, but there are still many aspects of management that lack high-level evidence to inform clinical practice. The Advanced Prostate Cancer Consensus Conference (APCCC) 2019 addressed some of these topics to supplement guidelines that are based on level 1 evidence.ObjectiveTo present the results from the APCCC 2019.Design, setting, and participantsSimilar to prior conferences, experts identified 10 important areas of controversy regarding the management of advanced prostate cancer: locally advanced disease, biochemical recurrence after local therapy, treating the primary tumour in the metastatic setting, metastatic hormone-sensitive/naïve prostate cancer, nonmetastatic castration-resistant prostate cancer, metastatic castration-resistant prostate cancer, bone health and bone metastases, molecular characterisation of tissue and blood, inter- and intrapatient heterogeneity, and adverse effects of hormonal therapy and their management. A panel of 72 international prostate cancer experts developed the programme and the consensus questions.Outcome measurements and statistical analysisThe panel voted publicly but anonymously on 123 predefined questions, which were developed by both voting and nonvoting panel members prior to the conference following a modified Delphi process.Results and limitationsPanellists voted based on their opinions rather than a standard literature review or formal meta-analysis. The answer options for the consensus questions had varying degrees of support by the panel, as reflected in this article and the detailed voting results reported in the Supplementary material.ConclusionsThese voting results from a panel of prostate cancer experts can help clinicians and patients navigate controversial areas of advanced prostate management for which high-level evidence is sparse. However, diagnostic and treatment decisions should always be individualised based on patient-specific factors, such as disease extent and location, prior lines of therapy, comorbidities, and treatment preferences, together with current and emerging clinical evidence and logistic and economic constraints. Clinical trial enrolment for men with advanced prostate cancer should be strongly encouraged. Importantly, APCCC 2019 once again identified important questions that merit assessment in specifically designed trials.Patient summaryThe Advanced Prostate Cancer Consensus Conference provides a forum to discuss and debate current diagnostic and treatment options for patients with advanced prostate cancer. The conference, which has been held three times since 2015, aims to share the knowledge of world experts in prostate cancer management with health care providers worldwide. At the end of the conference, an expert panel discusses and votes on predefined consensus questions that target the most clinically relevant areas of advanced prostate cancer treatment. The results of the voting provide a practical guide to help clinicians discuss therapeutic options with patients as part of shared and multidisciplinary decision making.

Published
2020

11. 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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12. Overall survival with circulating tumor DNA-guided therapy in advanced non-small-cell lung cancer

Author

Jee, Justin, Lebow, Emily S., Yeh, Randy, Das, Jeeban P., Namakydoust, Azadeh, Paik, Paul K., Chaft, Jamie E., Jayakumaran, Gowtham, Rose Brannon, A., Benayed, Ryma, Zehir, Ahmet, Donoghue, Mark, Schultz, Nikolaus, Chakravarty, Debyani, Kundra, Ritika, Madupuri, Ramyasree, Murciano-Goroff, Yonina R., Tu, Hai-Yan, Xu, Chong-Rui, Martinez, Andrés, Wilhelm, Clare, Galle, Jesse, Daly, Bobby, Yu, Helena A., Offin, Michael, Hellmann, Matthew D., Lito, Piro, Arbour, Kathryn C., Zauderer, Marjorie G., Kris, Mark G., Ng, Kenneth K., Eng, Juliana, Preeshagul, Isabel, Victoria Lai, W., Fiore, John J., Iqbal, Afsheen, Molena, Daniela, Rocco, Gaetano, Park, Bernard J., Lim, Lee P., Li, Mark, Tong-Li, Candace, De Silva, Madhawa, Chan, David L., Diakos, Connie I., Itchins, Malinda, Clarke, Stephen, Pavlakis, Nick, Lee, Adrian, Rekhtman, Natasha, Chang, Jason, Travis, William D., Riely, Gregory J., Solit, David B., Gonen, Mithat, Rusch, Valerie W., Rimner, Andreas, Gomez, Daniel, Drilon, Alexander, Scher, Howard I., Shah, Sohrab P., Berger, Michael F., Arcila, Maria E., Ladanyi, Marc, Levine, Ross L., Shen, Ronglai, Razavi, Pedram, Reis-Filho, Jorge S., Jones, David R., Rudin, Charles M., Isbell, James M., and Li, Bob T.

Published
2022
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13. 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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15. Effects of metformin and statins on outcomes in men with castration-resistant metastatic prostate cancer: Secondary analysis of COU-AA-301 and COU-AA-302

Author

Wilson, Brooke E., Armstrong, Andrew J., de Bono, Johann, Sternberg, Cora N., Ryan, Charles J., Scher, Howard I., Smith, Matthew R., Rathkopf, Dana, Logothetis, Christopher J., Chi, Kim N., Jones, Robert J., Saad, Fred, De Porre, Peter, Tran, NamPhuong, Hu, Peter, Gillessen, Silke, Carles, Joan, Fizazi, Karim, and Joshua, Anthony M.

Published
2022
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17. 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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20. 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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22. Randomized Phase 2 Trial of Abiraterone Acetate Plus Prednisone, Degarelix, or the Combination in Men with Biochemically Recurrent Prostate Cancer After Radical Prostatectomy

Author

Autio, Karen A., Antonarakis, Emmanuel S., Mayer, Tina M., Shevrin, Daniel H., Stein, Mark N., Vaishampayan, Ulka N., Morris, Michael J., Slovin, Susan F., Heath, Elisabeth I., Tagawa, Scott T., Rathkopf, Dana E., Milowsky, Matthew I., Harrison, Michael R., Beer, Tomasz M., Balar, Arjun V., Armstrong, Andrew J., George, Daniel J., Paller, Channing J., Apollo, Arlyn, Danila, Daniel C., Graff, Julie N., Nordquist, Luke, Dayan Cohn, Erica S., Tse, Kin, Schreiber, Nicole A., Heller, Glenn, and Scher, Howard I.

Published
2021
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24. CD38 in Advanced Prostate Cancers

Author

Robinson, Dan, Van Allen, Eliezer M., Wu, Yi-Mi, Schultz, Nikolaus, Lonigro, Robert J., Mosquera, Juan-Miguel, Montgomery, Bruce, Taplin, Mary-Ellen, Pritchard, Colin C., Attard, Gerhardt, Beltran, Himisha, Abida, Wassim, Bradley, Robert K., Vinson, Jake, Cao, Xuhong, Vats, Pankaj, Kunju, Lakshmi P., Hussain, Maha, Tomlins, Scott A., Cooney, Kathleen A., Smith, David C., Brennan, Christine, Siddiqui, Javed, Mehra, Rohit, Chen, Yu, Rathkopf, Dana E., Morris, Michael J., Solomon, Stephen B., Durack, Jeremy C., Reuter, Victor E., Gopalan, Anuradha, Gao, Jianjiong, Loda, Massimo, Lis, Rosina T., Bowden, Michaela, Balk, Stephen P., Gaviola, Glenn, Sougnez, Carrie, Gupta, Manaswi, Yu, Evan Y., Mostaghel, Elahe A., Cheng, Heather H., Mulcahy, Hyojeong, True, Lawrence D., Plymate, Stephen R., Dvinge, Heidi, Ferraldeschi, Roberta, Flohr, Penny, Miranda, Susana, Zafeiriou, Zafeiris, Tunariu, Nina, Mateo, Joaquin, Perez-Lopez, Raquel, Demichelis, Francesca, Robinson, Brian D., Schiffman, Marc, Nanus, David M., Tagawa, Scott T., Sigaras, Alexandros, Eng, Kenneth W., Elemento, Olivier, Sboner, Andrea, Heath, Elisabeth I., Scher, Howard I., Pienta, Kenneth J., Kantoff, Philip, de Bono, Johann S., Rubin, Mark A., Nelson, Peter S., Garraway, Levi A., Sawyers, Charles L., Chinnaiyan, Arul M., Guo, Christina, Crespo, Mateus, Gurel, Bora, Dolling, David, Rekowski, Jan, Sharp, Adam, Petremolo, Antonella, Sumanasuriya, Semini, Rodrigues, Daniel N., Ferreira, Ana, Pereira, Rita, Figueiredo, Ines, Mehra, Niven, Lambros, Maryou B.K., Neeb, Antje, Gil, Veronica, Seed, George, Terstappen, Leon, Alimonti, Andrea, Drake, Charles G., and Yuan, Wei

Published
2021
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26. Final Analysis of the Ipilimumab Versus Placebo Following Radiotherapy Phase III Trial in Postdocetaxel Metastatic Castration-resistant Prostate Cancer Identifies an Excess of Long-term Survivors

Author

Fizazi, Karim, Drake, Charles G., Beer, Tomasz M., Kwon, Eugene D., Scher, Howard I., Gerritsen, Winald R., Bossi, Alberto, den Eertwegh, Alfons J.M. van, Krainer, Michael, Houede, Nadine, Santos, Ricardo, Mahammedi, Hakim, Ng, Siobhan, Danielli, Riccardo, Franke, Fabio A., Sundar, Santhanam, Agarwal, Neeraj, Bergman, André M., Ciuleanu, Tudor E., Korbenfeld, Ernesto, Sengeløv, Lisa, Hansen, Steinbjorn, McHenry, M. Brent, Chen, Allen, and Logothetis, Christopher

Published
2020
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30. Single Cell Analysis of Treatment-Resistant Prostate Cancer: Implications of Cell State Changes for Cell Surface Antigen Targeted Therapies

Author

Zaidi, Samir, primary, Park, JooYoung, additional, Chan, Joseph M, additional, Roudier, Martine, additional, Zhao, Jimmy L., additional, Gopalan, Anuradha, additional, Wadosky, Kristine M., additional, Patel, Radhika A, additional, Sayar, Erolcan, additional, Karthaus, Wouter R, additional, Kates, D Henry, additional, Chaudhary, Ojasvi, additional, Xu, Tianhao, additional, Masilionis, Ignas, additional, Mazutis, Linas, additional, Chaligne, Ronan, additional, Obradovic, Aleksandar, additional, Linkov, Irina, additional, Barlas, Afsar, additional, Jungbluth, Achim, additional, Rekhtman, Natasha, additional, Silber, Joachim, additional, Manova-Todorova, Katia, additional, Watson, Philip A, additional, True, Lawrence D, additional, Morrissey, Colm M, additional, Scher, Howard I, additional, Rathkopf, Dana, additional, Morris, Michael J, additional, Goodrich, David W, additional, Choi, Jungmin, additional, Nelson, Peter S, additional, Haffner, Michael, additional, and Sawyers, Charles, additional

Published
2024
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31. Expert Perspectives on Controversies in Castration-Sensitive Prostate Cancer Management: Narrative Review and Report of the First US Prostate Cancer Conference Part 1

Author

Crawford, E. David, primary, Bryce, Alan H., additional, Hussain, Maha H., additional, Agarwal, Neeraj, additional, Beltran, Himisha, additional, Cooperberg, Matthew R., additional, Petrylak, Daniel P., additional, Shore, Neal, additional, Spratt, Daniel E., additional, Tagawa, Scott T., additional, Antonarakis, Emmanuel S., additional, Aparicio, Ana M., additional, Armstrong, Andrew J., additional, Boike, Thomas P., additional, Calais, Jeremie, additional, Carducci, Michael A., additional, Chapin, Brian F., additional, Cookson, Michael S., additional, Davis, John W., additional, Dorff, Tanya, additional, Eggener, Scott E., additional, Feng, Felix Y., additional, Gleave, Martin, additional, Higano, Celestia, additional, Iagaru, Andrei, additional, Morgans, Alicia K., additional, Morris, Michael, additional, Murray, Katie S., additional, Poage, Wendy, additional, Rettig, Matthew B., additional, Sartor, Oliver, additional, Scher, Howard I., additional, Sieber, Paul, additional, Small, Eric, additional, Srinivas, Sandy, additional, Yu, Evan Y., additional, Zhang, Tian, additional, and Koo, Phillip J., additional

Published
2024
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32. Expert Perspectives on Controversies in Metastatic Castration-Resistant Prostate Cancer Management: Narrative Review and Report of the First US Prostate Cancer Conference Part 2

Author

Bryce, Alan H., primary, Crawford, E. David, additional, Agarwal, Neeraj, additional, Hussain, Maha H., additional, Beltran, Himisha, additional, Cooperberg, Matthew R., additional, Petrylak, Daniel P., additional, Shore, Neal, additional, Spratt, Daniel E., additional, Tagawa, Scott T., additional, Antonarakis, Emmanuel S., additional, Aparicio, Ana M., additional, Armstrong, Andrew J., additional, Boike, Thomas P., additional, Calais, Jeremie, additional, Carducci, Michael A., additional, Chapin, Brian F., additional, Cookson, Michael S., additional, Davis, John W., additional, Dorff, Tanya, additional, Eggener, Scott E., additional, Feng, Felix Y., additional, Gleave, Martin, additional, Higano, Celestia, additional, Iagaru, Andrei, additional, Morgans, Alicia K., additional, Morris, Michael, additional, Murray, Katie S., additional, Poage, Wendy, additional, Rettig, Matthew B., additional, Sartor, Oliver, additional, Scher, Howard I., additional, Sieber, Paul, additional, Small, Eric, additional, Srinivas, Sandy, additional, Yu, Evan Y., additional, Zhang, Tian, additional, and Koo, Phillip J., additional

Published
2024
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33. Genomic correlates of clinical outcome in advanced prostate cancer

Author

Abida, Wassim, Cyrta, Joanna, Heller, Glenn, Prandi, Davide, Armenia, Joshua, Coleman, Ilsa, Cieslik, Marcin, Benelli, Matteo, Robinson, Dan, Van Allen, Eliezer M., Sboner, Andrea, Fedrizzi, Tarcisio, Mosquera, Juan Miguel, Robinson, Brian D., De Sarkar, Navonil, Kunju, Lakshmi P., Tomlins, Scott, Wu, Yi Mi, Rodrigues, Daniel Nava, Loda, Massimo, Gopalan, Anuradha, Reuter, Victor E., Pritchard, Colin C., Mateo, Joaquin, Bianchini, Diletta, Miranda, Susana, Carreira, Suzanne, Rescigno, Pasquale, Filipenko, Julie, Vinson, Jacob, Montgomery, Robert B., Beltran, Himisha, Heath, Elisabeth I., Scher, Howard I., Kantoff, Philip W., Taplin, Mary-Ellen, Schultz, Nikolaus, deBono, Johann S., Demichelis, Francesca, Nelson, Peter S., Rubin, Mark A., Chinnaiyan, Arul M., and Sawyers, Charles L.

Published
2019

34. 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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37. Radiographic Progression-Free Survival As a Response Biomarker in Metastatic Castration-Resistant Prostate Cancer: COU-AA-302 Results

Author

Morris, Michael J, Molina, Arturo, Small, Eric J, de Bono, Johann S, Logothetis, Christopher J, Fizazi, Karim, de Souza, Paul, Kantoff, Philip W, Higano, Celestia S, Li, Jinhui, Kheoh, Thian, Larson, Steven M, Matheny, Shannon L, Naini, Vahid, Burzykowski, Tomasz, Griffin, Thomas W, Scher, Howard I, and Ryan, Charles J

Subjects
Urologic Diseases, Clinical Trials and Supportive Activities, Prostate Cancer, Cancer, Clinical Research, Abiraterone Acetate, Androstenes, Antineoplastic Combined Chemotherapy Protocols, Biomarkers, Tumor, Bone Neoplasms, Disease-Free Survival, Double-Blind Method, Humans, Male, Neoplasm Metastasis, Prednisone, Prostatic Neoplasms, Castration-Resistant, Radiography, Survival Rate, Treatment Outcome, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeProgression-free survival (PFS) in metastatic castration-resistant prostate cancer (mCRPC) trials has been inconsistently defined and poorly associated with overall survival (OS). A reproducible quantitative definition of radiographic PFS (rPFS) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC.Patients and methodsrPFS was defined as ≥ two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan, ≥ two new confirmed lesions on any scan ≥ 12 weeks after random assignment, and/or progression in nodes or viscera on cross-sectional imaging, or death. rPFS was assessed by independent review at 15% of deaths and by investigator review at 15% and 40% of deaths. rPFS and OS association was evaluated by Spearman's correlation.ResultsA total of 1,088 patients were randomly assigned to abiraterone plus prednisone or prednisone alone. At first interim analysis, the hazard ratio (HR) by independent review was 0.43 (95% CI, 0.35 to 0.52; P < .001; abiraterone plus prednisone: median rPFS, not estimable; prednisone: median rPFS, 8.3 months). Similar HRs were obtained by investigator review at the first two interim analyses (HR, 0.49; 95% CI, 0.41 to 0.60; P < .001 and HR, 0.53; 95% CI, 0.45 to 0.62; P < .001, respectively), validating the imaging data assay used. Spearman's correlation coefficient between rPFS and OS was 0.72.ConclusionrPFS was highly consistent and highly associated with OS, providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials.

Published
2015

38. Tumor fraction-guided cell-free DNA profiling in metastatic solid tumor patients

Author

Tsui, Dana W. Y., Cheng, Michael L., Shady, Maha, Yang, Julie L., Stephens, Dennis, Won, Helen, Srinivasan, Preethi, Huberman, Kety, Meng, Fanli, Jing, Xiaohong, Patel, Juber, Hasan, Maysun, Johnson, Ian, Gedvilaite, Erika, Houck-Loomis, Brian, Socci, Nicholas D., Selcuklu, S. Duygu, Seshan, Venkatraman E., Zhang, Hongxin, Chakravarty, Debyani, Zehir, Ahmet, Benayed, Ryma, Arcila, Maria, Ladanyi, Marc, Funt, Samuel A., Feldman, Darren R., Li, Bob T., Razavi, Pedram, Rosenberg, Jonathan, Bajorin, Dean, Iyer, Gopa, Abida, Wassim, Scher, Howard I., Rathkopf, Dana, Viale, Agnes, Berger, Michael F., and Solit, David B.

Published
2021
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39. Comparison of Magnetic Resonance Imaging-stratified Clinical Pathways and Systematic Transrectal Ultrasound-guided Biopsy Pathway for the Detection of Clinically Significant Prostate Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Author

Woo, Sungmin, Suh, Chong Hyun, Eastham, James A., Zelefsky, Michael J., Morris, Michael J., Abida, Wassim, Scher, Howard I., Sidlow, Robert, Becker, Anton S., Wibmer, Andreas G., Hricak, Hedvig, and Vargas, Hebert Alberto

Published
2019
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40. 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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41. Optimal Systemic Treatment and Real-World Clinical Application of Ctdna in Patients with Metastatic Her2-Mutant Lung Cancer

Author

Liu, Si-Yang, primary, Erazo, Tatiana, additional, Jee, Justin, additional, Arfe, Andrea, additional, Gupta, Avantika, additional, Pike, Luke Roy George, additional, Santini, Fernando C., additional, Daly, Bobby, additional, Schoenfeld, Adam J., additional, Eichholz, Jordan E., additional, Johnson, Kaylie, additional, Martinez, Andres, additional, Sui, Jane, additional, Riaz, Nadeem, additional, Chang, Jason, additional, Yang, Soo-Ryum, additional, Travis, William, additional, Arcila, Maria E., additional, Guo, Jiannan, additional, Gagne, Eric, additional, Garg, Karvita, additional, Baehner, Frederick L., additional, Lee, Nancy Y., additional, Drilon, Alexander, additional, Kris, Mark G., additional, Scher, Howard I., additional, Razavi, Pedram, additional, Gomez, Daniel, additional, Jones, David R., additional, Rudin, Charles M., additional, Chandarlapaty, Sarat, additional, Isbell, James M., additional, and Li, Bob T., additional

Published
2024
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42. Updated Interim Efficacy Analysis and Long-term Safety of Abiraterone Acetate in Metastatic Castration-resistant Prostate Cancer Patients Without Prior Chemotherapy (COU-AA-302)

Author

Rathkopf, Dana E, Smith, Matthew R, de Bono, Johann S, Logothetis, Christopher J, Shore, Neal D, de Souza, Paul, Fizazi, Karim, Mulders, Peter FA, Mainwaring, Paul, Hainsworth, John D, Beer, Tomasz M, North, Scott, Fradet, Yves, Van Poppel, Hendrik, Carles, Joan, Flaig, Thomas W, Efstathiou, Eleni, Yu, Evan Y, Higano, Celestia S, Taplin, Mary-Ellen, Griffin, Thomas W, Todd, Mary B, Yu, Margaret K, Park, Youn C, Kheoh, Thian, Small, Eric J, Scher, Howard I, Molina, Arturo, Ryan, Charles J, and Saad, Fred

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Cancer, Prostate Cancer, Urologic Diseases, Rehabilitation, Aging, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Abiraterone Acetate, Aged, Androstenes, Antineoplastic Agents, Hormonal, Antineoplastic Combined Chemotherapy Protocols, Cytochrome P-450 Enzyme Inhibitors, Disease Progression, Disease-Free Survival, Double-Blind Method, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Metastasis, Neoplasms, Hormone-Dependent, Prednisone, Proportional Hazards Models, Prostatic Neoplasms, Castration-Resistant, Risk Factors, Steroid 17-alpha-Hydroxylase, Time Factors, Treatment Outcome, Abiraterone acetate, Chemotherapy-naive, Efficacy, Metastatic castration-resistant, prostate cancer, Safety, Metastatic castration-resistant prostate cancer, Urology & Nephrology, Clinical sciences
Abstract

BackgroundAbiraterone acetate (an androgen biosynthesis inhibitor) plus prednisone is approved for treating patients with metastatic castration-resistant prostate cancer (mCRPC). Study COU-AA-302 evaluated abiraterone acetate plus prednisone versus prednisone alone in mildly symptomatic or asymptomatic patients with progressive mCRPC without prior chemotherapy.ObjectiveReport the prespecified third interim analysis (IA) of efficacy and safety outcomes in study COU-AA-302.Design, setting, and participantsStudy COU-AA-302, a double-blind placebo-controlled study, enrolled patients with mCRPC from April 2009 to June 2010. A total of 1088 patients were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1).InterventionPatients were randomised 1:1 to abiraterone 1000mg plus prednisone 5mg twice daily by mouth versus prednisone.Outcome measurements and statistical analysisCo-primary end points were radiographic progression-free survival (rPFS) and overall survival (OS). Median times to event outcomes were estimated using the Kaplan-Meier method. Hazard ratios (HRs) and 95% confidence intervals (CIs) were derived using the Cox model, and treatment comparison used the log-rank test. The O'Brien-Fleming Lan-DeMets α-spending function was used for OS. Adverse events were summarised descriptively.Results and limitationsWith a median follow-up duration of 27.1 mo, improvement in rPFS was statistically significant with abiraterone treatment versus prednisone (median: 16.5 vs 8.2 mo; HR: 0.52 [95% CI, 0.45-0.61]; p2 yr.

Published
2014

43. Enzalutamide in Metastatic Prostate Cancer before Chemotherapy

Author

Beer, Tomasz M, Armstrong, Andrew J, Rathkopf, Dana E, Loriot, Yohann, Sternberg, Cora N, Higano, Celestia S, Iversen, Peter, Bhattacharya, Suman, Carles, Joan, Chowdhury, Simon, Davis, Ian D, de Bono, Johann S, Evans, Christopher P, Fizazi, Karim, Joshua, Anthony M, Kim, Choung-Soo, Kimura, Go, Mainwaring, Paul, Mansbach, Harry, Miller, Kurt, Noonberg, Sarah B, Perabo, Frank, Phung, De, Saad, Fred, Scher, Howard I, Taplin, Mary-Ellen, Venner, Peter M, and Tombal, Bertrand

Subjects
Urologic Diseases, Clinical Trials and Supportive Activities, Prostate Cancer, Clinical Research, Aging, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adenocarcinoma, Administration, Oral, Androgen Receptor Antagonists, Antineoplastic Agents, Hormonal, Benzamides, Disease Progression, Double-Blind Method, Humans, Male, Neoplasm Metastasis, Nitriles, Phenylthiohydantoin, Prostatic Neoplasms, Radiography, Receptors, Androgen, Survival Analysis, PREVAIL Investigators, Medical and Health Sciences, General & Internal Medicine
Abstract

BackgroundEnzalutamide is an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer in whom the disease has progressed after chemotherapy. New treatment options are needed for patients with metastatic prostate cancer who have not received chemotherapy, in whom the disease has progressed despite androgen-deprivation therapy.MethodsIn this double-blind, phase 3 study, we randomly assigned 1717 patients to receive either enzalutamide (at a dose of 160 mg) or placebo once daily. The coprimary end points were radiographic progression-free survival and overall survival.ResultsThe study was stopped after a planned interim analysis, conducted when 540 deaths had been reported, showed a benefit of the active treatment. The rate of radiographic progression-free survival at 12 months was 65% among patients treated with enzalutamide, as compared with 14% among patients receiving placebo (81% risk reduction; hazard ratio in the enzalutamide group, 0.19; 95% confidence interval [CI], 0.15 to 0.23; P

Published
2014

44. High-risk prostate cancer—classification and therapy

Author

Chang, Albert J, Autio, Karen A, Roach, Mack, and Scher, Howard I

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Cancer, Prostate Cancer, Urologic Diseases, Humans, Male, Prognosis, Prostatic Neoplasms, Prostatic Neoplasms, Castration-Resistant, Risk Factors, Treatment Outcome, Oncology and carcinogenesis
Abstract

Approximately 15% of patients with prostate cancer are diagnosed with high-risk disease. However, the current definitions of high-risk prostate cancer include a heterogeneous group of patients with a range of prognoses. Some have the potential to progress to a lethal phenotype that can be fatal, while others can be cured with treatment of the primary tumour alone. The optimal management of this patient subgroup is evolving. A refined classification scheme is needed to enable the early and accurate identification of high-risk disease so that more-effective treatment paradigms can be developed. We discuss several principles established from clinical trials, and highlight other questions that remain unanswered. This Review critically evaluates the existing literature focused on defining the high-risk population, the management of patients with high-risk prostate cancer, and future directions to optimize care.

Published
2014

46. Consensus on molecular imaging and theranostics in prostate cancer

Author

Fanti, Stefano, Minozzi, Silvia, Antoch, Gerald, Banks, Ian, Briganti, Alberto, Carrio, Ignasi, Chiti, Arturo, Clarke, Noel, Eiber, Matthias, De Bono, Johann, Fizazi, Karim, Gillessen, Silke, Gledhill, Sam, Haberkorn, Uwe, Herrmann, Ken, Hicks, Rodney J, Lecouvet, Frederic, Montironi, Rodolfo, Ost, Piet, O'Sullivan, Joe M, Padhani, Anwar R, Schalken, Jack A, Scher, Howard I, Tombal, Bertrand, van Moorselaar, R Jeroen A, Van Poppel, Heindrik, Vargas, Hebert Alberto, Walz, Jochen, Weber, Wolfgang A, Wester, Hans-Jürgen, and Oyen, Wim J G

Published
2018
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47. Effect of Preanalytic Variables on an Automated PTEN Immunohistochemistry Assay for Prostate Cancer

Author

Guedes, Liana B., Morais, Carlos L., Fedor, Helen, Hicks, Jessica, Gurel, Bora, Melamed, Jonathan, Lee, Peng, Gopalan, Anuradha, Knudsen, Beatrice S., True, Lawrence D., Scher, Howard I., Fine, Samson W., Trock, Bruce J., De Marzo, Angelo M., and Lotan, Tamara L.

Subjects
Prostatectomy -- Usage, Immunohistochemistry -- Usage, Prostate cancer -- Diagnosis -- Prognosis -- Care and treatment, Biological markers -- Usage, Medical schools, Surgery, Phosphatases, Tumors, Formaldehyde, Health
Abstract

* Context.--Phosphatase and tensin homolog (PTEN) is a promising prognostic and potentially predictive biomarker in prostate cancer. Objective.--To assess the effects of preanalytic variables on an analytically validated and fully automated PTEN immunohistochemistry assay. Design.--PTEN immunohistochemistry was performed on Ventana immunostaining systems. In benign prostate tissues, immunostaining intensity across variable conditions was assessed by digital image analysis. In prostate tumor tissues, immunostaining was scored visually. Results.--Delay of fixation for 4 hours or longer at room temperature or 48 hours or longer at 4[degrees]C and duration of formalin fixation did not significantly alter immunostaining intensity. Intensity of staining was highest in 10% formalin compared with other fixatives. Tumor tissues with PTEN loss processed using protocols from 11 academic institutions were all evaluable and scored identically. PTEN immunostaining of needle biopsies where tissue blocks had been stored for less than 10 years was more frequently scored as nonevaluable compared with blocks that had been stored for 10 years or longer. This effect was less evident for radical prostatectomy specimens, where low rates of nonevaluable staining were seen for 23 years or more of storage. Storage of unstained slides for 5 years at room temperature prior to immunostaining resulted in equivalent scoring compared with freshly cut slides. Machine-to-machine variability assessed across 3 Ventana platforms and 2 institutions was negligible in 12 tumors, and platform-to-platform variability was also minor comparing Ventana and Leica instruments across 77 tumors (k = 0.926). Conclusions.--Automated PTEN immunostaining is robust to most preanalytic variables in the prostate and may be performed on prostate tumor tissues subjected to a wide range of preanalytic conditions. These data may help guide assay development if PTEN becomes a key predictive biomarker. doi: 10.5858/arpa.2018-0068-OA, Tissue-based biomarkers hold great promise for the practice of personalized medicine in oncology. In particular, immunohistochemistry (IHC) assays, which enable the detection of proteins in situ in tissue specimens, are [...]

Published
2019
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48. Management of Biochemical Recurrence After Primary Treatment of Prostate Cancer: A Systematic Review of the Literature

Author

Punnen, Sanoj, Cooperberg, Matthew R, D’Amico, Anthony V, Karakiewicz, Pierre I, Moul, Judd W, Scher, Howard I, Schlomm, Thorsten, and Freedland, Stephen J

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Aging, Cancer, Prostate Cancer, Urologic Diseases, Humans, Male, Neoplasm Recurrence, Local, Prostate-Specific Antigen, Prostatic Neoplasms, Prostate cancer, Recurrence, Management, Urology & Nephrology, Clinical sciences
Abstract

ContextDespite excellent cancer control with the treatment of localized prostate cancer (PCa), some men will experience a recurrence of disease. The optimal management of recurrent disease remains uncertain.ObjectiveTo systematically review recent literature regarding management of biochemical recurrence after primary treatment for localized PCa.Evidence acquisitionA comprehensive systematic review of the literature was performed from 2000 to 2012 to identify articles pertaining to management after recurrent PCa. Search terms included prostate cancer recurrence, salvage therapy, radiorecurrent prostate cancer, post HIFU, post cryoablation, postradiation, and postprostatectomy salvage. Studies were selected according to Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines and required to provide a comprehensive description of primary and secondary treatments along with outcomes.Evidence synthesisThe data from 32 original publications were reviewed. The most common option for local salvage therapy after radical prostatectomy (RP) was radiation. Options for local salvage therapy after primary radiation included RP, brachytherapy, and cryotherapy. Different definitions of recurrence and risk profiles among patients make comparative assessment among salvage treatment modalities difficult. Triggers for intervention and factors predicting response to salvage therapy vary.ConclusionsRadiation therapy (RT) after RP can provide durable prostate-specific antigen (PSA) responses in a sizeable percentage of men, especially when given early (ie, PSA

Published
2013

49. Serum Androgens As Prognostic Biomarkers in Castration-Resistant Prostate Cancer: Results From an Analysis of a Randomized Phase III Trial

Author

Ryan, Charles J, Molina, Arturo, Li, Jinhui, Kheoh, Thian, Small, Eric J, Haqq, Christopher M, Grant, Russell P, de Bono, Johann S, and Scher, Howard I

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Pain Research, Chronic Pain, Prostate Cancer, Urologic Diseases, Aging, Cancer, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Abiraterone Acetate, Androgens, Androstadienes, Double-Blind Method, Humans, Liquid-Liquid Extraction, Male, Orchiectomy, Prednisone, Prognosis, Prostatic Neoplasms, Testosterone, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

PurposeIn the phase III study COU-AA-301, abiraterone acetate (AA) plus prednisone (P) prolonged overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel administration. In this article, we investigate the relationship between baseline serum androgen (SA) levels and OS.Patients and methodsCOU-AA-301 is a randomized, double-blind study of AA (1,000 mg every day) plus P (5 mg by mouth twice daily; n = 797) versus P alone (n = 398). Randomization was stratified by Eastern Cooperative Oncology Group performance status (0 to 1 v 2), pain (Brief Pain Inventory-Short Form over past 24 hours: 4 to 10, present; v 0 to 3, absent), prior chemotherapy (1 v 2), and progression (prostate-specific antigen v radiographic). Association of baseline SA (testosterone, androstenedione, dehydroepiandrosterone sulfate), was measured by ultrasensitive liquid-liquid extraction or protein precipitation and two-dimensional liquid chromatography coupled to mass spectrometry, with OS determined by bivariate and multivariable Cox models. OS was examined with SA as greater than median and less than or equal to the median.ResultsMedian survival increased with each quartile increase in testosterone level regardless of treatment arm. SA levels at baseline strongly associated with survival (P < .0001) in bivariate and multivariable analyses. Longer survival was observed for patients with SA above median compared with below median in both the AA and P arms (eg, testosterone, AA; hazard ratio, 0.64; 95% CI, 0.53 to 0.77; P < .0001). Treatment with AA led to longer survival versus P alone in the above- or below-median group for all androgens.ConclusionSA, measured with a novel ultrasensitive assay in COU-AA-301, is prognostic for OS and may be useful for risk stratification in mCRPC clinical trials.

Published
2013

50. High-intensity sequencing reveals the sources of plasma circulating cell-free DNA variants

Author

Razavi, Pedram, Li, Bob T., Brown, David N., Jung, Byoungsok, Hubbell, Earl, Shen, Ronglai, Abida, Wassim, Juluru, Krishna, De Bruijn, Ino, Hou, Chenlu, Venn, Oliver, Lim, Raymond, Anand, Aseem, Maddala, Tara, Gnerre, Sante, Vijaya Satya, Ravi, Liu, Qinwen, Shen, Ling, Eattock, Nicholas, Yue, Jeanne, Blocker, Alexander W., Lee, Mark, Sehnert, Amy, Xu, Hui, Hall, Megan P., Santiago-Zayas, Angie, Novotny, William F., Isbell, James M., Rusch, Valerie W., Plitas, George, Heerdt, Alexandra S., Ladanyi, Marc, Hyman, David M., Jones, David R., Morrow, Monica, Riely, Gregory J., Scher, Howard I., Rudin, Charles M., Robson, Mark E., Diaz, Jr., Luis A., Solit, David B., Aravanis, Alexander M., and Reis-Filho, Jorge S.

Published
2019
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