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516 results on '"Picus, Joel"'

1. A Phase 2 Study of Sitravatinib in Combination with Nivolumab in Patients with Advanced or Metastatic Urothelial Carcinoma

Author

Msaouel, Pavlos, Sweis, Randy F., Bupathi, Manojkumar, Heath, Elisabeth, Goodman, Oscar B., Jr, Hoimes, Christopher J., Milowsky, Matthew I., Davis, Nancy, Kalebasty, Arash Rezazadeh, Picus, Joel, Shaffer, David, Mao, Shifeng, Adra, Nabil, Yorio, Jeffrey, Gandhi, Sunil, Grivas, Petros, Siefker-Radtke, Arlene, Yang, Rui, Latven, Lisa, Olson, Peter, Chin, Curtis D., Der-Torossian, Hirak, Mortazavi, Amir, and Iyer, Gopa

Published
2024
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2. Pemphigus foliaceus in a patient with gastrointestinal stromal tumor treated with adjuvant imatinib mesylate

Author

Lewis, Hal A, Chen, David Y, Rosman, Ilana S, Picus, Joel, and Anadkat, Milan J

Subjects
pemphigus foliaceous, drug reactions, chemotherapy
Abstract

Pemphigus is an autoimmune bullous disease with a number of described associations, including medications, which have been grouped into three structural categories - thiol drugs, phenol drugs, and drugs with neither functional group [1]. Discontinuation of the offending medication is considered a mainstay of therapy. We report a patient in whom the onset of pemphigus foliaceus was associated with initiation of imatinib mesylate adjuvant therapy in a patient with resected gastrointestinal stromal tumor (GIST). Imatinib was continued because of the survival benefit to the patient with a resected, high risk GIST. Treatment with rituximab resulted in near resolution of his blistering rash and follow up enzyme-linked immunosorbent assay (ELISA) demonstrated reference range immunoreactivity for both desmoglein 1 and desmoglein 3. After dose increase of imatinib therapy owing to tumor growth, the patient subsequently again developed a similar eruption. Re-biopsy and ELISA were consistent with recurrence of pemphigus. In conclusion, although the patient's pemphigus was cleared with a single cycle of rituximab infusions while continuing imatinib therapy, the disease returned after imatinib dose was increased a year later, suggesting a dose-response relationship.

Published
2020

3. Health-related quality of life (HRQOL) results from PRESTO (AFT-19), a phase 3 randomized trial of intensification of androgen blockade in patients with high-risk biochemically relapsed castration sensitive prostate cancer.

Author

Chen, Ronald C., primary, Mazza, Gina L., additional, Fruth, Briant, additional, Xiao, Han, additional, Picus, Joel, additional, Taplin, Mary Ellen, additional, Dorff, Tanya B., additional, Appleman, Leonard Joseph, additional, Weckstein, Douglas Jay, additional, Patnaik, Akash, additional, Bryce, Alan Haruo, additional, Shevrin, Daniel, additional, Mohler, James L., additional, Anderson, Daniel M., additional, Rao, Arpit, additional, Tan, Alan, additional, Ryan, Charles J., additional, Eggener, Scott, additional, Morris, Michael J., additional, and Aggarwal, Rahul Raj, additional

Published
2024
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4. Preliminary safety, pharmacokinetics and clinical activity of DFF332, an oral HIF2α inhibitor, as monotherapy in a phase 1 dose escalation study in patients with advanced clear cell renal cell carcinoma.

Author

Pal, Sumanta Kumar, primary, Tannir, Nizar M., additional, Grell, Peter, additional, Gao, Xin, additional, Kotecha, Ritesh R, additional, Picus, Joel, additional, De Braud, Filippo G., additional, Takahashi, Shunji, additional, Wong, Alvin, additional, Suárez, Cristina, additional, Otero, Javier A, additional, Kundamal, Nicole, additional, Yang, Xin, additional, Sharaby, Sherif, additional, Roy, Mike, additional, Barzaghi-Rinaudo, Patrizia, additional, and Albiges, Laurence, additional

Published
2024
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5. Impact of exposure on outcomes with enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer.

Author

Petrylak, Daniel P., primary, Chia, Yen Lin, additional, Yu, Evan Y., additional, Powles, Thomas, additional, Flaig, Thomas W., additional, Loriot, Yohann, additional, O'Donnell, Peter H., additional, Heath, Elisabeth I., additional, Kojima, Takahiro, additional, Park, Se Hoon, additional, Sonpavde, Guru P., additional, Picus, Joel, additional, Matsubara, Nobuaki, additional, Obara, Wataru, additional, Chudasama, Vaishali, additional, Poondru, Srinivasu, additional, Harrison, Michael, additional, Kim, Eric, additional, Brancato, Sam Joseph, additional, and Rosenberg, Jonathan E., additional

Published
2024
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8. Management of Muscle-Invasive Bladder Cancer During a Pandemic: Impact of Treatment Delay on Survival Outcomes for Patients Treated With Definitive Concurrent Chemoradiotherapy

Author

Fischer-Valuck, Benjamin W., Michalski, Jeff M., Harton, Joanna G., Birtle, Alison, Christodouleas, John P., Efstathiou, Jason A., Arora, Vivek K., Kim, Eric H., Knoche, Eric M., Pachynski, Russell K., Picus, Joel, Rao, Yuan James, Reimers, Melissa, Roth, Bruce J., Sargos, Paul, Smith, Zachary L., Zaghloul, Mohamed S., Gay, Hiram A., Patel, Sagar A., and Baumann, Brian C.

Published
2021
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9. 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, primary, Heller, Glenn, additional, Hillman, David W., additional, Xiao, Han, additional, Picus, Joel, additional, Taplin, Mary-Ellen, additional, Dorff, Tanya, additional, Appleman, Leonard, additional, Weckstein, Douglas, additional, Patnaik, Akash, additional, Bryce, Alan, additional, Shevrin, Daniel, additional, Mohler, James, additional, Anderson, Daniel, additional, Rao, Arpit, additional, Tagawa, Scott, additional, Tan, Alan, additional, Halabi, Susan, additional, Dooley, Katharine, additional, O'Brien, Patrick, additional, Chen, Ronald, additional, Ryan, Charles J., additional, Eggener, Scott E., additional, Morris, Michael J., additional, Aggarwal, Rahul, additional, Kim, Charles, additional, Whang, Young, additional, Dakhil, Shaker, additional, Smith, Raymond, additional, Gartrell, Benjamin, additional, Fagbemi, Seth, additional, Mowat, Rex, additional, Farber, Charles, additional, Hashemi, Neda, additional, Humeniuk, Michael, additional, Ryan, Charles, additional, Ellerton, John, additional, Olsen, Mark, additional, Wang, Jennifer, additional, Karina Pascual, Sheila, additional, Michael Randall, James, additional, King, David, additional, Kilari, Deepak, additional, Monk, Paul, additional, Bitting, Rhonda, additional, Eugenio Najera, Jose, additional, Rowland, Kendrith, additional, Hauke, Ralph, additional, Shehadeh, Nasfat, additional, Curti, Brendan, additional, Gupta, Gopal, additional, Collins, Timothy, additional, Beer, Tomasz, additional, Tate, David, additional, Sheh, Bryant, additional, Basnet, Alina, additional, Conway, James, additional, Gross, Howard, additional, and Goodman, Michael, additional

Published
2024
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10. Supplementary Table S9 from Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma

Author

Petrylak, Daniel P., primary, Eigl, Bernhard J., primary, George, Saby, primary, Heath, Elisabeth I., primary, Hotte, Sebastien J., primary, Chism, David D., primary, Nabell, Lisle M., primary, Picus, Joel, primary, Cheng, Susanna Y., primary, Appleman, Leonard J., primary, Sonpavde, Guru P., primary, Morgans, Alicia K., primary, Pourhosseini, Pourya, primary, Wu, Ruishan, primary, Standley, Laura, primary, Croitoru, Ruslan, primary, and Yu, Evan Y., primary

Published
2024
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11. Supplementary Figure S2 from Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma

Author

Petrylak, Daniel P., primary, Eigl, Bernhard J., primary, George, Saby, primary, Heath, Elisabeth I., primary, Hotte, Sebastien J., primary, Chism, David D., primary, Nabell, Lisle M., primary, Picus, Joel, primary, Cheng, Susanna Y., primary, Appleman, Leonard J., primary, Sonpavde, Guru P., primary, Morgans, Alicia K., primary, Pourhosseini, Pourya, primary, Wu, Ruishan, primary, Standley, Laura, primary, Croitoru, Ruslan, primary, and Yu, Evan Y., primary

Published
2024
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12. Data from Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma

Author

Petrylak, Daniel P., primary, Eigl, Bernhard J., primary, George, Saby, primary, Heath, Elisabeth I., primary, Hotte, Sebastien J., primary, Chism, David D., primary, Nabell, Lisle M., primary, Picus, Joel, primary, Cheng, Susanna Y., primary, Appleman, Leonard J., primary, Sonpavde, Guru P., primary, Morgans, Alicia K., primary, Pourhosseini, Pourya, primary, Wu, Ruishan, primary, Standley, Laura, primary, Croitoru, Ruslan, primary, and Yu, Evan Y., primary

Published
2024
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13. Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of AGS15E Monotherapy in Patients with Metastatic Urothelial Carcinoma

Author

Petrylak, Daniel P., primary, Eigl, Bernhard J., additional, George, Saby, additional, Heath, Elisabeth I., additional, Hotte, Sebastien J., additional, Chism, David D., additional, Nabell, Lisle M., additional, Picus, Joel, additional, Cheng, Susanna Y., additional, Appleman, Leonard J., additional, Sonpavde, Guru P., additional, Morgans, Alicia K., additional, Pourhosseini, Pourya, additional, Wu, Ruishan, additional, Standley, Laura, additional, Croitoru, Ruslan, additional, and Yu, Evan Y., additional

Published
2023
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14. 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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15. Epigenetic Therapy Using Belinostat for Patients With Unresectable Hepatocellular Carcinoma: A Multicenter Phase I/II Study With Biomarker and Pharmacokinetic Analysis of Tumors From Patients in the Mayo Phase II Consortium and the Cancer Therapeutics Research Group

Author

Yeo, Winnie, Chung, Hyun C, Chan, Stephen L, Wang, Ling Z, Lim, Robert, Picus, Joel, Boyer, Michael, Mo, Frankie KF, Koh, Jane, Rha, Sun Y, Hui, Edwin P, Jeung, Hei C, Roh, Jae K, Yu, Simon CH, To, Ka F, Tao, Qian, B., Brigette, Chan, Anthony WH, Tong, Joanna HM, Erlichman, Charles, Chan, Anthony TC, and Goh, Boon C

Subjects
Digestive Diseases, Rare Diseases, Clinical Research, Orphan Drug, Liver Cancer, Liver Disease, Cancer, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adult, Aged, Biomarkers, Pharmacological, Carcinoma, Hepatocellular, Comorbidity, DNA Repair Enzymes, DNA-Binding Proteins, Disease-Free Survival, Epigenomics, Female, Hepatitis B, Chronic, Histone Deacetylase Inhibitors, Humans, Hydroxamic Acids, Liver Cirrhosis, Liver Neoplasms, Male, Maximum Tolerated Dose, Middle Aged, Sulfonamides, Survival Analysis, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeEpigenetic aberrations have been reported in hepatocellular carcinoma (HCC). In this study of patients with unresectable HCC and chronic liver disease, epigenetic therapy with the histone deacetylase inhibitor belinostat was assessed. The objectives were to determine dose-limiting toxicity and maximum-tolerated dose (MTD), to assess pharmacokinetics in phase I, and to assess activity of and explore potential biomarkers for response in phase II.Patients and methodsMajor eligibility criteria included histologically confirmed unresectable HCC, European Cooperative Oncology Group performance score ≤ 2, and adequate organ function. Phase I consisted of 18 patients; belinostat was given intravenously once per day on days 1 to 5 every 3 weeks; dose levels were 600 mg/m(2) per day (level 1), 900 mg/m(2) per day (level 2), 1,200 mg/m(2) per day (level 3), and 1,400 mg/m(2) per day (level 4). Phase II consisted of 42 patients. The primary end point was progression-free survival (PFS), and the main secondary end points were response according to Response Evaluation Criteria in Solid Tumors (RECIST) and overall survival (OS). Exploratory analysis was conducted on pretreatment tumor tissues to determine whether HR23B expression is a potential biomarker for response.ResultsBelinostat pharmacokinetics were linear from 600 to 1,400 mg/m(2) without significant accumulation. The MTD was not reached at the maximum dose administered. Dose level 4 was used in phase II. The median number of cycles was two (range, one to 12). The partial response (PR) and stable disease (SD) rates were 2.4% and 45.2%, respectively. The median PFS and OS were 2.64 and 6.60 months, respectively. Exploratory analysis revealed that disease stabilization rate (complete response plus PR plus SD) in tumors having high and low HR23B histoscores were 58% and 14%, respectively (P = .036).ConclusionEpigenetic therapy with belinostat demonstrates tumor stabilization and is generally well-tolerated. HR23B expression was associated with disease stabilization.

Published
2012

16. BRCAAway: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) bearing homologous recombination-repair mutations (HRRm).

Author

Hussain, Maha H. A., Kocherginsky, Masha, Agarwal, Neeraj, Adra, Nabil, Zhang, Jingsong, Paller, Channing Judith, Picus, Joel, Reichert, Zachery R, Szmulewitz, Russell Zelig, Tagawa, Scott T., Kuzel, Timothy, Bazzi, Latifa, Daignault-Newton, Stephanie, Whang, Young E., Dreicer, Robert, Stephenson, Ryan D., Rettig, Matthew, Shevrin, Daniel, Chinnaiyan, Arul, and Antonarakis, Emmanuel S.

Published
2024
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17. Apatorsen plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial carcinoma (Borealis-2)

Author

Rosenberg, Jonathan E., Hahn, Noah M., Regan, Meredith M., Werner, Lillian, Alva, Ajjai, George, Saby, Picus, Joel, Alter, Robert, Balar, Arjun, Hoffman-Censits, Jean, Grivas, Petros, Lauer, Richard, Guancial, Elizabeth A., Hoimes, Christopher, Sonpavde, Guru, Albany, Constantine, Stein, Mark N., Breen, Tim, Jacobs, Cindy, Anderson, Kirsten, Bellmunt, Joaquim, Lalani, Aly-Khan A., Pal, Sumanta, and Choueiri, Toni K.

Published
2018
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18. LBA02-11 UPDATED PROGRESSION-FREE SURVIVAL FROM PRESTO: A PHASE 3 RANDOMIZED STUDY OF ANDROGEN ANNIHILATION FOR HIGH-RISK BIOCHEMICALLY RELAPSED PROSTATE CANCER (AFT-19)

Author

Aggarwal, Rahul, primary, Eggener, Scott, additional, Heller, Glenn, additional, Xiao, Habn, additional, Hillman, David, additional, Picus, Joel, additional, Wang, Jennifer, additional, Taplin, Mary Ellen, additional, Dorff, Tanya, additional, Appleman, Leonard, additional, Weckstein, Doug, additional, Patnaik, Akash, additional, Bryce, Alan, additional, Shevrin, Dan, additional, Halabi, Susan, additional, Mohler, James, additional, Anderson, Daniel, additional, Rao, Arpit, additional, Tagawa, Scott, additional, Tan, Alan, additional, Ryan, Charles, additional, and Morris, Michael, additional

Published
2023
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19. 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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20. Association Between Local Radiation Therapy to the Primary Bladder Tumor and Overall Survival for Patients with Metastatic Urothelial Cancer Receiving Systemic Chemotherapy

Author

Fischer-Valuck, Benjamin W., Patel, Sagar A., Brenneman, Randall J., Christodouleas, John, Sargos, Paul, Kim, Eric, Weiss, Aaron, Hershatter, Bruce, Rao, Yuan J., Picus, Joel, Roth, Bruce, Arora, Vivek, Carmona, Ruben, Reimers, Melissa, Zaghloul, Mohamed S., Gay, Hiram, Michalski, Jeff M., and Baumann, Brian C.

Subjects
Male, Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Oncology, Urology, Urinary Bladder, Humans, Female, Radiology, Nuclear Medicine and imaging, Surgery, Prospective Studies, Article, Retrospective Studies
Abstract

There are limited data on the role of local therapy for metastatic urothelial carcinoma of the bladder (mUC). In this retrospective cohort analysis, we queried the National Cancer Data Base for patients with newly diagnosed mUC (cT1-4 N0-3 M1). Overall survival (OS) was compared between treatment with chemotherapy (CT) alone (n = 4122) and CT plus bladder-directed radiation therapy (CT + RT; n = 337). Multivariable Cox proportional-hazards analyses and matching and landmark analyses were performed. CT + RT was independently associated with better OS (hazard ratio 0.70, 95% confidence interval 0.62-0.79; p0.0001) and this result persisted in matched and landmark analyses. These findings are hypothesis-generating and limited by inherent confounding factors; however, a prospective trial evaluating the impact of bladder RT in mUC is warranted. PATIENT SUMMARY: For patients with bladder cancer that has already spread to other parts of the body, it is unclear if radiation therapy directed at the primary bladder tumor would provide any improvement in survival. In this study, we found that aggressive radiation therapy directed at the bladder combined with chemotherapy may provide a survival benefit in some patients with metastatic bladder cancer compared to chemotherapy alone.

Published
2022
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21. Supplementary Figure 6 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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22. Supplementary Figure 1 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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23. Supplementary Tables and Figures from Angiokines Associated with Targeted Therapy Outcomes in Patients with Non–Clear Cell Renal Cell Carcinoma

Author

Armstrong, Andrew J., primary, Nixon, Andrew B., primary, Carmack, Andrea, primary, Yang, Qian, primary, Eisen, Tim, primary, Stadler, Walter M., primary, Jones, Robert J., primary, Garcia, Jorge A., primary, Vaishampayan, Ulka N., primary, Picus, Joel, primary, Hawkins, Robert E., primary, Hainsworth, John D., primary, Kollmannsberger, Christian K., primary, Logan, Theodore F., primary, Puzanov, Igor, primary, Pickering, Lisa M., primary, Ryan, Christopher W., primary, Protheroe, Andrew, primary, George, Daniel J., primary, and Halabi, Susan, primary

Published
2023
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24. Supplementary Figure 5 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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25. Supplementary Data from Pharmacodynamic and Clinical Results from a Phase I/II Study of the HSP90 Inhibitor Onalespib in Combination with Abiraterone Acetate in Prostate Cancer

Author

Slovin, Susan, primary, Hussain, Syed, primary, Saad, Fred, primary, Garcia, Jorge, primary, Picus, Joel, primary, Ferraldeschi, Roberta, primary, Crespo, Mateus, primary, Flohr, Penelope, primary, Riisnaes, Ruth, primary, Lin, Chihche, primary, Keer, Harold, primary, Oganesian, Aram, primary, Workman, Paul, primary, and de Bono, Johann, primary

Published
2023
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26. Supplementary Figure 4 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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27. Supplementary Figure 4a from Angiokines Associated with Targeted Therapy Outcomes in Patients with Non–Clear Cell Renal Cell Carcinoma

Author

Armstrong, Andrew J., primary, Nixon, Andrew B., primary, Carmack, Andrea, primary, Yang, Qian, primary, Eisen, Tim, primary, Stadler, Walter M., primary, Jones, Robert J., primary, Garcia, Jorge A., primary, Vaishampayan, Ulka N., primary, Picus, Joel, primary, Hawkins, Robert E., primary, Hainsworth, John D., primary, Kollmannsberger, Christian K., primary, Logan, Theodore F., primary, Puzanov, Igor, primary, Pickering, Lisa M., primary, Ryan, Christopher W., primary, Protheroe, Andrew, primary, George, Daniel J., primary, and Halabi, Susan, primary

Published
2023
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28. Supplementary Methods and Figure Legend from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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29. Supplementary Figure 3 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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30. Supplementary Table 1 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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31. Supplementary Figure 2 from Targeted MET Inhibition in Castration-Resistant Prostate Cancer: A Randomized Phase II Study and Biomarker Analysis with Rilotumumab plus Mitoxantrone and Prednisone

Author

Ryan, Charles J., primary, Rosenthal, Mark, primary, Ng, Siobhan, primary, Alumkal, Joshi, primary, Picus, Joel, primary, Gravis, Gwenaëlle, primary, Fizazi, Karim, primary, Forget, Frédéric, primary, Machiels, Jean-Pascal, primary, Srinivas, Sandy, primary, Zhu, Min, primary, Tang, Rui, primary, Oliner, Kelly S., primary, Jiang, Yizhou, primary, Loh, Elwyn, primary, Dubey, Sarita, primary, and Gerritsen, Winald R., primary

Published
2023
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32. HCRN GU14-188: Phase Ib/II study of neoadjuvant pembrolizumab and chemotherapy for T2-4aN0M0 urothelial cancer.

Author

Brown, Jason, primary, Kaimakliotis, Hristos Z., additional, Kelly, William Kevin, additional, Ammons, Vikki, additional, Picus, Joel, additional, Walling, Radhika, additional, Hashemi-Sadraei, Neda, additional, Fu, Pingfu, additional, Margevicius, Seunghee P, additional, Adra, Nabil, additional, Garcia, Jorge A., additional, McKay, Rana R., additional, and Hoimes, Christopher J., additional

Published
2023
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33. Baseline characteristics associated with PSA progression-free survival in patients (pts) with high-risk biochemically relapsed prostate cancer: Results from the phase 3 PRESTO study (AFT-19).

Author

Aggarwal, Rahul Raj, primary, Heller, Glenn, additional, Hillman, David W., additional, Xiao, Han, additional, Picus, Joel, additional, Taplin, Mary-Ellen, additional, Dorff, Tanya B., additional, Appleman, Leonard Joseph, additional, Weckstein, Douglas Jay, additional, Patnaik, Akash, additional, Bryce, Alan Haruo, additional, Shevrin, Daniel H., additional, Mohler, James, additional, Anderson, Daniel M., additional, Rao, Arpit, additional, Tagawa, Scott T., additional, Tan, Alan, additional, Eggener, Scott E., additional, Ryan, Charles J., additional, and Morris, Michael J., additional

Published
2023
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34. Phase I Study of Single-Agent Anti–Programmed Death-1 (MDX-1106) in Refractory Solid Tumors: Safety, Clinical Activity, Pharmacodynamics, and Immunologic Correlates

Author

Brahmer, Julie R., primary, Drake, Charles G., additional, Wollner, Ira, additional, Powderly, John D., additional, Picus, Joel, additional, Sharfman, William H., additional, Stankevich, Elizabeth, additional, Pons, Alice, additional, Salay, Theresa M., additional, McMiller, Tracee L., additional, Gilson, Marta M., additional, Wang, Changyu, additional, Selby, Mark, additional, Taube, Janis M., additional, Anders, Robert, additional, Chen, Lieping, additional, Korman, Alan J., additional, Pardoll, Drew M., additional, Lowy, Israel, additional, and Topalian, Suzanne L., additional

Published
2023
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40. A pilot trial of neoantigen DNA vaccine in combination with nivolumab/ipilimumab and prostvac in metastatic hormone-sensitive prostate cancer (mHSPC).

Author

Shah, Koral, primary, Ganapathy, Aravinda, additional, Borkowski, Ariel, additional, Shah, Nakul, additional, Bansal, Dhruv, additional, Beck, Rachel, additional, Knoche, Eric Marshall, additional, Picus, Joel, additional, Reimers, Melissa Andrea, additional, Roth, Bruce J., additional, Gulley, James L., additional, Schreiber, Robert, additional, and Pachynski, Russell Kent, additional

Published
2022
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41. Eight-year survival rates by baseline prognostic groups in patients with metastatic hormone-sensitive prostate cancer (mHSPC): An analysis from the ECOG-ACRIN 3805 (CHAARTED) trial.

Author

Tripathi, Abhishek, primary, Chen, Yu-Hui, additional, Jarrard, David Frazier, additional, Hahn, Noah M., additional, Garcia, Jorge A., additional, Dreicer, Robert, additional, Liu, Glenn, additional, Hussain, Maha H. A., additional, Shevrin, Daniel H., additional, Cooney, Matthew M., additional, Eisenberger, Mario A., additional, Kohli, Manish, additional, Plimack, Elizabeth R., additional, Vogelzang, Nicholas J., additional, Picus, Joel, additional, Carducci, Michael Anthony, additional, DiPaola, Robert S., additional, and Sweeney, Christopher, additional

Published
2022
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42. BRCAAWAY: A randomized phase 2 trial of abiraterone, olaparib, or abiraterone + olaparib in patients with metastatic castration-resistant prostate cancer (mCRPC) with DNA repair defects.

Author

Hussain, Maha H. A., primary, Kocherginsky, Masha, additional, Agarwal, Neeraj, additional, Zhang, Jingsong, additional, Adra, Nabil, additional, Paller, Channing Judith, additional, Picus, Joel, additional, Reichert, Zachery R, additional, Szmulewitz, Russell Zelig, additional, Tagawa, Scott T., additional, Whang, Young E., additional, Dreicer, Robert, additional, Kuzel, Timothy, additional, Bazzi, Latifa, additional, Gerke, Travis A., additional, Daignault-Newton, Stephanie, additional, Chinnaiyan, Arul, additional, and Antonarakis, Emmanuel S., additional

Published
2022
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43. Tissue based biomarkers in non-clear cell RCC: Correlative analysis from the ASPEN clinical trial

Author

Halabi, Susan, Yang, Qian, Carmack, Andrea, Zhang, Shiqi, Foo, Wen-Chi, Eisen, Tim, Stadler, Walter, Jones, Robert J., Garcia, Jorge, Picus, Joel, Hawkins, Robert, Hainsworth, John, Kollmannsberger, Christian, Logan, Theodore, Puzanov, Igor, Pickering, Lisa, Ryan, Christopher, Protheroe, Andrew, George, Daniel, and Armstrong, Andrew

Abstract

Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC), particularly papillary renal cell carcinoma, in order to inform on initial treatment selection and identify potentially novel targets for therapy. We enrolled 108 patients in ASPEN, an international randomized open-label phase 2 trial of patients with metastatic papillary, chromophobe, or unclassified NC-RCC treated with the mTOR inhibitor everolimus (n=57) or the vascular endothelial growth factor (VEGF) receptor inhibitor sunitinib (n=51), stratified by MSKCC risk and histology. The primary endpoint was overall survival (OS) and secondary efficacy endpoints for this exploratory biomarker analysis were radiographic progression-free survival (rPFS) defined by intentionto- treat using the RECIST 1.1 criteria and radiographic response rates. Tissue biomarkers (n=78) of mTOR pathway activation (phospho-S6 and -Akt, c-kit) and VEGF pathway activation (HIF-1, c-MET) were prospectively explored in tumor tissue by immunohistochemistry prior to treatment and associated with clinical outcomes. We found that S6 activation was more common in poor-risk NC-RCC tumors and S6/Akt activation was associated with worse PFS and OS outcomes with both everolimus and sunitinib, while c-kit was commonly expressed in chromophobe tumors and associated with improved outcomes with both agents. C-MET was commonly expressed in papillary tumors and was associated with lower rates of radiographic response but did not predict PFS for either agent. In multivariable analysis, both pAkt and c-kit were statistically significant prognostic biomarkers of OS. No predictive biomarkers of treatment response were identified for clinical outcomes. Most biomarker subgroups had improved outcomes with sunitinib as compared to everolimus.

Published
2021

49. Angiokines associated with outcomes after sunitinib or everolimus treatment in patients with non-clear cell renal cell carcinoma

Author

Armstrong, Andrew J., Nixon, Andrew B., Carmack, Andrea, Eisen, Tim, 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, George, Daniel J., and Halabi, Susan

Subjects
urologic and male genital diseases
Abstract

Purpose: Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC) to inform treatment selection but also to identify novel therapeutic targets. We thus sought to profile circulating angiokines in the context of a randomized treatment trial of everolimus versus sunitinib. \ud \ud Experimental Design: ASPEN (NCT01108445) was an international, randomized, open-label phase 2 trial of patients with metastatic papillary, chromophobe, or unclassified NC-RCC with no prior systemic therapy. Patients were randomized to everolimus or sunitinib and treated until disease progression or unacceptable toxicity. The primary endpoint was radiographic progression-free survival (PFS) defined by RECIST 1.1 criteria. Plasma angiokines were collected at baseline, cycle 3, and progression and associated with PFS and overall survival. \ud \ud Results: We enrolled 108 patients, 51 received sunitinib and 57 everolimus; of these, 89 patients had evaluable plasma for 23 angiokines. At the final data cutoff, 87 PFS and 62 mortality events had occurred. Angiokines that were independently adversely prognostic for OS were osteopontin (OPN), HGF, and VCAM-1, and these were also associated with poor risk disease. SDF-1 was associated with improved survival. OPN was also significantly associated with worse PFS. No statistically significant angiokine-treatment outcome interactions were observed for sunitinib or everolimus. OPN, HGF, TIMP-1, VCAM-1, PDGF-AA and IL-6 levels increased with progression on everolimus, while OPN, PlGF, TIMP-1, VEGF, and soluble VEGFR-2 and VCAM-1 increased with progression on sunitinib. \ud \ud Conclusions: In patients with metastatic non-clear cell RCC, we identified several poor prognosis angiokines and immunomodulatory chemokines during treatment with sunitinib or everolimus, particularly OPN.

Published
2021

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