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Your search keyword '"Rathkopf, Dana E."' showing total 12 results
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12 results on '"Rathkopf, Dana E."'

1. Gene-based Confirmatory Germline Testing Following Tumor-only Sequencing of Prostate Cancer

Author

Truong, Hong, Breen, Kelsey, Nandakumar, Subhiksha, Sjoberg, Daniel D., Kemel, Yelena, Mehta, Nikita, Lenis, Andrew T., Reisz, Peter A., Carruthers, Jessica, Benfante, Nicole, Joseph, Vijai, Khurram, Aliya, Gopalan, Anuradha, Fine, Samson W., Reuter, Victor E., Vickers, Andrew J., Birsoy, Ozge, Liu, Ying, Walsh, Michael, Latham, Alicia, Mandelker, Diana, Stadler, Zsofia K., Pietzak, Eugene, Ehdaie, Behfar, Touijer, Karim A., Laudone, Vincent P., Slovin, Susan F., Autio, Karen A., Danila, Daniel C., Rathkopf, Dana E., Eastham, James A., Chen, Yu, Morris, Michael J., Offit, Kenneth, Solit, David B., Scher, Howard I., Abida, Wassim, Robson, Mark E., and Carlo, Maria I.

Published
2023
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2. 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

3. CD38 in Advanced Prostate Cancers

Author

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

Published
2021
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4. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302

Author

de Bono, Johann S., Smith, Matthew R., Saad, Fred, Rathkopf, Dana E., Mulders, Peter F.A., Small, Eric J., Shore, Neal D., Fizazi, Karim, De Porre, Peter, Kheoh, Thian, Li, Jinhui, Todd, Mary B., Ryan, Charles J., and Flaig, Thomas W.

Subjects
Elderly, Metastatic castration-resistant, Urology, Docetaxel, prostate cancer, Article, Metastatic castration-resistant prostate cancer, Abiraterone acetate, Subsequent therapy, Treatment patterns
Abstract

Background Treatment patterns for metastatic castration-resistant prostate cancer (mCRPC) have changed substantially in the last few years. In trial COU-AA-302 (chemotherapy-naïve men with mCRPC), abiraterone acetate plus prednisone (AA) significantly improved radiographic progression-free survival and overall survival (OS) when compared to placebo plus prednisone (P). Objective This post hoc analysis investigated clinical responses to docetaxel as first subsequent therapy (FST) among patients who progressed following protocol-specified treatment with AA, and characterized subsequent treatment patterns among older (≥75 yr) and younger (

Published
2016

5. Clinical Outcomes from Androgen Signaling–directed Therapy after Treatment with Abiraterone Acetate and Prednisone in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302

Author

Smith, Matthew R., primary, Saad, Fred, additional, Rathkopf, Dana E., additional, Mulders, Peter F.A., additional, de Bono, Johann S., additional, Small, Eric J., additional, Shore, Neal D., additional, Fizazi, Karim, additional, Kheoh, Thian, additional, Li, Jinhui, additional, De Porre, Peter, additional, Todd, Mary B., additional, Yu, Margaret K., additional, and Ryan, Charles J., additional

Published
2017
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6. Subsequent Chemotherapy and Treatment Patterns After Abiraterone Acetate in Patients with Metastatic Castration-resistant Prostate Cancer: Post Hoc Analysis of COU-AA-302

Author

de Bono, Johann S., primary, Smith, Matthew R., additional, Saad, Fred, additional, Rathkopf, Dana E., additional, Mulders, Peter F.A., additional, Small, Eric J., additional, Shore, Neal D., additional, Fizazi, Karim, additional, De Porre, Peter, additional, Kheoh, Thian, additional, Li, Jinhui, additional, Todd, Mary B., additional, Ryan, Charles J., additional, and Flaig, Thomas W., additional

Published
2017
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7. Phase 2 Study of the Safety and Antitumor Activity of Apalutamide (ARN-509), a Potent Androgen Receptor Antagonist, in the High-risk Nonmetastatic Castration-resistant Prostate Cancer Cohort

Author

Smith, Matthew R., primary, Antonarakis, Emmanuel S., additional, Ryan, Charles J., additional, Berry, William R., additional, Shore, Neal D., additional, Liu, Glenn, additional, Alumkal, Joshi J., additional, Higano, Celestia S., additional, Chow Maneval, Edna, additional, Bandekar, Rajesh, additional, de Boer, Carla J., additional, Yu, Margaret K., additional, and Rathkopf, Dana E., additional

Published
2016
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8. Low Incidence of Corticosteroid-associated Adverse Events on Long-term Exposure to Low-dose Prednisone Given with Abiraterone Acetate to Patients with Metastatic Castration-resistant Prostate Cancer

Author

Fizazi, Karim, primary, Chi, Kim N., additional, de Bono, Johann S., additional, Gomella, Leonard G., additional, Miller, Kurt, additional, Rathkopf, Dana E., additional, Ryan, Charles J., additional, Scher, Howard I., additional, Shore, Neal D., additional, De Porre, Peter, additional, Londhe, Anil, additional, McGowan, Tracy, additional, Pelhivanov, Nonko, additional, Charnas, Robert, additional, Todd, Mary B., additional, and Montgomery, Bruce, additional

Published
2016
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9. Prior Endocrine Therapy Impact on Abiraterone Acetate Clinical Efficacy in Metastatic Castration-resistant Prostate Cancer: Post-hoc Analysis of Randomised Phase 3 Studies

Author

Bellmunt, Joaquim, primary, Kheoh, Thian, additional, Yu, Margaret K., additional, Smith, Matthew R., additional, Small, Eric J., additional, Mulders, Peter F.A., additional, Fizazi, Karim, additional, Rathkopf, Dana E., additional, Saad, Fred, additional, Scher, Howard I., additional, Taplin, Mary-Ellen, additional, Davis, Ian D., additional, Schrijvers, Dirk, additional, Protheroe, Andrew, additional, Molina, Arturo, additional, De Porre, Peter, additional, Griffin, Thomas W., additional, de Bono, Johann S., additional, Ryan, Charles J., additional, and Oudard, Stéphane, additional

Published
2016
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10. Impact of Bone-targeted Therapies in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Patients Treated with Abiraterone Acetate: Post Hoc Analysis of Study COU-AA-302

Author

Saad, Fred, primary, Shore, Neal, additional, Van Poppel, Hendrik, additional, Rathkopf, Dana E., additional, Smith, Matthew R., additional, de Bono, Johann S., additional, Logothetis, Christopher J., additional, de Souza, Paul, additional, Fizazi, Karim, additional, Mulders, Peter F.A., additional, Mainwaring, Paul, additional, Hainsworth, John D., additional, Beer, Tomasz M., additional, North, Scott, additional, Fradet, Yves, additional, Griffin, Thomas A., additional, De Porre, Peter, additional, Londhe, Anil, additional, Kheoh, Thian, additional, Small, Eric J., additional, Scher, Howard I., additional, Molina, Arturo, additional, and Ryan, Charles J., additional

Published
2015
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11. Effects of Cabozantinib on Pain and Narcotic Use in Patients with Castration-resistant Prostate Cancer: Results from a Phase 2 Nonrandomized Expansion Cohort

Author

Basch, Ethan, primary, Autio, Karen A., additional, Smith, Matthew R., additional, Bennett, Antonia V., additional, Weitzman, Aaron L., additional, Scheffold, Christian, additional, Sweeney, Christopher, additional, Rathkopf, Dana E., additional, Smith, David C., additional, George, Daniel J., additional, Higano, Celestia S., additional, Harzstark, Andrea L., additional, Sartor, A. Oliver, additional, Gordon, Michael S., additional, Vogelzang, Nicholas J., additional, de Bono, Johann S., additional, Haas, Naomi B., additional, Corn, Paul G., additional, Schimmoller, Frauke, additional, and Scher, Howard I., additional

Published
2015
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12. Patient-reported Outcomes for Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1/2 Gene Alterations: Final Analysis from the Randomized Phase 3 MAGNITUDE Trial.

Author

Rathkopf DE, Roubaud G, Chi KN, Efstathiou E, Attard G, Olmos D, Small EJ, Saad M, Castro E, Kim W, Wu D, Bertzos K, Dibaj S, Zhang J, Francis P, and Smith MR

Abstract

Background and Objective: The phase 3 MAGNITUDE trial assessed the efficacy and safety of niraparib 200 mg and abiraterone acetate 1000 mg plus prednisone 10 mg (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) and alterations in homologous recombination repair (HRR) genes. Here we report final analysis results for patient-reported outcomes (PROs) in the HRR + cohort with a focus on BRCA1/2 alterations (BRCA + )., Methods: Protocol-specified endpoints evaluated patient-reported symptoms, health-related quality of life (HRQoL), and tolerability (side-effect bother) using the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires. Evaluations were completed on day 1 of designated treatment cycles and during follow-up., Key Findings and Limitations: All patients with BRCA + mCRPC (n = 225) were included in the PRO analyses with average on-treatment PRO compliance >80% when completed on-site. Time to deterioration in pain according to BPI-SF and FACT-P scores did not significantly differ between niraparib + AAP and placebo + AAP. During treatment, EQ-5D-5L revealed no clinically meaningful differences in overall HRQoL between treatment arms in the BRCA+ subgroup. Finally, tolerability was similar between arms; side effect bother rated as "not at all" or "a little bit" ranged from 79.8% to 95.9% during treatment. Limitations include a sample size that may not have been powered to detect a difference in PROs., Conclusions and Clinical Implications: Treatment with niraparib + AAP maintained HRQoL with minimal side-effect bother reported by most patients with BRCA + mCRPC. Differences between treatment groups in time to pain deterioration did not meet conventional levels of statistical significance. The MAGNITUDE trial is registered on ClinicalTrials.gov as NCT03748641., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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