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2. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study

Author

de Wit, R., Wülfing, C., Castellano, D., Kramer, G., Eymard, J.-C., Sternberg, C.N., Fizazi, K., Tombal, B., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdóttir, Á., Theodore, C., Feyerabend, S., Helissey, C., Foster, M.C., Ozatilgan, A., Geffriaud-Ricouard, C., and de Bono, J.

Published
2021
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3. Efficacy and safety of rucaparib in previously treated, locally advanced or metastatic urothelial carcinoma from a phase 2, open-label trial (ATLAS)

Author

Grivas, P., Loriot, Y., Morales-Barrera, R., Teo, M. Y., Zakharia, Y., Feyerabend, S., Vogelzang, N. J., Grande, E., Adra, N., Alva, A., Necchi, A., Rodriguez-Vida, A., Gupta, S., Josephs, D. H., Srinivas, S., Wride, K., Thomas, D., Simmons, A., Loehr, A., Dusek, R. L., Nepert, D., and Chowdhury, S.

Published
2021
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5. 1363MO Cabazitaxel every 2 weeks versus every 3 weeks in older patients with metastatic castration-resistant prostate cancer (mCRPC): The CABASTY randomized phase III trial

Author

Oudard, S., primary, Beuzeboc, P., additional, Voog, E., additional, Barthelemy, P., additional, Thiery-Vuillemin, A., additional, Bennamoun, M., additional, Hasbini, A., additional, Aldabbagh, K., additional, Saldana, C., additional, Sevin, E., additional, Amela, Y.E., additional, Von Amsberg, G., additional, Houede, N., additional, Besson, D., additional, Feyerabend, S., additional, Boegemann, M., additional, Pfister, D., additional, Schostak, M., additional, Huillard, O., additional, and Helissey, C., additional

Published
2022
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7. 630P Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial

Author

Gratzke, C.J., primary, Fizazi, K., additional, Shore, N.D., additional, Smith, M.R., additional, Feyerabend, S., additional, Grabbert, M., additional, Carles, J., additional, Lebret, T., additional, Vjaters, E., additional, Werbrouck, P., additional, Miskic, M., additional, Ortiz, J., additional, Schmall, A., additional, Le Berre, M.A., additional, and Verholen, F., additional

Published
2021
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8. 611P Pembrolizumab (pembro) monotherapy for docetaxel-pretreated metastatic castration-resistant prostate cancer (mCRPC): Updated analyses with 4 years of follow-up from cohorts 1-3 of the KEYNOTE-199 study

Author

Antonarakis, E.S., primary, Piulats, J.M., additional, Gross-Goupil, M., additional, Goh, J.C., additional, Vaishampayan, U.N., additional, De Wit, R., additional, Alanko, T.V., additional, Fukasawa, S., additional, Tabata, K., additional, Feyerabend, S., additional, Berger, R., additional, Ojamaa, K., additional, Hoimes, C.J., additional, Sezer, A., additional, Omlin, A.G., additional, Yachnin, J., additional, Niu, C., additional, Poehlein, C.H., additional, Schloss, C., additional, and de Bono, J.S., additional

Published
2021
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9. 618P Apalutamide (APA) for advanced prostate cancer in older patients (pts): Combined analysis of TITAN & SPARTAN

Author

Shen, J., primary, Chowdhury, S., additional, Agarwal, N., additional, Karsh, L.I., additional, Oudard, S., additional, Gartrell, B.A., additional, Feyerabend, S., additional, Saad, F., additional, Pieczonka, C.M., additional, Chi, K.N., additional, Brookman-May, S.D., additional, Rooney, B., additional, Bhaumik, A., additional, Londhe, A., additional, McCarthy, S.A., additional, Bevans, K.B., additional, Mundle, S.D., additional, Small, E.J., additional, Smith, M.R., additional, and Graff, J.N., additional

Published
2021
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10. Clinical benefit and safety profile of darolutamide in patients who crossed over to darolutamide from placebo during the open-label period of the phase 3 ARAMIS study

Author

Feyerabend, S., primary, Shore, N., additional, Smith, M., additional, Kopyltsov, E., additional, Antonyan, I., additional, Damber, J., additional, Gasparro, D., additional, Yildirim, A., additional, Hellstrom, M., additional, Vjaters, E., additional, Ortiz, J., additional, Srinivasan, S., additional, Sarapohja, T., additional, and Fizazi, K., additional

Published
2021
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11. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study

Author

de Wit, R. Wuelfing, C. Castellano, D. Kramer, G. and Eymard, J. -C. Sternberg, C. N. Fizazi, K. Tombal, B. and Bamias, A. Carles, J. Iacovelli, R. Melichar, B. and Sverrisdottir, A. Theodore, C. Feyerabend, S. Helissey, C. and Foster, M. C. Ozatilgan, A. Geffriaud-Ricouard, C. de Bono, J.

Subjects
fungi
Abstract

Background: There is growing evidence that a high neutrophil-to-lymphocyte ratio (NLR) is associated with poor overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC). In the CARD study (NCT02485691), cabazitaxel significantly improved radiographic progression-free survival (rPFS) and OS versus abiraterone or enzalutamide in patients with mCRPC previously treated with docetaxel and the alternative androgen-receptor-targeted agent (ARTA). Here, we investigated NLR as a biomarker. Patients and methods: CARD was a multicenter, open-label study that randomized patients with mCRPC to receive cabazitaxel (25 mg/m(2) every 3 weeks) versus abiraterone (1000 mg/day) or enzalutamide (160 mg/day). The relationships between baseline NLR {[}< versus >= median (3.38)] and rPFS, OS, time to prostate-specific antigen progression, and prostate-specific antigen response to cabazitaxel versus ARTA were evaluated using Kaplan-Meier estimates. Multivariable Cox regression with stepwise selection of covariates was used to investigate the prognostic association between baseline NLR and OS. Results: The rPFS benefit with cabazitaxel versus ARTA was particularly marked in patients with high NLR \{8.5 versus 2.8 months, respectively; hazard ratio (HR) 0.43 {[}95\% confidence interval (CI) 0.27-0.67]; P < 0.0001\}, compared with low NLR {[}7.5 versus 5.1 months, respectively; HR 0.69 (95\% CI 0.45-1.06); P = 0.0860]. Higher NLR (continuous covariate, per 1 unit increase) independently associated with poor OS {[}HR 1.05 (95\% CI 1.02-1.08); P = 0.0003]. For cabazitaxel, there was no OS difference between patients with high versus low NLR (15.3 versus 12.9 months, respectively; P = 0.7465). Patients receiving an ARTA with high NLR, however, had a worse OS versus those with low NLR (9.5 versus 13.3 months, respectively; P = 0.0608). Conclusions: High baseline NLR predicts poor outcomes with an ARTA in patients with mCRPC previously treated with docetaxel and the alternative ARTA. Conversely, the activity of cabazitaxel is retained irrespective of NLR.

Published
2021

12. Baseline neutrophil-to-lymphocyte ratio as a predictive and prognostic biomarker in patients with metastatic castration-resistant prostate cancer treated with cabazitaxel versus abiraterone or enzalutamide in the CARD study.

Author

UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, de Wit, R, Wülfing, C, Castellano, D, Kramer, G, Eymard, J-C, Sternberg, C N, Fizazi, K, Tombal, Bertrand, Bamias, A, Carles, J, Iacovelli, R, Melichar, B, Sverrisdóttir, Á, Theodore, C, Feyerabend, S, Helissey, C, Foster, M C, Ozatilgan, A, Geffriaud-Ricouard, C, de Bono, J, UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, UCL - (SLuc) Service d'urologie, de Wit, R, Wülfing, C, Castellano, D, Kramer, G, Eymard, J-C, Sternberg, C N, Fizazi, K, Tombal, Bertrand, Bamias, A, Carles, J, Iacovelli, R, Melichar, B, Sverrisdóttir, Á, Theodore, C, Feyerabend, S, Helissey, C, Foster, M C, Ozatilgan, A, Geffriaud-Ricouard, C, and de Bono, J

Abstract

There is growing evidence that a high neutrophil-to-lymphocyte ratio (NLR) is associated with poor overall survival (OS) for patients with metastatic castration-resistant prostate cancer (mCRPC). In the CARD study (NCT02485691), cabazitaxel significantly improved radiographic progression-free survival (rPFS) and OS versus abiraterone or enzalutamide in patients with mCRPC previously treated with docetaxel and the alternative androgen-receptor-targeted agent (ARTA). Here, we investigated NLR as a biomarker. CARD was a multicenter, open-label study that randomized patients with mCRPC to receive cabazitaxel (25 mg/m every 3 weeks) versus abiraterone (1000 mg/day) or enzalutamide (160 mg/day). The relationships between baseline NLR [< versus ≥ median (3.38)] and rPFS, OS, time to prostate-specific antigen progression, and prostate-specific antigen response to cabazitaxel versus ARTA were evaluated using Kaplan-Meier estimates. Multivariable Cox regression with stepwise selection of covariates was used to investigate the prognostic association between baseline NLR and OS. The rPFS benefit with cabazitaxel versus ARTA was particularly marked in patients with high NLR {8.5 versus 2.8 months, respectively; hazard ratio (HR) 0.43 [95% confidence interval (CI) 0.27-0.67]; P < 0.0001}, compared with low NLR [7.5 versus 5.1 months, respectively; HR 0.69 (95% CI 0.45-1.06); P = 0.0860]. Higher NLR (continuous covariate, per 1 unit increase) independently associated with poor OS [HR 1.05 (95% CI 1.02-1.08); P = 0.0003]. For cabazitaxel, there was no OS difference between patients with high versus low NLR (15.3 versus 12.9 months, respectively; P = 0.7465). Patients receiving an ARTA with high NLR, however, had a worse OS versus those with low NLR (9.5 versus 13.3 months, respectively; P = 0.0608). High baseline NLR predicts poor outcomes with an ARTA in patients with mCRPC previously treated with docetaxel and the alternative ARTA. Conversely, the activity of cabazitaxel is retai

Published
2021

14. 1836P Blood based biomarkers identify metastatic castration-resistant prostate cancer (mCRPC) with the greatest benefit from continuing enzalutamide (ENZ) beyond progression in combination with docetaxel (Doc): A pre-specified biomarker study of the phase IIIb PRESIDE trial

Author

Ruiz Vico, M., Wetterskog, D., Thakali, S., Orlando, F., Jayaram, A.K., Vainauskas, O., Castellano Gauna, D.E., Martins, K.D., Iwata, K., Gourgioti, G., Serikoff, A., Astrom, L., Matveev, V., Esen, A.A., Feyerabend, S., Senkus-Konefka, E., Gupta, S., Merseburger, A.S., Demichelis, F., and Attard, G.

Published
2023
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15. 1808P Pain response and health-related quality of life (HRQL) analysis in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving cabazitaxel every 2 weeks (16 mg/m2) versus every 3 weeks (25 mg/m2) in the CABASTY phase III trial

Author

Oudard, S., Ratta, R., Voog, E., Barthelemy, P., Thiery-Vuillemin, A., Bennamoun, M., Hasbini, A., Aldabbagh, K., Saldana, C., Von Amsberg, G., Houede, N., Besson, D., Feyerabend, S., Boegemann, M., Falcoz, A., Vernerey, D., Belhouari, H., Kotti, S., Tran, Y., and Helissey, C.

Published
2023
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17. Neutrophil-lymphocyte ratio (NLR) as a prognostic and predictive biomarker in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel (CBZ) vs abiraterone or enzalutamide in the CARD study

Author

de Wit, R. Wuelfing, C. Castellano Gauna, D. Kramer, G. and Eymard, J-C. Sternberg, C. N. Fizazi, K. Tombal, B. and Bamias, A. Carles, J. Iacovelli, R. Melichar, B. and Sverrisdottir, A. Theodore, C. Feyerabend, S. Helissey, C. and Poole, E. M. Ozatilgan, A. Geffriaud-Ricouard, C. de Bono, J.

Published
2020

19. 231P Phase II study of pembrolizumab in docetaxel-pretreated patients with metastatic castration-resistant prostate cancer (mCRPC): Updated follow-up of cohorts (C) 1-3 from KEYNOTE-199

Author

Goh, J.C.H., primary, Piulats, J.M., additional, Gross-Goupil, M., additional, Vaishampayan, U.N., additional, de Wit, R., additional, Alanko, T.V., additional, Fukasawa, S., additional, Tabata, K., additional, Feyerabend, S., additional, Berger, R., additional, Wu, H., additional, Kim, J., additional, Schloss, C., additional, de Bono, J.S., additional, and Antonarakis, E.S., additional

Published
2020
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20. 624P Tolerability of olaparib (OLA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) and homologous recombination repair (HRR) gene alterations: PROfound

Author

Roubaud, G., primary, Ozguroglu, M., additional, Penel, N., additional, Matsubara, N., additional, Mehra, N., additional, Kolinsky, M.P., additional, Procopio, G., additional, Feyerabend, S., additional, Joung, J.Y., additional, Gravis, G., additional, Nishimura, K., additional, Gedye, C., additional, Padua, C., additional, Shore, N., additional, Thiery-Vuillemin, A., additional, Gresty, C., additional, Brickel, N., additional, Burgents, J., additional, Allen, A., additional, and Fizazi, K., additional

Published
2020
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21. 630P Apalutamide for non-metastatic castration resistant prostate cancer (nmCRPC): A comparison of real-life experience from an international named patient program (NPP) vs the prior phase III clinical study

Author

Payne, H.A., primary, Bulbul, M., additional, Hatzimouratidis, K., additional, Feyerabend, S., additional, Kase, M., additional, Manduley, A., additional, McCaffrey, J., additional, Procopio, G., additional, Saad, M., additional, Santoni, M., additional, Sayers, I., additional, Schnöller, T.J., additional, Shatkovskaya, O., additional, Antoni, L., additional, Diels, J., additional, Lopez-Gitlitz, A., additional, McCarthy, S., additional, Mundle, S.D., additional, Pissart, G., additional, and Bögemann, M., additional

Published
2020
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22. 629P Neutrophil-lymphocyte ratio (NLR) as a prognostic and predictive biomarker in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel (CBZ) vs abiraterone or enzalutamide in the CARD study

Author

de Wit, R., primary, Wülfing, C., additional, Castellano Gauna, D., additional, Kramer, G., additional, Eymard, J-C., additional, Sternberg, C.N., additional, Fizazi, K., additional, Tombal, B., additional, Bamias, A., additional, Carles, J., additional, Iacovelli, R., additional, Melichar, B., additional, Sverrisdóttir, Á., additional, Theodore, C., additional, Feyerabend, S., additional, Helissey, C., additional, Poole, E.M., additional, Ozatilgan, A., additional, Geffriaud-Ricouard, C., additional, and de Bono, J., additional

Published
2020
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23. KEYNOTE-365 cohort c updated results: Pembrolizumab (pembro) plus enzalutamide (enza) in abiraterone (abi)-pretreated patients with metastatic Castration-Resistant Prostate Cancer (mCRPC)

Author

Feyerabend, S., primary, Berry, W., additional, Fong, P., additional, Piulats, J.M., additional, Appleman, L., additional, Conter, H., additional, Shore, N., additional, Gravis, G., additional, Laguerre, B., additional, Gurney, H., additional, Retz, M., additional, Romano, E., additional, Mourey, L., additional, De Bono, J., additional, Kam, A., additional, Emmenegger, U., additional, Wu, H., additional, Schloss, C., additional, Poehlein, C., additional, and Yu, E.Y., additional

Published
2020
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24. Pembrolizumab (pembro) plus olaparib in docetaxel-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): KEYNOTE-365 cohort A updated results

Author

Piulats, J.M., primary, Yu, E., additional, Gravis, G., additional, Laguerre, B., additional, Arranz, J., additional, Oudard, S., additional, Fong, P., additional, Kolinsky, M., additional, Augustin, M., additional, Feyerabend, S., additional, Kam, A.., additional, Gurney, H., additional, Tafreshi, A., additional, Retz, M., additional, Berry, W., additional, Mar, N., additional, Wu, H., additional, Schloss, C., additional, Poehlein, C., additional, and De Bono, J., additional

Published
2020
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25. Pembrolizumab (pembro) for docetaxel-pretreated metastatic Castration-Resistant Prostate Cancer (mCRPC): Update on KEYNOTE-199, cohorts 1-3

Author

Piulats, J.M., primary, Antonarakis, E.S., additional, Gross-Goupil, M., additional, Goh, J.C., additional, Vaishampayan, U.N., additional, De Wit, R., additional, Alanko, T., additional, Fukasawa, S., additional, Tabata, K., additional, Feyerabend, S., additional, Berger, R., additional, Wu, H., additional, Kim, J., additional, Schloss, C., additional, and De Bono, J.S., additional

Published
2020
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26. Erratum to: Biomodulatory Treatment of Patients with Castration-Resistant Prostate Cancer: A Phase II Study of Imatinib with Pioglitazone, Etoricoxib, Dexamethasone and Low-Dose Treosulfan

Author

Vogelhuber, M., Feyerabend, S., Stenzl, A., Suedhoff, T., Schulze, M., Huebner, J., Oberneder, R., Wieland, W., Mueller, S., Eichhorn, F., Heinzer, H., Schmidt, K., Baier, M., Ruebel, A., Birkholz, K., Bakhshandeh-Bath, A., Andreesen, R., Herr, W., and Reichle, A.

Published
2015
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27. Assessment of the Safety of Glucocorticoid Regimens in Combination With Abiraterone Acetate: A Randomized, Open-Label Phase 2 Study

Author

Attard, G., Merseburger, A. S., Arlt, W., Sternberg, C. N., Feyerabend, S., Berruti, A., Joniau, S., Geczi, L., Lefresne, F., Lahaye, M., Shelby, F. N., Pissart, G., Chua, S., Jones, R. J., Tombal, B., UCL - SSS/IREC/CHEX - Pôle de chirgurgie expérimentale et transplantation, and UCL - (SLuc) Service d'urologie

Abstract

IMPORTANCE: Abiraterone acetate is combined with prednisone, 5 mg, twice daily for metastatic castration-resistant prostate cancer (mCRPC) and with prednisone, 5 mg, once daily for newly diagnosed, high-risk, metastatic castration-sensitive prostate cancer. Understanding the physiological effects of these and other regimens is important. OBJECTIVE: To evaluate the safety of abiraterone acetate with 4 glucocorticoid regimens. DESIGN, SETTING, AND PARTICIPANTS: Open-label, randomized clinical trial (1:1:1:1) of 164 men with mCRPC from 22 hospitals in 5 countries who were randomly assigned to 1 of 4 intervention groups between June 2013 and October 2014. Analyses were conducted from August 2017 to June 2018. INTERVENTIONS: Abiraterone acetate, 1000 mg, once daily with prednisone, 5 mg, twice daily (n = 41), 5 mg once daily (n = 41), 2.5 mg twice daily (n = 40), or dexamethasone, 0.5 mg, once daily (n = 42). MAIN OUTCOMES AND MEASURES: Primary end point was no mineralocorticoid excess (grade ≥1 hypokalemia or grade ≥2 hypertension) through 24 weeks (6 cycles) from treatment. RESULTS: Of 164 men (median [range] age, 70 [50-90] years) randomized to receive abiraterone acetate, 1000 mg, daily with prednisone, 5 mg, twice daily, once daily, or 2.5 mg twice daily, or dexamethasone, 0.5 mg, once daily, 24 (70.6%) of 34 patients (95% CI, 53.8%-83.2%), 14 (36.8%) of 38 patients (95% CI, 23.4%-52.7%), 21 (60.0%) of 35 patients (95% CI, 43.6%-74.4%), and 26 (70.3%) of 37 patients (95% CI, 54.2%-82.5%), respectively, had no mineralocorticoid excess. Plasma adrenocorticotrophic hormone and urinary mineralocorticoid metabolites after 8 weeks were higher with prednisone, 2.5 mg, twice daily and 5 mg once daily than with 5 mg twice daily or dexamethasone, 0.5 mg, once daily. The level of urinary glucocorticoid metabolites appeared higher in patients who did not meet the primary end point, regardless of glucocorticoid regimen. Total lean body mass decreased in the prednisone groups and total body fat increased in the prednisone, 5 mg, twice daily and dexamethasone groups. In the dexamethasone group, there was an increase in serum insulin and homeostatic model assessment of insulin resistance, while total bone mineral density decreased. In the prednisone, 5 mg, twice daily, 5 mg once daily, 2.5 mg twice daily, and dexamethasone groups, median radiographic progression-free survival was 18.5, 15.3, 12.8, and 26.6 months, respectively. CONCLUSIONS AND RELEVANCE: Abiraterone acetate with prednisone, 5 mg, twice daily or dexamethasone, 0.5 mg, once daily met the prespecified threshold for the primary end point (95% CI excluded 50% mineralocorticoid excess); abiraterone acetate with prednisone, 5 mg, once daily or 2.5 mg twice daily did not meet the threshold. Abiraterone acetate in combination with dexamethasone appeared to be particularly active but may be associated with adverse metabolic consequences. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01867710.

Published
2019

28. Cabazitaxel versus abiraterone or enzalutamide in metastatic prostate cancer

Author

De Wit, R. De Bono, J. Sternberg, C.N. Fizazi, K. Tombal, B. Wülfing, C. Kramer, G. Eymard, J.-C. Bamias, A. Carles, J. Iacovelli, R. Melichar, B. Sverrisdóttir, Á. Theodore, C. Feyerabend, S. Helissey, C. Ozatilgan, A. Geffriaud-Ricouard, C. Castellano, D.

Abstract

BACKGROUND The efficacy and safety of cabazitaxel, as compared with an androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear. METHODS We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling–targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling–targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed. RESULTS A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling–targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P

Published
2019

29. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer

Author

de Wit, R., de Bono, J., Sternberg, C.N., Fizazi, K., Tombal, B., Wulfing, C., Kramer, G., Eymard, J.C., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdottir, A., Theodore, C., Feyerabend, S., Helissey, C., Ozatilgan, A., Oort, I.M. van, Geffriaud-Ricouard, C., Castellano, D., de Wit, R., de Bono, J., Sternberg, C.N., Fizazi, K., Tombal, B., Wulfing, C., Kramer, G., Eymard, J.C., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdottir, A., Theodore, C., Feyerabend, S., Helissey, C., Ozatilgan, A., Oort, I.M. van, Geffriaud-Ricouard, C., and Castellano, D.

Abstract

Contains fulltext : 215761.pdf (publisher's version ) (Open Access), BACKGROUND: The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who were previously treated with docetaxel and had progression within 12 months while receiving the alternative inhibitor (abiraterone or enzalutamide) are unclear. METHODS: We randomly assigned, in a 1:1 ratio, patients who had previously received docetaxel and an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide) to receive cabazitaxel (at a dose of 25 mg per square meter of body-surface area intravenously every 3 weeks, plus prednisone daily and granulocyte colony-stimulating factor) or the other androgen-signaling-targeted inhibitor (either 1000 mg of abiraterone plus prednisone daily or 160 mg of enzalutamide daily). The primary end point was imaging-based progression-free survival. Secondary end points of survival, response, and safety were assessed. RESULTS: A total of 255 patients underwent randomization. After a median follow-up of 9.2 months, imaging-based progression or death was reported in 95 of 129 patients (73.6%) in the cabazitaxel group, as compared with 101 of 126 patients (80.2%) in the group that received an androgen-signaling-targeted inhibitor (hazard ratio, 0.54; 95% confidence interval [CI], 0.40 to 0.73; P<0.001). The median imaging-based progression-free survival was 8.0 months with cabazitaxel and 3.7 months with the androgen-signaling-targeted inhibitor. The median overall survival was 13.6 months with cabazitaxel and 11.0 months with the androgen-signaling-targeted inhibitor (hazard ratio for death, 0.64; 95% CI, 0.46 to 0.89; P = 0.008). The median progression-free survival was 4.4 months with cabazitaxel and 2.7 months with an androgen-signaling-targeted inhibitor (hazard ratio for progression or death, 0.52; 95% CI, 0.40 to 0.68; P<0.001), a prostate-specific antigen response occurred in 35.7% and 13.5% of the patie

Published
2019

30. CARD: Randomized, open-label study of cabazitaxel (CBZ) vs abiraterone (ABI) or enzalutamide (ENZ) in metastatic castration-resistant prostate cancer (mCRPC)

Author

de Wit, R., primary, Kramer, G., additional, Eymard, J.-C., additional, de Bono, J.S., additional, Sternberg, C.N., additional, Fizazi, K., additional, Tombal, B., additional, Wülfing, C., additional, Bamias, A., additional, Carles, J., additional, Iacovelli, R., additional, Melichar, B., additional, Sverrisdottir, A., additional, Theodore, C., additional, Feyerabend, S., additional, Helissey, C., additional, Picard, P., additional, Ozatilgan, A., additional, Geffriaud-Ricouard, C., additional, and Castellano, D., additional

Published
2019
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32. ATLAS: A phase 2, open-label study of rucaparib in patients with locally advanced or metastatic urothelial carcinoma

Author

Rodriguez-Vida, A., primary, Feyerabend, S., additional, Loriot, Y., additional, Necchi, A., additional, Gupta, S., additional, Josephs, D., additional, Srinivas, S., additional, Zakharia, Y., additional, Nepert, D., additional, Wride, K., additional, Thomas, D., additional, Dusek, R., additional, Simmons, A., additional, Grivas, P., additional, and Chowdhury, S., additional

Published
2019
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33. Sparing androgen-deprivation therapy upon treatment with abiraterone in patients with chemotherapy-naive castration-resistant prostate cancer: Results from the SPARE-trial (NCT02077634)

Author

Ohlmann, C.H., primary, Zilmann, R., additional, Rüssel, C., additional, Hellmis, E., additional, Suttmann, H., additional, Janssen, M., additional, Marin, J., additional, Hübner, A., additional, Dahm, J., additional, Gleißner, J., additional, Scheffler, M., additional, Feyerabend, S., additional, Telle, J., additional, Jäschke, M., additional, and Klier, J., additional

Published
2019
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34. TRITON2: An International, Multicentre, Open-Label Phase 2 Study of the PARP Inhibitor Rucaparib in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Associated with Homologous Recombination Deficiency (HRD)

Author

Heidenreich, A., Carl, S., Feyerabend, S., Gleissner, J., Gruellich, C., Heinrich, B., Merseburger, A., Miller, K., Stenzl, A., Steuber, T., Wirth, M., Watkins, S., Simmons, A., Go, J., Golsorkhi, T., Abida, W., Scher, H. I., Heidenreich, A., Carl, S., Feyerabend, S., Gleissner, J., Gruellich, C., Heinrich, B., Merseburger, A., Miller, K., Stenzl, A., Steuber, T., Wirth, M., Watkins, S., Simmons, A., Go, J., Golsorkhi, T., Abida, W., and Scher, H. I.

Published
2018

35. TRITON3: An International, Randomised, Open-Label Phase 3 Study of the PARP Inhibitor Rucaparib vs Physician's Choice of Therapy for Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Associate with Homologous Recombination Deficiency (HRD)

Author

Merseburger, A., Carl, S., Feyerabend, S., Gleissner, J., Grimm, M. -O., Gruellich, C., Heidenreich, A., Heinrich, B., Miller, K., Stenzl, A., Steuber, T., Wirth, M., Watkins, S., Simmons, A., Passler, L., Shetty, S., Golsorkhi, T., Ryan, C., Chowdhury, S., Merseburger, A., Carl, S., Feyerabend, S., Gleissner, J., Grimm, M. -O., Gruellich, C., Heidenreich, A., Heinrich, B., Miller, K., Stenzl, A., Steuber, T., Wirth, M., Watkins, S., Simmons, A., Passler, L., Shetty, S., Golsorkhi, T., Ryan, C., and Chowdhury, S.

Published
2018

36. PROfound: A randomized phase III trial evaluating olaparib in patients with metastatic castration-resistant prostate cancer and a deleterious homologous recombination DNA repair aberration

Author

Binder, M, Ebert, T, Gleissner, J, Grüllich, C, Hellmis, E, Hölzer, W, Klier, J, Machtens, S, Stenzl, A, Suttmann, H, Feyerabend, S, Schmall, A, Binder, M, Ebert, T, Gleissner, J, Grüllich, C, Hellmis, E, Hölzer, W, Klier, J, Machtens, S, Stenzl, A, Suttmann, H, Feyerabend, S, and Schmall, A

Published
2018

37. LATITUDE study: PSA response characteristics and correlation with overall survival (OS) and radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) receiving ADT+abiraterone acetate and prednisone (AAP) or placebo (PBO)

Author

Matsubara, N., primary, Chi, K.N., additional, Ozguroglu, M., additional, Rodriguez Antolin, A., additional, Feyerabend, S., additional, Fein, L., additional, Alekseev, B.Y., additional, Sulur, G., additional, Protheroe, A., additional, Li, S., additional, Mundle, S.D., additional, De Porre, P., additional, Tran, N., additional, and Fazazi, K., additional

Published
2018
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38. Abiraterone acetate plus prednisone and LHRH therapy versus abiraterone acetate plus prednisone while sparing LHRH therapy in patients with progressive, metastatic and chemotherapy-naïve, castration-resistant prostate cancer: Results from the SPARE-trial (NCT02077634)

Author

Ohlmann, C., primary, Roger, Z., additional, Rüssel, C., additional, Hellmis, E., additional, Suttmann, H., additional, Janssen, M., additional, Hübner, A., additional, Dahm, J., additional, Gleißner, J., additional, Scheffler, M., additional, Feyerabend, S., additional, Telle, J., additional, and Klier, J., additional

Published
2018
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39. ATLAS: A phase II, open-label study of rucaparib in patients (pts) with locally advanced (unresectable) or metastatic urothelial carcinoma

Author

Chowdhury, S., primary, Feyerabend, S., additional, Loriot, Y., additional, Necchi, A., additional, Gupta, S., additional, Josephs, D.H., additional, Rodríguez-Vida, A., additional, Srinivas, S., additional, Zakharia, Y., additional, Nepert, D., additional, Wride, K., additional, Thomas, D., additional, Loehr, A., additional, Simmons, A.D., additional, and Grivas, P., additional

Published
2018
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40. Results of the randomized, placebo-controlled phase I/IIB trial of CV9104, an mRNA based cancer immunotherapy, in patients with metastatic castration-resistant prostate cancer (mCRPC)

Author

Stenzl, A., Feyerabend, S., Syndikus, I., Sarosiek, T., Kuebler, H., Heidenreich, A., Cathomas, R., Gruellich, C., Loriot, Y., Perez Gracia, S. L., Gillessen, S., Klinkhardt, U., Schroeder, A., Schoenborn-Kellenberger, O., Reus, V., Koch, S. D., Hong, H. S., Seibel, T., Fizazi, K., Gnad-Vogt, U., Stenzl, A., Feyerabend, S., Syndikus, I., Sarosiek, T., Kuebler, H., Heidenreich, A., Cathomas, R., Gruellich, C., Loriot, Y., Perez Gracia, S. L., Gillessen, S., Klinkhardt, U., Schroeder, A., Schoenborn-Kellenberger, O., Reus, V., Koch, S. D., Hong, H. S., Seibel, T., Fizazi, K., and Gnad-Vogt, U.

Published
2017

42. Results of the randomized, placebo-controlled phase I/IIB trial of CV9104, an mRNA based cancer immunotherapy, in patients with metastatic castration-resistant prostate cancer (mCRPC)

Author

Stenzl, A., primary, Feyerabend, S., additional, Syndikus, I., additional, Sarosiek, T., additional, Kübler, H., additional, Heidenreich, A., additional, Cathomas, R., additional, Grüllich, C., additional, Loriot, Y., additional, Perez Gracia, S.L., additional, Gillessen, S., additional, Klinkhardt, U., additional, Schröder, A., additional, Schönborn-Kellenberger, O., additional, Reus, V., additional, Koch, S.D., additional, Hong, H.S., additional, Seibel, T., additional, Fizazi, K., additional, and Gnad-Vogt, U., additional

Published
2017
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44. Prospective, non-interventional study on the influence of adherence measures on the therapy with Abiraterone Acetate (AA) + Prednisone/prednisolone (P) in patients with metastatic, castration resistant prostate carcinoma

Author

Suttmann, H., primary, Feyerabend, S., additional, Gleissner, J., additional, Huebner, A., additional, Neugebauer, E., additional, Mathes, T., additional, Baurecht, W., additional, Schuier, N., additional, and Tran, N., additional

Published
2016
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45. LBA13 - CARD: Randomized, open-label study of cabazitaxel (CBZ) vs abiraterone (ABI) or enzalutamide (ENZ) in metastatic castration-resistant prostate cancer (mCRPC)

Author

de Wit, R., Kramer, G., Eymard, J.-C., de Bono, J.S., Sternberg, C.N., Fizazi, K., Tombal, B., Wülfing, C., Bamias, A., Carles, J., Iacovelli, R., Melichar, B., Sverrisdottir, A., Theodore, C., Feyerabend, S., Helissey, C., Picard, P., Ozatilgan, A., Geffriaud-Ricouard, C., and Castellano, D.

Published
2019
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49. The prostate cancer registry: Patient characteristics, treatments and preliminary outcomes from a large observational study of metastatic castration-resistant prostate cancer (mCRPC)

Author

Chowdhury, S., primary, Birtle, A.J., additional, Bjartell, A., additional, Costa, L.A.M., additional, Feyerabend, S., additional, Galli, L., additional, Kalinka-Warzocha, E., additional, Kramer, G., additional, Rey, J.P. Maroto, additional, Lumen, N., additional, Matveev, V.B., additional, Paiss, T., additional, Spaeth, D., additional, Antoni, L., additional, Klumper, E., additional, Wapenaar, R., additional, and Lee, E., additional

Published
2016
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50. 762 Results of a phase I/II study in metastatic renal cell carcinoma patients treated with an adjuvant HLA personalized peptide vaccine after resection of metastases and comparison to a contemporary cohort of patients with mRCC

Author

Bedke, J., primary, Rausch, S., additional, Gouttefangeas, C., additional, Kruck, S., additional, Walter, K., additional, Feyerabend, S., additional, Hennenlotter, J., additional, Laske, K., additional, Stevanovic, S., additional, Rammensee, H-G., additional, and Stenzl, A., additional

Published
2016
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