Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer

A randomized trial involving patients with metastatic prostate cancer whose disease progressed after receipt of docetaxel and hormonal therapy showed that cabazitaxel was superior to an androgen-signaling–targeted agent in extending imaging-based progression-free survival, overall survival, and PSA...

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Published inThe New England journal of medicine Vol. 381; no. 26; pp. 2506 - 2518
Main Authors de Wit, Ronald, de Bono, Johann, Sternberg, Cora N, Fizazi, Karim, Tombal, Bertrand, Wülfing, Christian, Kramer, Gero, Eymard, Jean-Christophe, Bamias, Aristotelis, Carles, Joan, Iacovelli, Roberto, Melichar, Bohuslav, Sverrisdóttir, Ásgerður, Theodore, Christine, Feyerabend, Susan, Helissey, Carole, Ozatilgan, Ayse, Geffriaud-Ricouard, Christine, Castellano, Daniel
Format Journal Article
LanguageEnglish
Published United States Massachusetts Medical Society 26.12.2019
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Abstract A randomized trial involving patients with metastatic prostate cancer whose disease progressed after receipt of docetaxel and hormonal therapy showed that cabazitaxel was superior to an androgen-signaling–targeted agent in extending imaging-based progression-free survival, overall survival, and PSA response.
AbstractList BackgroundThe 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.MethodsWe 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.ResultsA 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 patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P=0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling–targeted inhibitor. No new safety signals were observed.ConclusionsCabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling–targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.)
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. 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. 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 patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed. Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).
A randomized trial involving patients with metastatic prostate cancer whose disease progressed after receipt of docetaxel and hormonal therapy showed that cabazitaxel was superior to an androgen-signaling–targeted agent in extending imaging-based progression-free survival, overall survival, and PSA response.
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.BACKGROUNDThe 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.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.METHODSWe 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.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 patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed.RESULTSA 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 patients, respectively (P<0.001), and tumor response was noted in 36.5% and 11.5% (P = 0.004). Adverse events of grade 3 or higher occurred in 56.3% of patients receiving cabazitaxel and in 52.4% of those receiving an androgen-signaling-targeted inhibitor. No new safety signals were observed.Cabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).CONCLUSIONSCabazitaxel significantly improved a number of clinical outcomes, as compared with the androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic castration-resistant prostate cancer who had been previously treated with docetaxel and the alternative androgen-signaling-targeted agent (abiraterone or enzalutamide). (Funded by Sanofi; CARD ClinicalTrials.gov number, NCT02485691.).
Author Feyerabend, Susan
Iacovelli, Roberto
Sverrisdóttir, Ásgerður
de Wit, Ronald
Ozatilgan, Ayse
Fizazi, Karim
Melichar, Bohuslav
Castellano, Daniel
de Bono, Johann
Bamias, Aristotelis
Tombal, Bertrand
Eymard, Jean-Christophe
Helissey, Carole
Theodore, Christine
Sternberg, Cora N
Carles, Joan
Geffriaud-Ricouard, Christine
Wülfing, Christian
Kramer, Gero
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  givenname: Ronald
  surname: de Wit
  fullname: de Wit, Ronald
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 2
  givenname: Johann
  surname: de Bono
  fullname: de Bono, Johann
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 3
  givenname: Cora N
  surname: Sternberg
  fullname: Sternberg, Cora N
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 4
  givenname: Karim
  surname: Fizazi
  fullname: Fizazi, Karim
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 5
  givenname: Bertrand
  surname: Tombal
  fullname: Tombal, Bertrand
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 6
  givenname: Christian
  surname: Wülfing
  fullname: Wülfing, Christian
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 7
  givenname: Gero
  surname: Kramer
  fullname: Kramer, Gero
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 8
  givenname: Jean-Christophe
  surname: Eymard
  fullname: Eymard, Jean-Christophe
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 9
  givenname: Aristotelis
  surname: Bamias
  fullname: Bamias, Aristotelis
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 10
  givenname: Joan
  surname: Carles
  fullname: Carles, Joan
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 11
  givenname: Roberto
  surname: Iacovelli
  fullname: Iacovelli, Roberto
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 12
  givenname: Bohuslav
  surname: Melichar
  fullname: Melichar, Bohuslav
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 13
  givenname: Ásgerður
  surname: Sverrisdóttir
  fullname: Sverrisdóttir, Ásgerður
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 14
  givenname: Christine
  surname: Theodore
  fullname: Theodore, Christine
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 15
  givenname: Susan
  surname: Feyerabend
  fullname: Feyerabend, Susan
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 16
  givenname: Carole
  surname: Helissey
  fullname: Helissey, Carole
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 17
  givenname: Ayse
  surname: Ozatilgan
  fullname: Ozatilgan, Ayse
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 18
  givenname: Christine
  surname: Geffriaud-Ricouard
  fullname: Geffriaud-Ricouard, Christine
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
– sequence: 19
  givenname: Daniel
  surname: Castellano
  fullname: Castellano, Daniel
  organization: From the Erasmus Medical Center, Rotterdam, the Netherlands (R.W.); the Institute of Cancer Research and the Royal Marsden Hospital, London (J.B.); Englander Institute for Precision Medicine, Weill Cornell Medicine, New York (C.N.S.); Institut Gustave Roussy and University of Paris Sud, Villejuif (K.F.), Jean Godinot Institute and Reims Champagne–Ardenne University, Reims (J.-C.E.), Foch Hospital, Suresnes (C.T.), Hôpital d’Instruction des Armées Bégin, Saint Mandé (C.H.), and Sanofi, Europe Medical Oncology, Paris (C.G.-R.) — all in France; Institut de Recherche Clinique, Université Catholique de Louvain, Louvain, Belgium (B.T.); the Department of Urology, Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona, Hamburg (C.W.), and Studienpraxis Urologie, Nürtingen (S.F.) — both in Germany; the Medical University of Vienna, Vienna (G.K.); Alexandra Hospital, National and Kapodistrian University of Athens, Athens (A.B.); Vall d’Hebron Institute of Oncology, Vall d’Hebron University Hospital, Barcelona (J.C.); Azienda Ospedaliera Universitaria Integrata, Verona, and Fondazione Policlinico Agostino Gemelli IRCCS, Rome — both in Italy (R.I.); Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic (B.M.); Landspitali University Hospital, Reykjavik, Iceland (Á.S.); Sanofi, Global Medical Oncology, Cambridge, MA (A.O.); and 12 de Octubre University Hospital, Madrid (D.C.)
BackLink https://www.ncbi.nlm.nih.gov/pubmed/31566937$$D View this record in MEDLINE/PubMed
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Iacovelli, Roberto
van Oort, Inge
Melichar, Bohuslav
Pérez Valderrama, Begoña
Schostak, Martin
Verschaeve, Vincent
Sternberg, Cora
Westgeest, Hans
Peters, Frank
Ritter, Manuel
Duran, Ignacio
McDermott, Ray
Welslau, Manfred
Barthelemy, Philippe
Mahammedi, Hakim
Fizazi, Karim
Gasparro, Donatello
Eymard, Jean-Christophe
Loidl, Wolfgang
Galceran, Joan Carles
Hellmis, Eva
Maeseneer, Daan De
Krainer, Michael
Kocak, Ivo
Merseburger, Axel
Finek, Jindrich
Matouskova, Michaela
Bögemann, Martin
Aglietta, Massimo
Kramer, Gero
Feyerabend, Susan
Théodore, Christine
Ertl, Sebastian
de Wit, Ronald
Dumez, Herlinde
Castellano, Daniel
Hardy-Bessard, Anne-Claire
Tombal, Bertrand
Helissey, Carole
Berruti, Alfredo
Strauss, Arne
Gil, Thierry
Wülfing, Christian
Culine, Stephane
Hübner, Andreas
Azria, David
Papandreou, Christos
Bamias, Aristotelis
Nuhn, Philipp
Efstathiou, Eleni
Gravis, Gwenaëlle
Koenig, Franck
Facchini, Gaetano
Knobel, Heidi
Martinez Chanza, Nieves
Falcone, Alfredo
Rottey, Sylvie
Linassier, Claude
Grimm, Marc-Oliver
McCaffey, John
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Snippet A randomized trial involving patients with metastatic prostate cancer whose disease progressed after receipt of docetaxel and hormonal therapy showed that...
The efficacy and safety of cabazitaxel, as compared with an androgen-signaling-targeted inhibitor (abiraterone or enzalutamide), in patients with metastatic...
BackgroundThe efficacy and safety of cabazitaxel, as compared with an androgen-signaling–targeted inhibitor (abiraterone or enzalutamide), in patients with...
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SubjectTerms Aged
Aged, 80 and over
Analgesics
Androgen Antagonists - administration & dosage
Androgen Antagonists - adverse effects
Androgens
Androstenes - administration & dosage
Androstenes - adverse effects
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Cancer therapies
Castration
Colony-stimulating factor
Death
Granulocyte colony-stimulating factor
Humans
Infusions, Intravenous
Kaplan-Meier Estimate
Leukocytes (granulocytic)
Male
Metastases
Metastasis
Middle Aged
Pain
Patients
Phenylthiohydantoin - administration & dosage
Phenylthiohydantoin - adverse effects
Phenylthiohydantoin - analogs & derivatives
Prednisone
Prednisone - administration & dosage
Progression-Free Survival
Prostate cancer
Prostate-specific antigen
Prostatic Neoplasms, Castration-Resistant - drug therapy
Prostatic Neoplasms, Castration-Resistant - mortality
Safety
Survival
Taxoids - administration & dosage
Taxoids - adverse effects
Working groups
Title Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer
URI https://nejm.org/doi/full/10.1056/NEJMoa1911206
https://www.ncbi.nlm.nih.gov/pubmed/31566937
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https://www.proquest.com/docview/2299457633
Volume 381
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