Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA.
Identifieur interne : 000296 ( PubMed/Corpus ); précédent : 000295; suivant : 000297Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA.
Auteurs : Mario Eisenberger ; Anne-Claire Hardy-Bessard ; Choung Soo Kim ; Lajos Géczi ; Daniel Ford ; Loïc Mourey ; Joan Carles ; Phillip Parente ; Albert Font ; Gabriel Kacso ; Mustapha Chadjaa ; Wenping Zhang ; John Bernard ; Johann De BonoSource :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology [ 1527-7755 ] ; 2017.
English descriptors
- KwdEn :
- MESH :
- chemical , administration & dosage : Antineoplastic Agents, Taxoids.
- drug therapy : Prostatic Neoplasms, Castration-Resistant.
- chemical , therapeutic use : Taxoids.
- Aged, Disease-Free Survival, Dose-Response Relationship, Drug, Humans, Kaplan-Meier Estimate, Male.
Abstract
Purpose Cabazitaxel 25 mg/m(2) (C25) significantly improved overall survival (OS) versus mitoxantrone ( P < .001) in postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III TROPIC study. The phase III PROSELICA study ( ClinicalTrials.gov identifier: NCT01308580) assessed the noninferiority of cabazitaxel 20 mg/m(2) (C20) versus C25 in postdocetaxel patients with mCRPC. Methods Patients were stratified by Eastern Cooperative Oncology Group performance status, measurability of disease per Response Evaluation Criteria in Solid Tumors (RECIST), and region, and randomly assigned to receive C20 or C25. To claim noninferiority of C20 (maintenance of ≥ 50% of the OS benefit of C25 v mitoxantrone in TROPIC) with 95% confidence level, the upper boundary of the CI of the hazard ratio (HR) for C20 versus C25 could not exceed 1.214 under a one-sided 98.89% CI after interim analyses. Secondary end points included progression-free survival, prostate-specific antigen (PSA), tumor and pain responses and progression, health-related quality of life, and safety. Results Overall, 1,200 patients were randomly assigned (C20, n = 598; C25, n = 602). Baseline characteristics were similar in both arms. Median OS was 13.4 months for C20 and 14.5 months for C25 (HR, 1.024). The upper boundary of the HR CI was 1.184 (less than the 1.214 noninferiority margin). Significant differences were observed in favor of C25 for PSA response (C20, 29.5%; C25, 42.9%; nominal P < .001) and time to PSA progression (median: C20, 5.7 months; C25, 6.8 months; HR for C20 v C25, 1.195; 95% CI, 1.025 to 1.393). Health-related quality of life did not differ between cohorts. Rates of grade 3 or 4 treatment-emergent adverse events were 39.7% for C20 and 54.5% for C25. Conclusion The efficacy of cabazitaxel in postdocetaxel patients with mCRPC was confirmed. The noninferiority end point was met; C20 maintained ≥ 50% of the OS benefit of C25 versus mitoxantrone in TROPIC. Secondary efficacy end points favored C25. Fewer adverse events were observed with C20.
DOI: 10.1200/JCO.2016.72.1076
PubMed: 28809610
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA.</title><author><name sortKey="Eisenberger, Mario" sort="Eisenberger, Mario" uniqKey="Eisenberger M" first="Mario" last="Eisenberger">Mario Eisenberger</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Hardy Bessard, Anne Claire" sort="Hardy Bessard, Anne Claire" uniqKey="Hardy Bessard A" first="Anne-Claire" last="Hardy-Bessard">Anne-Claire Hardy-Bessard</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Choung Soo" sort="Kim, Choung Soo" uniqKey="Kim C" first="Choung Soo" last="Kim">Choung Soo Kim</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Geczi, Lajos" sort="Geczi, Lajos" uniqKey="Geczi L" first="Lajos" last="Géczi">Lajos Géczi</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Ford, Daniel" sort="Ford, Daniel" uniqKey="Ford D" first="Daniel" last="Ford">Daniel Ford</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Mourey, Loic" sort="Mourey, Loic" uniqKey="Mourey L" first="Loïc" last="Mourey">Loïc Mourey</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Parente, Phillip" sort="Parente, Phillip" uniqKey="Parente P" first="Phillip" last="Parente">Phillip Parente</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Font, Albert" sort="Font, Albert" uniqKey="Font A" first="Albert" last="Font">Albert Font</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Kacso, Gabriel" sort="Kacso, Gabriel" uniqKey="Kacso G" first="Gabriel" last="Kacso">Gabriel Kacso</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Chadjaa, Mustapha" sort="Chadjaa, Mustapha" uniqKey="Chadjaa M" first="Mustapha" last="Chadjaa">Mustapha Chadjaa</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Wenping" sort="Zhang, Wenping" uniqKey="Zhang W" first="Wenping" last="Zhang">Wenping Zhang</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Bernard, John" sort="Bernard, John" uniqKey="Bernard J" first="John" last="Bernard">John Bernard</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="De Bono, Johann" sort="De Bono, Johann" uniqKey="De Bono J" first="Johann" last="De Bono">Johann De Bono</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28809610</idno><idno type="pmid">28809610</idno><idno type="doi">10.1200/JCO.2016.72.1076</idno><idno type="wicri:Area/PubMed/Corpus">000296</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000296</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA.</title><author><name sortKey="Eisenberger, Mario" sort="Eisenberger, Mario" uniqKey="Eisenberger M" first="Mario" last="Eisenberger">Mario Eisenberger</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Hardy Bessard, Anne Claire" sort="Hardy Bessard, Anne Claire" uniqKey="Hardy Bessard A" first="Anne-Claire" last="Hardy-Bessard">Anne-Claire Hardy-Bessard</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Choung Soo" sort="Kim, Choung Soo" uniqKey="Kim C" first="Choung Soo" last="Kim">Choung Soo Kim</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Geczi, Lajos" sort="Geczi, Lajos" uniqKey="Geczi L" first="Lajos" last="Géczi">Lajos Géczi</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Ford, Daniel" sort="Ford, Daniel" uniqKey="Ford D" first="Daniel" last="Ford">Daniel Ford</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Mourey, Loic" sort="Mourey, Loic" uniqKey="Mourey L" first="Loïc" last="Mourey">Loïc Mourey</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Carles, Joan" sort="Carles, Joan" uniqKey="Carles J" first="Joan" last="Carles">Joan Carles</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Parente, Phillip" sort="Parente, Phillip" uniqKey="Parente P" first="Phillip" last="Parente">Phillip Parente</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Font, Albert" sort="Font, Albert" uniqKey="Font A" first="Albert" last="Font">Albert Font</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Kacso, Gabriel" sort="Kacso, Gabriel" uniqKey="Kacso G" first="Gabriel" last="Kacso">Gabriel Kacso</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Chadjaa, Mustapha" sort="Chadjaa, Mustapha" uniqKey="Chadjaa M" first="Mustapha" last="Chadjaa">Mustapha Chadjaa</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Wenping" sort="Zhang, Wenping" uniqKey="Zhang W" first="Wenping" last="Zhang">Wenping Zhang</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="Bernard, John" sort="Bernard, John" uniqKey="Bernard J" first="John" last="Bernard">John Bernard</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author><author><name sortKey="De Bono, Johann" sort="De Bono, Johann" uniqKey="De Bono J" first="Johann" last="De Bono">Johann De Bono</name><affiliation><nlm:affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of clinical oncology : official journal of the American Society of Clinical Oncology</title><idno type="eISSN">1527-7755</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Antineoplastic Agents (administration & dosage)</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Prostatic Neoplasms, Castration-Resistant (drug therapy)</term><term>Taxoids (administration & dosage)</term><term>Taxoids (therapeutic use)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term><term>Taxoids</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Taxoids</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose Cabazitaxel 25 mg/m(2) (C25) significantly improved overall survival (OS) versus mitoxantrone ( P < .001) in postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III TROPIC study. The phase III PROSELICA study ( ClinicalTrials.gov identifier: NCT01308580) assessed the noninferiority of cabazitaxel 20 mg/m(2) (C20) versus C25 in postdocetaxel patients with mCRPC. Methods Patients were stratified by Eastern Cooperative Oncology Group performance status, measurability of disease per Response Evaluation Criteria in Solid Tumors (RECIST), and region, and randomly assigned to receive C20 or C25. To claim noninferiority of C20 (maintenance of ≥ 50% of the OS benefit of C25 v mitoxantrone in TROPIC) with 95% confidence level, the upper boundary of the CI of the hazard ratio (HR) for C20 versus C25 could not exceed 1.214 under a one-sided 98.89% CI after interim analyses. Secondary end points included progression-free survival, prostate-specific antigen (PSA), tumor and pain responses and progression, health-related quality of life, and safety. Results Overall, 1,200 patients were randomly assigned (C20, n = 598; C25, n = 602). Baseline characteristics were similar in both arms. Median OS was 13.4 months for C20 and 14.5 months for C25 (HR, 1.024). The upper boundary of the HR CI was 1.184 (less than the 1.214 noninferiority margin). Significant differences were observed in favor of C25 for PSA response (C20, 29.5%; C25, 42.9%; nominal P < .001) and time to PSA progression (median: C20, 5.7 months; C25, 6.8 months; HR for C20 v C25, 1.195; 95% CI, 1.025 to 1.393). Health-related quality of life did not differ between cohorts. Rates of grade 3 or 4 treatment-emergent adverse events were 39.7% for C20 and 54.5% for C25. Conclusion The efficacy of cabazitaxel in postdocetaxel patients with mCRPC was confirmed. The noninferiority end point was met; C20 maintained ≥ 50% of the OS benefit of C25 versus mitoxantrone in TROPIC. Secondary efficacy end points favored C25. Fewer adverse events were observed with C20.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28809610</PMID><DateCreated><Year>2017</Year><Month>08</Month><Day>15</Day></DateCreated><DateCompleted><Year>2017</Year><Month>10</Month><Day>02</Day></DateCompleted><DateRevised><Year>2017</Year><Month>10</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1527-7755</ISSN><JournalIssue CitedMedium="Internet"><Volume>35</Volume><Issue>28</Issue><PubDate><Year>2017</Year><Month>Oct</Month><Day>01</Day></PubDate></JournalIssue><Title>Journal of clinical oncology : official journal of the American Society of Clinical Oncology</Title><ISOAbbreviation>J. Clin. Oncol.</ISOAbbreviation></Journal><ArticleTitle>Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m(2)) and the Currently Approved Dose (25 mg/m(2)) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA.</ArticleTitle><Pagination><MedlinePgn>3198-3206</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1200/JCO.2016.72.1076</ELocationID><Abstract><AbstractText>Purpose Cabazitaxel 25 mg/m(2) (C25) significantly improved overall survival (OS) versus mitoxantrone ( P < .001) in postdocetaxel patients with metastatic castration-resistant prostate cancer (mCRPC) in the phase III TROPIC study. The phase III PROSELICA study ( ClinicalTrials.gov identifier: NCT01308580) assessed the noninferiority of cabazitaxel 20 mg/m(2) (C20) versus C25 in postdocetaxel patients with mCRPC. Methods Patients were stratified by Eastern Cooperative Oncology Group performance status, measurability of disease per Response Evaluation Criteria in Solid Tumors (RECIST), and region, and randomly assigned to receive C20 or C25. To claim noninferiority of C20 (maintenance of ≥ 50% of the OS benefit of C25 v mitoxantrone in TROPIC) with 95% confidence level, the upper boundary of the CI of the hazard ratio (HR) for C20 versus C25 could not exceed 1.214 under a one-sided 98.89% CI after interim analyses. Secondary end points included progression-free survival, prostate-specific antigen (PSA), tumor and pain responses and progression, health-related quality of life, and safety. Results Overall, 1,200 patients were randomly assigned (C20, n = 598; C25, n = 602). Baseline characteristics were similar in both arms. Median OS was 13.4 months for C20 and 14.5 months for C25 (HR, 1.024). The upper boundary of the HR CI was 1.184 (less than the 1.214 noninferiority margin). Significant differences were observed in favor of C25 for PSA response (C20, 29.5%; C25, 42.9%; nominal P < .001) and time to PSA progression (median: C20, 5.7 months; C25, 6.8 months; HR for C20 v C25, 1.195; 95% CI, 1.025 to 1.393). Health-related quality of life did not differ between cohorts. Rates of grade 3 or 4 treatment-emergent adverse events were 39.7% for C20 and 54.5% for C25. Conclusion The efficacy of cabazitaxel in postdocetaxel patients with mCRPC was confirmed. The noninferiority end point was met; C20 maintained ≥ 50% of the OS benefit of C25 versus mitoxantrone in TROPIC. Secondary efficacy end points favored C25. Fewer adverse events were observed with C20.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Eisenberger</LastName><ForeName>Mario</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hardy-Bessard</LastName><ForeName>Anne-Claire</ForeName><Initials>AC</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Choung Soo</ForeName><Initials>CS</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Géczi</LastName><ForeName>Lajos</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ford</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mourey</LastName><ForeName>Loïc</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carles</LastName><ForeName>Joan</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Parente</LastName><ForeName>Phillip</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Font</LastName><ForeName>Albert</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kacso</LastName><ForeName>Gabriel</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chadjaa</LastName><ForeName>Mustapha</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Wenping</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bernard</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>de Bono</LastName><ForeName>Johann</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Mario Eisenberger, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Anne-Claire Hardy-Bessard, Centre Armoricain d'Oncologie, Centre Armoricain de Radiothérapie, d'Imagerie Médicale et d'Oncologie-Hôpital Privé Des Côtes d'Armor, Plérin; Loïc Mourey, Institut Claudius Regaud, l'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse; Mustapha Chadjaa, Sanofi, Vitry-sur-Seine, France; Choung Soo Kim, Asan Medical Center, Seoul, South Korea; Lajos Géczi, National Institute of Oncology, Budapest, Hungary; Daniel Ford, City Hospital, Cancer Centre at Queen Elizabeth Hospital, Birmingham; Johann de Bono, Prostate Cancer Targeted Therapy Team, Royal Marsden National Health Service Foundation Trust/The Institute of Cancer Research, Sutton, United Kingdom; Joan Carles, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona; Phillip Parente, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Victoria, Australia; Albert Font, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Gabriel Kacso, Iuliu Hatieganu Medical University, Amethyst Radiology Therapeutic Center, Cluj, Romania; Wenping Zhang, Sanofi, Bridgewater, NJ; and John Bernard, Sanofi, Cambridge, MA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>08</Month><Day>15</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Clin Oncol</MedlineTA><NlmUniqueID>8309333</NlmUniqueID><ISSNLinking>0732-183X</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D043823">Taxoids</NameOfSubstance></Chemical><Chemical><RegistryNumber>15H5577CQD</RegistryNumber><NameOfSubstance UI="C067311">docetaxel</NameOfSubstance></Chemical><Chemical><RegistryNumber>51F690397J</RegistryNumber><NameOfSubstance UI="C552428">cabazitaxel</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004305" MajorTopicYN="N">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D064129" MajorTopicYN="N">Prostatic Neoplasms, Castration-Resistant</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D043823" MajorTopicYN="N">Taxoids</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>10</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28809610</ArticleId><ArticleId IdType="doi">10.1200/JCO.2016.72.1076</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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