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Genitourinary tumours, prostate

3045 - FIRSTANA: Health-related quality of life (HRQL) and post-hoc analyses for the phase III study assessing cabazitaxel (C) vs docetaxel (D) in chemotherapy-naïve patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)


09 Oct 2016


Genitourinary tumours, prostate


Stephane Oudard


Annals of Oncology (2016) 27 (6): 243-265. 10.1093/annonc/mdw372


S. Oudard1, O. Sartor2, L. Sengeløv3, G. Daugaard4, F. Saad5, S. Hansen6, M. Hjelm-Eriksson7, J. Jassem8, A. Thiery-Vuillemin9, O. Caffo10, D. Castellano11, P.N. Mainwaring12, J. Bernard13, L. Shen14, M. Chadjaa15, K. Fizazi16

Author affiliations

  • 1 Medical Oncology Service, Hopital European George Pompidou, 75015 - Paris/FR
  • 2 Medicine And Urology, Tulane Cancer Center, 70112 - New Orleans/US
  • 3 Department Of Oncology, University Hospital Herlev, Herlev/DK
  • 4 Department Of Oncology, Rigshospitalet, Copenhagen University Hospital, 2100 - Copenhagen/DK
  • 5 Urologic Oncology, University of Montreal Health Center, Montreal/CA
  • 6 Oncology, Odense University Hospital, Odense C/DK
  • 7 Oncology, Karolinska University Hospital-Radiumhemmet, Stockholm/SE
  • 8 Oncology And Radiotherapy, Medical University of Gdansk, 80-211 - Gdansk/PL
  • 9 Medical Oncology, CHU Minjoz Besançon, 25030 - Besançon/FR
  • 10 Medical Oncology, Ospedale Sta Chiara, 38122 - Trento/IT
  • 11 Medical Oncology, University Hospital 12 De Octubre, Madrid/ES
  • 12 Medical Oncology, ICON Cancer Care, Brisbane/AU
  • 13 Research And Development, Sanofi Genzyme, Cambridge/US
  • 14 Research And Development, Sanofi Genzyme, Bridgewater/US
  • 15 Research And Development, Sanofi Genzyme, Vitry-sur-Seine/FR
  • 16 Department Of Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, 94805 - Villejuif/FR


Abstract 3045


FIRSTANA (NCT01308567), a post-marketing requirement, assessed the superiority of C 20 and 25 mg/m2 (C20, C25) versus D, in terms of overall survival (OS), in chemotherapy-naïve mCRPC pts.


Pts were randomized 1:1:1 to receive C20, C25 or D (plus prednisone). Primary endpoint was OS. Secondary endpoints: safety, progression-free survival (PFS), prostate-specific antigen (PSA) and tumor response (TR), HRQL (Functional Assessment of Cancer Therapy-Prostate [FACT-P] questionnaire) and pain response (PR; Present Pain Intensity score on McGill-Melzack scale). Post-hoc analyses assessed association of grade 3-4 neutropenia and neutrophil-lymphocyte ratio (NLR) with OS.


1168 pts were randomized (C20 389; C25 388; D 391) with similar pt characteristics across arms. OS, PFS and PSA response were not significantly different; TR was superior for C25 vs D (Table). Rates of Grade 3–4 treatment-emergent adverse events were: C20 41.2%; C25 60.1%; D 46.0%. Change from baseline to Cycle 16 in FACT-P total score differed between the C20 and D arms. Grade 3-4 neutropenia and NLR 


In chemotherapy-naïve mCRPC pts, OS was not superior for C20 or C25 vs D. TR was significantly higher for C25 vs D. C20 may have greater HRQL benefit than D. Grade 3–4 neutropenia and low NLR correlated with increased OS and may have prognostic value. Funding: Sanofi Genzyme.

Clinical trial identification


Legal entity responsible for the study

Sanofi Genzyme


Sanofi Genzyme


S. Oudard: Personal fees from Sanofi, during the conduct of the study and personal fees from Sanofi, Janssen, Astellas, Roche, and BMS, outside the submitted work.

O. Sartor: Personal fees and grants from Sanofi, outside the submitted work.

L. Sengeløv: Grants from MSD, grants from Ipsen Pharma, grants from Roche, grants from Ely Lilly, grants from AstraZeneca, personal fees from Novo Nordisk, outside the submitted work.

F. Saad: Personal fees from Abbvie, Astellas, Janssen, Amgen, Sanofi, Novartis, Bavarian Nordic, Millennium, Bayer, and grants from Astellas, Bayer, Amgen, Janssen, Bristol-Myers Squibb, Oncogenex, Sanofi, outside the submitted work.

A. Thiery-Vuillemin: Personal fees from Sanofi, during the conduct of the study, and personal fees from AstraZeneca, Janssen, and Astellas outside the submitted work.

O. Caffo: Personal fees from Sanofi Aventis, Astellas, Bayer, and Janssen, outside the submitted work.

P.N. Mainwaring: Personal fees from Roche, Astellas, Janssen, Novartis, Merck, Pfizer, other from Xing technologies, Astellas, Janssen, Merck, Pfizer, outside the submitted work.

J. Bernard: Employee of Sanofi Genzyme.

L. Shen: Employee of Sanofi Genzyme

M. Chadjaa: Employee of Sanofi.

K. Fizazi: Personal fees from Janssen, Astellas, Sanofi, Orion Pharma, Dendreon, Curevac, Novartis, Takeda, Ipsen, other from Amgen, and personal fees from Janssen, Sanofi, Astellas, Takeda, outside the submitted work.

All other authors have declared no conflicts of interest.

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