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.
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Legal entity responsible for the study
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.