Annals of Oncology 25 (Supplement 4): iv255–iv279, 2014 doi:10.1093/annonc/mdu336.19
771P
ANALYSIS OF OVERALL SURVIVAL (OS) FOR PATIENTS (PTS) WITH DIFFERENT PROGNOSTIC RISK FACTORS TREATED WITH CABAZITAXEL AND PREDNISONE (CBZ + P) AFTER DOCETAXEL (D) IN THE TROPIC TRIAL
K.N. Chi1, J.S. de Bono2, A. Bahl3, S. Oudard4, B. Tombal5, M. Özgüroğ lu6, S. Hansen7, I. Kocak8, G. Gravis9, L. Shen10, Z. Su11, O. Sartor12 1 Oncology, British Columbia Cancer Agency, Vancouver, BC, CANADA 2 Drug Development Unit, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, Sutton, UK 3 Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK 4 Medical Oncology, Hôpital Européen Georges Pompidou, René Descartes University, Paris, FRANCE 5 Division of Urology, Cliniques Universitaires Saint-Luc, Brussels, BELGIUM 6 Department of Medical Oncology, Cerrahpasa Medical Faculty, Istanbul University, Istanbul, TURKEY 7 Department of Oncology, Odense University Hospital, Odense, DENMARK 8 Department of Complex Oncology Care, Masarykuv Onkologicky Ustav, Brno, CZECH REPUBLIC 9 Medical Oncology, Institut Paoli Calmette, Hôpital de Jour, Marseille, FRANCE 10 Research and Development, Sanofi, Bridgewater, NJ, USA 11 Oncology, Sanofi Oncology, Cambridge, MA, USA 12 Department of Medicine: Section of Hematology & Medical Oncology and Department of Urology, Tulane University, New Orleans, LA, USA
Aim: TROPIC (NCT00417079) showed improved OS for Cbz + P vs. mitoxantrone (Mtx) + P in pts with metastatic castration-resistant prostate cancer (mCRPC). Cbz + P had a manageable safety profile similar to other chemotherapies (ctx). A novel prognostic model using TROPIC and SPARC trial data was developed to predict and validate OS in men with mCRPC progressing during/after D and scheduled to receive second-line ctx. The model identified 9 factors: presence of pain, measurable disease or visceral disease; ECOG PS; time since last D; time from first hormone therapy; haemoglobin (Hb); prostate-specific antigen (PSA); and alkaline phosphatase (ALP). The aim of this study was to explore the activity of Cbz + P in pts with different numbers of prognostic factors. Methods: We classified pts’ prognoses based on number of poor prognostic factors present ( presence of pain, measurable disease or visceral disease; ECOG PS [2/0,1]; time since last D [≤6/ > 6 months]; time from first hormone therapy [≤3.6/ > 3.6 yrs];
Hb [133/ ≤ 133 IU/L]). OS was compared between Cbz + P and Mtx + P in different groups defined by increasing numbers of poor prognostic factors. Results: 597 pts were included (158 pts had missing prognostic factor data). Using various definitions based on number of poor prognostic factors, pts grouped as good, intermediate or poor risk consistently demonstrated a significant difference in OS ( p < 0.0001). Furthermore, Cbz + P consistently improved OS vs Mtx + P independent of increasing numbers of poor prognostic factors. Conclusions: Increasing numbers of poor prognostic factors were associated with worse OS. Cbz + P improved OS vs Mtx +P regardless of the number of poor prognostic factors present. Table: 771P No. of factors
Patients, n
Estimated median OS (95% CI), months
Cbz vs Mtx
Cbz
Mtx
Hazard ratio (95% CI)
0.57 (0.40, 0.83) 0.72 (0.57, 0.90) 0.64 (0.48, 0.85) 0.69 (0.48, 1.01) 0.44 (0.25, 0.76)
0.0032
0–3
228
28.5 (24.9, –)
23.7 (18.7, –)
≥4
369
≥5
229
≥6
129
12.1 (10.5, 13.8) 11.0 (9.2, 12.6) 9.2 (6.0, 11.6)
9.7 (8.4, 11.2) 8.3 (7.0, 10.0) 7.4 (6.9, 8.6)
≥7
62
8.8 (5.6, 11.0)
6.3 (3.9, 7.4)
p-value
0.0043 0.0022 0.0532 0.0033
Disclosure: K.N. Chi: has held a compensated consultant/advisory role for Sanofi; J.S. de Bono: has received research funding from the Institute of Cancer Research; A. Bahl: has held a consultant/advisory role and received honoraria and research funding from Sanofi; S. Oudard: has held a consultant/advisory role and received honoraria and research funding from Sanofi; B. Tombal: has held a consultant/advisory role and received honoraria from Sanofi; M. Özgüroğlu: participated in advisory boards for Sanofi; S. Hansen: has held a compensated consultant/advisory role for Sanofi; L. Shen: is an employee (Biostatistics Director) of Sanofi and holds Sanofi stock; Z. Su: is an employee (Medical Director) of Sanofi and holds Sanofi stock; O. Sartor: has held a compensated consultant/advisory role for Sanofi. All other authors have declared no conflicts of interest.
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abstracts
genitourinary tumours, prostate
