933P - Impact of cabazitaxel (CBZ) + prednisone (P; CBZP) on overall survival (OS) at 2 yrs and in patients (pts) with aggressive disease: post-hoc analyse...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Prostate Cancer
Presenter Stephane Oudard
Authors S. Oudard1, J.S. De Bono2, M. Ozguroglu3, S. Hansen4, J. Machiels5, I. Kocak6, G. Gravis7, I. Bodrogi8, L. Shen9, A.O. Sartor10
  • 1Medical Oncology Service, Georges Pompidou Hospital and Rene Descartes University, 75015 - Paris/FR
  • 2The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, SM2 5PT - Surrey/UK
  • 3Department Of Medical Oncology, Istanbul University Cerrahpasa, 34098 - Istanbul/TR
  • 4Department Of Oncology, Odense University Hospital, 2000 - Odense/DK
  • 5Department Of Medical Oncology, Cliniques Universitaires Saint-Luc, 1200 - Bruxelles/BE
  • 6Department Of Complex Oncology Care, Masaryk Memorial Cancer Institute, 656 53 - Brno/CZ
  • 7Department Of Medical Oncology, Institut Paoli Calmettes, 13009 - Marseille/FR
  • 8Chemotherapy C And Clinical Pharmacology, National Institute of Oncology, 1122 - Budapest/HU
  • 9Research And Development, Sanofi, 08807 - Bridgewater/US
  • 10Departments Of Medicine And Urology, Tulane Medical School, 70112 - New Orleans/US

Abstract

Introduction

The TROPIC trial (NCT00417079) demonstrated that CbzP improves OS in pts with metastatic castration-resistant prostate cancer (mCRPC) vs mitoxantrone + P (MP) (hazard ratio [HR] 0.70; P < 0.0001). In this post-hoc analysis of TROPIC data, we examined OS at 2 yrs and in pts with aggressive disease.

Methods

OS in pts with poorly differentiated tumour histopathology at diagnosis (Gleason 7–10) and in pts with visceral disease (VD) at baseline was evaluated between treatment groups based on the original and updated analyses of the TROPIC trial data. In addition, the percentage of pts alive at 2 yrs was compared between treatment groups using a ? test. Baseline and treatment characteristics were assessed in pts with OS < 2 and ≥ 2 yrs to identify predictors of long-term OS.

Results

Analysis of the original data showed an OS benefit for CbzP vs MP in pts with Gleason 7–10 (median 15.2 mos CbzP [95% CI 14.1–17.2] vs 12.7 mos MP [95% CI 10.1–14.0], log rank test P < 0.0001). A positive trend in OS favouring CbzP treatment in pts with VD was also observed (HR 0.884 [95% CI 0.642–1.216]). Of the 755 pts enrolled in TROPIC, 15.9% (CbzP) and 8.2% (MP) survived ≥ 2 yrs (odds ratio [OR] 2.10 [95% CI 1.33–3.33]). Baseline characteristics known to predict OS, including presence of VD, pain, ECOG PS, haemoglobin, measurable disease, interval from prior docetaxel (D) to second-line (2L) chemotherapy (CT), and time from 1st hormonal treatment (HT) to 2L CT were well-balanced across the treatment arms (Table).

Summary of baseline pt characteristics.

OS ≥ 2 yrs OS < 2 yrs
CbzP MP CbzP MP
Total population, N (%) 60 (15.9)* 31 (8.2) 318 (84.1) 346 (91.8)
Visceral disease (liver and/or lungs), n (%) 9/60 (15.0) 6/31 (19.4) 81/318 (25.5) 83/346 (24.0)
Interval from end of prior D to 2L CT, months, median 6.2 6.5 3.7 3.4
Interval from 1st HT to 2L CT, years, median 6.1 5.5 3.9 3.8
Poorly differentiated tumour histopathology at diagnosis, n (%) 40/60 (66.7) 21/31 (67.7) 186/318 (58.5) 190/346 (54.9)

*OR 2.10 (95% CI 1.33–3.33)

Conclusion

The OS benefit of CbzP treatment demonstrated in TROPIC is maintained at 2 yrs and in the subset of pts with poorly differentiated tumours at diagnosis, as well as in mCRPC pts with VD. Baseline factors were similar between treatment groups, suggesting that the difference in OS benefit is likely due to a treatment effect of CbzP.

Disclosure

S. Oudard: Has acted as an advisor for, and received honoraria from Pfizer Oncology, Bayer Schering Pharma, Roche, GSK, Novartis and Sanofi,

J.S. de Bono: Has participated in an advisory board and has acted as a consultant for Sanofi. Has also received honoraria and research funding from Sanofi,

M. Özgüroğlu: Has acted as an advisor and consultant (compensated) for, and has received research funding from Sanofi,

S. Hansen: Has participated in an advisory board for Sanofi,

J. Machiels: Has acted as a consultant to Boehringer Ingelheim (uncompensated) and has received research funding from Sanofi,

G. Gravis: Has acted as an uncompensated consultant to Sanofi,

L. Shen: Is a Sanofi employee (Associate Director) and owns Sanofi stocks and shares,

A.O. Sartor: Has acted as a consultant for Sanofi. Has also received honoraria and research funding from Sanofi.

All other authors have declared no conflicts of interest.