Konference: 2012 37th Congress ESMO – účast ČR
Kategorie: Genitourinární nádory
Téma: Poster, Poster presentation I
Číslo abstraktu: 933P
Autoři: Dr. Stephane Oudard; Prof. MD Johann S. De Bono, FRCP; Prof.Dr. Mustafa Özgüroglu; Steinbjørn Hansen; MD Jean-Pascal Machiels; MUDr. Ivo Kocák, Ph.D.; Dr. Gwenaëlle Gravis; Dr. István Bodrogi; Liji Shen; MD A. Oliver Sartor
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 χ 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.
Datum přednesení příspěvku: 29. 9. 2012
