Konference: 2014 39th Congress ESMO - účast ČR
Kategorie: Genitourinární nádory
Číslo abstraktu: 771P
Autoři: Dr. Kim Chi; Prof. MD Johann S. De Bono, FRCP; Dr. Amit Bahl; Dr. Stephane Oudard; Prof. M.D. Bertrand F. Tombal, Ph.D.; Prof. Dr. Mustafa Özgürolu; Steinbjørn Hansen; MUDr. Ivo Kocák, Ph.D.; Dr. Gwenaëlle Gravis; Liji Shen; Zhen Su; MD A. Oliver Sartor
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.
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 [<120/ ≥ 120 g/L]; PSA [≥135/ < 135 ng/mL]; ALP [>133/ ≤ 133 IU/L]). OS was compared between Cbz + P and Mtx + P in different groups defined by increasing numbers of poor prognostic factors.
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.
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.
|Estimated median OS (95% CI), months|
|No. of factors||Patients, n||Cbz vs Mtx|
|Cbz||Mtx||Hazard ratio (95% CI)||p-value|
|0–3||228||28.5 (24.9, –)||23.7 (18.7, –)||0.57 (0.40, 0.83)||0.0032|
|≥4||369||12.1 (10.5, 13.8)||9.7 (8.4, 11.2)||0.72 (0.57, 0.90)||0.0043|
|≥5||229||11.0 (9.2, 12.6)||8.3 (7.0, 10.0)||0.64 (0.48, 0.85)||0.0022|
|≥6||129||9.2 (6.0, 11.6)||7.4 (6.9, 8.6)||0.69 (0.48, 1.01)||0.0532|
|≥7||62||8.8 (5.6, 11.0)||6.3 (3.9, 7.4)||0.44 (0.25, 0.76)||0.0033|
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.
Datum přednesení příspěvku: 27. 9. 2014