405P - Patients with metastatic prostate cancer enrolled in phase 1 trials: Outcomes and molecular alterations

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Drug Development
Presenter Clement Bonnet
Citation Annals of Oncology (2016) 27 (6): 114-135. 10.1093/annonc/mdw368
Authors C. Bonnet1, E. Castanon Alvarez1, J. Michot1, F. Bigot1, A. Varga1, A. Gazzah1, R. Bahleda1, A. Marabelle1, A. Hollebecque1, S. Aspeslagh1, E. Angevin1, J. Armand1, L. Albiges2, Y. Loriot2, S. Postel-Vinay1, J. Soria1, C. Massard1
  • 1Drug Development Department (ditep), Institut Gustave Roussy, 94800 - Villejuif/FR
  • 2Department Of Medical Oncology, Institut Gustave Roussy, 94805 Villejuif Cedex - Villejuif/FR



The purpose was to described characteristics of patients (pts) with castration-resistant prostate cancer (CRPC) referred to phase I unit for phase I trials or molecular screening programs.


All patients enrolled in clinical trials in the Gustave Roussy phase I unit (DITEP) from 2006 until April 2016 were reviewed. Baseline characteristics, PSA response, progression-free survival (PFS) and overall survival (OS) were investigated. Molecular alterations (MA) were collected from MOSCATO trial database comprising 1168 patients screened for genomic characterization.


Ninety-three pts had CRPC, enrolled in 30 different trials. At baseline, median age was 68.5y (63.5 – 73.0), 62 pts (66.7%) had an OMS PS 1, median PSA was 96 (32.9 – 369) ng/mL, median albumin 37 (35 – 39) g/L, median ALP 102 (72 – 178), median hemoglobin 11.9 (10.9 – 13.0) g/dL. Nineteen (20.4%) patients had a Royal Marsden Hospital Score of 2 to 3, 14 (15.1%) patients were chemo-naive and 25 (26.9%) had visceral metastases. The median number of previous treatments was 3 (range 0 - 7). Concerning efficacy, 27 (29%) pts had biological response (PSA decrease >50%) and 6 of them had a very good biological response (PSA decrease >90%). Among the cohort, PFS was 3.8 months (2.96 – 4.64) and OS 21.27 months (12.6 – 29.9). Factors significantly associated with OS were RMH score (HR 1.54; 95CI 1.13 – 2.09), number of previous lines of treatment (HR 1.40; 95CI 1.12 – 1.76), and Hemoglobin (HR 0.96; 95CI 0.92 – 0.99). Among patients screened for genomic characterization, 71 had CRPC and 33 (46,5%) were enrolled in phase I trials. MA were found in 49 (69%) of them. Most frequent MA found were : PTEN loss (63.3%), Androgen Receptor amplification or mutation (44.9%), PI3K mutation (22.4%), FGFR and MYC mutation (16.3%). Five pts (10.2%) had BRCA alterations. Ten patients were treated with a matched targeted therapy regarding their molecular alteration.


In our cohort of prostate cancer enriched population enrolled in phase I trials, not only RMS but the previous number of lines and hemoglobin should be taken into account to estimate OS. Moreover, targetable molecular alterations are frequently identified in advanced CRPC patients.

Clinical trial identification

Legal entity responsible for the study

Gustave Roussy, Université Paris-Saclay, DITEP, Villejuif, F-94805, France


Gustave Roussy, Université Paris-Saclay, DITEP, Villejuif, F-94805, France


L. Albiges: Consulting/ advisory Board : Novartis, Pfizer, Amgen, Bayer, BMS, Ceruleon, sanofi (compensated - myself) Research funding : novartis, Pfizer (myself). J-C. Soria: Personal fees AstraZeneca, Astex, Covagen, Clovis, GSK, Gammamabs, Lilly, MSD, Mission Therapeutics, Merus, Pfizer, Pierre Fabre, Roche-Genentech, Sanofi, Servier, Takeda. All other authors have declared no conflicts of interest.