804P - Prognostic stratification of advanced urothelial carcinoma (UC) receiving second-line systemic therapy including time from prior chemotherapy (TFPC)...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anticancer agents
Urothelial Cancers
Biological therapy
Presenter Guru Sonpavde
Authors G. Sonpavde1, G.R. Pond2, T. Choueiri3, R. Fougeray4, G. Niegisch5, Y. Wong6, S.S. Sridhar7, W.M. Stadler8, C.N. Sternberg9, J. Bellmunt10
  • 1Medical Oncology, Texas Oncology, Baylor College of Medicine, 77598 - Webster, TX/US
  • 2Biostatistics, Ontario Clinical Oncology Group and McMaster University, Hamilton/CA
  • 3Medical Oncology, Dana Farber Cancer Institute, Boston/US
  • 4Statistics, Institut de Recherche Pierre Fabre, Boulogne/FR
  • 5Urologic Oncology, Heinrich Heine University, Dusseldorf/DE
  • 6Medical Oncology, Fox Chase Cancer Center, Philadelphia/US
  • 7Medical Oncology, Princess Margaret Hospital, Toronto/CA
  • 8Medical Oncology, University of Chicago, Chicago/US
  • 9Medical Oncology, San Camillo Forlanini Hospital, Rome/IT
  • 10Medical Oncology, University Hospital del Mar, 08003 - Barcelona/ES



Prognostic factors for overall survival (OS) in patients receiving second-line chemotherapy for advanced platinum-pretreated urothelial carcinoma (UC) include ECOG performance status (PS) >0, hemoglobin (Hb) <10g/dL and liver metastasis (LM). We hypothesized that time from prior chemotherapy (TFPC) has an independent impact on OS.


Of 12 available phase II trials evaluating second-line therapy for advanced UC (n = 748), 7 trials with available baseline TFPC, Hb, PS and LM were utilized (n = 559). These trials evaluated vinflunine (2 trials), docetaxel alone or with vandetanib, paclitaxel-gemcitabine, nanoparticle-albumin-bound paclitaxel, cetuximab alone or with paclitaxel, and volasertib. The Kaplan-Meier method was used to estimate OS from date of starting second-line therapy. Cox proportional hazards regression stratified for trial was used to evaluate the prognostic effect of factors on OS. External validation was conducted in a second-line phase III trial comparing best supportive care (BSC) vs. vinflunine plus BSC (n = 352).


Median OS was 5.2, 7.1, 8.3, 7.6 and 10.6 months respectively for patients having TFPC <3 months, 3 to <6 months, 6 to <9 months, 9 to <12 months and >12 months. ECOG-PS >0 (HR = 1.66), LM (HR = 1.49), Hb <10 g/dL (HR = 1.67) and TFPC (HR = 0.79) were all significant prognostic factors on multivariate analysis. TFPC as a dichotomous (<3 months vs. 3+ months) or continuous (log-transform) factor were both significant. Type of prior chemotherapy (metastatic disease vs. perioperative) was not prognostic. External validation demonstrated TFPC remained significantly prognostic (p = 0.040) for PFS but not OS (p = 0.29) after adjusting for Hb, PS and LM. Median PFS for patients with 0, 1, 2 and 3-4 factors (PS > 0, Hb < 10g/dL, LM, TFPC <3 months) was 4.13, 3.84, 1.61 and 1.45 months respectively.


A shorter duration of TFPC exhibited a significant negative prognostic impact on OS independent of ECOG-PS >0, Hb <10 g/dL and LM in patients receiving second-line therapy for advanced UC. A prognostic grouping model consisting of these 4 factors may optimize risk stratification.


T.K. Choueiri: Research support to institution from Astrazeneca.

R. Fougeray: Employee of Pierre Fabre.

Y. Wong: Research support to institution from Imclone.

S.S. Sridhar: Research support to institution from Celgene.

J. Bellmunt: Research support to institution from Pierre Fabre.

All other authors have declared no conflicts of interest.