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 Anti-Cancer Agents & Biologic Therapy
Urothelial Cancers
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.