823P - Survival among advanced renal cell carcinoma (aRCC) patients with >2 prior targeted therapies

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Renal Cell Cancer
Presenter Emiliano Calvo
Authors E. Calvo1, R. Casciano2, L. Stern2, T. Brechenmacher3, S. Stergiopoulos3, J. Coombs4
  • 1Start Madrid, Early Clinical Drug Development Unit, Hospital Madrid Norte San Chinarro Centro Integral Oncologico Clara Campal, 28050 - Madrid/ES
  • 2Global Outcomes Research And Pricing, Analytica LA-SER, New York/US
  • 3Oncology, Novartis Pharmaceuticals, East Hanover/US
  • 4Novartis Oncology, East Hanover/US

Abstract

Background

Despite the emergence of VEGFR-TKIs and mTORs in aRCC, considerable unmet medical needs remain. There are no published guidelines for 3rd line treatment in aRCC and, despite significant advances, these patients have limited treatment options. This analysis examines the overall survival of patients after discontinuation from a phase III, randomized, double-blind, placebo-controlled trial (RECORD-1), who received at least two targeted therapies.

Methods

All patients in RECORD-1 received at least one prior VEGFR-TKI before randomization to everolimus (EVE) or placebo. Demographics, treatment sequence and overall survival were reported for patients who discontinued EVE for reasons other than death and received additional targeted therapy with either sorafenib or sunitinib.

Results

Of the 416 patients in RECORD-1, 274 received EVE, 258 discontinued EVE for reasons other than death and approximately one third of those (N = 87) received sunitinib or sorafenib as additional targeted therapy following EVE (49.4% sorafenib only, 40.2% sunitinib only and 10.3% both). Baseline patient demographics at RECORD-1 enrollment are provided in the Table. Median time from EVE discontinuation to additional sunitinib or sorafenib therapy was 0.9 months (mean 1.7, SD 2.5). The median overall survival for patients from start of the additional sunitinib or sorafenib therapy after EVE discontinuation was 13.9 months (95% CI 10.6–17.2 mo).

Baseline Characteristics Patients receiving sorafenib or sunitinib post-EVE
N = 87
Male, n (%) 73 (83.9%)
>= 65 years, n (%) 35 (40.2%)
MSKCC Intermediate Risk n (%) 52 (59.8%)
MSKCC Favorable Risk n (%) 29 (33.3%)
KPS— > =90 n (%) 63 (72.4%)
KPS—80 n (%) 20 (23.0%)

Conclusions

In this heavily pre-treated sub-population, following EVE discontinuation in RECORD-1, some patients experienced meaningful rescue therapy with a TKI, with a median overall survival of more than a year Clinical trials with investigational targeted therapies are ongoing, and may provide additional treatment options.

Disclosure

R. Casciano: Roman Casciano is an employee of Analytica LA-SER, which received funding for the research.

L. Stern: Lee Stern is an employee of Analytica LA-SER, which received funding for the research.

T. Brechenmacher: Thomas Brechenmacher is employed by Novartis Pharmaceuticals, which provided funding for the research.

S. Stergiopoulos: Sotirios Stergiopoulos is employed by Novartis Pharmaceuticals, which provided funding for the research.

J. Coombs: John Coombs is employed by Novartis Pharmaceuticals, which provided funding for the research.

All other authors have declared no conflicts of interest.