840P - Outcomes of advanced renal cell carcinoma patients (aRCC) treated with first-line pazopanib (PAZ) in a US community oncology setting

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Nicholas Vogelzang
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors N. Vogelzang1, M.D. Hackshaw2, T. Hutson3, D. Bhowmik4, M. Yap5, D. Rembert6, E. Jonasch7
  • 1Develop Therapeutics & Co-chair Gu Comm, US Oncology Research c/o Comprehensive Cancer Crts of NV, 89169 - Las Vegas/US
  • 2Us Health Outcomes, Oncology, GlaxoSmithKline, 19426 - Philadelphia/US
  • 3Gu Research, US Oncology/McKesson Specialty Health, 75254 - Dallas/US
  • 4Health Economics & Outcomes Research, Oncology, McKesson Specialty Health, 77380 - The Woodlands/US
  • 5Oncology, US Oncology/McKesson Specialty Health, 77380 - The Woodlands/US
  • 6Informatics & Information Services, Oncology, McKesson Specialty Health, 77380 - The Woodlands/US
  • 7Oncology, The University of Texas MD Anderson Cancer Center, Houston/US



Clinical trials demonstrated efficacy and safety of PAZ in aRCC but few studies have examined real world outcomes. This study assessed outcomes in patients treated with PAZ as first-line therapy outside of a controlled setting.


A retrospective, longitudinal analysis and chart review using US Oncology's iKnowMed electronic health records database. Adults (≥18 years) with aRCC (Stage III/IV), at least 2 visits and received PAZ first-line treatment from 1-Nov-2009 to 31-Aug-2012 were included. Exclusion criteria were diagnosis of other primary cancer, first-line treatment other than PAZ or enrollment in clinical trials. Key outcomes were overall survival (OS – months from PAZ initiation until death or censoring), progression-free survival (PFS – months from PAZ initiation until first progression, death, or censoring), time to treatment failure (TTF - months from PAZ initiation until treatment failure or censoring), adverse events, and treatment patterns. Cases were followed to 31-Oct-2013.


177 patients qualified for analyses. Baseline characteristics and clinical outcomes are shown below. Adverse events >20% incidence included fatigue (56%), diarrhea (52%), vomiting (44%), nausea (40%) and hypertension (27%). Average daily dose (SD) was 712 (150) mg. Average duration of treatment (SD) was 213 (210) days. Progression (44%) and toxicity (15%) were the main reasons for discontinuing therapy.

N = 177 n (%)
Age Mean (SD) 66 (11 )
Gender Male 131 (74)
Histology Clear cell 146 (82.6)
ECOG performance 0 101 (57.1)
ECOG performance 1 66 (37.3)
Nephrectomy Yes 109 (61.6)
Heng Risk Favorable 22 (12.4)
Heng Risk Intermediate 111 (62.7)
Heng Risk Poor 44 (24.9)
OS Median, months (95% CI) 22.0 (16.9 – *)
PFS Median, months (95% CI) 8.5 (7.1 – 11.2)
TTF Median, months (95% CI) 9.3 (7.4-13.8)

ECOG = Eastern Cooperative Oncology Group; CI = confidence interval; SD = standard deviation


Results suggest that in patients treated with first-line PAZ in this community setting (62% nephrectomy rate and 25% poor risk), outcomes (OS 22 mo, PFS 8.5 mo) are consistent with those observed in PAZ clinical trials. Future studies with larger cohorts and longer follow-up are needed to validate these findings. This study was supported by GlaxoSmithKline.


N. Vogelzang: has been a GSK paid advisor, has participated in GSK speakers bureau, and has conducted research with GSK through US Oncology. Dr. Vogelzang holds an employment position in US Oncology;

M.D. Hackshaw: Employed by GlaxoSmithKline and holds stock in GSK; T. Hutson: Consultant, Advisory Board, Speaker and Contracted Research (paid to my institution on my behalf): GSK, Pfizer, Novartis, Bayer, Aveo; D. Bhowmik: An employee of McKesson Specialty Health. with no other financial interest to disclose.

D. Rembert: Employment at McKesson with no other disclosures; E. Jonasch: Consultant: Astra Zeneca, Bayer, GSK, Novartis, Pfizer Research Support: Exelixis, GSK, Novartis, Onyx Pfizer. All other authors have declared no conflicts of interest.