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

Abstract

Aim

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.

Methods

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.

Results

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

Conclusions

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.

Disclosure

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.