847P - Outcomes of advanced renal cell carcinoma patients (aRCC) treated with mammalian target of rapamycin inhibitor (mTORi) therapy following first-line...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Renal Cell Cancer
Presenter Thomas Hutson
Citation Annals of Oncology (2014) 25 (suppl_4): iv280-iv304. 10.1093/annonc/mdu337
Authors T. Hutson1, M.D. Hackshaw2, N. Vogelzang3, D. Bhowmik4, M. Yap5, D. Rembert6, E. Jonasch7
  • 1Gu Research, US Oncology/McKesson Specialty Health, 75254 - Dallas/US
  • 2Us Health Outcomes, Oncology, GlaxoSmithKline, Philadelphia/US
  • 3Us Oncology Research, US Oncology/McKesson Specialty Health, 89169 - Las Vegas/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

Several studies investigated sequencing of aRCC therapies but none have evaluated real world outcomes in patients treated with first-line PAZ who then switched to mTORi therapy.

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, received PAZ first-line therapy, had evidence of progressive disease and then received either everolimus (EVE) or temsirolimus (TEM) as second-line therapy from 1-Nov-2009 to 31-Aug-2012 were included. Exclusion criteria were diagnosis of other primary cancer, first-line therapy other than PAZ or enrollment in clinical trials. Key outcomes were overall survival (OS – months from mTORi initiation until death or censoring), progression-free survival (PFS – months from mTORi initiation until first progression, death or censoring), time to treatment failure (TTF - months from mTORi initiation until treatment failure or censoring), adverse events, and treatment patterns. Cases were followed to 31-Oct-2013.

Results

Of 177 patients on first-line PAZ, 35 went onto second-line EVE (n = 24) or TEM (n = 11). Baseline characteristics and clinical outcomes are shown below. Adverse events >20% incidence included fatigue (51%) and nausea (34%). Average duration of treatment (SD) for EVE was 180 (191) days; the main reason for discontinuing therapy was toxicity (45%). For TEM, average duration (SD) was 56 (19) days; progression (43%) was the main reason for discontinuation.

N = 35 n (%)
Age Mean (SD) 67 (11 )
Gender Male 23 (66)
ECOG performance 0 19 (54.3)
ECOG performance 1 15 (42.9)
Nephrectomy Yes 22 (62.9)
OS Median, months (95% CI) 16.0 (10.7 - *)
PFS Median, months (95% CI) 5.7 (2.6 – 8.2)
TTF Median, months (95% CI) 2.6 (1.8 – 3.6)

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

Conclusions

This is the first study to investigate outcomes in aRCC patients treated with mTORi after progression with first-line PAZ. Low sample size limit generalizability of the results. Future studies with larger cohorts and longer follow-up are needed to validate these findings. This study was supported by GlaxoSmithKline.

Disclosure

T. Hutson: Consultant, Advisory Board, Speaker and Contracted Research (paid to my institution on my behalf): GSK, Pfizer, Novartis, Bayer, Aveo; M.D. Hackshaw: Employed by GlaxoSmithKline and holds stock in GSK; 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; 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.