875O - Quality of life in a randomised double-blind phase III trial of cediranib (AZD2171) in relapsed platinum sensitive ovarian cancer (ICON6)

Date 28 September 2014
Event ESMO 2014
Session Gynaecological cancers
Topics Anticancer agents
Ovarian Cancer
Therapy
Biological Therapy
Presenter Daniel Stark
Citation Annals of Oncology (2014) 25 (suppl_4): iv305-iv326. 10.1093/annonc/mdu338
Authors D. Stark1, A. Cook2, J. Brown3, G. Velikova1, M.D. Brundage4, A.C. Embleton2, F. Raja2, J.A. Ledermann5
  • 1St James’s Institute Of Oncology, University of Leeds, LS97TF - Leeds/GB
  • 2Mrc Clinical Trials Unit, University College London, London/GB
  • 3Leeds Institute Of Clinical Trials Research, University of Leeds, Leeds/GB
  • 4Division Of Cancer Care And Epidemiology, Queen’s University, Kingston/CA
  • 5Cancer Research Uk & Ucl Trials Centre, UCL Cancer Institute, London/GB

Abstract

Aim

ICON6 evaluated cediranib (20mg/d) added to standard chemotherapy (CT) in first relapse of platinum sensitive ovarian cancer. 456 patients received up to 6 cycles of CT and were randomised 2:3:3 between placebo (arm A), concurrent cediranib and maintenance placebo (B), concurrent and maintenance cediranib (C). Median follow-up was 16.6 months, 2 year restricted mean (unrestricted median) progression free survival was 3.1 (2.4) months longer in arm C than arm A (p < 0.001), mean (median) overall survival was 2.7 (6.8) months longer (p = 0.04). This sub-study addresses quality of life (QL) of patients over 1 year from randomisation.

Methods

QL was measured with EORTC QLQ-C30 and OV28 questionnaires at regular intervals until disease progression, then annually. Primary outcome was global QL at 1 year, arm A vs. C. Three secondary QL outcomes were prospectively defined: gastro-intestinal (GI) symptom resolution during CT, arm A v B/C; change in pain and physical function during CT among patients with symptomatic disease at enrolment, arm A v B/C; fatigue and social functioning during maintenance, arm C v A/B. Results were analysed using analysis of variance, controlled for baseline score.

Results

The mean global quality of life score 1 year after randomisation was slightly higher in arm C (68.4) than arm A (62.7). Adjusted for baseline, the mean difference was 5.51 points (p = 0.097, 95% CI -1.0 to 12.0). This is not clinically or statistically significant. Approximately 20% of patients have missing data at 1 year but sensitivity analyses suggest this result is robust. Secondary outcomes showed little difference between arms in GI symptoms or in pain or physical function during CT; social functioning or fatigue at 1 year.

Conclusions

ICON6 showed a benefit of cediranib in relapsed ovarian cancer, in both progression-free and overall survival. No clinically significant detriment was found in self-reported global or relevant pre-defined QL outcomes.

Disclosure

All authors have declared no conflicts of interest.