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 Anti-Cancer Agents & Biologic Therapy
Ovarian Cancer
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.