Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial.
BACKGROUND
The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment.


METHODS
Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance. Patients completed QOL questionnaires until disease progression every 3 weeks during chemotherapy and then every 6 weeks to 1 year. Patients alive with disease progression completed a QOL form 1 year after randomization. The primary QOL endpoint was the global score from the Quality of Life Questionnaire Core 30 (of the European Organization for Research and Treatment of Cancer) at 1 year, with the standard chemotherapy group compared with the concurrent-maintenance cediranib group.


RESULTS
The rate of questionnaire compliance was 90% at the baseline and 76% at 1 year and was similar across the 3 groups. The mean global QOL score at 1 year was 62.6 points for the standard chemotherapy group and 68.7 points for the concurrent-maintenance group (+4.5; 95% confidence interval, -2.0 to 11.0; P = .18). Sensitivity analyses suggested that this finding was robust to the effect of missing data, and the improvement became statistically significant after adjustments for self-reported diarrhea.


CONCLUSIONS
The 6th study by the International Collaboration in Ovarian Neoplasm (ICON6) showed a significant improvement in progression-free survival with cediranib as concurrent and maintenance therapy. No QOL detriment with cediranib was found 1 year after treatment was commenced. The maintenance of QOL along with prolonged cancer control suggests that cediranib has a valuable role in the treatment of relapsed ovarian cancer. Cancer 2017;123:2752-61. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
St. James's Institute of Oncology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, United Kingdom.
Dan P
DP
Stark
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Adrian
http://orcid.org/0000-0003-4417-2632
A
Cook
Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.
Julia M
JM
Brown
Queen's University, Kingston, Ontario, Canada.
Michael D
MD
Brundage
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Andrew C
AC
Embleton
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Richard S
RS
Kaplan
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Fharat A
FA
Raja
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Ann Marie W
AMW
Swart
St. James's Institute of Oncology, Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, United Kingdom.
Galina
G
Velikova
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Wendi
W
Qian
Medical Research Council Clinical Trials Unit, University College London, London, United Kingdom.
Jonathan A
JA
Ledermann
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D000077216:Carcinoma, Ovarian Epithelial; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D060046:Maintenance Chemotherapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011788:Quality of Life; D011799:Quinazolines / Q000627:therapeutic use*; D012074:Remission Induction; D007211:Indoles
D016190:Carboplatin; D017239:Paclitaxel; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C500926:cediranib; D007211:Indoles
chemotherapy; health-related quality of life; ovarian cancer