Quality of life with cediranib in relapsed ovarian cancer: The ICON6 phase 3 randomized clinical trial

Dan Stark, Adrian Cook, Julia Brown, Michael Brundage, Andrew Embleton, Richard Kaplan, Fharat Raja, Ann Marie Swart, Galina Velikova, Wendi Qian, Jonathan Ledermann

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12 Citations (Scopus)
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Abstract

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

Methods: 456 women were randomly allocated to either receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib concurrently and continued as maintenance. Patients completed QoL questionnaires until disease progression, 3-weekly during chemotherapy and then 6-weekly to one year. Patients alive with disease progression completed a QoL form at one year from randomisation. The primary QoL end point was the global score from the EORTC QLQ-C30 at one year, comparing the standard chemotherapy group with the concurrent plus maintenance cediranib group.

Results: Questionnaire compliance was 90% at baseline, and 76% at one year, similar across the three groups. Mean global QoL score at one year was 62.6 points in the standard chemotherapy group and 68.7 points in the concurrent plus maintenance group (+4.5, 95% CI -2.0 to 11.0, p = 0.18). Sensitivity analyses suggest this finding is robust to the effect of missing data, and the
improvement became statistically significant after adjusting for self-reported diarrhoea.

Conclusion: ICON6 showed a significant improvement in PFS using cediranib as concurrent and maintenance therapy. We report no QoL detriment with cediranib one year after commencing treatment. Maintained QoL, alongside prolonged cancer control, suggest cediranib has a valuable role in the treatment of relapsed ovarian cancer.
Original languageEnglish
Pages (from-to)2752–2761
Number of pages10
JournalCancer
Volume123
Issue number4
Early online date24 Mar 2017
DOIs
Publication statusPublished - 15 Jul 2017

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