ICON-6

the danger of changing study design midstream

John Norrie

Research output: Contribution to journalComment/debate

1 Citation (Scopus)
4 Downloads (Pure)

Abstract

Jonathan Ledermann and colleagues1 and 2 report the ICON-6 randomised trial findings for the tyrosine kinase inhibitor cediranib in relapsed platinum-sensitive ovarian cancer. Cediranib offered the prospect of improved efficacy with tolerable side-effects, and ICON-6 was a pragmatic trial to provide real-world evidence of the effectiveness, safety, and acceptability of cediranib plus chemotherapy (either concurrent or concurrent plus maintenance as long as patients were deriving benefit), compared with chemotherapy plus placebo. ICON-6 found ”meaningful improvement in progression free survival”2 (hazard ratio 0·56, 95% CI 0·44–0·72) for concomitant plus maintenance cediranib compared with placebo, as well as significantly more diarrhoea, hypothyroidism, and voice changes. However, after unexpected and major design changes were enforced, we still await data for overall survival; the safety data are less informative than might be necessary, and there are no convincing data yet for patient acceptability and quality of life, which can be particularly relevant to inform trade-offs between improved efficacy and increased side-effects. These design changes should not have been necessary, and clinical trials should be better structured to make sure this does not recur
Original languageEnglish
Pages (from-to)1031-1032
Number of pages2
JournalThe Lancet
Volume387
Issue number10023
Early online date11 Mar 2016
DOIs
Publication statusPublished - 12 Mar 2016

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Pragmatic Clinical Trials
Placebos
Maintenance
Safety
Drug Therapy
Hypothyroidism
Platinum
Ovarian Neoplasms
Protein-Tyrosine Kinases
Diarrhea
Quality of Life
Clinical Trials
Survival
cediranib

Cite this

ICON-6 : the danger of changing study design midstream. / Norrie, John.

In: The Lancet, Vol. 387, No. 10023, 12.03.2016, p. 1031-1032.

Research output: Contribution to journalComment/debate

Norrie, John. / ICON-6 : the danger of changing study design midstream. In: The Lancet. 2016 ; Vol. 387, No. 10023. pp. 1031-1032.
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