What is an active regimen in carcinoma of unknown primary sites? Analysis of correlation between activity endpoints reported in phase II trials. Correlation of activity endpoints in phase II trials - 19/03/15
, Thomas Ryckewaert 1, Andrew Kramar 2, 3Abstract |
Background |
The choice of the activity endpoint is crucial when designing phase II screening trials. This choice is usually guided by convention, but the level of evidence for picking-up one of them is limited.
Methods |
We have analysed the phase II trials in carcinoma of unknown primary patients (CUP; 48 strata). We calculated the Pearson correlation coefficient using weighted linear regression to measure the degree of association between the different available activity endpoints (Best objective response – BORR, best tumour control rate – BTCR, 3- and 6-month progression-free rates, 3- and 6-month PFR and median progression-free survival). We also explored the correlation between these endpoints and OS.
Results |
All activity endpoints were strongly correlated in CUP studies; all of these endpoints were strongly correlated with OS. The median BORR across the studies was 30%. Positive trials defined by BORR≥30% were associated with statistically longer PFS (4.8 versus 3.7 months, P=0.013) and OS (10.0 versus 8.0, P=0.0007).
Discussion |
In phase II studies with CUP patients, BORR and the threshold of BORR>30% for defining promising drug appears adequate.
Le texte complet de cet article est disponible en PDF.Key words : phase II trials, activity endpoint, correlation, carcinoma of unknown primary, advanced soft-tissue sarcoma
Plan
Vol 101 - N° 4
P. E19-E24 - avril 2014 Retour au numéro
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