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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.

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.