Table 2.
Power calculations for a multicenter trial estimating the association between percent change in FDG PET SUV and pathologic response to neoadjuvant chemotherapy for patients with locally advanced breast cancer, calculated by simulation of 10,000 datasets with characteristics described in Table 1.
Error conditions for each scenario: | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
---|---|---|---|---|---|---|---|
Ref. power | 20%/40% | 20%/40% | −20%/−40% | 0.25/0.50 | 0.25/0.50 | −0.25/−0.50 | |
Simulation scenarios: | pct error | pct bias | pct bias | abs error | abs bias | abs bias | |
75% from primary sites | |||||||
| |||||||
- all data analyzed (no selection by SUV0) | 0.92 | 0.71 | 0.78 | 0.60 | 0.78 | 0.78 | 0.79 |
| |||||||
- enriched sample (observed SUV0 ≥ 3) | 0.87 | 0.70 | 0.79 | 0.54 | 0.73 | 0.76 | 0.70 |
| |||||||
25% from primary sites | |||||||
| |||||||
- all data analyzed (no selection by SUV0) | 0.92 | 0.54 | 0.69 | 0.36 | 0.67 | 0.66 | 0.68 |
| |||||||
- enriched sample (observed SUV0 ≥ 3) | 0.87 | 0.57 | 0.71 | 0.32 | 0.62 | 0.65 | 0.57 |
SUV0 is SUV of first scan
N=100 for unselected design (200 scans), N < 100 for enrichment design (200 scans)