Table 2.
Characteristic | Category | No. | % of |
---|---|---|---|
Response | Stable disease | 11 | 31.4 |
Increase disease | 23 | 65.7 | |
Indeterminate | 1 | 2.9 | |
PFS > 6 Months | No | 30 | 85.7 |
Yes | 5 | 14.3 | |
Cycles of | 1 | 7 | 20.0 |
2 | 18 | 51.4 | |
3 | 1 | 2.9 | |
4 | 4 | 11.4 | |
6+ | 5 | 5.7 | |
Alive | Without progression | 1 | 2.9 |
With progression | 6 | 17.1 | |
Dead | From disease | 26 | 74.3 |
From Rx and disease | 1 | 2.9 | |
From neither Rx nor | 1 | 2.9 |
The observed proportion responding was 0.0%. The approximate 90% confidence interval for the true response rate is 0 – 6.4%. The observed proportion of patients surviving progression free for at least 6 months was 14.3%. The approximate 2-sided 90% CI for the probability of being PFS at 6 months is 5.8 – 30.0%. The approximate 1-sided 90% CI for the probability of being PFS at 6 months is 0.0– 26.8%. The required number of patients with either responses or PFS at 6 months to declare the regimen interesting was 7 and 7 out of 35 patients (20.0%), respectively.