Table 2.

Patient Response and Progression-Free Survival Status

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.