Table 2.

Resampling Simulation Results for FOLFOX Versus IFL, FOLFOX Versus IROX, and FOLFOX Versus FOLFOX for Various End Points and Sample Sizes

End Point	Sample Size Per Arm (No.)
	20		40		60		80
	Significant Trials (%)*	95% CI	Significant Trials (%)*	95% CI	Significant Trials (%)*	95% CI	Significant Trials (%)*	95% CI
FOLFOX v IFL
PFS	55.1	53.9 to 56.2	77.1	76.2 to 78.1	88.5	87.8 to 89.3	94.6	94.1 to 95.1
TTG	54.2	53.0 to 55.3	75.7	74.7 to 76.7	88.0	87.2 to 88.7	93.3	92.8 to 93.9
Log ratio at 6 weeks	37.0	35.9 to 38.2	54.5	53.3 to 55.6	65.2	64.1 to 66.4	73.7	72.6 to 74.7
Log ratio at 12 weeks	37.9	36.8 to 39.1	57.1	56.0 to 58.3	68.3	67.3 to 69.4	76.8	75.8 to 77.8
Log ratio at 18 weeks	43.9	42.7 to 45.0	64.3	63.2 to 65.4	76.0	75.0 to 77.0	84.6	83.8 to 85.5
FOLFOX v IROX
PFS	33.8	32.7 to 34.9	48.4	47.2 to 49.6	58.3	57.1 to 59.4	66.6	65.5 to 67.7
TTG	41.7	40.6 to 42.9	59.6	58.5 to 60.7	72.4	71.4 to 73.5	81.7	80.8 to 82.6
Log ratio at 6 weeks	39.5	38.3 to 40.6	57.0	55.9 to 58.2	69.1	68.1 to 70.2	78.1	77.2 to 79.1
Log ratio at 12 weeks	39.6	38.5 to 40.8	56.8	55.7 to 58.0	68.1	67.0 to 69.1	77.6	76.6 to 78.5
Log ratio at 18 weeks	41.6	40.5 to 42.8	59.3	58.1 to 60.4	72.1	71.1 to 73.1	80.3	79.4 to 81.2
FOLFOX v FOLFOX†
PFS	9.8	9.1 to 10.5	10.2	9.5 to 10.9	10.3	9.6 to 11.0	10.8	10.1 to 11.5
TTG	9.9	9.2 to 10.6	10.0	9.3 to 10.7	10.3	9.6 to 11.0	9.2	8.5 to 9.9
Log ratio at 6 weeks	9.3	8.6 to 10.0	11.1	10.4 to 11.9	10.0	9.3 to 10.7	10.1	9.4 to 10.8
Log ratio at 12 weeks	10.0	9.3 to 10.7	11.0	10.3 to 11.8	10.2	9.5 to 10.9	9.7	9.1 to 10.4
Log ratio at 18 weeks	10.2	9.5 to 11.0	10.5	9.8 to 11.2	10.4	9.7 to 11.1	9.6	9.0 to 10.3

Abbreviations: FOLFOX, infusional fluorouracil, leucovorin, and oxaliplatin; IFL, irinotecan and bolus fluorouracil plus leucovorin; IROX, irinotecan plus oxaliplatin; PFS, progression-free survival; TTG, time to tumor growth.

^*Of 5,000 replicates.

^†Null hypothesis.