Table 3.

Impact of Tumor Response on OS and PFS. Tumor shrinkage categories are shown for each treatment cohort of patients.

		OS			PFS
	n	Median (months)	P-Value	HR (95% CI)	Median (months)	P-Value	HR (95% CI)
Overall Cohort
−100% to <−60%	283	54.5	<0.001	0.27 (0.20–0.35)	17.3	<0.001	0.35 (0.29–0.43)
−60% to <−30%	547	26.4	<0.001	0.70 (0.59–0.83)	10.8	<0.001	0.65 (0.56–0.74)
−30% to <0%	1155	16.6	Reference	Reference	6.5	Reference	Reference
0% to <+20%	390	10.4	<0.001	1.62 (1.38–1.89)	2.5	<0.001	2.65 (2.29–3.07)
≥+20%	156	7.3	<0.001	1.92 (1.54–2.39)	1.4	<0.001	11.78 (9.48–14.63)
No Post-Baseline Imaging	218	2.0	<0.001	4.37 (3.61–5.29)	1.1	<0.001	4.89 (3.99–5.99)
Line of Therapy
First-Line
−100% to <−60%	208	NR	<0.001	0.28 (0.20–0.40)	16.7	<0.001	0.38 (0.30–0.47)
−60% to <−30%	336	25.5	<0.001	0.70 (0.58–0.86)	11.1	<0.001	0.62 (0.52–0.74)
−30% to <0%	708	14.9	Reference	Reference	5.5	Reference	Reference
0% to <+20%	247	10.4	<0.001	1.48 (1.22–1.79)	2.3	<0.001	2.55 (2.12–3.07)
≥+20%	101	6.2	<0.001	1.96 (1.52–2.54)	1.4	<0.001	9.39 (7.18–12.19)
No Post-Baseline Imaging	159	1.8	<0.001	4.61 (3.68–5.78)	1.0	<0.001	4.96 (3.94–6.26)
Second-Line
−100% to <−60%	75	48.1	<0.001	0.21 (0.12–0.36)	19.1	<0.001	0.24 (0.17–0.36)
−60% to <−30%	211	30.1	0.012	0.67 (0.49–0.91)	10.2	<0.001	0.66 (0.53–0.83)
−30% to <0%	447	18.9	Reference	Reference	7.9	Reference	Reference
0% to <+20%	143	10.4	<0.001	1.90 (1.43–2.53)	2.9	<0.001	3.04 (2.38–3.89)
≥+20%	55	9.9	0.008	1.81 (1.17–2.81)	1.4	<0.001	19.00 (13.02–27.71)
No Post-Baseline Imaging	59	3.2	<0.001	3.453 (2.36–5.05)	1.3	<0.001	4.82 (2.97–7.82)
Type of Therapy
Axitinib, sorafenib, or sunitinib
−100% to <−60%	221	54.5	<0.001	0.20 (0.14–0.28)	17.7	<0.001	0.32 (0.26–0.41)
−60% to <−30%	446	26.8	<0.001	0.61 (0.49–0.76)	11.2	<0.001	0.62 (0.52–0.73)
−30% to <0%	737	18.0	Reference	Reference	7.8	Reference	Reference
0% to <+20%	196	10.4	<0.001	1.84 (1.45–2.34)	2.9	<0.001	2.73 (2.20–3.38)
≥+20%	76	9.2	<0.001	1.92 (1.33–2.77)	1.4	<0.001	18.60 (13.42–25.80)
No Post-Baseline Imaging	97	3.2	<0.001	3.09 (2.22–4.28)	1.1	<0.001	4.04 (2.71–6.02)
Temsirolimusa
−100% to <−60%	19	28.4	0.010	0.39 (0.19–0.79)	9.2	0.017	0.51 (0.29–0.89)
−60% to <−30%	55	16.3	0.2	0.79 (0.54–1.15)	7.4	0.1	0.76 (0.55–1.06)
−30% to <0%	202	10.9	Reference	Reference	5.5	Reference	Reference
0% to <+20%	60	6.1	<0.001	1.91 (1.35–2.71)	1.9	<0.001	2.57 (1.80–3.66)
≥+20%	23	5.1	<0.001	2.72 (1.61–4.61)	1.7	<0.001	8.81 (5.08–15.26)
No Post-Baseline Imaging	57	1.6	<0.001	8.21 (5.61–12.01)	1.1	<0.001	7.73 (5.33–11.23)
IFN-α
−100% to <−60%	43	NR	<0.001	0.27 (0.14–0.50)	18.8	<0.001	0.22 (0.18–0.44)
−60% to <−30%	46	27.4	0.002	0.48 (0.30–0.78)	10.9	0.002	0.54 (0.37–0.80)
−30% to <0%	216	18.0	Reference	Reference	5.3	Reference	Reference
0% to <+20%	134	13.0	0.074	1.29 (0.98–1.71)	2.4	<0.001	2.22 (1.70–2.90)
≥+20%	57	6.6	0.006	1.63 (1.15–2.30)	1.4	<0.001	6.42 (4.42–9.33)
No Post-Baseline Imaging	64	2.1	<0.001	3.62 (2.56–5.12)	0.9	<0.001	3.60 (2.51–5.16)
ECOG Performance Status
ECOG 0
−100% to <−60%	169	NR	<0.001	0.21 (0.14–0.34)	19.0	<0.001	0.31 (0.24–0.40)
−60% to <−30%	319	32.2	0.019	0.73 (0.56–0.95)	11.0	<0.001	0.64 (0.53–0.78)
−30% to <0%	537	24.9	Reference	Reference	7.9	Reference	Reference
0% to <+20%	153	19.4	0.008	1.48 (1.11–1.99)	3.7	<0.001	3.14 (2.46–4.01)
≥+20%	63	12.6	0.006	1.74 (1.17–2.59)	1.3	<0.001	30.23 (20.31–45.02)
No Post-Baseline Imaging	41	32.0	0.028	1.97 (1.17–2.59)	1.9	0.2	1.58 (0.82–3.06)
ECOG 1
−100% to <−60%	106	41.7	<0.001	0.29 (0.20–0.42)	13.9	<0.001	0.38 (0.29–0.51)
−60% to <−30%	222	20.3	<0.001	0.65 (0.52–0.81)	10.7	<0.001	0.63 (0.52–0.77)
−30% to <0%	594	11.8	Reference	Reference	5.5	Reference	Reference
0% to <+20%	223	7.9	<0.001	1.65 (1.36–2.00)	2.2	<0.001	2.48 (2.05–2.99)
≥+20%	91	5.8	<0.001	2.03 (1.55–2.67)	1.5	<0.001	8.70 (6.62–11.45)
No Post-Baseline Imaging	151	2.0	<0.001	4.51 (3.60–5.64)	1.1	<0.001	4.92 (3.85–6.28)

^aIncludes regimens containing IFN and temsirolimus combination.

CI = confidence interval, ECOG = Eastern Cooperative Oncology Group, HR = hazard ratio, IFN-α = interferon alpha, NR = not reached, OS = overall survival, PFS = progression-free survival.