Table 2.

Clinical and radiological features before and during therapy

	Overall	After 2 cycles of sunitinib	After 3 cycles of sunitinib	Intermediate-risk disease	Poor-risk disease
n	52	19	33	35	17
Overall response (RECIST) at the time of surgery, n (%)
PR	5 (10)	2 (11)	3 (9)	4 (11)	1 (6)
SD	33 (63)	13 (68)	20 (61)	23 (66)	10 (58)
PD	12 (23)	4 (21)	8 (24)	7 (20)	5 (29)
Not evaluablea	2 (4)	0 (0)	2 (6)	1 (3)	1 (6)
Response of renal tumour (RECIST) at the time of surgery, n (%)
PR	3 (4)	1 (5)	2 (6)	3 (9)	0 (0)
SD	46 (94)	16 (95)	30 (90)	30 (88)	16 (94)
PD	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Not evaluable	3 (2)	1 (0)	2 (3)	2 (3)	1 (6)
Median shrinkage of primary tumour (%)	12 % (+ 8 to −35)	11% (+ 1 to −28)	12% (+ 6 to −35)	13% (+ 8 to −35)	10% (+6 to−28)
Response in metastatic sites (RECIST), n (%)
PR	14 (27)	5 (26)	9 (28)	9 (23)	5 (29)
SD	21 (40)	10 (53)	11 (33)	16 (20)	5 (29)
Tumor growth/PD	12 (22)	4 (21)	8 (24)	7 (20)	5 (29)
Not evaluableb	5 (11)	0 (0)	5 (15)	3 (9)	2 (12)
Median progression-free survival (months) with 95% CIs	8 months (6–15)	7 months (5–19)	8 months (6–15)	10 months (6–NA)	7 months (6–NA)
Cause of death, n (%)
Total	22 (46)	8 (41)	14 (42)	12 (34)	10 (58)
Renal cancer	18 (34)	7 (36)	11 (33)	9 (26)	9 (52)
Surgery related	1 (2)	0 (0)	1 (3)	1 (3)	0 (0)
Otherc	3 (6)	1 (5)	2 (6)	2 (6)	1 (6)

^aStopped sunitinib and non-cancer-related death before assessment.

^bPatients with bone only as a site of metastatic were not evaluable in terms of size of tumour reduction (n = 3). These data also include two non-assessable patients (infection death and changed therapy).

CI, confidence interval; NA, not achieved; PD, progression of disease; PR, partial response; SD, stable disease.

^cEuthanasia/suicide (two) and infection.