67 148
undetermined nodal involvement, Fuhrman grade 2, and
ECOG PS 1; or T4 and/or nodal involvement) and those
with Fuhrman grade 3/4. The updated OS data are not
mature enough to draw reliable conclusions regarding the
impact of adjuvant sunitinib treatment on OS; however, no
detrimental effect on OS was observed for sunitinib
treatment.
Author contributions:
Robert J. Motzer had full access to all the data in
the study and takes responsibility for the integrity of the data and the
accuracy of the data analysis.
Study concept and design:
Motzer, Ravaud, Lechuga, Serfass.
Acquisition of data:
Motzer, Ravaud, Patard, Pandha, George, Patel, Chang,
Escudier, Donskov, Magheli, Carteni, Laguerre, Tomczak, Breza, Pantuck,
Staehler.
Analysis and interpretation of data:
All authors.
Drafting of the manuscript:
All authors.
Critical revision of the manuscript for important intellectual content:
All
authors.
Statistical analysis:
Lin, Casey.
Obtaining funding:
Serfass.
Administrative, technical, or material support:
Serfass, Lechuga, Gerletti.
Supervision:
Serfass, Lechuga, Gerletti.
Other:
None.
Financial disclosures:
Robert J. Motzer certi
fi
es that all con
fl
icts of
interest, including speci
fi
c
fi
nancial interests and relationships and
af
fi
liations relevant to the subject matter or materials discussed in the
manuscript (eg, employment/af
fi
liation, grants or funding, consultan-
cies, honoraria, stock ownership or options, expert testimony, royalties,
or patents
fi
led, received, or pending), are the following: Robert J. Motzer
has received research funding and consultant fees from P
fi
zer. Alain
Ravaud is a member of advisory boards on renal cell carcinoma for P
fi
zer,
Novartis, GSK, Roche, and BMS; has received institutional support grants
from P
fi
zer and Novartis, and meetings expenses from P
fi
zer, Novartis,
BMS, AstraZeneca, and MSD. Jean-Jacques Patard has received consulting
fees from P
fi
zer and GSK. Daniel J. George has received honoraria
and consulting fees from Dendreon, Sano
fi
, Novartis, and Bayer;
consulting fees from Medivation, Merck, and Genentech; grants from
Table 3
–
Differences between the S-TRAC and ASSURE studies
Category and variable
ASSURE
[21]S-TRAC
[4]Study conduct
Study sites (
n
)
226
97
Patients treated with
sunitinib/placebo (
n
)
647/647
309/306
Regions
USA, Canada
Americas, Europe, Asia, Australia, Middle
East
Treatment arms (
n
)
3
2
Blinded independent
central review of scans
At baseline
No
Yes
At recurrence
No
Yes
Strati
fi
cation
1. Histology (CC vs NCC)
2. Surgery (laparoscopic vs open)
3. ECOG PS (0 vs 1)
4. Risk category
1. ECOG PS (
<
2 vs 2)
2. Risk category
3. Country
Patient characteristics
CC RCC (%)
79
>
99
NCC RCC (%)
21
a<
1
Risk groups included
T1b G3
–
4 and/or N+
bT3 and/or N+
cRCC stage I
–
II (%)
33
a0
Treatment
Completed the full 1-yr treatment (%)
49
56
Dose administered
Starting dose levels
2 (50 mg and 37.5 mg)
1 (50 mg)
Sunitinib starting dose of 50 mg/d (%)
70
d100
Minimum dose reduction allowed (mg)
25.0
37.5
Median number of cycles (
n
)
8
9
Median actual cumulative
sunitinib exposure, mg (IQR)
6800
(2600
–
9900)
9638
(5550
–
12200)
Safety
Discontinuations due
to AEs/refusal/other (%)
41
32
AEs (%)
G3
G4
G5
G3
G4
G5
Hypertension
17
<
1
0
8
0
0
Fatigue
17
1
0
4
<
1
0
Hand-foot skin reaction
15
0
0
15
1
0
Diarrhea
10
0
0
4
0
0
All AEs
57
5
1
48
12
0
AE = adverse events; CC = clear cell; ECOG PS = Eastern Cooperative Oncology Group performance status; G = grade; IQR = interquartile range; NCC = non
–
clear
cell; RCC = renal cell carcinoma.
a
In the sunitinib arm.
b
pT1b, G3
–
4, no or undetermined nodal involvement, no metastasis, or any T, any G, with local nodal involvement (fully resected), and no metastasis.
c
T3 or T4, no or undetermined nodal involvement, no metastasis, or any T stage with local nodal involvement; and for all patients, any Fuhrman grade and
any ECOG PS.
d
The remaining patients started at a reduced dose of 37.5 mg.
E U R O P E A N U R O L O GY 7 3 ( 2 0 18 ) 6 2
–
6 8
67