Table 1 –
S-TRAC selected baseline characteristics and summary of study outcome
| Sunitinib | Placebo | |
|---|---|---|
| Patients assigned for treatment/treated (n) | 309/306 | 306/304 |
| Median age, yr (interquartile range) | 57 (49–64) | 58 (51–66) |
| Male/female (%) | 72/28 | 75/25 |
| ECOG PS, n (%) | ||
| 0 | 228 (74) | 220 (72) |
| 1 | 79 (26) | 84 (28) |
| ≥2 | 1 (0.3) | 0 |
| UCLA integrated staging system, n (%) | ||
| T3 low a | 115 (37) | 112 (37) |
| T3 high b | 165 (53) | 166 (54) |
| T4 or any T/N+ c | 29 (9.4) | 28 (9.2) |
| Patients who completed full 1-yr treatment, n (%) | 170 (56) | 211 (69) |
| Median treatment duration, mo (interquartile range) | 12.4 (6.0–12.5) | 12.4 (9.2–12.5) |
| Median daily dose, mg (interquartile range) | 45.9 (38.4–50) | 50 (49–50.2) |
| Median DFS, yr (95% CI) d | 6.8 (5.8–NR) | 5.6 (3.8–6.6) |
| DFS hazard ratio (95% CI) for sunitinib vs placebo d | 0.76 (0.59–0.98) |
CI = confidence interval; DFS = disease-free survival; ECOG PS = Eastern Cooperative Oncology Group performance status; NR = not reached; UCLA = University of California Los Angeles.
a
T3, no or undetermined nodal involvement, no metastasis, any Fuhrman grade, ECOG PS 0 or Fuhrman grade 1, ECOG PS 1.
b
T3, no or undetermined nodal involvement, no metastasis, Fuhrman grade ≥2, ECOG PS ≥1.
c
T4 or any T with nodal involvement, no metastasis, any Fuhrman grade, any ECOG PS.
d
According to blinded independent central review.